Home

HLA Fusion IVD User Manual v3_0_EN

1. DQA1 02 01 DOA1 02 01 96 18 105 33 0 1052 01 105 33 414 68 7778 55 105 33 3605 22 1660 79 105 33 486 46 10819 39 105 33 4147 56 15959 16 105 33 5546 33 5278 57 6197 67 4 Ojjj D Aaj DA a Aa Oe o v LABScreen PRA SA Raw data table Click on a header to sort the table by that category Note You can select a different formula from the Formula drop down list either baseline ratio scoring or raw data but if you do this you must also adjust the Min Value lowest value of a positive for the current sample based on the selected reaction threshold so it correlates with the new formula 2 Click on the Ml button located at the upper right corner of the table or the Close button to exit and to return to analysis Raw Data Report For easier navigation exporting and printing you can create a report containing the raw data information for the current sample HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 179 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 1 Once the Raw Data Table is displayed click the Report button on the bottom right portion of the Raw Data Table window to display a report of the raw data Displaying DSA Donor Specific Antigen Match Mismatch By clicking the M b
2. Lumines Min Exist i p p CITI eC CI CTI peer paz omororz sfasa ho N p2 eones NONE v patert DMI CER CI CU CREI A 4 01 Pas 710 2012 37 33 DO Pad lt NONE gt lt NONE gt Pater CC CE Pes ONES ONES el Pe set pas omororz afas po m pas nome aone fate zen Paz omorzor2 zfs ho N 7 aon faon iPatiert een Pae omona 30 30 ho N fpe aone NONE v patert z C E OACI IET TI ETE NS Pare wez Pato jormono xfa ho n Pan Ns ans lira f Highlight a Sample Row for Deletion 8 Press the Delete key on your keyboard to delete the sample and prevent it from being imported as part of the session 9 When session and sample information have been verified click the Import button The session is now displayed in Blue at the top of the Navigator tree V Auto Analysis If you selected the Auto Analysis check box the session was imported and analyzed when you clicked the Import button The session is now displayed in the Navigator as an Analyzed session HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 54 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual You can continue importing more Luminex files or you can click on a Session in the Navigator to start Batch Analysis Note Once a CSV file has been imported it no longer displays on the Luminex session import list unless you select the Include Imported CSV check box HLAF MAN
3. RSSOH2B1 002 00d NONE LAMBDA 0 00 button on the Fusion toolbar or click Analyze Data on Click to down load updated Reference Files To see which Reference File updates are available Click here to modify the LAB Type Global Settings Click these links to display Catalog Worksheet and Probe Primer documents The Reference file Updates function upper right corner does not work for NMDP or seroequivalent files HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 43 One Lambaa Inc Assign Patient Type to corresponding Patient ID Patient Donor Patient vi Patient Patient Patient Patient Patient Patient Patient Double click HLA Fusion Software Version 3 x x User Manual Sample Patient details Patient ID s to see the current patient list Date is highlighted in E qe Allows regional supplemental LABType toolbar Nomenclature settings do not etwoon an a button Session ID Catalog ID IMGT version match between HLA Fusion To combine Analyze Data Reports Data Sample Patient Info Profile Utilities Help CSV files for 4 42 Q q Ao analysis Current To list Combine CSV 1 Include Imported spate File Path 0L1 FUSJON data session LABType RSSOMICA_002 csv CSV files Catalog ID RSSOMICA_004_03 O MV Set emp
4. Ism12_Lot012 FowPRA The LABScreen Session Import window displays TIER Select to automatically analyze Date ll be denia bi if uminex aii session samples when CSV s esiona settings do not matc etween the current CSV file and Fusion The CSV file s Session I D al are imported Default location on Negative computer or nan A Serum NS network sm12_Lot012 Date 10 18 2012 values for e Path CAOLI FUSION data session Data Referee Files sm12_Lot012 beads Catalog ID Nomenclature ovantiplex Beads none IMGT version Click here F Set empty Patiert ID to Sample 7 Ato Analysis to sort by Luminex Min i i TT patient Click any of these headings or donor to sort in ascending or descending order Assign Patient Type Double click any Patient ID to asap aren di see the current patient list O a Patient ID 155 HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 1 Click the small folder icon at the top of the LABScreen CSV File Name list fLABScreen 4 Click folder icon to browse for CSV files Include Imported 103 c OLI Fusion datalgession CSV File Name Select a file from the list of previously imported CSV files or click the Folder Icon to browse to the location of LABScreen CSV f
5. Lab Code s Lab Code Description 010 SSO 020 SSP One Lambda Distributor B Bob Smith Contact Email BSmith onelambda com Note The Lab information will be printed on HLA Fusion reports FONE LAMBDA 000 HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 294 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Editing the Lab Profile Laboratory information displays on most reports and includes contact information for your lab This information is initially entered during installation and can be edited any time from the Lab Profile menu Fields marked with an asterisk are required 1 From the main menu select Profile gt Lab Profile 2 Edit lab profile information 3 Click Save to save changes and return to the main menu or click Cancel to return to the main menu without saving any changes Managing Lab Codes Lab codes are used on NMDP reports to identify contract labs Multiple lab codes may be entered and stored in HLA Fusion You can select the lab code you wish to use when creating an NMDP report Only the first three digits of a lab Code are used on NMDP reports lab code descriptions are not included on reports 1 From the main menu select Profile gt Lab Profile Add edit or delete Lab codes e Click Add Lab Code to add a new lab code Enter information into the new row e Highlight a lab code to be edited Click Edit Lab Code to edit the la
6. Probe Recognition Site Summary Click the OK button to dismiss the Recognition Site Summary e You can enter up to two alleles separated by space in the Allele Text Field 91 22 01 c 03 38 02 and press the Enter key on your keyboard e Or you can search alleles by double clicking the allele pair on the Possible Allele Pairs results list in Quadrant 4 Recognition Site Allele Pairs QC Rxn RecSite Local QC Patient Sample Results HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 85 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual All probes that are reactive to the selected allele s are colored e Allele 1 Magenta e Allele 2 Cyan Local QC Tab The Local QC tab displays a histogram of the reaction profile for the current bead against all samples this user has ever run for the same product same lot revision and over a specified date range ac xn Rec Site Local QC patient Sample Results One Lambda cut off line Sample GO265 Session R55014_006 Well Position G2 MormmalWalue 47 Local QC Tab Fach Green bar represents a QC sample and its height represents the normalized reaction value This will serve as a user created QC graph e Hover your cursor over any sample and the sample details are displayed e The graph is continually updated as you analyze the product over time e The cut off line represents the One Lambda defa
7. MS LCT_20120328150916_LCT Reanalyze with New Catalog Allows the session to by re analyzed using a new or updated catalog file 1 Rename the session 2 Click the drop down arrow in the New Catalog ID field and select a new catalog from the list 3 Click the Analysis button The session on which you right clicked is reanalyzed with the catalog file you just selected Reanalyze with a new catalog lala HLA Fusion Old Session ID LC T_20120330085145_LCT 604BC_031_1 Rename the new session to avoid duplicate session names New Catalog ID LCT 60ABC_031_00 bd DOES Y HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 237 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Sample Level Options The Related Records and Side By Side Analysis menu options are available if you right click on an active sample in the Navigator first activate the sample with a left click Related Records A related record is a record that is associated with the current sample by patient or sample ID Note This option is also available by using the Related Records toolbar button Ep e Select this menu option to load all records related to the current sample into the Sample drop down list Use the sample navigation arrows to display the analysis of each related record one by one e To go back to viewing the samples in the current sessions click the lt lt
8. e Togo back to the older allele format you can navigate to another sample and then return to this sample Save Assignments Note Make sure you ve made the assignments before you save Lab technicians and supervisors can save analysis results for further review and approval Saved samples are available for confirmation by a Lab Supervisor only e From the analysis window click the Save button located in the bottom right corner of the analysis window to save analysis results for all the specificities currently listed in the Final Assignments results box e The Save gt gt button does not assign results it simply saves the sample results and comments HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 110 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Note If comments are added the sample must be saved in order to also save the comments e After saving Fusion automatically moves to the next sample e For confirmation a Supervisor needs to access the sample for which you have saved the assignments You can return to the sample any time prior to confirmation e Ifyou need to make changes click the Reanalyze button and then the Save button again Confirm Assignments Lab Supervisors can confirm analysis results When they do samples are marked as Approved The Confirm button is colored Purple when you view a confirmed sample e From the analysis window click the Co
9. Allele Possible Allele Possible Allele Pair Assig More Tq Status 1 A2 2 B2 3 C2 4 D2 5 E2 6 F2 7 G2 8 H2 DQA1 DQB1 patienti 3951 78 2704 1 3047 68 2236 86 100 14 05 DQA1 0102 DQA1 03XX1 DQA1 010201 DQA1 030101 FALSE Batch Imported DQA1 D0B1 3406 66 2481 04 3255 3 1718 74 100 14 29 DQA1 0102 DQA1 0201 DQA1 010201 DQA1 0201 Confirmed DQA1 DQB1 patientt 3495 62 2291 87 3230 99 1950 26 1007 15 48 DQA1 0102 DQA1 03XX1 DQA1 010201 DQA1 030101 Saved DQA1 DQB1 Y 3688 2 2435 19 2963 37 2203 51 100 14 49 DQA1 01XX1 DQA1 0402 DQA1 010101 DGA1 040101 Saved DQA1 DQB1 2993 8 2448 42 3278 71 1877 01 100 11 54 DQB1 03XX1 DQB1 0501 DQA1 010101DQA1 0503 FP 071 Batch Imported DQA1 DQ81 3194 2 2606 06 3218 02 1928 06 1007 13 88 DOAT 01Xx1 DQA1 05 02 DQA1 010101 DQA1 050101 Saved DQA1 DQB1 Y 3290 39 2589 82 3543 2 1977 4 100 13 6 DQB1 02XX1 DQB1 0601 DQA1 0103 DQA1 050101 FP 071 FALSE Batch Impo DQA1 DQB1 Y 3016 05 2652 65 3012 27 1957 62 100 13 41 DQB1 03XX1 DQB1 0602 DQA1 010201DQA1 0503 FP 071 FALSE Batch impo ot NS ovat atotnta e Click the Preview button to review a report of the Summary Table before printing or sav ng Print Preview Screen G Print Preview 10 x File View Tools 4 0 mR a O 100 H E gt cose p j7 Modo gt 1 Op Use
10. Catalog Catalog Description Worksheet Click links LS1A01 001 00 LABScreen Single Antigen HLA Class Antibody Detection Test Lot LS1A01 001 WS to dis la LS1A01 002 00 LABScreen Single Antigen HLA Class Antibody Detection Test Lot LS1A01 002 WS pay catalog LS1A01 003 00 LABScreen Single Antigen HLA Class Antibody Detection Test Lot LS1AD1 003 WS worksheet probe primer LS1A01 004 00 LABScreen Single Antigen HLA Class Antibody Detection Test Lot LS1AD1 004 WS LS1A01 005 00 LABScreen Single Antigen HLA Class Antibody Detection Test Lot LS1AD1 005 WS TERE ans e e e aii The LABScreen Home page is displayed HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 154 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Note Open worksheets and probe primer sheets to verify the accuracy of revision numbers these documents do not contain a revision number in their filename Place a checkmark here to list previously imported CSV files Click the folder 020206 Ism11_1D380 icon to search 05_12_05 Ism12_10_ID60 tor Camie 061205_lsm12 110_1D64 Select a session from the CSV File Name list CSV session 062906 LSM12 Lot 12 Final QC Session files in the 20080110_LSM_14_ID655 files are default AntiB SuggestedAllele Pairs listed location DNA SuggestedAllelePairs here
11. Click to open the Catalog Manager A o00 0 000 0 Active Catalogs 12 Last Update Date 3 30 2012 Details Serology Equivalent 201 wary 3 30 2012 NMDP Update Reference file Updates 0 LABType Configuration Code NMDP V31 Edil Cross Code No Active Demographic Allele Frequency none AE Fades O Display Low Bead Count Low Positive control message No Bw4 Bw6 Information No Minimum Positive Control 1000 ee ee Minimum Bead Count 100 Save Force 1 Pairs No Minimum Bead Failure Threshold 10 Close Bead Reaction Threshold 3 LABType Product Documents Catalog E Catalog Description eme a Probe Primer RSSO2Q 004 05 January 2010 LABType SSO Class II DQA1 DQB1 Typin RSSO2Q 004 WS RSSO2Q 004 BPI RSSO2Q 005 02 January 2010 LABType SSO Class II DQ A1 DQB1 Typin RSSO2Q 005 WS RSSO2Q 005 BPI RSSOH1A 001 00 Jul 07 LABType SSO Class A Locus High Resol RSSOH1A 003 06 January 2010 LABType HD Class A Typing Test Lot 40 RSSOH1A 003 WS RSSOH1A 003 BPI RSSOH1B 001 00 Jul 07 LABType SSO Class B Locus High Definit RSSOH1B 004 04 January 2010 LABType HD Class B Locus Typing Test RSSQH1B 004 WS RSSOH1B 004 BPI RSSOHIC 001 04 January 2010 LABType HD Class C Locus Typing Test RSSOHI1C 001 WS RSSOHIC 001 BPI RSSOH1C 002 03 January 2010 LABType HD Class C Locus Typing Test RSSOH1C 002 WS rasotHte s02Br i
12. Patient Sample Results tab Quadrant 2 Bead Data There are three tabs in this quadrant which are explained in the following sections Bead Tab The Bead Tab Click to reset displays the The first bead Previous bead Next bead Last bead values to default histogram for the Bead Pee Bead infi currently selected bead Each bar 100 represents a sample 30 The bar height represents the normalized reaction i value for the selected ma bead in that sample 50 The Red bar m represents the currently selected sample 10 Cut off bar The Bead Tab Current sample HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 87 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Double click on a bar to navigate to the analysis of that selected sample You can click the arrow buttons to select a Bead Bar and display the selected bead in Quadrant 2 Alternatively you can also select the bead from the Bead Navigator at the top e X axis Samples sorted in order of reactivity weakest to strongest e Y axis Normalized value positive e Data points Bars represent the normalized value of a sample for the current bead e The Bar Colors All bars are Green except the current sample which is Red e A white bar indicates samples with a low PC positive control e Cut off line The cut off line is located at the cut off value for the current bead values above this
13. SESSION LEVEL OPTIONS or A did 112 Create AA E O A renee eR aor nen eer renner 112 SESSION INC VIEW A a A o cece a A 113 REONGIVZE WIERD INEW NOMICNGIGEUNC nda ti 114 SAMPLE EVE OPTIONS AA thaw aed A 114 Redl ed RE COMAS o Tees 115 SAO DESEAS a A cae 115 Te FUSION Exp ONE ii 116 MICRO SSP ANAL SIS ora A A a aa 118 START ao A O 119 CONFIGURE MICRO SSP DATA ANALYSIS unico a a dd dia 123 E e ERA 123 BWA BWO IN SETOV ra EE cita ION AIR ION E ai iaa 124 Dem gr phic INformations E A rd 124 USING THE MICRO SSP ANALYSIS WINDOW ninia canicas A E E 125 TSE CHEM a eet PESA A a AE O PA cued E EIA aus anid TSE ET O A E E A A at A A E A 126 WICW VV CH DETOU aio 128 Working WILT GOI TMOGES ue nd caendan a es 128 Ada SAMPES Sawa Rrere Reet Cer R eRe En orc EEE T CcERer er en ert terete ax 130 PX ROOCHION TA e PORO PO PEO A told eels secs Pr II A annua 132 NUMIDEF OF Allowable False Reactions A da 134 FOFCSONE FOIS Caca thr prt ee rer tre Mor Merce eee enn a eee renee PVR eee nme ea rtd tada 134 MICRO SSP COMBINED ANALYSIS os 135 MAKE TYPING ASSIGNMENTS IN MICRO SSP ANALYSIS cccscssccecccsccsccsccesccsccnccescnssceccescesscescescsscescescesscescessessonsoesees 137 ASSIOM ON AIICIESPGIF TIONING suggested Std los 138 MOD TADA AA AAA GUE ANA E OAs 138 Manual Anele Par Assignment rsisi ia E E bas 139 POSSIDICAILCIC COMES a O OS 139 Aele Coue ASSIGHINICIE sti A A PI ae ee 140 Manual ANCE COSAS SIAM AS A NAAA RS 140 Unknown Allele CodeS a
14. Test Date C Catalog C Session Date Navigator Tree Fa LABT ype hm O406W0RKSHOP_DRB345_ ES 0406workshop_DRAB1_lot 10_ Bay 0406workshop_dqb1_lot 6_ID Pe wk b1_lot2_ Usingthe Navigator tree you can easily move between E lic oe es bio analysis products sessions samples and test dates 0406workshop_C_lot 6_1040 om O407wkshp_msob1_ cl 10104 3 Micros SP ee Micro SSP_20110927130414 BS Micro SSP_20110927125212 LAB Screen RE 0405_LSM12 003_ID172_itali Ss 06 28 05 John Hopkins L52_ ee 0407L514004_001_1D328 AS 020206_Ism11_1D 380 ee 02131_LSM12_011_01_ID32 Note Double click on a session or click the sign to the left of the Catalog Date or Product module to display the list of sessions Podat Test Date i CO Catalog C SeronDate E ree D40Eworkshop_4 Lot 7_ID40 i 040309 DOG 004 12 18 200 Sessions HLA Fusion in the Na 4 Products l E 0407wksp_A5502345_005_1 vigator eS O405workshep_DRB1_lot 10_ a gt O406workshop Clot 6_ 10404 Click a sample name to display it in the analysis window HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Results Grouping The sessions and samples displayed though the Navigator tool can be sorted by various criteria e Product type e Session Date e Catalog e Test Date The default is to group by Product See the next few sections for
15. xls spreadsheet on your computer or on the network the default location isc OLI FUSION data report The Print and Preview buttons displayed here provide functionality similar to other HLA Fusion programs HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use HLA Fusion Software Version 3 x x User Manual 160 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Using the LABScreen Mixed Analysis Window For each LABScreen Mixed sample in the current session you can view the test data adjust cutoffs assign screening results and more o Review data and make overall assignments Circle antigens in the specificity table View molecular specificities o View Class I Class II and MIC screening results e Adjust cutoffs e Review a raw data table for all beads in the sample o Overlay the negative serum sample on the current sample o Add comments mark the sample for more testing and view a sample analysis report o Save and confirm results The LABScreen Mixed Analysis Screen Find multiple antigens by listing each one separated by a space Analysis tools Antigen search Ne F FT OMA Use K wa ind Ag Default Graph ii 103 144 O 3 O o oo o ms mi 78 ae x Re 2D 0 i0 G DD 0D as 0D 0D oF a DR TE e e a a a Ze FSG ERA BE Sraka EZIN SSRN ns 28 8 b DR 2 aa A S88 Bsesgss Specificities a meee a AR e UA
16. 1 12 0287 7867 8 AB DR 14AB 21DR 074 SDF Format Fach field is separated by commas This file lists in this order BoxSlot DonarID SampleType AB DR or AB DR TurnaroundTime 14 21 or 14AB 21DR DonarCenter Example line 1120287 7867 8AB DR14 21074 Local Sample Patient ID Only This file is a Microsoft Excel file This file lists in this order Row 1 Column Title Local and Sample and Patient Column A LocalID Column B SampleIDName required Column C PatientIDName Column D Date Example A B LocalID Sample PatientID Date 1 20449 0235 14B DR14 8 10 1957 1 40449 0239 3AB DR14 5 12 1958 1 50449 0236 9AB DR14 12 1 1960 1 gt 3 1 30449 0238 54B DR14 2 10 1942 A 3 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 267 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Viewing and Editing Sample Information Sample information can be edited but associated patient IDs cannot only new patient IDs can be added 1 From the Main Menu select Sample gt Manage Sample Info Use Filter to Search for Sample Information Search Criteria Sample ID Category Local Bsc Sample List TurnAround Date Range Location X I 7 19 2012 I 3 13 2013 y y Category Turnaround Location Patient ID Sample may appear multiple times if it is associated with different sample list group Manage S
17. 1 2 7 CL II ve 1 5 o MIC ve 1 2 1 2 CL II ve 1 2 NC Threshold MIC 50 50 CREG Bar Ga a a ca all la Cal O ld PT ysis Results E Results Final Assignment Spec re re mm A a Making Assignments The Final Assignment radio buttons display the Fusion suggested assignment To accept the assignment as displayed save or confirm the sample To modify the suggested assignment do the following e From the analysis window select an assignment for each class using the Final Assignment options Positive Negative or Undetermined Class Class Il MIC E ELE Computer Assignment Positive Computer Assignment Negative ae eee Positive Final Assignment Positive Negative Negative C Undetermined Undetermined HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Saving Assignments Lab technicians and supervisors can save analysis results for further review and approval Saved samples are available for confirmation only by a lab supervisor e From the analysis window click the Save button located at the bottom right corner of the analysis wndow to save analysis results for all the specificities currently listed in the Final Assignments field After clicking the Save button Fusion automatically moves you to the next sample For confirmation a supervisor needs to access the sample for which you saved
18. 9 5C Blslelsla EE E E mente An Do the following if you want to use a different CREG table e Click the LABScreen home page button or select Utilities gt Antibody Product Configuration gt Set Analysis Configuration os EPITOPE e From the Home page click the Edit link to display the Analysis Configuration Settings menu e Select a table from the CREG drop down list e Click the Save button at the bottom of the menu Note For information on creating or editing a CREG list review the section Managing CREG List Information Find Antigen To enter multiple antigens use a space to separate each entry All entered antigens are circled in the specificity field Clicking on the labels for Tail Analysis Results Epitope Analysis Results or Final Assignment fields circles all specificities listed in the selected results field Clicking the Excluded Antigen field label circles the excluded antigens If you use the Find Antigen feature while the window is displaying molecular specificities you are not able to see the circled antigens until you deselect the DNA check box HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 173 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 1 From the analysis window type antigens or CREG groups e g 1C or 2C into the field next to the Find Ag Antigen button 2 Click the Find Ag nia button and Fusion will circle
19. Bw B Bw6 B Blank Bw B41 Bw6 IB 08 01 01 5140 88 B 41 10 41 11 40 88 41 10 41 11 40 88 41 10 41 11 40 88 41 10 41 11 B 08 01 B 08 01 B 08 01 B 038 01 B 08 01 B 08 01 B 03 01 B 08 01 B 03 01 B 08 01 B 08 01 01 01 01 01 01 02 01 02 01 02 01 03 01 03 01 03 01 04 01 04 01 04 Pars Force Type SubType Match Seo 72 One Lambaa Inc Demographic Information The Demographic Information option allows you to organize alleles according to their frequency Based on the demographic selection you make HLA Fusion displays as many as three allele groups in the allele pairs list e Group 1 Frequent on both alleles e Group 2 Frequent on one or the other of the alleles only e Group 3 Frequent on neither allele Demographic Configuration Option NMDP Code No Code Local Code P Grouping G Grouping Cross Code Bw4 Bw6 in Serology Demographic Information gt Minimum Positive Control 3 Common Jan 2012 v2 Minimum Bead Count gt Set Sure Reaction Bead view QC Low Positive Threshold Note HLA Fusion Software Version 3 x x User Manual Demographic Frequency Pais Force Haplo Match Sero Local Demographic Data Caucasian A A 01010101 A 24020101 61 A 01010101 A 2443 G1 Group 2 frequent on one allele A 01010101 4 240203 G2 A 01010101 A 240205 G2 4 01010101 A 240206 G2 A 01010101 A 240210 G2 4A 010
20. Crossmatch Result Enforce ISBT format for PatientyMgnor ID uc Oy State Province Country Postal Code Region Phone Patient Donor Info Patient or Donor ID 29817 Patient Donor Flag CA USA 92357 NNW 714 298 1045 714 298 1045 714 298 1045 714 298 1045 Ir aol com KB Homes 203 z Patient Leopoldo Ramos LEO Leopoldo 11 29 1949 Male Female 9 Human Animal 102 00 1322 hispanic 78 Joshua Street Tissue After selecting a patient or Fullerton Special IA EI Louisa Donor ID wath patient Comments Louisa N Manage Donor Relation Code Table TER256 Sister 38559 Brother 714 298 1045 View or add patient donor relation codes donor place a check mark here to edit the information po ca uee Te irae Cr fields W NONE LAMBDA 0 00 d Tools to manage patient and donor information Converts assigned allele code and pairs to the new nomenclature format and stores this information in the Fusion database 278 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Enter an ID in the Patient Donor field The ID can be alphanumeric contain letters and or number or click Search and select a patient donor from the list Enter patient donor information Fields with an aster
21. Select New Product HLA Fusion Old Session ID New Session ID New Catalog ID HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x ae 021302 L5M14 hna lot g_10639 as 042805LSM12_010_ID534 RS 20080117_SAG _LOT4_ID53 t LS1A01_001_G1_G _Test1 ES 022708 CD HD A_ID1530 ae 022708 CD HD A_ID1530_HD am 022708 CD HD A_ID1530_HD 20080117 PRA_LOT11_ID50 20080117 PRA_LOT11_ID50 LS1PRA NC7_010_02 LSIPRANC _010_02 LS1PRANC10_013_06 LS1PRANC1O_014_04 LSTPRANC10_015_01 LS1PRANC11_013_06 LSIPRANCI1 014 04 LS1PRANC11 015 01 LSTPRANC12_ 014 04 LSIPRANCT 015_01 LSIPRANC6 012 03 LS1PRANC7_011_02 LSIPRANC Y 012 03 LSIPRANC7_013_05 LSTPRANCS_011_03 Reanalyze with New Settings Catalog Allows the session to be reanalyzed using new settings or an updated catalog Here s how 1 Click the drop down arrow in the New Catalog ID field and select a new catalog LSIPRANCES 012 03 LSIPRANCS 013 05 from the list i L51 PRANCS 014 02 pe 2 Rename the session Sessions must have LSIPRANCS 014 02 unique names f L52A07NC10_007_08 L52401NC10_008_08 S2ADINC11 007 08 i 3 Click the Analysis button The ie oe session on which you right clicked is e reanalyzed with the catalog you ve LS2A01NC7_007_08 po f selected LS2A01NC8_D07 08 L52401NC11 _009_05 For In Vitro Diagnostic Use 188 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Sample Level Options There are two menu
22. 1F 2A 2F etc e Where the product has a blank well the corresponding reaction button is disabled e Sample list entry for the tray is listed along the side of the panel You must enter a sample ID before the reaction can be saved to the database The session does not require that all wells of the tray be used e Once you analyze a tray you can no longer add any more sample information to that tray HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 201 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Using the ELISA Reader To read analysis data directly from the Biotek ELX 800 ELISA reader the computer on which you are running HLA Fusion must be connected to the ELISA reader Connect and calibrate the ELISA reader according to product specifications HLA Fusion can analyze only 96 well Terasaki trays ELISA reads the trays and transfers the raw data to HLA Fusion e From the analysis window click Read From to import data from the ELISA reader Note The Read From button is displayed only when your computer is connected to the ELISA reader and you have not yet entered any manual reactions for the current test LAT Mixed Histogram This histogram displays the reaction value for each well position of the current tray in a session It also displays the average negative control wells for the test group as a narrow light green bar superimposed on each reaction well bar
23. Change Normalization Formula By default LABScreen analysis uses the Baseline normalization formula You can change the normalization formula used in analysis to any of the following Ratio Scoring Mixed and Raw Data When using the Raw Data normalization formula the sample negative control is shown as a black line on the Bead reactivity graph Changes apply only to the current sample From the analysis window select a new normalization formula from the Formula drop down list The sample is re analyzed Normalization Formula Selection Miced Formula Ratio Scoring CutOf Baseline User CutOf Raw Data User CutOff Ratio Exclude Antigen s from Analysis All antigens entered are excluded from analysis To enter multiple antigens use a comma to separate antigen entries 1 From the analysis window click the Excl Ag button The Exclude Antigen pop up box is displayed HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 176 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Y 4 a ll Se camay LS Sample18 2 Typethe antigens to be excluded and click the OK button If you change your mind and click the Clear button your entries will osos nit be ncuded be deleted and you ll see this message EA The sample is re analyzed and the excluded antigens are listed in the Excluded Antigens field under the analysis statistics box ZG 62 749 78 7495
24. DPB1 13 01 137 58 f DPA1 02 01 DPB1 15 01 6891 33 A 4 DPA1 02 01 DPB1 18 01 2 Click on a column header i e Baseline to sort the table by that criteria 3 Click the Close X button located at the upper right corner of the screen to close the Raw Data Table window and return to analysis Raw Data Report For easier navigation exporting and printing you can create a report containing raw data information for the current sample 1 Once the Raw Data Table is displayed click the Report button in the bottom right portion of the Raw Data Table window to display a report of the raw data You may also use the Print Screen button to export data HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 166 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Statistics Table This section of the LABScreen Mixed analysis window is in the lower left corner of the window and displays statistics for each type of screening results The values shown vary according to the screening results tab that is active LABScreen Mixed Statistics tables Class 1 amp 11 Mic Class lAl Mic Statistics PC 002 2090 3 Pc 002 2030 9 NC 001 4 02 NC 001 4 02 LEE SA Ee PC NC 520 13 NC Threshold CL1 50 50 HC Threshold L27 50 50 Cut off Default Cut off Default Current CL I 1 5 ee E CL I ve we 1 5 5
25. Edit s ft l Bw4 Bw6 Information T Computer Assigned Serology Min Positive Control Min Bead Count Min Bead Failure Threshold Close Bead Rxn Threshold I Display Popup message for Low Bead Count Low Positive Control T Allow Auto Accept All T Save Force 1 Pairs ONE LAMEDA MORE LAMEDA e LABType and Micro SSP Configuration settings HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 312 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 3 Change configuration values as needed e Save Force 1 Pairs stores force 1 pairs in the database during analysis The force 1 pairs are also displayed in reports that contain this information e Allow Auto Accept All can only be selected by someone with Supervisor user privileges and allows you to select a button on LABType session summary to accept the batch analysis results for all samples e Computer Assigned Serology can only be selected by someone with Supervisor user privileges and automatically populates LABType and Micro SSP analysis serology assignment fields as well as stores results in the database If this is selected a warning message displays as a reminder that the assignments are estimates and should not be accepted without verification Serology auto assignment warning HLA Fusion This option enables auto assignment of Serology which is a suggested assi
26. Ene SEA dE LA 2012070074387 JA i L Zl WU ade L HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 197 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual You can select a session from the Fusion Navigator to view its summary then select a sample from the session summary to view its analysis Or you can continue importing samples from the Import Sample list 5 Inthe Navigator click on a Session Name The Session Summary Table is displayed Donor PRA Fields Summary Report Session LATMIXEDTest01142012 Catalog LATM10X5_009_02 Session Date 10 10 2012 Number of Samples 10 E Class Class Il MIC A Es E lo E 0 E 0 E 0 E 0 E 0 E 0 NON 0 E 0 F T E Auto Accept All Click to allow auto acceptance of as signments and results both tail and epitope upon import LAT Mixed only e Double click a sample in the Summary Table to go directly to the analysis screen for this sample e Scroll left or right to display all of the Summary Table fields e Click on the Field Chooser button to the left of the table headings In this window you can select or clear the check boxes next to column headings to include or exclude those columns from the Summary Table Selecting or clearing check boxes in this wndow instantly updates the table
27. LSTA03NC6_006 LS NC 6 1 LS1A03NC6_007 LS NC 6 1 LS1A04_001 LS NC 6 1 ILSIPRA_010 LS NC6 1 LS2A01 NC6_004 LS NC 6 1 PRA 01 NU Visi Sissi Sisiis PS WO EA 3 Click the browse button to locate and select NS files 4 Click Import NS File When an NS file is successfully imported it is listed in Existing NS Files 9 Click Close to return to the Update Reference menu HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 317 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Choosing General Settings You can set a number of general system settings including printer defaults and URLs and Paths 1 Select Utilities gt General Settings from the HLA Fusion main menu The General Settings dialog box is displayed FEN Fusion Setup pos Y AL sS 7 i Lp Sh y AA E HLA Fusion 000000 General Seting Enable Audit Trail Logging F Enable Auto Download of Reference Files E Default PatientDonor Type Patient ELISA Reader Serial Port COM Auto Donor PRA Calculation 7 S ooo Stay Curent Sample After Save or Confirm F Secondary Ab m FV ONE LAMBDA 000 Fusion General Settings 2 Usethe drop down menus or select check boxes to make your selections on this dialog box 3 When you have made all of your selections click Save Printer Defaults From the Printer
28. Manual Assignments Manual assignments can be entered in the field below the Final Assignments results box Enter multiple manual assignments simultaneously by leaving a space between each specificity HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 182 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 1 From the analysis window type a manual antigen specificity assignment in the field under the Final Assignment box The Manual Assignment field 2 Click the Assign button A just above the Manual Assignment field or press the Enter es key to add the assignment to the Final Assignment results box Assigning Negative Sample Values You can assign a negative value to a sample even if analysis shows some positive results e From the analysis window click the Assign ve button located just above the Manual Assignment field to force the sample to have a negative value Removing Assignments Specificities can be removed from the Final Assignments results box You can remove more than one specificity by holding down the Ctrl key and clicking each specificity you want to remove e From the analysis window click to highlight specificities on the Final Assignment list hold down the Ctrl e key to select more than one and click the Remove button located below the Final Assignments results box Saving Assignments Lab Technicians and Supervisors can save analy
29. New packing list format This file gives the fields in this order Shipmentloc 1 13 SamplelDName 0198 0398 0 SampleType AB DR or AB DR TurnaroundTime 14 21 or 14AB 21DR DCN 3 digit Example line 1 13 0198 0398 0 AB DR 14AB 21DR 074 Pack list Old Standard X samples This file gives the fields in this order ShipmentLoc SampleIDName SampleType 1 2 3 and an X for AB DR samples DCN Example line L 12 028 7807 080 X 074 Old packing list format 11 for AB DR samples This file lists in this order ShipmentLoc SampleIDName SampleType 1 2 3 and an 11 for AB DR samples DCN Fxample line 1 15 0287 0779 2 11 074 Comma Delimited Format Fach field is separated by commas The use of quotes around a field is optional and is required only if the contents of the field use a comma which could confuse field separation This file lists in this order ShipmentLoc SampleIDName SampleType AB DR or AB DR TurnaroundTime 14 21 or 14AB 21DR DCN Example line in M12 0287 7867 8 AB DR 14AB 21DR 074 HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 266 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Tab Delimited Format Each field is separated by a tab This file lists in this order ShipmentLoc SampleIDName SampleType AB DR or AB DR TurnaroundTime 14 21 or 14AB 21DR DCN Example line
30. Note If you do not see a particular field available through the field chooser and you are sure it should be there go to C HLA Fusion temp and delete the file named x_x_x antigen type _ Layout xml e Click on any column header of the Summary Table to sort the table by that column The arrow in the column header indicates the sorting order up for ascending and down for descending Columns can also be dragged and dropped to change their order e The session summary table columns and order can be modified When you close the Field Chooser a pop up message displays to let you choose whether or not to save any changes you made If you click Yes your changes are saved for all future LAT session summaries on this same computer until further modifications are saved HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 198 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual e Click the Export button to save the Summary Table on your computer or the network default locations C OLI FUSION data report The file is saved in Excel xls format Summary Table exported as an Excel spreadsheet Ca i qu fo N LATMIXEDTest01142012a xls Compatibility Mode Microsoft Excel X C33 Home Insert Page Layout Formulas Data Review View Add Ins 0 x G D E F G H J K L M N o R E Patient Comment UserComment AnalysisDa AnalysisUse Class l Class ll MoreTest LocallD Con
31. Road Valencia Ci NUU US2 91355 kde lions net 662 234 1098 662 234 1098 662 234 1098 662 234 1098 Traveller s Insurance Kenneth 4 Kenneth 662 234 1095 221 Henry Mayo Hospital AB Tissue Paltiellrrrssrrrrsrrrrrsrrrrrrrararrrrarrasr pee CU CWO 0P4 36559 Human Prater Katie P Prater O01 78 1009 7 17 1949 F caucasoid 60 Prosper Road Irvine Ca NT US4 91120 pkatiebmen com 714 760 1987 714 760 1987 714 760 1987 7114 760 1957 General Moters Jerry AB Jerry 714 760 1967 103 Irvine General BONE MARROW Transplant B Marrow DONOr srrrrrrrrrrrrrrrrsrrrrrsrrrrrsrarcaararr pores PRIO DRIO p DOe DO 35720 Human Quinn Gayle OG Quinn 111 12 1212 5 25 1987 F black 120 Papa Road Anaheim CA nnu VSA 92017 gguinnimsn com 714 367 1022 714 367 1022 714 367 1022 714 367 1022 TY Mortgage Franklin 0 Franklin 714 367 1022 501 Anaheim Memorial Hospital BONE MARROW Transplant 46 BONE MARROW Patleltrrssrrrssrrrrrarrrriraaiaraaaaaraa gree DE pe ee 29817 Human Leopoldo Ramos LEO Leopoldo 102 00 1322 11 29 1949 hispanic 73 Joshua Street Fullerton C NNU US4 92357 lrdaol com 714 298 1045 714 295 1045 714 298 1045 714 296 1045 EB Homes Louisa 0 Louisa 714 25 1045 205 Fullerton Special Tissue O Tissue PACLenty peer errr eccrcceceererereree ere eee ee ep ALl A BIS BiG Cw DRO DRS3 DRSe DP17 38533 Human Riva
32. by default stored in C OLI Fusion data NMDPExport select Save in text file x To add the unknown code information to an Excel file xl by default stored inc OLI rr Gece SUE cde et Mex Fusion data expo rt NMDPE xpo rt select Save In SSP _20111222133904_SSPR 1 C04_002_07 csv Excel File or simply left click the mouse button a When you re done click the Lx button to remove the buttons from display Note The Rpt button retains the last selection you made direct text or Excel so it can be used as a shortcut unless you want to change your selection the next time you report XX code simply click the Rpt button The following shows examples of each result BIOINFORMATICS NMDP ORG NLA RESOURCES SEARCH STHATEGES PUBLICATIONS EDUCATION POLES Beene E A Shree Cocos DNA Type Lonag Tee Direct to ALA Resources NMDP HLA Fea ouroes DNA Type Lookup Tool Hapiosimtm Lipdal lo MHOF Allele coda nomema ES Hicrosont Ema aredp code report Hiro SOF 0110122133004 SSP ee 004 Der E Ele Edt View poeri Formal Toss Dota iio Eo Adee PF ea question frheo 2 et 1443341701404 40 08 z3 ao aio Ae Y A fe loci Allele Code Update to Y Hapistme Eregue trochana PGE Dianna Rara Adele Lists B Locus em j ede Codes gt A a nd erp i PA 8 OS 33404 35 04 37 04 36 04 ee 42 04 43 04 44 04 45 04 46 04 47 04 4604 Se Sa 5304 A
33. fi lename c FUSIONError log operatormai l customerinquiry onelambda com gt lt fexceptionmanagement gt lt appsettings gt lt add key connectionstring value Data Source 1ocal SQLXPRESS_2008 Initial Catalog FUSION_130_0616 Integrated security SSPI Connection Timeout 300 gt lt add key SMTPServer value gt lt add key SmMTPUser value qjha oli com gt lt add key Defaultmailinfo value xml gt lt add key Contact value Contact Name gt lt add key FusionGUIMode value Crescent gt lt Optional value Navigator gt lt RUO Version gt lt add key Productkey value gt lt add key ReportPath value C o ReportDes1gner lt add key UserDatabasemode value lt fappsettings gt lt confi guration gt e Please note that all the report files used in HLA Fusion are installed in the directory C OLI Fusion rpt and they all have the extension of rpt These files can be moved anywhere for central HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 247 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual access but to do so you must update OneLambda Fusion Interface exe file to reflect the new location see figure above e When you open a report to customize it a backup copy is automatically created with the timestamp as the suffix of the report name This allows you to retrieve the original report format if
34. gt gt Y Cutoff Summary Y NC and PC Values PRA or SA and Cutoffs by Region SSO Graph METI hacian I Test Values Rin Raw Normalized Count SFI Include Cutoff Summary I Sero Specificty Sort byf Fon 7 Iv Gel Image SSP only IV Include Chart lv Allele Specificity ASC DESC TORE LAMBDA Molecular Custom report setup screen Antibody Custom report setup screen The Custom Report Setup window is displayed allowing you to customize report content by selecting from various categories and fields Custom Molecular and Antibody Report Setup 1 Enter a name or select one from the drop down list 2 Select the check box next to each field you want to include in this report Note To include all related fields you can click the Check All button to select all the fields in the category 3 Click the Save button to save the custom report setup you have just selected HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 250 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Sample Summary The Sample Summary feature lists multiple samples and their typing results e Select samples using the Reports window e Click the Sample Summary button The Sample Summary window is displayed it contains two tabs Molecular and Antibody Sample Summary window di Sample Summar
35. la x Your own Comments 255 characters maximum Comments are only saved after you click the Save button Comments F ei Well 1G entered by gf HLA Fusion Note The larger User Comments field expands to allow for a maximum of 255 characters Flagging a Sample for Further Testing You can indicate the need for further testing of a sample by selecting the More Tests check box followed by clicking the Save gt gt button The More Tests indication is displayed in results data look up and reports for the sample e In the analysis window click the More Tests check box located below the Assignments area Printing the Current Analysis Window The Print Screen button prints the currently displayed analysis window e From the analysis window click the Print Screen button on the toolbar to print the Current analysis screen HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 145 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Preview or Print Reports To view a Micro SSP report for the current sample use the Preview Report and or Print Report button on the toolbar Reports Data Sample Patent into Profle Uti Patient Summary Patient Typing for Batch Patient Custom In the analysis window click the Preview Report button E or the Print Report button E to display a list of reports you can preview Sn aa i or print for the current sample The drop down
36. the system then considers the closest bead match between the session and all available catalogs If only one catalog is a close match it is automatically selected and you can go to 5 When session and sample information has been verified click the Details button If there is more than one match a catalog validation dialog box is displayed with the best bead matches You can confirm the selected catalog by clicking the Close button Or you can double click a catalog name on the list of Suggested Catalogs LABScreen Catalog Validation gt Catalog validation E HLA Fusion 00 Validation Results Bead mismatch exists Detail Disol Suggested Catalogs Double click to select and continue 2 jet ae me Catalog ID Nomenclature ETT a catalog files L52A01_0065_00 HLA Fusion a having the TS OLR 081 034 q same or greater number of SS A a A bead 13 018 005 matches NW VNSRELAMEDA 000 6 Following catalog validation the system may ask you if you would like to associate that template name with the catalog This means that in the future for any CSV files referencing this template the system automatically selects it you can select a different catalog for the CSV file though before you import it Note If you want to see the selected negative serum NS sample overlaid with the default NS for the current sample you must do so before you import the
37. 03 40 DRB1 03 41 DRB1 03 43 DRB1 03 44 DRB1 Bead Info Button Allele Specificities e You can also resize these graphs by placing your cursor in the area between the graphs until the cursor image changes to F Then you can click and drag the cursor to resize the graphs HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 65 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual e To scale the histograms on the QC Panel Graph enter a value in the Max Scale text box and press the Enter key on your keyboard This resets the upper Y axis value of the bead profile histogram for both the QC and the current session e Using the Bead Navigation buttons you can navigate between the beads e You can also select individual beads from the drop down list Bead drop down list e Check the Exclude Bead box to remove the current bead from the analysis session The excluded bead is listed in the comment field with a notation that the bead has been excluded In addition excluded beads are displayed on the graphs during analysis as bars e Adjustments made to probe cut off values in Bead Analysis affect all samples in this session Pre adjusting values to account for an individual lab s testing conditions can save time during analysis by changing all samples at once i e globally Make global cut off adjustments by doing the following e Click and hold the horizontal adjust probe cu
38. 2 3 or XPONENT 3 1 e The data file name also known as a Session ID must be 40 characters or less in length and include the csv file extension e The data is generated based on original unmodified templates provided by One Lambda Inc e The user is responsible for final assignments and must review all suggested results HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 17 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Technical Support For technical support or to report software problems contact your One Lambda representative From the United States call 800 822 8824 or in the Greater Los Angeles Area call 818 702 0042 Contact us by e mail at techsupport onelambda com For system requirements see the HLA Fusion Software Installation Guide HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 18 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Scope of this Manual This manual provides information on how to import raw data make changes in cut off values and other configuration and control adjustments as necessary for analysis as well as howto track and report analysis results It is very important to recognize that the QC Quality Control data used with this program and the defaults set in this program are based on One Lambda s experience with the product in a tightly controlled research and development envir
39. 20 2011 4 37 12 GAP R5502345010_101147 04 04 2072 2 12 2010 DRB1 Locus DZ 0414 2010 A session with all samples selected a E Samples a G G a oa 3 Y TestDate W Product Type W LABT ype LABT ype LABT ype LABT ype LABT ype Pam fen me wl ms Opera BSmith d BSmith BSmith Sessions BSmith BSmi i Includ 7 NB 7 NM 7 Mor Fatient ID 7 Sample 7 Wel 7 wi Batol Batch Y Bata T i 1 Select the check boxes next to each sample you want to include in a report Select the check box next to a session ID to include all of its samples Deselect the check box of any sample or session you do not want to include in the report 2 Ifat least one sample has been selected for a session the Include cell for that session is highlighted with grey If all samples for a session are selected there is a check box in the Include In cell 3 Optional To view all the samples available or to view only the samples you have selected so far click the Samples tab and select or deselect the check box for Show selected samples 4 Alternatively you can right click on a session or sample and apply one of the following HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Dia
40. 33 03 01 G1 C 03 XX5 C 08 19 A 31 02 A 33 05 G1 C O3 XX6 C 15 12 A 31 04 A 33 01 01 61 C 04 XX7 C 04 XX8 C Cw8 i Add New Sampie A 31 04 A 33 05 G1 C 04 XX10 C 15 12 Click here side action en o Ea The Results a A 31 06 A 33 03 01 61 C 08 19 C 15 12 A 31 01 02 A 33 01 01 a to view A 31 06 A 33 05 G1 iis i2 Crisi y 4 31 01 02 A 33 01 02 area gt A 31 01 02 4 33 01 03 A 31 01 02 A 33 01 04 y or add a gel image 4 Assigned Allele Pairs x v Assigned Allele Code A 31 01 02 A 33 05 AF31 XX1 A 33 XX2 431 433 User Comment E A System Comment Other Assignment Y Possible Homozygous E More Tests de Patient A ssian ASSIGN gt gt Place a check mark here A check mark here will to indicate the need for assign the analysis additional tests results to the patient Sample ID BSmith019965 7127 2012 H G F E D C B Test Gel Pane The pane on the left side of the window displays each well of the test in rows that are intended to duplicate the test gel Each well is shown with a reaction button When clicked or entered from the keyboard you can modify the reaction for the selected well between the following settings e 8 positive reaction e 1 negative reaction e Q no clear amplification wells with a O will be excluded from analysis HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 126 One Lambaa Inc HLA Fusion Software Version 3 x x Us
41. 442444 4 Patient Summary Patient Custom To view or print an LAT PRA SA report for the current sample click the Preview Report button on the Fusion toolbar Antibody Screening ID Antibody Screening Results Antibody Custom e Inthe analysis window click the Preview Report button or LAT Mixed Raw Data Print Report button to display a list of reports you can print or cas preview for the current sample Note If you select Molecular Custom you cannot create a new custom report at this point The only custom reports available from the analysis window are those previously created through the Reports window Making Final Assignments Final assignments can be made from either the Tail or Epitope results lists Once a specificity has been moved to the Final Assignments area it no longer displays in its initial results box HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 215 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual From the analysis window do one of the following to make assignments e Double click an antigen specificity in the Tail or Epitope Analysis results box to list the specified antigen in the Final Assignment field e Click to highlight the specificity and click the Assign Single button to move it to the Final Assignment list e Click the Assign All button to the right of the Tail or Epitope list to move all the current results on that list to the Final A
42. 4F 30 3c 24 2c 20 z 1F 18 o N U A QA y oO Ww HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 230 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Select Minimum Positive Threshold You can change the minimum positive threshold using the pull down menu e From the analysis window select a new positive threshold from the Threshold drop down list next to the analysis tools near the top of the window The sample is re analyzed according to the new threshold The effects of the threshold change is seen in the result boxes Setting the Minimum Positive Threshold Threshold i Exclude Antigen from Analysis All antigens entered are excluded from analysis To enter multiple antigens use a comma to separate antigen entries 1 From the analysis window click the Excl Ag button 42 The Exclude Antigen popup box is displayed A Exclude Antigen Antigens to be Excluded e g 41 423 855 Po Exclude Patient Typing ox der a Exclude Antigen setting Type in antigens to exclude and click OK Note To also exclude all typing antigens for the associated patient select the Exclude Patient Typing check box The sample is re analyzed and the excluded antigens are listed in the Excluded Antigens field under the analysis statistics box To include these antigens again click the Excl Ag button again click Clear to remove antigens from
43. 70 xO 411 99 6411 93 To include all these antigens again click the Excl AgL amp 43 button 2 L gi tied again click the Clear button to remove antigens from the field and Saat Miiran then click OK to re analyze with these antigens included ore Formula Raw Data Note To also exclude all typing antigens for the associated patient select the Exclude Patient Typing check box Include Exclude Cw You can include or exclude Cw antigen specificities from analysis 1 Near the top of the analysis window select the Cw check box to re analyze with Cw specificities Clear the Cw check box to re analyze without Cw specificities HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 177 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual AS AA A AP Raw Data pen fpnresereeeseseenseseenseneeneee ff 6Graph E Normalized Graph Reset All Options to Default Any changes you make can be returned to the default values e From the analysis window click the Use Default button in the upper right corner of the window to return all changed settings to the default values for this sample e The sample is re analyzed with the default values Force Positive If a sample has a low bead count the Force ve button is displayed allowing you to force a positive result by recalculating for allowance of low bead counts e For low negative control samples click t
44. Accept All button to allow automatic assignment and acceptance both Tail and Epitope of results upon import Note If you do not see a particular field available through the field chooser and you are sure it should be there go to C HLA Fusion temp and delete the file named x_x_ x antigen type _Layout xml For a list of the names used to represent the layout files for the different screening antigen products consult the section Session Summary Layout File Naming HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 159 One Lambaa Inc Note The session summary table columns and order can be modified x and your selections saved When you exit the Field Chooser a pop up message displays asking whether you want to save any O cb changes you made in the field chooser If you select Yes only o the selected columns display on this same computer until further modifications are made and saved e e Two columns of session data will always display even if you save the field chooser settings Sample ID and Well Pos In addition to the Field Chooser you can click on any column header in the Summary Table to sort the table by that column The arrows in the column header indicate the sorting order up for ascending and down for descending You can also click on a column header and drag and drop it to change the column order Click the Export button to save the Summary Table as an Excel
45. CC oer low or zs a a faa nas nse Jara awe one owe ows sex o a fa nas oe nes owe ows ow pae h kar eae ot e Joss Joar 1 1 Al 268 W aseze e e aa ase fase as7 pva pwe owe ov sree e e ae aaa ou nes awa owe ows ows sas a a f2 aaa pns ass awe one ow ow aseos a a aa aaa ase neo owe ow oo case CC pe a CC aa ae Joe e E ti For In Vitro Diagnostic Use lol x One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Raw Data Report For easier navigation exporting and printing you can create a report containing raw data information for the current sample 1 Once the Raw Data Table is displayed click the Report button in the bottom right portion of the Raw Data Table window to display a report of the raw data LCT Raw Data Report BSmith 015353 Patient SB 2101 Session LCT_20120330085145_LCT S0ABC 031_00 Test Date Catalog ID LCT 60ABC 031 00 Pos Threshold Well Position Probe CelI D EawData LA Specificity A1 42 B35 B63 Bw4 Bw4 04 007 Al 473 B49 B57 Bw4 Cw7 Al A26 B38 B73 Bod Bud C1015 A1 A79 B8 B45 Bw6 06 0w7 A1 432 B42 B44 Bw4 Bw6 0w5 0w17 A1 433 B8 B62 Bw6 Ca 7010 Al A66 B50 B58 Bw4 Bet Cod Co A1 AGE B7 B27 BvA Ert C2 A1 468 B18 857 Bw4 B04 C04 Cv7 A2 411 813 B46 Bw4 B04 Cw 1 06 A1 411 B13 B55 Bw4 Bw4 Cw 1 07 A1 A11 B56 B60 Bw40w7 0w10 12 411 B58 E60 E Cali PeMNBHRHRRBEERE AAA Donor PRA You can display the percentage of
46. FAQ s about HLA Fusion software e The build and version number of the HLA Fusion Software application you are currently using Note The online help can be accessed from anywhere within the HLA Fusion application when you press the F1 key on your keyboard Occasionally updates are made to the online help between releases of the HLA Fusion To ensure you have the most current help file check the OLI download site at download onelambda com pub tray_info Windows HLA Fusion _Catalogs Documen ES Exit x Do you want to exit HLA Fusion When you select this menu item a dialog box displays that allows you either to select Yes to exit and close the HLA Fusion application or select No to keep the current session open No Exit Confirmation Message Toolbar Buttons HLA Fusion provides a toolbar displayed just below the main menu bar options with access to commonly used functions Fusion Toolbar buttons Help Exit 2014818314 1d taaan Analyze Data Reports Data Sample Patient Info Profile Utilities e You can also hover your mouse over the buttons and a label will pop up with the name of each button e Please note that some buttons are only available to use when you re on an Analysis Screen The following table describes each toolbar button HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 32 One Lambaa Inc HLA Fusion Software Version 3 x x User Man
47. For In Vitro Diagnostic Use 199 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Using the LAT Mixed Analysis Window For each sample in the current session you can view the test data and assign screening results HLA Fusion analyzes a sample when you move to view that sample To analyze an entire session you must view all samples in the session and assign the results From the analysis wndow you can Note View and print sample analysis results Circle antigens in the specificity table Sort by well position Add comments and mark the sample for more testing View a Quick Report for the current sample Export reaction data to a CSV file You can return to a session summary from the analysis window any time by clicking the lt lt Summary link from the HLA Fusion toolbar next to the sample session ID HLA Fusion R 40 a tm HS amp Class Class Il Analyze Data Reports Data Sample PatientInfo Profile Utilities Help Exit 04 84 4612 301405 11M e lt lt Summary TEST 3 LAT Mixed Analysis Screen Wd bbl Class xa y Class Il xe y Threshold pane o o Coronas Jl eames resurs E a a a aca new Tray _ Sample ID TEST 3 ew Tray 2 Tests o OOO Class 1 Class 4 TESTA sl E 4l p f 4 j El Suggested Result Positive Undetermined Io IIA a a Hoo A RE D Era mpmDS Undetermined Undetermined 5 nana al El El El E cwomesaa 18 25 34 37 r
48. HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 256 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Report Types There are several report types available Although most report types are listed in this section please note that because new reports are sometimes added between updates to this user manual you may see more reports listed in the software Patient all patients in the Fusion database Patient Summary summary of both typing and antibody testing results associated with a patient 1D Patient Typing for Batch typing summary report over different loci for a set of samples based on a selected session Patient Custom you select the type of patient data to include for the selected samples Generic Typing typing data from analyzed LABType and MicroSSP samples Molecular Custom you select the type of molecular data to include for a set of samples Custom Typing Results by Sample you select the type of molecular data to include for se lected samples Allele Summary typing report of possible allele pairs and assigned allele code results for a set of samples Allele Code typing report of possible allele codes and assigned allele code results for a set of samples Molecular Typing Summary typing report of the possible allele code assigned allele code assigned allele pairs assigned serology and other assignments for a set of samples LAB
49. Hire PRE CETL tere CRE eres ore Prism A ereT OE ORT Oe Oe inne eee Er ee eee Ee e 36 Patien Donor in ormat A AER a 37 REO TERESA a ras 38 Siae Dy SIGS AMON SIS A A A eats 38 PRODUCT DATA ANALYSIS dd 39 Sample NOIA A A de 39 SAMPDORIA vere eeteer On ereere rer teren ttre errr 40 LABTYPE ANA SI lll is 41 START EABTY PE ANALY IS a denebac tous cvtsaeceuca san uted soenebsctees cnateaec vious tarcuneewocdeusteecs 43 IMPORTING LABTYPE SESSION DATAINON HDi td 43 ACOUIRING LAB TYPE SESSION DATAN AD orota tesa E A A 50 ANALYZINGIEXON 4 SESSION Sii ene e E A AE 56 LABTYVPE SESSION SUMMARY Sii A eden E EE A hada AA 59 TAC Session summary Field CNOOS CM asias aaa 59 Export Preview Gna PINE BULL ONS o uae Sl 60 LAB TYPE SESSION SUMMARY TABS sia ii A A deisel A Setiavnscitetcageh ont 61 SOMA TO tt tt 61 CONTO EVA TE TOD o ee ae 62 TNE POSIOVE Conto Sunn AV rera aA EAE E ade 62 Negative CONTOS UMATA A AAA A ETTO 63 Bead COUNT SUTMIMIGIY A A A A A A e 63 THEBEADANALYSIS TAB vccosc ali rit 64 Fale Reaccion SUNINMA Vader eee aoe 64 GENERAL SESSION SUMMARY FEATURES call 68 EXCIUGING a Sample from ANOS di o aa ias 70 CONFIGURE LABTYPE ANALYSIS FOR THE CURRENT SAMPLE sscsscsscssccsccscsscsscsscsscsscsscsscnsscosccscesccssescsscescsscsscnsossonces 71 CHANGE CONFIGURATION FOR THE CURRENT SAMPLE cotilla 71 ASSON COTE iS A A A ats A a Ra 72 BWA BWO HP SOCIOLOGY ia tt ds 72 Pemograp Nici ormat ON eal ee IO RE 73 ITU FoS VEe CONTO si ood vi ad 73
50. ID Combined 20120214092 72 7 Note If there are no samples displayed on the Combined tab you have selected sessions that can t be combined You cannot combine cross loci sessions e g A locus and B locus 9 Click a CSV file to display its associated samples in the Sample Patient Details table ica Sertion ID DWGecrkshop_C_fol 10404 Cate nm 47112012 E Samples a Plesce check date formal Fie Pell KAR AHLA Fisico Bald Session FlesALAB Types 0M0Gmaicihop C kt E IDAM cow Catalog 10 AS25010_002 05 E NO0Marmgt Jub 2009 E suey Pata oia o nd aa Gren ce Jones oe Patek 2 HOME gt NONE Fasan HOHE HONE E Patient El a Cc lr E 51 HOME gt MONE gt E Patent al HOME gt HOME gt Aras ess i El Mem vo e mme me e LABType Session Patient Sample Details table Note The Supplemental button can be used to add sessions that have already been analyzed to the current one for a combined analysis e g B7 sessions with B locus sessions This does not work for combinations of cross loci sessions such as A locus and B locus 46 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 10 If a sample is already associated with a patient the Patient ID and any existing or related patient information is displayed To add patient information do one of the fol
51. ID button or the Print Report button to display alist cate ae e of reports you can print or preview for the current A LATMixed Raw Data sample LAT Mixed Note If you select Antibody Custom you cannot create a new custom report at this point The only custom reports available from the analysis window are ones you previously created through the Reports window HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 207 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Using the LAT PRA Single Antigen Analysis Window This window provides detailed analysis information for each sample in the session It allows you to review the specificity assignments suggested by the program and to modify and accept the assignments HLA Fusion suggests possible screening results but the final assignment must be made by the user From the analysis wndow menu you can do the following Note e Select minimum positive threshold e Exclude selected or Cw specificities You can return to a session summary from the analysis window any time by clicking the lt lt Summary link from the HLA Fusion toolbar next to the sample session ID LAT PRA Single Antigen Analysis Find Ag Excl Ag fil cw CREG OLI Run Class 11 Threshold xs y O pna 2B 1E 1D 1C 18 14 VAS AE N tm a O N s DA E M rrea gt DUOO a QO PFANONNO OMA SAD a DwODODWWHWWNHA
52. LABScreen results e Reaction Assignment Report export report including sample ID and reaction string e NMDP Code Report The following specialty reports are customized for specific users e LBSW e HML VO0 2 e HMLVO 3 e LC e NBS e Thai Export e UMC Utrecht Report e BML e ABMDR e CMDP Statistical statistical or aggregate data for trending measurement monitoring etc e Allele Group Frequency displays the frequency of allele groups based on the first two digits of an allele assignment for selected sessions or the database e Allele Group Frequency Extended displays the frequency of allele groups based on NMDP code results or allelic level assignment for selected sessions or the database e Cutoff Adjustment Summary summary of all cutoff changes made for selected sessions or based on a specific catalog file HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 259 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Miscellaneous reports that do not fall into one of the above categories Database Information describes the usage of the current database Batch Data File Summary a log of the status of all the sessions run in the system Serological Equivalent list of alleles and their serological equivalent definitions NMDP Code list of NMDP codes and their allele definition Typing Query database search report that lists the samples found for a selected
53. LL Position Sample Y Patient pee Ed Eo E pe eee a LocallD Confirm Confirm Nin NC PC PCNCRAtio E 100 129 13 Aa 15 623 LS LS Sample17 12 28 2012 lt NONE gt oli Sample17 8 42 10 AM B1 LS Sample18 12 28 2012 lt NONE gt oli 8 42 11AM_ 12 28 2012 lt NONE gt oli ol 85 84 47 2471 6 29 261 9 LS Sample19 ooser En 51 91 2537 9 48 892 8 42 11 AM 12 28 2012 lt NONE gt oli 8 42 11 AM 12 28 2012 lt NONE gt oli 8 42 11 AM 12 28 2012 lt NONE gt oli 8 42 11 AM 95 167 33 2830 2 16 914 9 74 54 08 1601 5 29 615 d o ra papa 187 1100 12 2543 6 25 406 l 1 Class Il PRA SA Class II Class II Donor PRA Class II Epitope Class II Final Class II Tail Comment Confim Date Confirm User Family LABScreen Session Summary Screen o pc click a sample in the Summary Table to go directly to the analysis screen for this sample e Scroll left and right to see all the columns of the Summary Table e Click on the Field Chooser button to the left of the table headings The Field Chooser box displays You can select or clear the check boxes next to column headings to include or exclude those columns from the Summary Table Selecting or clearing check boxes in this window instantly updates the table e Click the Auto
54. Level Configuration Menu Sample Patient Info Profile Utilities Help Exit El A wo amp 11 A Gl a amp lt lt summary Smith gt ejes aloe J Lind atte G F E B A Rn Joye bine N ai D Cc Assign Code By default the system assigns NMDP codes to the alleles However the user can optionally change these codes to one of the following options e No Code The results allele pairs assembled into a string with no formatted code are simply condensed without applying a coded format e P Grouping Codes Allele strings in P grouping as published by IMGT e G Grouping Codes Allele strings in G grouping as published by IMGT e Local Code assigns user defined code definitions code used by your Lab for suggested code results 123 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual e Cross Code allows allele combinations that cross serological groups e g EAPW DRB1 04 01 33 35 38 72 76 By default cross coding is turned off so that allele pairs are condensed only within the same allele groups e Bw4 Bw6 in Serology Bw4 Bw6 in Serology Serology has identified many pairs of HLA B alleles which appear to differ only at the Bw4 Bw6 region the two mutually exclusive serological epitopes If you select this option Bw4 Bw6 is added to the serology results Germoagraphec Info Demographic
55. Low Bead Count samples are highlighted 71 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 48 One Lambaa Inc You may want to delete these samples because they often slow analysis you can no longer track these samples Take the following steps if you want to delete any of these samples 13 Click in the border to the left of the Well position column to highlight the entire row for the sample Wiel Sample heh so Date Values Bead Crit 6 F1 JE jeu e 2200 2757 40 Sample PE Lumines Min Exist o gJ masjo o zi Jesar y o 2569 100 iy O EME o a y 3020 2553 100 fY 3244 2674 99 Y HLA Fusion Software Version 3 x x User Manual Patient First Patients Name Donor Elizabeth Farggotti Patient had In DE Ethnicity Last Name Chung Asian e Patient i 5 Joanna Clicka sample to select it press the Delete key on your keyboard to remove it 14 Press the Delete 0 key on your computer keyboard to remove the sample and prevent it from being imported as part of the session 15 When session and sample information has been verified click the Import button The newly imported session is displayed in the Navigator tree in Blue at the top of the list If you selected the Auto Analysis check box the session is imported as well as analyzed when you click Import and it is displayed on the Fusion Navigator as an analyzed sessi
56. One Lambaa Inc HLA Fusion Software Version 3 x x User Manual The new format will affect allele code and allele pairs assigned to the selected patient donor and will be stored in the Fusion database in the new format 1 From the Main Menu select Patient Info gt Manage Patient 2 3 4 O Select a patient donor record Click Translate Alleles Click Save to save data Click Close to return to the Main Menu Associating Patient and Donor Records A Patient ID can be associated with more than one donor record and a donor ID can have more than one patient record associated with it 1 Ze From the Main Menu select Patient Info gt Manage Patient Select a patient donor record Click the Test Info tab Click the Associate Donor IDs button In the Patient Donor Sample Association window highlight a Donor ID and click gt to add vee the Patient Donor Sample List Click lt to remove a highlighted Donor ID from the Click Save to save data Click OK to return to patient record Click Close to return to the Main Menu Associating a Donor with Donor PRA Results Donor Info A Donor ID can be included in the calculation for Donor pears Living related PRA percentage for the antigen products 1 Include in Donor PRA M From the Main Menu select Patient Info gt Donor Group EE Manage Patient Select a donor or create a new one Make sure the Patient Donor filed is set to Dono
57. PRA from available donors in the system or from selected donor groups who match the computer assigned antibodies for the current sample Note To select a donor group s select Utilities gt General Settings To create a donor group select Patient Info gt Manage Patient select Donor in the Patient Donor field and fill in the donor group field 1 For Single Antigen or PRA analysis click the DPRA button DPRA pop up message A pop up box displays the percentage of matching donor PRA and the total i Donor PRA 0 number of donors that were considered in the calculation M of Donors 5 2 Click OK to close the box o y The percentage and number of donors remains displayed next to the Donor PRA AA button HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 233 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Adding Comments to Samples Sample comments are displayed for the sample s results in the current analysis session in all analysis data look up and reporting functions in HLA Fusion 1 In the analysis window type sample comments into the Comments field below the Assignments area alti x User Comment Standard comment field Comment Window is J displayed if you double i click in the standard C cor comments field ow Bood Count Invalid Test Bend Court Fah so 439 Comments are only saved when you click Save Flagging a Sam
58. RunfileIndex is usually hidden SE To see it select My Computer Show Hidden Files E in Windows gt gt Folder Options NETAS File name HD Session 1_HD y Open Netw e Files of type a Files y Cancel Zo Session ID BRAZ DR4_ID556_HD 5 HD Session Listing Luminex 2 2 2 3 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 51 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Fusion assigns a Session ID by default Optionally you can change the Session ID If the HD file has not been converted it will be named Output until it is imported at which point it will have the name of the original output session folder regardless of whether you rename the folder followed by _HD Note A Session ID must be unique to the Fusion database If the Session ID already exists the software prompts you to rename the session It is also highly recommended that you do not use any special characters in this field since they may serve a specific purpose as field separators Note To see the RunFilelndex file if using Windows XP open Windows Explorer and Click the Folders button Then click View on the Windows Title bar and select Folder Options from the drop down menu Now click the View tab and scroll down to Hidden files and folders Select Show hidden files and folders and Exit When viewing a selection of CSV files change the Files of type to All File
59. Sample Patient Sample Date Session Catalog ID Local ID ImgtWer 07 17 12 PP3914 Bw4L6 RSSO1S4_005_01 3 C1 9093 07 17 12 PP3914 BW4L6 RSSO1S4 005 01 3 7 0 4 D1 9256 07 17 12 PP3914 Bw4L6 RSSO1S4 005 01 3 7 0 11 C2 El8149 07 17 12 PP3914 BW4L6 RSSO1S4_005_01 3 7 0 14 F2 21675 07 17 12 PP3914 Bw4L6 RSSO1S4_005_01 3 7 0 22 F3 K 07 17 12 PP3914 BwW4L6 RSSO1S4_005_01 37 0 24 H3 PAST 07 17 12 PP3914 Bw4L6 RSSO1S4_005_01 3 7 0 25 A4 PORTER 07 17 12 PP3914 Bw4L6 RSSO1S4_005_07 3 7 0 e Selecting a sample from this list in the Sample ID field makes that sample the active sample in the analysis window Alternatively you can use the forward gt or back Y arrow buttons to select different samples e Click this button to go to the first sample Click this Bll button to go to the last sample e Clicking lt lt Summary takes you back to the session summary for the current sample Sample Date sient ID to Sample Sample Date For the sample currently being analyzed the Sample Date field displays the date the sample was obtained The sample date can be set and auto filled from the Session Import table HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual LABType Analysis The HLA Fusion LABType analysis module analyzes Luminex CSV output files for LABType products including HD output
60. Sharpitis Thomas T Sharpitis 023 19 0002 11 1950 F caucasoid 9701 Bicycle Lane Cystal VWillace Ca SWMM 134 91002 hst nildra haa com 17141 978 1098 21491 97A 109A t714 978 1098 14141 209 7817 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 284 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Patient Antibody Tracking You can track antibody strength for each patient over a period of time The information tracked is taken from the typing data stored in their Patient Donor Info card and the antibody data in their analysis samples LABScreen Single Antigen and LABScreen Singles for the specified date range Take the following steps to display graphs and data that track a patient s antibody data Make sure you have patient and donor information entered into HLA Fusion If not you can import it from a patient list and or manually enter the data on the Test Info tab of the Patient Donor Info card Patient and donor records must be associated 1 Select Patient Info gt Ab Tracking The Patient Antibody Tracking window is displayed Pasent ip DANEM Clicking the Save ree sur nue si button here saves any samples listed Sy in this area for future analysis as samples within the chosen date range Patient Antibody Tracking window 2 Click the drop down arrow next to the Patient ID field to select from a list of patients st
61. Tos os be Tos Tos os os os os Tos Tos os HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x If you want to expand the table to its full size click the Maximize button To minimize the view click the button again Double click anywhere in the area just above the table between the Rxn Reset and the Max buttons to expand the table To size the table back to its original quadrant size double click in the same area again Click on the blank gray row header to the left of an allele name or reaction to move all the beads with that reaction to the left Click the Rxn Reset button to reset the table to its original configuration For In Vitro Diagnostic Use 82 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual When a column header is clicked the table is sorted by reaction criteria for that bead The first click sorts in ascending order from top Sample Rxn to bottom The second click sorts in x x k k descending order Coe Jl Samen e roy ace C x Double click on the allele column to bring the selected allele up to the top of the Reaction Pattern Table just below the sample If you use the Analyze Combined button to analyze two or more analyses for the same sample Bead IDs in additional analyses are differentiated from the current one in the Rxn Table by an underscore and a sequential number For example if the current sample contains a bead with Bead
62. a probe the bead graph in Quadrant 2 updates and a pop up information box displays the following fields L BeadID 2 Recognition Site 3 Exon number Gap or specialty probes are indicated by a yellow connector that joins two recognition sites The recognition site data that displays when you click a specialty probe is for both of the connected probes HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 84 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual The Recognition Bar Activate the Recognition Bar by clicking the Recg Bar button Initially the bar will appear on the left side of the graph Drag the bar to the right with your mouse pointer Once you release the bar the system will display the Recognition Site Summary Positive Negative and Excluded probes for wherever this bar is positioned in the window Click to activate the Recognition Bar A summary of ac Rxn Rec Site Local QC Patient Sample Results 002 020 MINA The a 0221 lea 31 Recognition Site Summary ar Positive Probes si 031 65 G HK H V Q 73 066 72 H VD 78 065 I 358 Negative Probes E 010 5180 65 72 H V76 all probes that 00 614 5 72 HN 76 lt 004 M 036 63N 65 76VD 78 lie in the area 010 012 EN 037 71 N 77 before the new 042 62RM 66 79RIALR83 bar position 117 058 69 75 019 MN pil ga
63. ad 141 OTHER Nh 01g 1A 6 lt 1 6 aier a aaa a 143 POSI C1 SCLOIOGV CNG ices areca ES Acree cd es E E E cota A 143 Translate noncurrent nomenclature format Only iersinii iiaii nan EAE R ANN 144 Adding Comments LO SOMPICS AAA A AAA A AA AAA E T 144 FIONA SOM PIC FOR Father TESTA e EEA 145 PARE the Current Analysis VWVINGOW niei enaa EA E TENT E seamen E ae eine 145 PFEVICWHOMPTING REDONS rata 146 ASSIGN Code RESUMS noorena e E E E a sodas cea E 146 SAVE ASSIM NES Rod 146 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 6 One Lambda Inc HLA Fusion Software Version 3 x x User Manual CONTI TASS GNER E antaes 147 MICRO SSP SESSION SUMMARY iii A A AS 148 NAVIGATOR RIGHT CLICK MENU OPTIONS FOR MICRO SSP ccssccsscssccsccesccsccsccescescsscescesscnscescsssosccescessoescescessonsoesees 150 SESSION LEVEL OPTIONS ionen ioeo eia A AS 150 Redandiyze WITH NEW NOMENCIAtTUTE tds 150 Sample Leve OPENS oaa AAEN T AOE ATEA EET EN ETON EET EE AAE 151 Related RECOU S A E T E A E N CA 151 Sde BY SIGS ANAIS S aE EE E E T E O E E NAE O NAI 151 LABSCREEN ANALY SIS oe a A A A 153 STARTING LABSCREEN ANALY SIS taa A ds 154 ACQUIRING LABSCREEN SESSION DATA iii 154 PAB SCREEN SESSION SUMMARY SCREEN eonucaslrt s 159 USING THE LABSCREEN MIXED ANALYSIS WINDOW cccssccsscsscssccesccsccsccescescsscescesssscescesscsscessessonscescessonscessessoncoesees 161 FIND ANTE NUDO oie 162 VIEW MOLECULAR TYP
64. again displaying in the previous nomenclature format HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 103 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Press the Enter key to move the allele code you typed in to the Assigned Allele Code field Note If you have a homozygous result the assigned code can be edited in the Manual Allele Code field to show the homozygous coded results once Unknown Allele Codes Unknown allele codes are marked with XX followed by a sequential number The numbers are reset to 1 for each sample and locus When you see unknown codes you should first make certain you have imported the latest NMDP file If you have the latest code file and are still seeing XX codes you can store these unknowns for later submission to the NMDP in a txt file named nmdp_code_report txt by default stored in c OLI Fusion data NMDPExport but the location can be changed by modifying the path in Utilities gt URLs amp Paths Code information is appended to this text file as it is added the newest additions are at the bottom LJ More Ti 1 From the Possible Allele Code field click the XX codeto 37 LI Patient display the NMDP Code Report buttons to the right of the Date iz s pirect request NMDP System Comment field NMDP Code Report Buttons Click the Assign button V and choose one of the following e To send the unknown code information direc
65. and then click the LCT button again to return to the import process 4 Accept the current date or select a different test date and click Next gt The analysis wndow for this session is displayed HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 223 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual LCT Analysis Window Sedan 8 2 2012 y raro eta E cw crec ou Tread fis yl e A AAA A B D E F ee A A A go et Pee ate eRe ig eee eG NY ge aes HERRERA HH AA AA AA A ttt CLUS A nnn SEGONE GERR RER E mmm 5 o _ _ _ 4 7 FP e ed Rail lt kk __ 5_ SE4 lt gt lt lt GLAAAA _ lLtLLIIgITmII MAMA a Rnnaah aaa anna aan naaa Tae eee aaa y 11F6D 3B 28 2 18 10090 48 SE 30 20 10F3 7A SC 4C 12412B12012012 12F 11E11011C11811A10A10B810010E9F 9C SB SA 8A 88 3C 8D SF 7F TE 70 7C 7B GA 6B 6C GE GF SF SE SD SB SA 4A 4D 4E 4F SF SE SC 3A 2A 20 2F IF 1E 1D 1C 14 4 El El E 66 33 14 11 8 2 58 52 23 53 16 9 55 44 37 27 22 72 71 70 69 GB 67 G5 64 63 62 61 60 59 57 56 54 51 50 49 48 47 46 45 43 42 41 40 35 38 36 35 34 32 31 30 29 28 26 25 24 21 20 19 18 17 15 13 12 107 6 5 4 3 A YNNN EE O gt f unn se WHWWWWWNNNNNNNNNNNN 9 oa S EET A E E 86 2 25 8 BBe 223888 LEE 1 4 1 6 1 1 2 B Hina Eos a TT gt oe EEE O D R Ia w A N aw E 00 00 A 00 00 enoa o olan omwonst O Au woo nN B ArPrPuvotranawnwterensteananyvroaanas o YD MO
66. antigens here gt DO gt de O O E f Sw a pos DQ8 DRS DR13 OR17 OR16 DRS DR103 a O gt ees ee A E gt A click any A e pe e A Cree ysis Results Epitope Analysis Results Final Assignment box here rej rej m mw r Spec gt xe lt Xe DRS1 i 2 View Molecular Typing for Antigens o LS Sample 17 1 From the analysis window select the DNA check box below the Sample Name at the top to display molecular typing for the antigens in the sample Molecular typing is displayed in Purple in the central specificity area of the screen Clear the DNA check box to return to the display of serological specificities HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 163 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual View MIC Antibody Screening Results Select the tab labeled MIC to review MIC results for the sample 1 From the analysis window click the MIC tab to display MIC screening results MIC Antibody Analysis Screen MICA MICB Classi amp ll mic To return to Class I and Class II results click the Class I amp II tab at the bottom left Adjust Cut offs You can change the positive or negative cut off value for each sample by clicking and moving the cut off lines on the histograms However you can change only one threshold cut off at a time e From the analysis window click on the cutoff bar a
67. auto updated from the One Lambda download site http download onelambda com 1 From the main or any of the product home pages click the Download link or from the main menu select Utilities gt Update Reference gt Update Reference File HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 303 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual The Update Reference File dialog box displays Update Reference file Serology Equivalent e Reference File xj 0000090 Directory Folder Tree Serology C Catalog O NMOP LocalGode PG O ET Equivalent Import Serology Equrvaient option _import Serology Auto Update Gu lo gi Last Update 2911 denisany RIE Apr 14 02 OMELAMEDA 000 Ready 2 Select the Serology Equivalent option 3 Click Auto Update to open the One Lambda Catalog Updates Selection window 4 Select the check box next to all files you want to import 5 Click Import Serology to import the selected files Catalog files are ready for use without restarting HLA Fusion 6 A confirmation dialog box displays import results click OK 7 Click Close and then Yes to return to the Update Reference menu e If Auto Update does not respond verify your network connectivity and that the URL you set for Serological in Utilities gt URLs amp Paths is correct Catalog Management and Information Archive Catalogs You can archive catalog files
68. default location click drag and drop the Explorer at the far left of the main screen HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 117 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Micro SSP Analysis The Micro SSP HLA typing trays use the sequence specific primer technology These trays are available in 96 well format Analysis results are based on catalog specifications NMDP code and serology equivalent references that you can import through the Fusion software The software suggests the allele pair assignments but the final assignment has to be made by the user The results can be saved in the database for further review by lab technicians and for final approval by the lab supervisors There are a few things that should be completed or verified before you start an analysis session e Make sure you have the latest catalog files as well as NMDP code local code if used or serology equivalent reference files before you analyze You can download or update catalogs from the Micro SSP Home Page e View and modify global product configuration settings before starting analysis Global settings are displayed and be can be modified on the Micro SSP Home Global settings apply across all newly imported sessions e The default setting of HLA Fusion is to automatically move to the next sample after a sample has been saved or confirmed If you prefer to remain on a sample m
69. deleting from the list is easy Adding Reports to My Favorite 1 Make sure you have selected the report you want to add to My Favorite verify that its name is displayed in the Report Options section of the Reports window Add a new report to the My Favorites menu My Favorite Add to My Favorite Remove from My Favorite HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 245 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 2 Select My Favorite gt Add to My Favorite The current report name is added to your My Favorite menu When you want to generate this report just click on its name from the bottom portion of the My Favorite menu Add to My Favorite Remove from My Favorite Saved reports are listed below this line LCT Specificity and can be accessed at any time Removing Reports from My Favorite 1 Select My Favorite and select the report you want to remove from the list of reports at the bottom of the menu The My Favorite menu closes 2 Select My Favorite gt Remove from My Favorite Add to My Favorite Remove from My Favorite LET Specificity The report you selected in step 1is no longer displayed at the bottom of the My Favorite menu HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 246 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Reports Tools Customizing
70. details about the various display options Group by Product Reviewed Unreviewed Sessions HM avigatar Product Test Date C Catalog Session Date Group e a 040 ksp_A5502345 005 3 O4O0brmorkshop_dpb1_lot2 10 U d J 0406workshop Bta iD40 A f reviews The Navigator displays imported sessions for each product type 4 n406workshop B lot 9 ID40 sessions are ae f i 8 0406workshop_A_Lot 7_ID40 BLUE based on the date range and other criteria set in the Find ronald option If you are already in the analysis mode for a certain Reviewed product just the sessions that fit within the date range for that a 406workshop_DRB1_lot 10_ e 406workshop_C_lot 6_ID40 LABS sessions are product will display 26 20080116_PRA1_LOT11_ID BLACK 06 29 05 John Hopkins LS1_ 85 04200701 2_071lo_1D 1081 Click the sign next to the product type you are interested in to cy b 042007152401_004_10 329 i aS 02131_LSM12_011_01_ID32 display 1ts sessions me 021308 LSM14 hna lot g IDG 4 130907 _L5M_13 WBCOD0E_ 29 06 28 05 John Hopkins LS2_ e The sessions displayed in blue are the ones that have not yet been reviewed Once you review a session its color on the Navigator list changes to black e Click a session name to display the samples within that session For LABT ype and LABScreen the system also performs a batch analysis and displays the results in the Session Summary Sample Failed in Batch Analysis
71. displayed if you want to compare the tracking with different formulas You can double click on a graph to expand it and there are right click options available from each graph see graphic above You can also use the expand contract buttons Al in the upper right corners to expand the graphs HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 28 7 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual e Optional You can add donor data if desired by using the drop down arrow next to the Donor ID field to select from a list of donors associated with the selected patient You can also create a new donor on the fly by typing a unique name into the Donor 1D field and filling in the molecular and sero typing e Optional Enter a numeric value in the User defined cutoff field If you want to track the antibody signal strength with or without the cutoff applied select or deselect the check box next to User defined cutoff e Optional Select the check box next to Track DSA to track donor specific antigens If this is selected and there are donor specific antigens that are not tested with OLI product kits these are listed DEUDA 2 BIA Il 3 3 103 4 Line Time Scale Column Sample Donor ID drop down list Typing Class II Sero A3 A24 B51 B60 Cw4 Cw12 DR4 DR11 DQ1 DG3 tracking Typing Select to track antigens s 1 Name Catalog ID we 2 Include A
72. for all future LCT session summary tables on this same computer until further changes are saved e Ifyou want to exclude a sample from an analysis session select the Exclude check box next for that sample The sample is still displayed on the Reports sample list so to prevent it from being included in report data do not select that sample during report creation Note Certain columns of data are considered key and cannot be excluded for longer than the current display of the Summary Table If you exclude one of these fields its column is not displayed until you navigate elsewhere in the application If you return to this Summary Table from a sample analysis window or the Navigator that column is re displayed The data columns considered key is product specific HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 226 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Using the LCT Analysis window For each LCT sample in the current session you can view the test data adjust the cut off and assign screening results There are several tasks you can perform from the LCT analysis window e Review data and assign specificities e Circle antigens in the specificity table e View molecular specificities e View screening results e Add comments and mark the sample for more testing e View areport for the current sample Baseline Threshold Click to sort by Antigen Search box setting well po
73. functionality to help with the validation process required by Labs Clinics and hospitals seeking to comply with GCP GLP and GMP Validation of the HLA Fusion software for your lab environment for regulatory or performance reasons can be automated by using the IQ Installation Qualification and OQ Operational Qualification options from the Utilities gt Validation menu Your lab may choose to run these as a standard regulatory validation process to help troubleshoot issues or to provide information to prepare for a software upgrade IQ Installation Qualification The IQ process assists you with installation qualification of HLA Fusion software by providing a built in function Once the Installation qualification completes a results report is generated which you can save print or export to Excel Note If your IQ results concern you export them to an Excel file and e mail the file to OLI customer support 1 From the Main Menu select Utilities gt Validation gt IQ The validation test runs When it is complete a report is displayed with the following categories of data e Systems Information e g operating system e Environment e g directory path where the HLA Fusion program files are stored e URLs e g the URL for the catalog download site e Database Information e g name of the database e Number and types of files installed e g dll e Lab Information e g name and address of your lab e Analysis Confi
74. ga y J 00 gt 1114 1 1 1 1 8 E EF E e E7 H os gt y e e 123294 ES vil Ya 33 E Bw F Fi IF a IIF PIF GETE ot l MEDC e o a ar ar a AGS LOMAS IN HA EE SE sag ee a Ne To Tague Ske a a ans Oe eee A ee E E SO A 0 8 s G n i d aj ETS j ok a Ch ak d ad 25 120 N N DO O 0 Om o on 30000 an gt o an on ooo N o zZz i hi lo ls Ya a E 5 le oO E 9 t 8 9 8 Lz EA OL 2 Data Entry Order Sample Count Strength Index PRA 8 6 4 2 23 PRA 8 6 4 SPRA 8 6 PRA 8 Exclude al es Each LCT session consists of as many samples as you wish to analyze with the same catalog information LCT Session Summary Screen The Summary Table can be launched by clicking a session in the Navigation tree It lists each sample in the session This option allows you to quickly analyze a session and save it for later review and final assignments Field Chooser Donor PRA Fields Session LET_20120314142406_LCT 1430_024 00 Catalog LCT 1430_024 00 Session Date 3 14 2012 Number of Sample 1 Class Class II User Assignment Test Date User BeadCnt Benti Lon BSmith2012 10 10 O o Patient Sample Y LocallD Sample User Analysis Family Analysis Other More Confirm Confirm Min NC PC PCNCRatio Date Comment Date LCT Session Summary Table e Double click a sample in the Summary Table or a data point to go directly t
75. is displayed using the ratio formula for each bead in the sample e Beads coated with Class I antigens are listed on the Class I histogram on the left side of the Class I II window and beads coated with Class IT antigens are shown on the Class II histogram on the right side of the window The X axis labels show bead numbers and the Y axis labels list ranges of normalized bead values for each histogram Bar Colors o Positive PU o Negative p e Undetermined uy Find Antigen Enter single or multiple antigens to circle the antigen s on the specificity center area of the analysis window 1 From the analysis window type antigens separated by a space into the field next to the Find Ag Antigen button The antigen strings you type in must match the antigen displayed on the window The Find Antigen Field gf W aAA o HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 162 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Click the Find Ag button to circle the entered antigens Note If the antigen entered is a broad antigen then its split antigens will be circled For example if A9 is entered then A23 and A4 will be circled You may also click on any of the boxes in the CREG Bar as shown above to circle the antigens in the Specificity area without having to type the antigen in the Find Antigen field To circle
76. is highlighted yellow it indicates a regional code mismatch In this case it is recommended that you use the drop down selector in the second date field to choose the appropriate date taking into consideration regional date format differences If a sample is already associated with a patient the patient ID and any existing related patient informa tion is displayed HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 156 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual To add patient information do one of the following e To add data from the system double click in the Patient ID column of the Sample Patient Details table or click the Patient List button on the toolbar The Import Patient window is displayed allowing you to import the patient information file e To manually add patient data type data into the patient related fields of the table e You can assign the sample ID to empty patient ID fields by selecting the check box for Set empty patient ID to Sample To assign secondary Ab to the samples do one of the following e To assign secondary Ab to individual samples select from the Secondary Ab drop down or type one in the associated field e To assign a secondary Ab to all of the samples select from the Apply to all drop down or type one in the field and then select the Apply to all check box The system assigns a session ID automatically Optionally you ca
77. it that way e Bars are colored according to reaction Green 2 7 light blue 4 yellow 6 brown 8 red e When you hover your cursor over a bar a pop up o o aoe window displays Bead ID Tray Position Rxn Raw Data Threshold Well Specificity ProbejCell ID Class II Mix HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 210 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual CREG Table The CREG groups are displayed at the top of the table with the specificities for the group displayed below Specificities are highlighted in one of the following colors Note If you want to hide the display of the CREG bar click the CREG title at the top of the window A dialog box displays asking if you want to hide the CREG bar Click Yes to hide it To re display it click again on the CREG title and click the Yes button to show it e Purple positive assignments from the Epitope Analysis Results box e Pink Tail assignments that are masked by Epitope analysis e Blue Cwassignments e Green Bw4 and Bw assignments e Click a CREG group or antigens to circle the corresponding specificities e Right click an antigen to move the specificity to the Final Assignments box Do the following if you want to use a different CREG table 1 Click the LAT Home Page button or select Utilities gt Antibody Product CREG pu Edit Configuration gt Set Analysis E OLI C
78. line are considered positive e The cut off line on this histogram can be modified To adjust sample cut off values do this 1 Click and hold the horizontal cut off bar and drag it up or down to a new cut off setting The cut off value is displayed next to the cursor and changes as you drag the bar up or down Adjusting the Cut off Bar 2 To reset the cut off values to the default for the current sample click the Reset button and choose a default option e When a Sample Bar is double clicked the analysis module displays the results for the selected sample e Hover your cursor over any sample and the bar turns yellow and sample details are displayed HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 88 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Sample ID Name 60224 Well Position B Normal Value 71 Raw Data Trimmed Mean 1775 Sample Cutoff 15 OLI Cutoff 15 Sample Detail e Ifyou wish to exclude a bead from analysis check the Exclude box When checked the current bead is excluded from the analysis of the current sample Analysis results are refreshed to reflect the change and a notation is added to the System Comment field Exclude Bead bead id system Comment Exclude BeadH4020 4054 Possible Homozygous Adjust BeadH046 71 40 40772410 Excluded Bead in System Comments e IfHLA Fusion cannot determine any results that exactly match
79. needed 1 Select Reports gt Tools gt Customize Report Use the Crystal Report Designer tools to modify the appearance of your report Once you have made changes to the report format save it Make sure you do not change the name of the report file Next time you run this report in HLA Fusion the report will have the appearance you last saved in Crystal Report Designer Creating Custom Data Export Templates 1 Select Tools gt Setup Export to customize report data export by setting up templates that determine the type of report data session sample patient results etc is exported when you select that template Tools The Export Data Setup dialog box is displayed allowing you to select the name of the export template the fields to be included and the field order you want for the template Select check boxes on the left to select category and fields On the right side of the dialog box drag and drop the fields or hold CTRL and press the Up Down arrow keys to change the order Customize Report setup Data Export Export Data Didi cin lola HLA Fusion 0000009 X Export Name T Limited to 20 characters ONE LAMBDA 000 Export Data Setup screen HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 248 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 2 When you are done click the Save button The ne
80. new location on the Field Chooser For In Vitro Diagnostic Use 59 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual When you close the Field Chooser a message displays to let you choose whether or not to save any changes you ve made If you click Yes your changes are saved for all future LABType Session Summaries on this same computer until further modifications are made and saved Note If you do not see a particular field available in the field chooser and you are sure it should be there goto C HLA Fusion temp and delete the file named Labtype_Layout xml Export Preview and Print Buttons Clicking the Export button on the Fusion toolbar will format the Summary as a Microsoft Excel spreadsheet file Fusion suggests a Session Name for the spreadsheet but you can change it Clicking the Print Preview button on the Fusion toolbar not only opens a new window which shows you how a session will look when printed but also allows you to select which pages and or specific parts of pages you would like to print When you click the Print button the Summary is sent directly to the printer Snapshot Page Width View whole Drop down Send Tool Dynamic view page Zoom Summary pont Margin Zoom Out Zoom In to printer too Width tool tool y G Print Preview loj x je view W jil F i j j sl al Es A a7 40 i A Close y Navigate e i from pa
81. or the one you want Is not available review the Utilities section of this manual for instructions on how to add new catalog files to the database HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 52 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual e Ifthe CSV file specifies a template name only applies to CSV files from Luminex 2 2 and later and one of the available catalog files is associated with that template then that catalog file is automatically selected If you want to select a different catalog file you can use the drop down list in the Catalog ID field to select from any other catalog files listed there e Ifthereis no template match the system then considers the closest bead match between the session and all available catalog files A catalog validation dialog box is displayed You can confirm the selected catalog file simply by clickingthe Close button Or double click another catalog name on the list of Suggested Catalogs Note The catalogs listed in the validation dialog box for HD sessions may also include non HD catalogs You can identify an HD catalog by the H in the name e g RSSOH2B1_003_05 HLA Fusion Selected Catalog AsS5018_014 11 Validation Results All beads match Suggested Catalog Double click to select and continue A list of all Catalog ID Nomenclature Date Imgt Version catalog files having the ite of matches The lett
82. qu 2 If a session sample is listed in Red it means the Group Product Date Catalog g f E LABT ype sample failed in Batch Analysis G11 408 580 002_HD_A As 105722 230110_361_4 e Click a Sample Name to display it in an analysis 48 105722_290110_361_4 window jo do E G052510105115vV lt G NEG CONTROL 28 HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Group by Catalog Group by Catalog Navigator When you select the Catalog group option in the Navigator Group E Product Test Date sessions are displayed in alphanumeric order by Catalog Session Date Catalog Name EFLTHD_003 01 AA FlowPRA_20110823103509 FlowPRA_20110823104141 LAT1240_002_00 ie 14701112008 AA latmixed Dtest Group by Test Date Navigator Group gt Produ C Catalog Session Date IOEDIAEN When you select the Test Date group option sessions are displayed in a ne chronological order by their test dates 88 20080116_PRA1_LOT11_ID 9414 2012 ff 021308 L5M14 hna lot g_IDE Ba ce ONE Otherwise the use of this tool is the same as described previously in Group 4 20 2012 by Product e O42007LS2401_004_1D329 88 420078012 013 lo 11051 H 479 2012 H 8 30 2011 H 4 11 20 H 2 28 2011 Group by Session Date iaa C Product C TestDate Cats Session Date gt 1
83. reaction pattern for the sample The pairs are suggested by HLA Fusion Pata Display alle pas Allows one force positive or negative Displays two sets of alleles When one of the first is selected matches from the second are highlighted Pairs Force Type SubType Match Sero Close Bead Rxn A 03 01 01 01 A 30 31 A 03 01 01 01 A 30 35 A 03 01 01 01 A 30 36 Possible Allele Code A 03 01 01 01 A 30 37 XX1 03 01 03 01N 03 03N 03 0 2 A 03 01 01 01 A 30 38 XX2 30 01 30 15 30 18 30 19 y A 03 01 01 01 A 30 40 x 4 gt Assigned Allele Pairs Assigned Sero A 03 01 01 01 A 30 15 A 03 XX1 A 30 XX2 A 03 01 01 01 A 30 24 Groups and condenses pairs with the same reaction pattern PO O a Other Assignment o a O Patient Assign Displays all suggested serology equivalent data for the sample e The list identifies the pairs and groups them by either full match pairs no false reactions or the number of false reactions e Results with false reactions are listed with the false reacting bead well identified e The results display one allele pair per row Assigned Allele Pairs A Z916 A 6301 e Possible homozygous NMDP coded results are noted in the a zs15 ar6901 System Comment field A 2917 A 6901 A 2917 A 6901 HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 96 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Allele pa
84. report information about a catalog file and generate a report from the Catalog Information menu 1 2 From the Main Menu select Utilities gt Update Reference gt Catalog Management Click a column header if you want to sort the catalog file list e Optional If you want a report in the old format select the check box next to Old Format report Click Report to display a printable exportable report of the currently displayed catalog information Associating Product Catalog Files and Luminex Templates You can associate a catalog file with the Luminex template name used for a specific product HLA Fusion automatically associates catalog ID and template names the first time you run the analysis for the product After an association has been made HLA Fusion automatically selects the catalog file associated with the template used in the CSV file when you start analysis You can also manually add remove or change associations 1 From the Main Menu select Utilities gt Catalog Template Association Add remove or modify an association Z 3 6 7 Add a New Association Select a catalog file Type in a new template name or click Browse to select a Luminex template file 1xt format to associate with the filename Remove an Association Select a catalog file Select a template name and click Remove Modify an Association HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro D
85. report menus are Sre identical for either Preview Report or Print Report Allele Summary Molecular Typing Summary Custom SSP Report SSP Report Note If you select Molecular Custom you are not be able to create a new custom report at this point The only custom reports available from the analysis window are ones you previously created through the reports window Assign Coded Results Use the Assign button to assign and save all unambiguous possible coded results those results for which there is only one coded result Save Assignments Lab Technicians and Supervisors can save analysis results for further review and approval Saved samples are available for confirmation by a lab supervisor only e From the analysis window click the Save button located in the bottom right corner of the analysis window to save the analysis results e Fusion will automatically move to the next sample e Samples must be saved in order to associate any user created comments in the database or reports For confirmation a supervisor needs to access the sample for which you saved the assignments HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 146 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Confirm Assignments Lab Supervisors can confirm analysis results Samples are marked as Confirmed e From the analysis window click the Confirm button located in the bottom right corner of the analys
86. samples in the current session click the lt lt Summary link at the top of the window Side By Side Analysis Use this option to compare the current sample analysis with one previously conducted Note This option is also available by using the Side By Side Analysis toolbar k button Session RSSO1A_005 RSSO1A_011_06 RSSO1A_006 RSSO1A_011_06 RSSO1B_006 RSSO1B_013_07 RSSO2B1_008_1 RSSO2B1_015_06 Current Sample RSSO2B1_008 RSSO2B1_015_06 The current on screen sample analysis has a light Brown background ONE LAMBDA 000 Side by Side Analysis menu option HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 115 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Select a previous sample analysis from the displayed list to compare to the current one 1 Click the OK button and the two analysis windows are then displayed in a comparison window QC Rxn Rec Site Local QC Patient Sample Results Set Confia Bead Raw Bead info gt at Fetal nese One Lambda QC ID 016 Probe ID OLR4101 Max Scale Current Analysis olx a Rec Site Local QC Patient Sample Results Set Confia Bead Raw Bead Info El One Lambda QC ID 004 Probe ID OLR4103 Max Scale Bead foot y k lt gt a C txctuaej H reset Previous Analysis Example of Side by Side Analysis Windows Each windo
87. session If you pick a Class I Single Antigen CSV file and a catalog with W6 32 data I Apply 16 22 in it the Apply W6 32 check box displays If this check box is displayed you can choose whether or not to normalize the imported data for W6 32 by selecting the check box 158 HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual You must import a LABScreen Single Antigen catalog type and a CSV file containing W6 32 data to apply W6 32 normalization 7 When session and sample information has been verified click the Import button The session is displayed in the Navigator tree on the right for subsequent analysis You can continue importing Luminex session files or you can click a session on the Navigator to start analysis Either way you can navigate between sessions and samples in various ways during analysis LABScreen Session Summary Screen In the Navigator Tree click on a Session Name The Session Summary Table is displayed Click to display the LABScreen Batch Report Click to open the Field Chooser Class I Il and MIC donor PRA a Summary Report Session LS1A01_001_G1_G2 Test Catalog LS2A01_006_00 Session Date 12 28 2012 Luminex Luminex Version 1 7 69 Number of Sample 6 3 A A ee A md geben eee gt e an Class Class Il MC Donor Donor PRA PRA PRA 3 z
88. slider to move from page to page Possible Homozygous Low Bead Count Low Bead Count Possible Homozygous Click and drag up to zoom in or downto zoom out Page 1 of 12 6 Moy Ovo ovo ooo HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 69 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual e Inthe Print Preview window the left side displays symbols for each page of the report Use the Slider to move from page to page or click on a page icon to go to that page e Use your mouse Scroll Wheel or click and move your mouse up and down to zoom in and out of each page in the Print Preview window Excluding a Sample from Analysis Sess Ifyou want to exclude a sample from an analysis session select the Exclude check box next to that sample You can also right click the sample on either of the graphs on the Control Value tab and select Exclude Sample This means the selected sample is not displayed in Fusion reports or in Bead Analysis Control Value data or as results in the sample Analysis Window e The False Sample rows in the Summary table are highlighted in Pink sample rows having multiple matches are highlighted Orange e Ifyou want HLA Fusion to search the entire session for XX codes and replace them with the most current NMDP codes you have imported click the Replace XX Code Psisexo button It is recommended that you use
89. special characters in this field since they may serve a specific purpose as field separators Select the Combine CSV check box Place a check Include Imported 6 Then select the check boxes to the left of two or more mark here STF session file s to combine them Make sure you CSV Fie Name z combine loci sessions with session files from an 0407workshoprssoA_008_1D319 040 workshoprssoB_011_ID320 Appropriate eu pD a ents le as 040 workeshoprssoC_007_ 10321 Ny ene TH CrossCode_OL_648_DR_L11_1D2563B Once you have combined sessions additional tabs are Session tiles rra displayed on the Sample Patient Details table to the DQA_DQB_LOT2_ID2786 right of the Current tab representing the combined 32_10_A_L9_1D3919 CSV files AEREE 45 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Added tabs for the combined sessions 7 Make sure the Catalog ID field contains the Combined Session ID displayed to the right of it DP_DL_ID324 0407workshop_DP_Lot3_1D324 Current Combined 040 workshop Lumines Lumines 10015 2 3 Session ID 0407 workshop_DP Lota 103 4 File Path cNOLI FUSION data sessionSLab T ype 040 workshop DP Lots 100324 cew Combined Cata logs alysis 8 Click the Import button The combined session is displayed in the Session ID field with the word Combined appended to the front of its Session ID name Combined Session ID Session
90. stand alone on a single computer and network environments The features of this software allow you to do the following e Import raw data from the LABScan 100 flow analyzer e Manually enter reaction patterns for Micro SSP FlowPRA LAT and LCT products e Read ELISA results for LAT products e Analyze the raw data and review the results in graphical form e Adjust cut off values to clarify the results e Easily update product information i e new product and lot information e Search for specific data and create standard or custom reports Note Make sure you have downloaded the 2011 January Nomenclature or later Serology Equivalent file before you import catalogs or attempt to analyze sessions samples Also please make sure your collation of SQL Server matches the collation of any client instances a collation encodes the rules governing the proper use of characters for a language or an alphabet If you are not certain please verify with your system database administrator HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 14 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Product Documentation and Update Files The HLA Fusion online help contains the most current HLA Fusion information and procedures Itis accessible from within the Fusion software application by pressing the F1 key or by selecting Help HLA Fusion Help While this document the HLA Fusion User Manual is kept
91. the field and then click OK to re analyze with these antigens included HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 231 One Lambaa Inc Include Exclude Cw HLA Fusion Software Version 3 x x User Manual You can choose to include or exclude Cw antigen specificities from analysis 1 Near the top of the analysis window select the Cw check box to re analyze with Cw specificities 2 Clear the Cw check box to re analyze without Cw specificities Raw Data Table Positive beads are displayed in red text Rows highlighted in yellow have normalized values over the minimum value entered in the Min Value box Changes made to the normalization formula and minimum normalized value apply only to the raw data table and not to analysis 1 From the analysis window click the Raw Data button in the bottom night of the analysis window to display raw data table 2 Click on a header to sort the table by that category 3 Click in the upper right corner of the table to close the window and to return to analysis A Raw Data Table Raw Data Table Sample BSmith 01553 Patient SB 2101 Session LCT_20120330085145_LCT 60ABC_031_00 Test Date Catalog LCT 60ABC_031_00 Pos Threshold x2 ME EA Raw Ran s1 s2 s3 s ss se s7 ES HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x astas e Jo ax az os pes ows ows ows ise eee ras
92. the Export button located at the bottom right above the Save gt gt button to export session data into a file similar to the Luminex output CSV format If you have a separate workstation for ELISA and analysis the exported file can be imported for analysis and used on another computer Raw Data Table Positive beads are displayed in Red text Rows highlighted in Yellow have normalized values over the minimum value Changes made to the normalization formula and the minimum normalized value apply only to the raw data table and not to analysis 1 From the analysis window click the Raw button at the bottom right of the analysis window to display raw data table HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 205 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Raw Data table A Raw Data Table Sample TEST 1 Patient Session Test Date Catalog LATM10X5_009_02 Pos Threshold x4 2D 112 QA 1 i GA 1 BLANK 1 BLANK 1 1 BLANK Class 1 Hix Class I Hix af BwMIX BwMIX DQUIX DOMIX AMIX AMIX DRHIX Class II Hix Class II Hix NAC HAL BLANK OT har i l j l l l l l l I i I G h h AS e a d H Click a column header to sort the table by that category Click the Exit button at the upper right corner of the table to close the window and to return to analysis Raw Data Quick Report For easier navigat
93. the system clipboard so it can be pasted into an Excel spreadsheet Pairs Force Type SubType Match Sero Allele 1 Allele y A 01 56N TEDEN Type Subtype Tab _ A 01 58 A 01 59 Oren When an allele from the left side of the list is Allele1 selected the matching allele s are highlighted on lag side to show the possible match ups in the amar 3 gag selected amz allele 2 result Type Subtype Tab HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 99 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Note The side by side placement of the two lists is not intended to imply any allele pairing Match Tab The Match Tab displays the coded format of the actual allele pairings for the sample A Matched Reaction Pair is a pair of alleles or group of alleles with a reaction pattern that completely matches the reaction pattern of the current sample Pairs Force TypeSubType Match Sero Alee o Al e2z e This result differs from the Possible Allele Code results The Possible Allele Code condenses the results into a single code where possible e Hovering your cursor over a coded allele format displays its code definition Match Tab Sero Tab The Sero serology tab displays all suggested serology equivalent data for the sample based on the possible allele pairs Note Make sure you have imported the current serology equivalent file t
94. this feature if the current NMDP file was recently imported Note For individual samples the replace code function can be performed by selecting the Reanalyze button from the analysis window HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 70 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Configure LABType Analysis for the Current Sample Global default LABType configurations can be set from the Utilities menu In addition configurations can also be set from within the LABType analysis window for the current sample Change Configuration for the Current Sample Before starting analysis you can change analysis options for the current sample by using the configuration menu as shown below Changes to configuration settings during analysis affect the current sample only To change configuration settings for the current sample click the Set Config button at the top of Quadrant 1 of the analysis window Set Config button on the QC Graph in Quadrant One Ran Rec Site Local QC Patient Sample Results One Lambda OC ID 038 Probe ID A126 Max Scale HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 71 One Lambaa Inc Assign Code By default Fusion assigns NMDP codes to the alleles However you can optionally change these codes to one of the following options Bw4 Bw6 in Serology Bw4 Bw6 in Serology h HLAF MAN
95. to open the Update Reference Files screen Click to open the Available Reference Updates screen catalogs display nomenclature dates and revision notes Click to edit the MicroSSP global settings Click any link to display the selected catalog worksheet or probe primer worksheets Open worksheets and probe primer sheets to verify the accuracy of revision numbers these documents do not contain a revision number in their filename 1 Begin by clicking the Batch Entry button at the top left side of the screen Place a check mark Y next to Include Imported if you also want to bring in batches which have previously been imported The Batch Entry windowis displayed HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use Micro SSP Include Imported 119 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Select locus to filter catalog list Sample Name field Patient ID Field Batch Name Micro BSP_20111215142100 Existing Batches Sa Batch Date 6 18 2012 12 15 2012 m Sa AAA HA Go to the Browse for Start a new batch Save the current Micro SSP batch information analysis screen CSV files The system assigns a Batch Name automatically Optionally you can change the name Note A batch must be unique to the Fusion database for each product type If it already exists the software prompts you to rename the batch It is highly reco
96. to unarchive the catalog belie The letter A i indicates that pm a the catalog Place a check mark here and Ei RSSO1A 01 _ 08 ILABTy has been click the Archive button to archive the catalog C foson een R5SS014A_12R_00 LABT From the Archive Catalog window select the check boxes next to the catalogs you want to unarchive and click Unarchive Viewing Catalog File Information You can view information about a catalog file and generate a report from the Catalog Information menu Catalog files displayed with an A in their Status column have been archived 1 From the Main Menu select Utilities gt Update Reference gt Catalog Management 2 Click a column header if you want to sort the catalog file list 3 Click Report to display a printable exportable report of the currently displayed catalog information Deleting Catalog File Information You can delete a catalog file from the Catalog Management menu Catalog files displayed with an A in their Status column have been archived HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 306 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual From the Main Menu select Utilities gt Update Reference gt Catalog Information Management Select the check box next to any catalog you want to delete Click Delete to remove the catalog information Reporting Catalog File Information You can view and
97. top of the LAT Home panel Analysis 2 Inthe top text field of the next window enter a unique name for the new manually A entered LAT Analysis session 3 Click the Down Y Arrow of the Select Product Catalog field and select the appropriate LAT Product Catalog 4 Next type in the correct Test Date or click the Down Y Arrow to reveal the pop up calendar and select the test date LAT_20120106150035 ea Pod Cl amiamo mam Test Dista 10183013 o eb ed 5 a Mu LATM20X5 011 00 EN october 2012 sun Men Tue Wed Thu 5 Click the Next button The Data Input Menu displays Sample Date 10 16 2012 y Top Sample c This allows you to input reaction values for a new sample You can enter the samples and reactions into a session a 10 test tray or a 20 test tray Data may be entered manually by clicking on each well or by obtaining raw data values from an ELISA reader 6 Enter a Sample Name s A unique Sample Name is required for analysis The Sample Date may be changed here if necessary w co J lez th po w ro O E F G ojala O 0 Aso SER rm HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 193 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Manual Batch Entry To manually enter a more than one session for analysis do the following 1 Click the Batch Entry button Batch Entry A blank Session Summary Scree
98. v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 55 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Analyzing Exon 4 Sessions HLA Fusion allows you to analyze Exon 4 data with generic HD or non HD LABType samples to provide higher resolution results You can apply Exon 4 resolution to locus A B or C typing data Please follow these steps to analyze LABType samples with Exon 4 resolution 1 Click the LABType button Bum The LABType home page is displayed LABType Home Page Exon 4 Luminex Luminex 1 S 2 3 Session ID 0406workshop_A_Lot 7_1D402 Date 8 29 2012 8 29 2012 y Samples jam File Path c OLI FUSION Catalog ID RSSO1E47_001_03 z NOM Imat January 2011 3 3 0 0406workshop_A Lot 7_1D402 0406workshop_B lot 9_1D403_Toks_Manb 0406workshop_DRB1_lot 10_1D405 Ethnicity A 0407wkshp_rssoB1_cl_ID1047 0407workshop_DP_DL_ID324 0407workshop_DQ_CK_ID322 040 7workshoprssoB_011_1D320_ManipulateMrT J o 10022008RSS0Q_003RR_ID696 Q Alleles_UNICAMP_PLC244_A7_150906_ID lt lt lt lt lt lt lt lt Le Le Le Le ee Le E EE EE EE EEN itt Lcr 2 Click the Download link on the upper right side of the LABType home page and download the catalogs you need to analyze generic A B and or C locus and Ex
99. without restarting Fusion Updating Catalog Files from the One Lambda Download Site e Product catalog files are available on the One Lambda download site http download onelambda com 1 From the main or any of the product home pages click the Download link or from the main menu select Utilities gt Update Reference gt Update Reference File The Update Reference File dialog box displays 2 Click Auto Update to open the One Lambda Catalog Updates Selection window 3 Select the check box next to the files you want to import Click the plus or minus signs on the file directory tree to locate the catalog files for each product You can also click Select All or Deselect All to select or clear all the check boxes at once HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 299 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 4 Click Import to import the selected catalog files 5 When the confirmation dialog box displays import results click OK 6 Click Close and then Yes to return to the Update Reference menu Imported catalog files can be used without restarting Fusion Note You can also click Go to OLI click the links for the products and catalog files you want to import and follow the download instructions If Auto Update does not respond verify your network connectivity and that the URL you set for One Lambda in Utilities gt URLs amp Paths s correct
100. 0 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 152 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual LABScreen Analysis The LABScreen analysis feature of the program allows you to analyze Luminex CSV output files from LABScreen products Analysis results are based on the catalog specifications provided with the HLA Fusion software A few things should be completed or verified before you start an analysis session Note Make sure you have the latest catalog files You can download or update catalogs from the LABScreen Home Page Some features such as w632 normalization may not be available if you have not already imported the appropriate catalog s View and modify global product configuration settings before starting analysis Global settings are displayed and be can be modified on the LABScreen Home Page or through the Utilities menu Global settings apply across all newly imported sessions Save time importing CSV files by verifying that the default URLs and paths are pointing to the locations where these files are commonly stored on your system or network These settings can also be modified in the General Configuration section of the default Fusion Home page If you prefer HLA Fusion to stay on a sample you have just saved or confirmed rather than automatically move to the next sample this can be set in the General Configurations section of the Fusion Explorer Home page Some of the abov
101. 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 16 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Limitations of the Program All One Lambda software products are designed to assist personnel experienced in HLA analysis by suggesting typing and antibody screening results However results must be carefully reviewed by a person qualified in HLA typing or antibody screening to assure correctness This software may be used to aid in suggesting results but should not be used as the sole method for determining reportable results This software is meant as a laboratory aid not as a source of definitive results For the reliability of patient information stored in the database users must ensure that the identifier for each patient is unique and that each sample identifier is unique The storage capacity of HLA Fusion is limited by your version of Microsoft SQL Server Please see the Fusion Database Utility Users Guide or the Microsoft website www microsoft com for more information about the storage capacity of the various versions of SQL Server HLA Fusion assumes that data for each required input is in standard format that has not been modified Raw data files must be in a Comma Separated Values CSV file format and must follow these guidelines e The data file is a CSV generated by LABScan100 using software versions 1 7 2 2 2 3 or xPONENT 3 1 e All HD products must be acquired on software version 2 2
102. 01 01 03 A arororaz i A 01 01 03 reaction A pattern A201 01 05 A 01 01 07 Bead ID s for LabType tests used in combined Default configuration analysis with the current MicroSSP sample e Wells Beads if it s a combined analysis with LABType are sorted by sample reaction e The well ID depends on the row and location of the sample in the test gel pane e The current sample appears in a Blue font just below the cross loci row e Positive alleles are listed below the sample row and are highlighted in yellow e Cross loci wells are identified with the pound sign e Salmon coloring indicates a false positive Green indicates a false negative HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 132 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Positive reactions are displayed as an X on the table blue for the current sample and black for the rest PC NC and excluded beads are displayed as 0 on the table If you want to expand the table to full window size click the button To minimize it again click the button Double click in the area just above the table between the Find Allele and Max buttons to expand the table to half the analysis window To size the table back to its original size double click in the same area again Type an allele into the field and click the Find Allele button to display the allele and its rea
103. 07_03 4 Select an existing negative serum or Select NS Add New NS Name Current NS OLINS Default NS 104 8 206 2306 1828 8 9 6 5 A 156 as Sa 152 8 ME 197 2 153 6 191 1 1655 104 156 230 168 130 165 7 Select Add New NS Name from the pull down menu to create a new negative serum Type a name for the new negative serum into the Current NS field Edit Default NS values for the desired beads Click Save to save the changes LABScreen Mixed Product configuration Click Close Set Mixed Product Configuration HLA Fusion Le JELAMBDA 000 Changing LABScreen Mixed Product Configuration You can change LABScreen Mixed analysis positive and negative threshold settings for each product or lot The new cutoff threshold values are used in every analysis session for that product or lot 1 From the LABScreen home page click Edit or select Utilities gt Antibody Product Configuration from the HLA Fusion main menu 2 Click Set Mixed Product Configuration to open the LABScreen Mixed Configuration menu HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use Catalog ID LSM12NC6_015_03 7 Class Positive Threshold 19 Negative Threshold 12 Nc Threshold 50 Class Positive Threshold Negative Threshold Ne Threshold MIC Positive Threshold Negative Threshold Nc Threshold 315 One L
104. 1 004 WS R550151 004 BPI T Status Ba r gt A User Name Po Server Name local SQLEXPRESS Database Name FUSION New ver 3 0 0 This user interface option gives you access to the individual product home pages import data and view analysis windows It also allows you to view or access system or product data reference file downloads and configuration settings Note If the current page does not show updated information upon modification or downloads go back to the main Home page and then return to the product home page to see the changes This interface is what you will see when you first log in to HLA Fusion 25 HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual To display the home page for one of the products listed in the bottom left area of the page click the button or menu option For LABScreen e From the main Fusion home page click the LABScreen button or click the LABScreen button on the HLA Fusion toolbar at the top of the screen OR Y e Select Analyze Data gt LABScreen from the Fusion Menu Bar Notice how the screen changes to fit the selected One Lambda product Note Migrated and upgraded databases use the same interface If you want to make one of the product home pages the default home page so that each time you login to HLA Fusion that particular home page is displayed do the followin
105. 1 1a abe32bd 4 10 2012 DREHS A HD Fl x 402012 Blue Assagneed Albea Black Hol Assigned 5 Select one sample or several by holding and dragging the mouse and use the left arrows button lt lt to assign these samples to a well in the plate Repeat this until you have completed your plate design To remove a sample from the plate highlight the well containing the sample and click X 6 Click Optimize to allow the Fusion system to organize the selected samples appropriately on the plate 7 Click Save to save your plate design HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 274 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 8 Click Report if you want to view and print a report of your plate design information Well Position Sample ID name and Test ID name 9 Click Export to Luminex IS to create a plate design that is exported and can be opened and used from the Luminex IS software If you select this option you will need to assign Luminex templates to each test type in the plate design Reports Assigning Luminex Templates Export Plate to Luminex IS software This utility exports the plate design to Luminex IS software Plate Multi B atch Hame Platel Esport to Lumines salseves TOL Templates Selection Export to Luminex 15 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 275 One Lambaa I
106. 10101 A 240211 G2 A 01010101 A 240213 62 A 01010101 A 240214 G2 A 01010101 A 2405 6G2 A 01010101 A 2409N G2 A 01010101 A 2411N G2 A 01010101 A 2415 62 A 01010101 A 240202 G2 4 01010101 A 2421 G2 A 01010101 4 2423 62 A 01010101 A 240202 G2 A 01010101 A 2426 G2 A 01010101 A 2427 G2 A 01010101 4 2430 62 A 01010101 A 2434 G2 A 01010101 A 2435 G2 A 01010101 A 2436N G2 A 01010101 A 2437 G2 A 01010101 A 2438 G2 A 01010101 A 2440N G2 A 01010101 A 240202 G2 be lt ta e If the Demographic Information option is not available e grayed out it means you need to import an allele frequency input file On the Fusion Menu bar select Utilities gt Update Reference gt Allele Frequency Click the browse button and locate the Allele Frequency files Click Import Allele Frequency Minimum Positive Control Set Minimum Positive Contral NMDP Code No Code Local Code P Grouping The default Minimum Positive Control value assigned by the G Grouping system is 1000 If desired enter a new value in the Minimum Cross Code Positive Control Value field and press the Enter key on your Bw4 Bw6 in Serology Demographic Information keyboard Minimum Positive Control gt Minimum Bead Count b Set Sure Reaction Bead view QC Low Positive Threshold HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 73 One Lamba
107. 204 D B1 030101 D B1 030102 DAB1 030103 DAB1 030201 DAB1 030202 DAB1 030203 DAB1 030204 D B1 030302 DQB1 030303 DOB1 0304 D B1 030501 DAB1 030502 D B1 030503 When you click the Bead Info tab it displays the 030804 DOBI 0308 DORT 0308 DOBI 0309 DOBISO310 DOBI al i th tl ed b d DQB1 0319 DAB1 050101 D B1 050102 DAB1 050201 DAB1 050202 DAB1 050301 lele specificities of e most recen y select ea D B1 050302 DOB1 0504 DAB1 0505 DAB1 060301 DOB1 050302 D B1 060401 DQB1 060402 DOB1 060403 DOB1 060501 DAB1 060502 DOB1 0606 DAB1 0607 from the OC histogr am Or bead profile gr aph as well DQB1 060801 DAB1 060802 D B1 0609 D B1 061101 DAB1 061102 D B1 0612 as the recognition site of the probe DGB1 0617 D B1 0618 D B1 0621 D B1 0625 D B1 0626N D B1 0627 D B1 0628 DOB1 0630 Bead Info Tab HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 91 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Quadrant 3 Reaction Profile The Reaction Profile Quadrant3 displays the reaction profile for the current sample against all beads in the analysis Change the value of the Click to view the difference between signal normalized scale Y axis strength and cut off value for each bead Maximize button Max Scale Reaction Data Bead ID 027 Bead Count 143 1 Normal Value 0 Raw Data Tammed Mean 9 57 Sample Cutoff 45 OLI Cutoff
108. 4 LGS z OSL NARA O OOOO 0 100 0 0 0 42 90 0 Reports View Records Screen 2 Clickthe View Records button 3 Usethe arrow buttons to navigate through samples 4 Click the View Analysis button 4 4n4ss_ to open the analysis window for the current sample The analysis window can be resized HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 253 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Reports View Records Screen _ Data Display Sampla ik 1073 berg Session EX 012000_1012_19_ 10404 MALocus Dingie Antigen lt lt gt gt gt Local Mr Catalog i LJIADLNCS DO 0 Operator TestDate jun 15 2000 C Moca Test Chose Test Pos 11003 Noten NO Raw t 00 5 Click the Close 2 button to close the window and return to the Reports window Patient Info You can view patient records associated with selected samples by clicking on the Patient Info tab Patient information can also be viewed by patient ID using the Patient look up function of the Patient Management menu From the Patient Info menu you can view Patient Donor records To view patient information you must select a sample s You can view but not edit the displayed information 1 Select sessions or samples from the Reports window that have an associated Patient Donor ID 2 Click the Patient Info button Pate The Patient Donor information scree
109. 45 Beads in numeric order e X axis Beads listed in numeric order from left to right e Y axis Normalized value positive e Data points Bars represent the normalized value for all beads in the current sample e Bar colors Positive reaction Red negative reaction Blue current bead Green e False Positive or False Negative e Excluded bead Gray When a bar is selected on this histogram the bead profile histogram in Quadrant 2 and QC panel histogram in Quadrant 1 refresh to display the selected bead HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 92 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual This histogram may be expanded when you click the Maximize button at the top left corner The histogram maximizes to the width of your screen allowing for more space to view the bars in graph Click the button again to return the histogram to its original size within the quadrant The diamonds inside the histogram indicate the current cutoff position for each bead Bead level cutoff adjustments can be made in this quadrant by dragging and dropping the arrows within the bars To adjust bead cutoff values follow these instructions e Click and hold the bead cutoff diamond and drag it up or down to a new cutoff setting The cutoff value is displayed next to the cursor and changes as you drag the bar up or down Adjust Bead Cut off Settings Click drag and
110. 5502B1_015 06_LA4B y TONE LAMBDA Create new QC Session Dialog Box HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 112 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual After accepting or entering the name click the Create button e The system then saves the current session as a local QC using the selected name appended with a date and time stamp format yyyymmddhhmmss e Fornew sessions this local QC is available for selection from the catalog file drop down list when you import LABType sessions e This QC is also listed in the View QC drop down via the LABType sample configuration menu when you open a new analysis session Set Config Local QC after being selected from View Lab QC Session Review This right click option provides various sub menus filter criteria that allow you to review the samples in a session according to the type of results obtained Review All Review All default all samples are listed and available oe for analysi S Multiple Pairs Not Analyzed e Single Pair only samples with unambiguous results are Miss listed samples displayed with red square markers in the False Reaction Results Summary graph on the session Summary tab e Multiple Pairs only samples with ambiguous results are listed samples displayed with orange square markers in the Results Summary graph on the session Summary tab e Not Analyzed
111. 7 17 2011 99 0406workshop_B_lot 9_1D403 130907_LSM_13_ WBCO006_ID53 O406workshop_DRB1_lot 10_ID405 O406workshop_C_lot 6_ID404 20080116 _PRAI_LOT11_ID42 06 28 05 John Hopkins LS2_009_2 06 28 05 John Hopkins LS1_009 1 042007lsm12_013lo_ID1051 042007L52401_004_1D329 02131_LSM12_011_01_ID3214 021308 LSM14 hna lot g_ID69 FlowPRA_20111117170511_FL2HD A FlowPRA_20111117170441_FL1SP ris When you select the Session Date option sessions are displayed in order of their creation dates YI A 2424424444 iaaa YY Otherwise the use of this tool is the same as described above in Group by Product HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 29 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Accessing HLA Fusion Software Functions Main Menu Options A HLA Fusion y Analyze Data Reports Data Sample Patient Info Profile Utilities Help Exit pu Ala a a gt EA e Options on the Fusion Menu Bar You can access HLA Fusion functionality at any time from the toolbar s Main Menu which is displayed at the top of all HLA Fusion application windows See the following sections for a list of the options available under each main menu item Analyze Data Analyze Data O LABType Each option under this menu item is either a molecular or antibody product Micro SSP for which you can import CSV files or manually e
112. AB DR14 21028 1100509 2103 0AB DR14 21028 1110493 1296 0AB DR14 21028 O 10449 0234 4AB DR14 21042 O 1 20449 0235 1AB DR14 21042 O 1 30449 0238 5AB DR14 21042 40449 0239 3AB DR14 21042 O 1 50449 0236 9AB DR14 21042 O 60449 0237 7AB DR14 21042 0 70509 2113 9AB DR14 21028 1 80509 2111 3AB DR14 21028 90509 2106 3AB DR14 21028 1 100509 2103 0AB DR14 21028 1 110493 1296 0AB DR14 21028 4 4 2012 4 4 2012 4 4 2012 4 4 2012 4 4 2012 4 4 2012 4 4 2012 4 4 2012 4 4 2012 4 4 2012 4 4 2012 4 4 2012 4 4 2012 4 4 2012 4 4 2012 4 4 2012 y Note Sample ID limited to 50 characters Additional characters would be truncated upon import The Import Sample List wndow displays yA HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x Click the Search Sample List button browse for the sample list to be imported and click Open Type a name in the List ID field and if necessary select a Lab code or Contact ID from the drop down list Confirm sample information and edit if needed Click to clear the check boxes of any samples you do not want to import Click Import List to import the selected sample lists Click Close to return to the Main Menu For In Vitro Diagnostic Use 265 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Information Formats for Sample Lists The information inside a sample list you import into HLA Fusion must be in one of the following formats
113. B Ml El oa aa Comments D more Test So a a 3 a ana aaa w B ap aH a nF Blank 1 HLA Neg 1 HLA Pos L Pos Neg 0 06 QA 1 Well 13 PID LID SID LATMIXEDTest0 1142012 aD LATM10x5_009_02 NOM Imgt Test Date 4 14 2012 Ver 3 0 0 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x 200 For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Entering Data and Reaction Pattern The data input menu displays the current reaction for an existing sample or allows you to input reaction values for a new sample This area allows you to enter the samples and reactions into a session 10 test tray or 20 test tray Data may be entered manually or by obtaining raw data values from ELISA reader ReAnalyze Blank 1 HLA Neg 1 HLA Pos L Pos Neg 0 06 QA 1 Data input and reaction pattern 10 test tray e The format of the data input section mimics an LAT mixed analysis worksheet The reaction input panel has a tray layout The row of wells for the current test is highlighted by a blue rectangle e Each well is a button that cycles through reaction values 1 8 6 4 2 0 Buttons are color coded to match the reactions e You can enter reactions by clicking a button and typing a reaction value or by clicking the button until it displays the desired reaction When the button changes the focus shifts to the next button e Button navigation occurs from left to right 1A
114. Bottom Sample fields and press the Enter key for two test trays enter both top and bottom sample names Enter reaction patterns by clicking on wells to change the reaction value Or select a well and type the reaction value HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 208 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 3 Clickthe Reanalyze button There is no requirement that all wells of a tray be used The tray input is a group of buttons representing each well The buttons cycle through reaction values when clicked 1 8 6 4 2 0 By default 1is displayed The colors of the buttons reflect the values entered 1 Green 2 light blue 4 magenta 6 red 8 dark blue You can enter reactions by clicking a button and typing a reaction value or by clicking the button until it displays the desired reaction When the button reaction value changes the focus shifts to the next button Button navigation is from left to right 1A 1F 2A 2F etc The image of the tray button order well position etc emulates the actual LAT tray that is run So fora 2 test tray the top of the tray is shown first for the first sample and the bottom half of the tray is shown second for the second sample When you add a new tray the top half is displayed first then the bottom half if applicable You can add information about the tray such as expiration date by clicking the I
115. Click the drop down arrow in the Sample Date field and select a date The analysis window for this session is displayed 8 Enter an ID in the Patient ID field If this is an existing patient donor ID other fields such as the First and Last Name and Ethnicity are populated with existing data You can also double click in the Patient ID field to display the Select Patient window from which you can search for and select a patient ID If they are not already filled in you can enter a name for the patient or donor in the First Name and Last Name fields 9 Ifitis not already filled in click the drop down arrow in the Ethnicity field to choose the patient donor ethnicity 10 If not already filled in click the drop down arrow in the Patient Donor field to choose either patient donor or both 11 If you want to associate a gel image with the sample double click in the Gel Image field and browse to the location of the image you want to add to the sample Note Fusion supports the BMP JPG BMP and TIF image formats However certain versions of the TIF format may not be supported by the Windows version used on your computer Select Gel Image Browser Easting Batches e Rind Batch Date xl g ys o v Data Reference Files Micro SSP v a Search Micro SSP 9 j Organize New folder Wiz Image dna 149 dr15 jpg El File name Jans 149 dr15 jpg e Repeat the above steps until you comp
116. Click to modify LAT global settings LAT Analysis Configuration settings de net apply to LAT Mixed Analysis _ Catalog Description Lambda Artigen Tray Case 14 1 2 Tests Lot 002 Lambda Antigen Tory Cinsa 14 li 2 Teata Loe Lambda Artigen Iray Cass 14 ll Z Tests LATON Lambda Antigen Tray Class 14 Ii 2 Tests Lotmoos Click these links to display selected catalog worksheet doc uments La GodA Lambda Antigen ley asa 14 ii 2 Tests Lambda Antigen Tray LATTM Class 14 11 Lot1 007 Lambda Antigen Temy LAT Claas 18 11 Lee E 004 Lambda Artigen Iray LAT Olas 14 Il Lat A OOS Lambda Antigen Tray LAT Class 18 ll er Aedigers Tarry LAT Class 1 4 Il Let 2007 Lambda Antigen Tray Class 1 Lor 2 004 Lambda Antigen Tey Cinsa 1 Lot 2 005 Lambda Antigens Tray LATTM Cass Lott006 Lambda Antigen Tray Clase 1 2 Tes Tray Lot 004 ATI 004 Y Place a check mark HLA Fusion here to include bs previously imported CSV files CSV File ra list LAT Product Documents Note Open worksheets to verify the accuracy of revision numbers these documents do not contain a revision number in their filename HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x 192 For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Single Session Manual Entry To manually enter a single session for LAT Analysis do the following 1 Click the Manual Entry button at the
117. Donor Info ID Patient D Fl i atient Donor Flag Patient ba SEPEN Diagnosis Family ID Country Blood Type First Name Postal Code Middle Name Rh Region Status Last Name Phone Birthdate lt Select Date gt a Mobile Transplant Type Gender eh et NR Work From Other Facility Facility Name Category Group iman Animal Fax SSN Email Address Ethnicity Address Donor Center ID Employer Division Hospital Name City M Spouse Info Spouse Name Blood Type Emergency Contact Phone 7 NONE LAMBDA Patient Donor Information Screen e Patient Info Profle Utiliti Import Patent List Manage Patient You can also open the Patient Donor Information screen at any time by clicking Patient Info on the Fusion Menu Bar followed by Manage Z Patient HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 37 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Related Records A Related Record is a sample that is associated in some way with the current sample or patient From any Analysis Screen click the Related Records button to load all records related to the current sample into the drop down list in the Sample ID field Use the sample navigation arrows to display the analysis of each related record one by one To exit from the Related Records mode and return to the previous analysis screen click the lt lt Summ
118. Fusion 3 0 0 Testing Luminex xPONENT 3 1 Test http www onelambda com Source pdffiles laa pedos ss Convert One Lambda Inc P G Groups Download URL nba clic MAHLA Fusion 3 0 0 Testing HD Converted files One Lambda Inc Tutorial Video Download URL at http download onelambda com pub Aray_info Windows HLA_Fusion_Catalogs Document HLA Fusion Tutori c OLI FUSION dataWHLA Fusion Tutoria e ONE LAMBDA ONE LAMBDA URL s Tab Paths Tab 2 Entera URL and verify it works by clicking Ls For paths use the browse button to locate the directory you want to use for the specified purpose e g where you want to store reports when they are generated 3 Click Save Ls Activating Products Analysis Product Selection E The Products Selection option on the Utilities menu allows you to activate or de activate the various OLI analysis products that may be used with HLA Fusion HLA Fusion Please select the product s 1 From the Main Menu select Utilities gt Products Selection Select or clear the check box next to the product s you wish to activate or de activate Note Please select at least one product Select Activate products Click OK Lx HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 320 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Software Validation The HLA Fusion software has
119. Fusion menu HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 273 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 2 Enter a name for a new plate or select an existing plate name from the Plate Name drop down list to edit a plate Plate Designer Last edited from Ta Plate Name 11 1 2012 El Y 4 2013 E Assay type 3 Select LABScreen or LABType from the Assay type drop down list 4 Do one of the following to search for samples e Click the Search by sample tab use the search criteria to specify the samples that you would like to assign to the plate wells and click Search Search e Click the Search by test list use the search criteria to specify the test lists that you would like to assign to the plate wells and click Search Search Create a plate design Search by Test List Search by sample Search by test list Extemal File Tesi assigned between Test name Test hat Fromm To A j veaz ba 4116 2012 h Test List Sample Update Date Plate Design Plate Detal beslist _1 4710 2012 su u Fi 4702012 000000000000 Fdo ener 000000000000 F1 4710 2002 F1 noan 0000000 T pd 0000000000009 Fl FI arroz OL J9191 101 11 101 10 ae 0000000000005 F1 1 AO tenini 4wa F7 1 Alan 1 2 3 4 5 m Fl 6 3 A 470202 p Fi 7 4410 2012 A IOLDI IOL I I IOL I B A 3 oO F1 13 be 4 10 2012 Tests BC DREI BWA DOA DOB DOA DOB F
120. HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 68 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual jagaan Field Chooser Field Chooser xi Analysis Date Analysis User Assigned Allele Code Assigned Allele Pair Assigned Sero Bw Catalog Code Definition Comment e Click on any column header of the Summary Table to sort the table by that column The triangle A in the column header indicates the atalgg R5S01C_005_07 NOM sorting order up for ascending and down V for descending Comment Repositioning a Field Conon Date Exon2 Ed e Columns can also be dragged and dropped to tPossiffs AIEE JOUS Exon3DPA1 Eso change their order e When you close the Field Chooser a pop up message displays to let you aac choose whether or not to save any changes you made If you click Yes your oe el Ge changes are saved for all future LABType session summaries on this same ae sl computer until further modifications are saved e Click the Export button to save the Summary Table on your computer or the network default location is CA OLI FUSION data report The file is saved in Excel XLS format e Click the Print button to immediately print out a report of the Summary Table An Exported Summary Table Excel Spreadsheet format Al fe Position B D E F G H J K L M N Local ID Locus Patient Exon2 DqExon2 Dq Exon3 Dq Exon3 Dq Min Bead NC Possible
121. HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 300 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Updating Molecular Typing Reference Files Reference files contain allele code and serology equivalent information used in analysis It is important to update them regularly for accurate allele code and serology assignments From the Update Reference menu you can download the necessary files e NMDP codes e Local codes e Serology Equivalent files Updating NMDP Codes from a Local or Network Drive The National Marrow Donor Program NMDP provides a list of allele codes that can be used in molecular typing analysis If you have a current list stored on your local or network drive use this procedure to import it so HLA Fusion can access it The most current NMDP code file is available on the NMDP download site 1 From the main or any of the product home pages click the Download link or from the main menu select Utilities gt Update Reference gt Update Reference File The Update Reference File dialog box displays Update Reference File M Import Directory Folder Directory 2 Select the NMDP option p NMDP Code Local Code PGroup G Group Serology Equivalent option Import NMDP Information on last Ps Version Update Date 4 13 2012 Last Download Date 4 13 2012 Go to NMDP download and update PONE LAMBDA 000 Ready U
122. HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 4 One Lambda Inc HLA Fusion Software Version 3 x x User Manual Miim IE COG CON ada AAA fessor O TOET 74 Set S re Reaction BEGG ida 74 VICW OC iorta A rA A A ateueaacee 75 LOW POSITIVE TR CSIOIG SCLUING a E E EET A E A to De 75 USING THE LABTYPE DATA ANALYSIS WINDOW ssessessesssoseossossossossoseseossoseoseossossossoscoseososeossossossossossoseoscoscseossoseossossossoseo 76 KEYBOARD SHORTCUTS FOR LABTYPE ANALYSIS NAVIGATION ssssssssssesssssssesssesssessrresressrressressresrressressessrresereseresereseresreeseresreeseeereeereeeseee 80 QUADRANT LIOC HISTOGRAM sintio 80 QC TOD anaE AE E E O O T O T E T A O N 80 R rede nEn LADA NA A AA AN 81 Rec RECOJO Site TODA AAA AAA AAA AA EA AAA ANA AAA AED AE AAA EA 83 TIE FROCO QI EOIN ON rehire eld arena ld el de ll do oe Oil a ties 85 Laca QC TOD arolia ad ecghs nedemovadta caseaeadeatianiisen de llocs 86 Patient Sample nessa ta data dt cra datos 86 QUADRANT 2 BEAD DATA sama iia 87 Beda Eolo AAA At EEC O E O eee ere eee ree eee 87 KOW TOD es recep cre clare eae De en inal nee atada rere a aes eric ote la ea 90 Bead LAO TAN A ATA AA Coe Se oT ee ene 91 QUADRANT S REACTION PROFILE clava e ra NE ATE TANASE 92 The REGCUON PrO NE aE AE E A E 92 QUADRANT Ansans ia da lacas 95 WEFO TO a E T T T meee E E T E A E tre Stretch et eee Tere 96 Assign an Al le Pair rom the Suggested USE as 97 Double click on an a
123. IC kioii 1 DAER IOTI DAS DRAS OLIOT E Treg Sero Typing Je om oF Lars yim vu gt a Frec Oh Date Range m a A Daa inaa k ne de caps E as TE lt Praia ml ni iz w St as noel Aner ui apige i EEC BMI I Mipibei Comened Ahani Coman LA 57 cae AA 2 LEE mit a Megara Cessna SOE Coman JiB log wad 7 pa 3 Bo igi WEY Ho ij ag J Comores SES bi Conrad a aay Ed por q pa Fi aer 1 AHIMA Comm E Cortnad iF 1 AM Samples TO ab 4 ESTER dar BO anah Abana Comes 200TH Coma FO aed i ihm Binat IHH BB Corra DINA Commend Jot ki 2 E DORADA T ikog Bic Ta Gh PE MEE qail 2 11 LLAD Loi T UE LEILI Eiri i a 7 a le A HAT 11 Cork Cath ah ab Lia Let LETADE Figi ar 7 Oban t BH n s JAO air anh ea Baia Dosana Sie Cosa AHO a Examples of the graphs that can be displayed with Ab Tracking THA OPt gt DATO DOTADO DATAN H ATAJA e o o e Auto Scale Set Min Scale F Set Max Scale Include Allele Options ee ee a 4 DREO J available Set Time Scale Interval Days 7 DREN 0404 if you Display Sample Date for Line Chart a iw DRES f E E DRE 0402 right click Export Graph Line Time Scale DRE1 0403 on a graph Print Graph Sample include Y Antiger A nea A pa ZE Sample Dilution MS Include Antigen List 10 Select the formula to use for the graphs by clicking the drop down arrow in the Formula field Default versus Raw The formula can also be changed after the graphs are
124. ID Remove All 2 Typein a name for the new test list and click Continue gt gt HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 269 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Search for samples to add to the test list using the search fields and click Apply to view search results Highlight samples and click Add gt gt to add them to the test list Click Save to save the new test list Click Close to return to the Main Menu Viewing and Editing Existing Test Lists Test Lists can be viewed or edited at any time 1 2 3 4 From the Main Menu select Manage Samples gt Manage Test List Use the drop down list to select a test list and click Continue gt gt Click Delete List to permanently delete the selected test list Click Close to return to the Main Menu Deleting Existing Test Lists Deleting a test list removes the list from the database but the sample IDs are not removed or changed in the database 1 Ze From the Main Menu select Manage Samples gt Manage Test List Use the pull down menu to select a test list and click Continue gt gt Add remove or move samples as desired Click Save to save the new test list Click Close to return to the Main Menu Exporting Test Lists Test lists can be exported for use outside of HLA Fusion only as a txt files 1 PA 3 From the Main Menu select Manage Samples
125. IDOO2 and you analyzed it in combination with an additional analysis for the sample that same bead for the second sample analysis is listed as O02 0 in the Rxn Table The number following the underscore increments for additional samples you may add to the combined analysis _ 1 for a third sample test etc Rec Recognition Site Tab This graph maps the recognition sites of all probes in the sample and highlights those probes that pick up any of two user selected alleles for comparison e X axis probe binding site in reference to the exons amplified in the test kit used starting with exon 2 s on the left and going to exon 4 s or higher on the right if applicable to the sample e Y axis bead From the LABType analysis window in Quadrant 1 click the Rec Site tab HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 83 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual ac Rxn Rec Site Local QC Patient Sample Results Probes that are _ positive are RED Gap or specialty probes are shown connector Negative probes are colored BLUE Probes that are positive for the selected alleles are colored Red and are displayed at the top of the plot Negatives are colored Blue and are displayed below the positives Probes are identified by a horizontal bar at the location of the recognition site The probe position is labeled next to the bar e When you click
126. ING FOR ANTIGENS scared pc s 163 VieW MIC ANTIDOGY SCrECNING RESUMS a ero ben weenie 164 AUS C CUT OIS A AA AA AAA AA OIA Ta AAA ae 164 A e RA E 165 ROWIDOTE TA ES EA EA dedo e Ud 166 ROW DOT ROD OM A A A A idad 166 CREG BAR as as 167 Making AS SIG OA NES A AAA AAA AAA A A ONT 167 SO VIO ASS ONES E AA AAA AAA AAN Cucina E TAO O ERA 168 CONFIRMINGASSIGNMENTS 2 iii 168 ADDING COMMENTS TO SAMPLES cusicocrirso a i de EE NEE nen weviete des duey cox AA EAE EEEE AEAEE ASN 168 FIAGGING A SAMPLE FOR FURTHER TESTING catar dd did 169 Printing the CUeENEANGIVSIS VIA iaa 169 PREVIEWING AND PRINTING REPORTS rsssnrs sacd 169 USING THE LABSCREEN PRA SINGLE ANTIGEN SINGLES ANALYSIS WINDOW ccsscosccssccscceccesccsccescesccscceccesscnccesees 171 CREG A Seana cine aticet eda cre curaniescciiceip ly ataansic ao E E EE E dean eaten tdenaieanceacane 172 EVA AN ad 173 rollo A AAA 0 a a a 174 VIEW Molecular Ss Dec ces a A A ACA ES Aia 175 PIG JUS ECUESTRE AAA A 175 Select Minimum Positive TALESIIOIG ci a AAA AAA AAA A A A A AAA 176 chande NOTMONZOTION FOL Gs reser tenet o a o Set eet ae ha e li Ll ee 176 EXCIUGE ANTIGCH S ONAN GIVSIS vic hecedoocanespic E becsaraituewadeatinestoist vaciasaid bewcuiesdice E a boninvadcidead Sevamatven 176 CTS TE AE AAA O ese sla aera awd aa O II T 177 RESET All Options tO DE A 178 FORCE POS IVONNE aiweians 178 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diag
127. Inc HLA Fusion Software Version 3 x x User Manual Using the Reports Window The following sections describe how to create save and print a report containing your analysis data Here are the main steps you must take to create a report from this wndow 1 Select a report type 1 As needed select criteria to refine report input such as date range 2 Select the sessions or samples to include in the report 3 Select the View Report or the Export Report button Accessing the Reports Window Access the Reports window in one of two ways e On the home page click Reports button on the Fusion Explorer e Orclick sports on the Fusion menu bar The Reports windowis displayed with a list of any sessions that fall within the date range based on the session date range set in the Find eal dialog box If no session are displayed try modifying the date range Set the Shortcuts Create a Save and To format order and to other Separate Access reports sort criteria Fusion To close Report upto18 and create for report menu the reports for each different data columns options window sample dd export View Report types oe _ es we i jiy Slatebcal My Favorite S Saar oa U 1 Sample Per Report E e email a Date range a emain A report Report SBE di ee dl Mame Combined Panel Summary HMEN Ale Report isplaye title sessions Tf gre Nba 7 NM Mor 7 Well Well Satis PatemiD 7 Anal
128. Information NMDP Code a p Info Profle Utibes EAT atent o No Code Local Code The Demographic Information option allows you to organize alleles based on their frequency P Grouping G Grouping Cross Code Bw Bw Common Jan 2012 v2 Based on the demographic selection you make HLA Fusion displays as many as three allele groups in the allele pairs list e Group 1 Frequent on both alleles e Group 2 Frequent on one or the other of the alleles only e Group 3 Frequent on neither allele If the Demographic Information option is not active it means you need to import an allele frequency input file HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 124 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Using the Micro SSP Analysis window The analysis window displays detailed analysis information for each sample in the session You can review the allele assignments suggested by the program modify and accept the assignments HLA Fusion suggests possible typing results but you must make the final assignment Any adjustments made in the analysis window are sample specific and affect only the current sample From the Analysis Window you can do the following e Use the test gel pane to change reactions and sample row positions e Change the allowable number of false reactions e Force one false reaction e View and print sample analysis results e Add comments and mark fo
129. LA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual General Session Summary Features Aside from the functionality on the three LAB Type Session Summary tabs there are other features that allow you to manipulate the summary table data Sample Markers Summary Control Value Bead Analysis March M Mechs MORIA AAA AAA E AAA AAA AAA AAA AAA Sees Fabs E Session ASSO1C_006 Catalog RSSO1C_009 07 NOM January 2011 330 Locus C Session Date 2162012 Luminex Lurrinex Vermon 1769 Number of Sargia 5 Field Poswiblo Possible Possible Ez Ap elas Column Exctude Position Sample Y Pojem Comment Y Crore ele Exon3 MC ele Debinition Beod Status User Us 8 WC ox Eno GT CMON EE 030203 050 250 270 3403 3503 E ie na lt a oy nanm A O e TA B40 95 a x 100 0216 2012 Gaich imp Semet 2967 c06 co520 2029 1015 C0520 06 0206 1006 12 06 13 06 A0506 I r en c o 08200 l E TOUDE 1806 1805 2008 21082206 25062 100 Garteratt2 Basch imp Band Ft C4638 HX gt Ve 1972 10 63 E 0202 01 lt e k 00 02 16 2012 Baich imp emit r Gm cass x CHIN SNS CU Eee 100 02 16 2012 Batch imp Demis F 0147 16X 3960101 ax 0306 O A gt Baich Imp Bermit er FEA 2683 05200 CUKI 1851 1443 020201 Ae O2KI02 0702 0802 0902 100211002 ra AAA A Par E Am C06 Ge 0101 ISU 19 00 2000 2102 2302 2402260022 100 02162012 Dutch imo Demi r
130. LA2 DRB 1 HLA1_DRB3 HLA2_DRB3 HLA1_DRB4 HLA2_DRB4 HLA1_DRB5 HLA2_DRB5 HLA1_DOB1 HLA2_DOB1 HLA 1_DOA1 HLA2_DOA1 HLA1_DPB1 HLA2_DPB1 HLA3 HLA1_DRB4 HLA2_DRB4 HLA1_DRB5 HLA2_DRB5 HLA 1_DOB1 HAHLA2_DOB1 HLA1_DOA1 HLA2_DOA1 HLA1l DPB1 HLA2 _DPB1 HLA1 DPA1 HLA2 DPA1 HLA1_MIC A HLA2_MICA HLA MICB HLA2_MICB HLA_KIR ClassI_AbSpec ClassII_AbSpec MIC_AbSpec Unacc eptableAntigens AcceptableAntigens Notes SHLA1 A SHLA2_A SHLA1_B SHLA2_B SHLA1_Cw SHL A2_ Cw SHLA1_DR SHLA2 DR SHLA1_DR345 SHLA2_ DR345 SHLA1 DQ SHLA2 DQ SHLA1 DP SHLA2 DP D onorType IncludeInDonorPRA Subsequent lines must list the actual patient information alphanumerically can be letters and or numbers separated by commas If there is no information for the patient in a particular field that field still requires a comma as a placeholder HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 283 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Note For all manual serology entries the locus must precede the value For example for an A locus of value 23 you must enter A23 Example Patient Donor List PatientID CategoryGrp FamilyID FirstName MiddleName LastName Ssn Dob Gender Ethnicity Address City State Region Cou try zipcode Email Phone WEPhone Cellular Fax Employer SpouseWName SpouseBloodType EmergencyContact EmergencyTel DCH ospitalName Division BloodType Disease RhBloodType PatientDonorFlg Ass
131. LIQC each Probe for the selected sample of the QC histogram Rec Site Local oc Patient Sample Results LAB QC buconfia One Lambda OC ID 4011 Probe ID A130 Max Scale Quadrant 1 100 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 77 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Qu ad ra n t 2 Resets the cut off Check to for the selected Displays the Displays the Displays Bead exclude the Set the numberof bead to the OLI or Bead Graph Raw Bead data information current bead false reactions User default hee Use to select beads from Current the current Sample sample Red Positive Reaction RED BAR COLORS 4 Negative Reaction BLUE Current Bead GREEN _ These bars indicate the Normalized Value of each bead in a sample Represents the Raw Data Values for the Positive and Negative Gray diamonds are the current control beads of a LABType assay cut off for each bead Magenta Positive Control Wie CEND oo pS ll A E TN ol Le Ne ative A vana ema ven y sud ss ss eee Oe A CL eet lo a ps pl o E El Le a a dn njin nin aa aa aa ai ia ia ka ia gahn g al Control Normalized Gate Beads in numeric order Qu ad rant 3 Positive HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 78 One Lambaa Inc Allows one Displays results force positive as types and or negative
132. Lac le fl Ls ls KAN 10 11 2012 10 11 2012 10 11 2012 10 11 2012 10 11 2012 dE a 3 i EME E ECHN KAN KON KAE lt lt lt lt lt lt lt lt olulolan a wn Caution Luminex 2 2 2 3 Make sure you select the CSV file from the same directory that contains all the run files and the run index file generally a hidden file in the directory that were output from the Luminex machine into a session folder Each sample in the session must correlate to a run file in this directory This is essential if the HD CSV file is not yet converted HLA Fusion automatically converts any unconverted HD files during import ifthe unconverted output file resides in the same location as the run files and run index file for that session XPONENT 3 1 The output file can be located anywhere There is no run index file But the run files must be together in a directory that is structured with the session directory and underneath that the run files A converted HD Original HD Output file Output file not converted Select CSY Files za KIEL Fe xa fa a fa fa There should be a Run Alessia 030608 DRB1 HD Session Output Rund01 Run002 File for every sample in ocuments lot 12 2 HD an HD Session HD_ID 26_52 i E y Fa a a Fa Desktop RunD03 Run004 Run005 Run006 Runo o o My Documents a fa a fe The RunFilelndex file gt Run008 Run009 Rund10
133. NG PRODUCT CONFIGURATION SETTINGS sasasasavssscasassaasonacnssennnisaorsanenusaancassssaetsananapeansnsnsisantanstauswessesaasaetansacecsess 312 CHANGING MOLECULAR PRODUCT CONFIGURATION scccseccessauiescwsqasnstnsvaniesceseneanteanadecaetaswactadsawesantaqmaartanesncanteqennbatrenys telaaeaeteaesaacattedenain 312 Creating a Combined LABScreen Session Catalog cccccsseecccseseccnsnseccnsnseccsensccsauseessuueeesausecssauseesaaueessaunecssauseesaaesessaunsessges 314 changing LABScreen Desault Negative SelM dd 315 Changing LABScreen Mixed Product CONFIQUIOTION cccccssesceccnnesseccusesececcsuseesssscueessssuueeesssaussesssaaunecessaauneeesssaueeeenas 315 Changing Antibody Screening Analysis CONFIQUrUtiON ccoccooncconccnonnnononnonononnnnonnnonnnnnnronnnnnnnrnonnnnonrnonnnnnnronnnnnnnronnnnnnaronnos 316 IMPORTA WS Meira oda 317 CHOOSING GENERAL SETTINGS orina A OE 318 P er De OU Sarai 318 SETTING HLA FUSION DEFAULT URLS AND DIRECTORY PATHS sra A AOE OAE 319 ACTUVATING PRODUCTS sor rE E ETE E EE AE E EE EAE ETET A 320 dold a 320 SOFTWARE VALIDATION iaa ANNA 321 IQ INSTALLATION QUALIFICATION sisas 321 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 13 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Introduction TM What is HLA Fusion Software HLA Fusion Software is a companion to One Lambda s molecular typing and antibody screening products This software runs in both
134. Note This option is also available when you use the Related Records toolbar button ia e Right click a sample from the Navigator and select Related Records to load all records related to the current sample into the Sample drop down list at the top center of the screen Sample ID s Navigation buttons Use the sample navigation buttons to display the analysis of each related record one by one To go back to viewing the samples in the current sessions click the lt lt Summary link at the top of the window Side By Side Analysis Use this option to compare the current sample analysis with one previously conducted Note This option is also available when you use the Side By Side Analysis toolbar button m HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 151 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual select Side By Side Analysis Sample HLA Samp 2493072 ONE LAMBDA e Right click the sample and select Side By Side Analysis e Select a previous sample analysis from the displayed list to compare it to the current one The two analysis windows are then displayed in a comparison window Side by Side analysis display Current Analysis 4 ata ar Previous Analysis e Fach window can be resized and moved by dragging and dropping e Click the Side By Side Analysis toolbar button again to cancel the comparison display HLAF MAN V3 x x EN 0
135. OA e LS A A hn A A A A AA A AM DA AA a Aa a DQ DOOR a aa na na MA DADA A HAS Cwnen 4 a SS Ae S oaet 4 awe a 3 DP Ad 23 enea nanan 04 y n a o w so oso Ss aa 0 0 0 0 yy gt a o gt lt a OP ea See 5 6 oan yv aaa gt seran fue gt Class 1 Class 1 MIC de 0 43 a Computer Assignment Positive Computer Assignment Positive Computer Assignment Positive e a pcmc T m he o 50160 Final Assignment Positive Final Assignment Pome table cs ott telbuis Current C Negative C Negative cL I pl 1 1 5 C Undetermined C Undetermined fi Pate 2 3 CL II ve 1 2 1 2 ments j I More Test gt z od O A Soe The tabs User System Click to display Save Confirm displayed change comments Comments Raw datafor assignment assignments depending on each bead type of kit used HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 161 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Note If you prefer to make Graph Raw the default view when you access the LABScreen analysis window go to the LABScreen product configuration settings and select the check box next to Display Graph Raw by Default e Both HLA Class I and Class IT are displayed in a single window on the first tab of the screening results MIC results can be accessed from a subsequent tab Analysis results are either positive negative or undetermined e Thenormalized value
136. Patient Info gt Manage Patient select Donor in the Patient Donor field and fill in the donor group field 1 For Single Antigen or PRA analysis click the DPRA button A pop up box displays the percentage of matching donor PRA and the total number of donors that were considered in the calculation HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 214 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 2 Click OK to close the box The percentage and number of donors remains displayed next to the Donor PRA button Adding Comments to Samples Comments that you or Fusion add to the Comments Field are displayed with the results in the current analysis session data look up and reporting functions in HLA Fusion e Inthe analysis window type sample comments into the Comment field below the Assignments area You may click and drag the bottom right corner to resize the Comments box Comments are only saved after you click the Save button after completion of the analysis Flagging a Sample for Further Testing Marking a sample for more testing displays the More Tests check box for the sample s results in the current analysis session in all analysis data look up and reporting functions in HLA Fusion e Inthe analysis window check the More Tests check box located below the Epitope Analysis Results section M Reports Data Sample Patentinfo Profle Previewing and Printing Reports SEB
137. Reference gt CREG Information Management The CREG Management window displays CREG Management screen x HLA Fusion 0 0 0 0 0 9 0 CREG Type OLI New CREG Type Group Detail z opie AASA eO AAA o A1 A36 ABD AMS AZMA A244 A3 A1 Eo AAA Esce B57 4 B58 4 835 6 8534 851 4 852 4 878 6 B62 6 863 4 875 6 876 6 877 4 871 6 872 6 849 4 850 6 818 6 837 4 B37 4 B27 4 B47 4 B13 4 B7 6 B41 6 B42 6 B46 6 B48 6 B73 6 B81 6 B60 6 B61 6 B54 6 B566 B5506 pee BB 6 B39 6 B67 6 B64 6 B65 6 B18 6 B38 4 B59 4 pre B13 48444B456 B49 4 850 6 860 5 861 6 841 6 84 5 B82 6 lA ECON ETT jee Bt 4 SONE LAMBDA 0 0 0 2 Select an existing CREG group from the CREG Type drop down list or Enter a name for a new group in the New CREG Type field Do one of the following e Enter new or modify existing information in the Group Name and or Group Detail fields and click Save e Highlight a row of existing group information and click Delete Group 3 When you have completed CREG group creation or modification click Close Note Please verify your data before saving and please do not mix alleles with the older nomenclature format with alleles in the newer format within the same CREG table HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 311 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Changing Product Configur
138. Report Appearance Note You must be a supervisor level user in HLA Fusion and have Crystal Report Designer software installed on your computer to use this feature This feature allows you to format the appearance of HLA Fusion reports to meet your specific needs For example you can change font style size and color as well as the location of text and data fields on the report e HLA Fusion automatically launches the report designer if it is installed in the default directory C Program Files Business Objects Business Objects Enterprise 12 0 win32_x86 crw32 exe e Use Notepad to open theOneLambda Fusion Interface exe file located in C Program Files One Lambda HLAFusion IvD Make sure that Crystal Report Designer path name is entered on the following line of this file see figure below lt add key ReportDesigner value C Program Files Business Objects BusinessObjects Enterprise 12 0 win32_x86 crw32 exe gt Editing OneLambda Fusion Interface exe P Untitled Notepad File Edit Format View Help lt xml version 1 0 7 gt lt configuration gt lt contigsections gt lt section name exceptionmManagement type Microsoft ApplicationBlocks Except ionManagement Except ionManager Sect ionHandler Microsoft ApplicationBlocks excep tionManagement gt lt configsect ions gt lt except1onManagement mode on gt lt publisher assembly OneLambda Fusion Fusioncommon type OneLambda Fusion Fusioncommon ExceptionPublisher
139. S eae 189 ROO Lea RECO OS A eee ee 189 A A OAAR 189 ATANASIO oa 191 STARTING UAT ANA SIS id IND A AAA AS AA AAA RARAS 192 ACQUIRING LAT SESSION DA TA oi naaa 192 Smale ESSON Manua E e a OS 193 Manual BOEM ENY orin ea AE A ta 194 IMPORTING CSV FILES INLAT tic id a a a a T 195 USING THE LAT MIXED ANALYSIS WINDOW ona risas 200 ERLCTING DOCG ANA REICH POL CI eaa o eae 201 USING THE ELSA READER ca a caus E E A 202 MOKING ASSIONMENTS sorrisi TES e E EEE EEE ORE AEE OE E OEE E EEA Tri OTE 203 SOVEASSIONMENT e a E T a a A 203 CONFIRMASSIGNMENTS unan a a aal 204 Adang Comment SOMO SA A AA T 204 FiagGging a Sample for Further TESTA eds 204 Adding Tray InJormal ON rerasan aaa aa a 205 EXPO FUNES SON DIT A T A AA A A ASEO 205 ROWDOTETADIE di AAA AAA A E ET 205 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 8 One Lambda Inc HLA Fusion Software Version 3 x x User Manual RAW Data QUICK KEPO atada AAA ria 206 PrINtING TNE CULFENTANGIVSIS WING OW ta iaa 207 PYEVICWING ana Protina REPOSO 207 USING THE LAT PRA SINGLE ANTIGEN ANALYSIS WINDOW ccccsssssscccccccssssssscecccccccsssseeeccccccecssseeeecceeeaassseeeecceeeaassses 208 ENTERING THE REACTION PATTERN ica sn aceehosiei das atwaaleedap EO E O 208 USING THE ELISA READER arne a anestesia tito ida succes stuscaataseontohtananeaeeunauacauanstaccuated Len A 210 LAT PRAZSINGIE ANTIGEN AITOR AM a tas aro 210 CRESTA ea 211 FING ANNUO A AAA AA AAA ASA AAA O
140. SSO1S1_003_05 LABType B January 2010 2 28 0 LIE A Rssotst_oos 02 taBtype fe arwary 2010 JA RSSO1S1_004_04 LABType B July 2010 3 1 0 LIF essorstz00406 Labtype e vamaaon 330 E RSSO1S1_005 00 LABType B January 2011 3 3 0 El AFI rssorsa 00 07 LaBType B Jeruary 2010 2250 January 2010 nomenclature update based on MGTIHLA database vers ly Ki gt 7 Show Archived Catalogs T Check Al ONE LAMBDA IMGT Catalog Notes January 2010 nomenclature update based on IMGT HLA database vers July 2010 nomenclature update based on IMGT HLA database version January 2011 nomenclature update based on IMGT HLA database vers January 2011 nomenclature update based on IMGT HLA database vers New lot Based on January 2011 IMGT HLA database version 3 3 0 a January 2010 nomenclature update based on IMGT HLA database vers January 2010 nomenclature update based on IMGT HLA database vers July 2010 nomenclature update based on IMGT HLA database version January 2011 nomenclature update based on IMGT HLA database vers January 2011 nomenclature update based on IMGT HLA database vers January 2010 nomenclature update based on IMGT HLA database vers January 2010 nomenclature update based on IMGT HLA database vers July 2010 nomenclature update based on IMGT HLA database version January 2011 nomenclature update based on IMGT HLA database vers January 2011 nomenclature update based on IMGT HLA database
141. SSP1 01 002 ws SSP1 01 002 PRI SSPR1 01 003 Micro SSP Allele Specific HLA Class DNA Typing Tray A 01 A 36 Lot 003 SSPR1 01 003 SSPR1 01 003 PRI A 02 Lot 005 ssp1a2 005 WS SSP1A2 005 PRI SSP1A2 005 10 SSP1 03 002 08 Micro SSP Allele Specific HLA Class DNA Typing Tray Micro SSP Allele Specific HLA Class DNA Typing Tray A 03 Lot 002 SSP1 03 002 WS SSP1 03 002 PRI SSP1 03 003 06 Micro SSP Allele Specific HLA Class DNA Typing Tray A 03 Lot 003 SSP1 03 003 WS SSP1 03 003 PRI SSPR1 03 004 Micro SSP Allele Specific HLA Class DNA Typing Tray A 03 Lot 004 SSP1 23 002 09 Micro SSP Allele Specific HLA Class DNA Typing Tray A 23 Lot 002 SSP1 23 002 WS SSP1 23 002 PRI SSPR1 23 003 Micro SSP Allele Specific HLA Class DNA Typing Tray A 23 Lot 003 SSPR1 23 003 SSPR1 23 003 PRI SSP1 24 002 09 Micro SSP Allele Specific HLA Class DNA Typing Tray A 24 Lot 002 SSP1 24 002 WS SSP1 24 002 PRI SSPR1 24 003 Micro SSP Allele Specific HLA Class DNA Typing Tray A 24 Lot 003 SSP1 25 002 08 Micro SSP Allele Specific HLA Class DNA Typing Tray A 25 34 66 Lot 002 Ssp1 25 002 WS SSP1 25 002 PRI Click
142. Sead mw teas inte l Cree Lambda 00 0 004 Probe 100 OLA om re Ls Ls La F Excadefy team Previous Analysis Side by Side Analysis View Note This function can also be accessed by right clicking a sample in the Fusion Navigator Product Data Analysis Click any of the Product Data Analysis ie B YA buttons on the Fusion toolbar to display that product s home page import a session file manually enter a session or display and select from the Navigator List of previously imported sessions for that product Fusion Explorer e You can also click on any of the Fusion products located in the Fusion Explorer at the bottom left side of the screen to open a product s home page Sample Navigation The Sample Navigation tools only accessible from an Analysis Screen give you access to all the samples in the current session You can select a different sample within the same session either by selecting from the drop down list in the Sample ID field or by clicking the forward back arrow buttons next to the drop down field cos a ORES SHI D DI The Sample Navigator HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 39 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Click lt lt Summary to return to the summary for that session Clicking on the drop down V arrow displays all the samples within the current session as shown below Sample Drop down A well
143. Setup tab on the General Settings dialog box you can select settings such as default printer and paper size which will be in place when you print reports or do a print screen 1 Select Utilities gt General Settings and click the Printer Setup tab HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 318 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Fusion Setup HLA Fusion General Setting Printer Setup URLs Paths Print Screen Show print preview dialog Yes No Default printer Select one Paper size Select one Print Report Show print report dialog Yes No Default printer Select one Paper size Colact one ONE LAMBDA 0 0 Printer Setup 2 Select from the following options for both the Print Screen and Print Report panels of the dialog box e Ifyou want to see a print preview or print report dialog each time you print make sure the Yes option is selected Otherwise select No e Ifyou do not want to select a printer each time you print select the default printer and paper size from the drop down menus Note This default printer configuration may be overwritten by the specific page properties of certain reports 3 Click Save s 1 Setting HLA Fusion Default URLs and Directory Paths The URLs amp Paths option under the General Settings menu allows you to set the default URLs for OLI and NMDP
144. Summary link at the top of the window Side By Side Analysis Use this option compare the current sample analysis with one previously conducted Note This option is also available by using the Side By Side Analysis toolbar button rl Side by Side analysis drapes Daia ae a Deis ieee Pue jio Profle Lita heip Pot Le E Current Analysis OR a l d a 1 Ei a E E B i a a E E a 5 B H HE H E ll nn AAA 3 Analysis a a noonoo ee ooenovaeaeo reenen x UU MERE wu is BAN RA RRERR ERE RRR SHEL SHERRRER EHS BEHRENS SS SRR RBH ENS ZA ESSERE SEESE SEEM F SPERES ELAS BRO SHEERRERER SPRE DEG SPRITE DAR CJE SSE REET ASADO AS SEL ESA ER AER SRR ASS RSH SHAR SG 1 Right click a sample from the Navigator A list of available samples is displayed 2 Select a previous sample analysis from the displayed list to compare to the current one The two analysis windows are then displayed in a comparison window Each window can be resized and moved by dragging and dropping Click the Side By Side Analysis toolbar button to cancel the comparison display HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 238 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Reports HLA Fusion provides different report formats in which to output your analysis data and results From the Reports menu you can do the following e Create print and export reports for analysis da
145. The Raw Data graph shows the raw Mean Fluorescent Intensity MFI value of each bead overlaid with the imported NC Serum MFI 1 From the analysis window click the Graph Raw button in the upper right portion of the window to display a raw data graph with background values from the selected or default NS for each bead a dd dd ki da a aa dd dS is id Hi i ab J0 eR ua da al Mo at Mod i H Gi G2 EC bh Zia 9 165 HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 2 Clickthe Normal button top right to return to a normalized graph Raw Data Table Analysis information is displayed in tabular form Positive wells are in Red text Rows highlighted in A have reaction values over the threshold 1 To display a sample s data in tabular form click the Raw Data button in the lower right portion of the LABScreen analysis window LABScreen Mixed Raw Data Table LS Sample13 Patient LS Sample18 Well Pos B1 LS51401_001_G1_G2 Testi Current Formula BaseLine Test Date 12 28 2012 3 42 11 AM LS2A01_006_00 Min Region Threshold X6 Formula Baseline v 1 Negative Control Sample OLINS Min Value 2069 99 Sample Raw j 84 47 2471 69 281 64 y i 113 37 4231 38 f 4017 91 8973 91 502 13 110 72 142 67 i DPB1 02 02 119 87 t y i DPA1 02 01
146. The previous test must have the same sample ID Note To combine a generic or HD LABType sample with Exon 4 7 the combination must be done from the Exon 4 7 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 106 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual From the Analysis Window click on the Analyze Combined button The next pop up window displays a list of previous sessions that have used the current sample and share the same sample ID 1 Select the desired previous session s by selecting the associated Combine check box 2 Clickthe Analyze button at the bottom of the pop up window e The reaction pattern table includes bead information for all the sample tests This table s Bead ID listings provide indication that the selected sessions have been combined and reanalyzed e Ifyou combine one sample in the previous nomenclature format with a sample in the newer nomenclature format the possible and assigned allele pairs and code are displayed in the new format If the sample with the previous nomenclature format contains an allele that is not included in the new nomenclature that older allele is dropped To rerun the combined analysis click the Reanalyze Combine button e Ifthe nomenclature dates between the current one and the one s being combined with it conflict then the session s you selected is highlighted red e Ifyou click the Analyze button and there is a co
147. Type data from analyzed LABType samples Panel Summary report of the final NMDP coded assignment and the positive probes for a set of sample in a session QC Overview summary of samples with low bead count low positive control pre analysis global cutoff changes as well as sample specific changes for a session of samples Combined Panel Summary NMDP spreadsheet of final NMDP code assignments for sin gle or multiple sessions HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 257 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual MicroSSP data from analyzed Micro SSP samples e SSP Report detailed typing report for Micro SSP tests that may be customized Generic Antibody antibody data from analyzed LABScreen FlowPRA LAT or LCT samples e Antibody Custom User may customize a report for antibody data for a set of samples e Antibody Screening ID antibody data report that is fixed in format e Antibody Screening Results summary table for a selected set of samples which includes the overall final results made PRA other assignments and comments LABScreen data from analyzed LABScreen samples e LSM Detail detailed test information for antibody mixed analysis records e LSM Summary overall test results for antibody mixed analysis records e LSM Overview overall tests results for antibody mixed analysis records including total num ber of positive
148. User Manual HLA Fusion Software HLA Fusion Software v 3 x x For In Vitro Diagnostic Use A ONE LAMBDA INC 21001 Kittridge Street Canoga Park CA 91303 2801 Tel 818 702 0042 www onelambda com One Lambda Inc HLA Fusion Software Version 3 x x User Manual LABType LABScreen and FlowPRA are registered trademarks of One Lambda Inc HLA Fusion LCT LAT TM Micro SSP M and LABScan 100 are trademarks of One Lambda Inc Luminex is a registered trademark of Luminex Corporation Windows is a registered trademark of Microsoft Corporation Copyright 2012 One Lambda Inc CE All of One Lambda software products are designed to assist personnel experienced in HLA analysis by suggesting typing results However any clinical or diagnostic results must be carefully reviewed by a person qualified in HLA typing to assure correctness This software may be used to aid in suggesting results but should not be used as the sole method for determining reportable results This software is meant as a laboratory aid not as a source of definitive results The software design does not mitigate hazards associated with the software The laboratory director or technologist trained in histocompatibility testing is required to review all data to detect any problems with the software Please note that this document was prepared in advance of the HLA Fusion software release Therefore you may notice slight differences in the con
149. User Manual v3 x x For In Vitro Diagnostic Use 298 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual If you select a catalog to import that is in the old allele format you are notified with a message If you do not see this message proceed to the next step If you do see the message select the translate option you want to use before going to the next step Note If you select Yes or Yes All the software will translate the old allele format into the latest format For the Molecular products LABType or Micro SSP the software will drop the old format allele completely if it does not find a matching allele in the new format list For Antibody products if the software does not find a matching allele in the new format it keeps the old format allele but adds a colon Translate alleles Option Translate Allele _ The catalog LS1404_002_03 you want to import was created using the old allele format If you wish the system will translate these alleles into new allele format Please note that the old alleles which do not have matching new allele names will be kept and imported as is Do you wish to translate No Yes All No All 5 Click Yes or Yes All to import the selected catalog files Note Catalog import takes longer when you choose to translate alleles 6 A confirmation dialog box displays import results click Close 7 Click Close to return to the Update Reference menu Imported catalog files can be used
150. WWNHA AN QUQ t L g99 z 28m AUL OOanmnFt aon na 9 9 t 9 yA 8 9 PHOLZE 9 PISZE6 9 PZ ZEB 9799p O 22 20205 Ae ESE EES EEE gt gogga EM e 1 1 e 1 e PEREFRPEEREN S gt a B l Fe eee Ek CO Ei Fieri 9 E CE T I a N v de un D o w o E E E4 7 AA EXA E E Cd A EZRA 8 gt A oa o MEN es a as a i aa ia i sososze c oi go ez z SS coarse z gt e M 2Gp pz ez bo i as o j os oe o ce Be iid eee EG EG en biG dd esam j css pp cam pitti dl esam ppp pp can pi ppp zsa ppp zsa j ppp ca ippo ca ii ppp com ip i i AI samm pipi coa Pitti tf poc ces Pi iii dd cM j j EE EY com ee EE ci j i jj exe cee EEE sx zNa EE asm pp ppp cu cs EE poe pasm EG ae OOM EE wW Add New Tray Cw 1 PRR 2 l2 4 33 Data Entry Order 1 Sample Count ah Strength Index 60 PRA 8 6 4 2 50 PRA 8 6 4 PRA 8 6 PRA 8 25 0 6 421 6 6 4 5 2 4 1 7 Raw save gt gt Confirm gt gt Entering the Reaction Pattern Click each well to change its reaction value or type a reaction value when the well is highlighted Wells with white borders are control wells wells with black borders are reaction wells From the analysis window type a sample name into the Top
151. Wells are sorted by test groups Class I Class IT and control wells are sorted together e X axis shows the well position e Y axis lists ranges of reaction values e g 1to 10 Bars are color coded based on their reaction value e 8 Red e 6 Orange e 4 Gold e 2 Blue e 1 Green HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 202 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Horizontal lines represent the positive threshold you set for Class I and Class IT The line s assumes the same color as the RXN color code Making Assignments The Final Assignment option buttons display the software suggested assignment Positive Negative or Undetermined To accept the assignment save or confirm the sample see the following sections To modify the suggested assignment do the following 1 From the analysis window select an assignment for each Class using the Final Assignment option buttons Positive Negative or Undetermined LAT Assignments area RESULTS Sample ID TEST 1 Class Class Il Suggested Result Positive Undetermined Assigned Result Positive C Positive Negative Negative Undetermined Undetermined Cut off 8 6 4 2 18 3 42 46 Comments O More Test _ info Confirm gt gt Save Assignments Lab Technicians and Supervisors can save analysis results for further review and approval Saved samples are available for
152. a o 4 E o 019 1084 8 p a o o 4 a Vesa No Reaction if bead is excluded EJ y GE E 5 E ie e TELE lali li Raw Tab The columns in the Raw Data table display the following types of data e Rxn I negative 8 positive O no reaction e Raw raw data for the trimmed mean fluorescent e Normal normalized value e PosCtl positive control bead ID e OLI Cutoff default OLI positive threshold cut off e Sample Cutoff sample positive threshold cut off e Count bead count The beads having reactions that fall within the range of the close bead threshold are highlighted in Close Bead Ran e These close beads are also listed in the Close Bead text box in eT a Quadrant 4 HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual The Close Bead Threshold can be set for all newly imported LABType sessions by using the Utilities gt Molecular Product Configuration menu This sets the range of close beads based on the normalized values from the current cut off for the bead so that a bead can be considered a close bead and be highlighted yellow on the raw data table The default value is 3 To change the threshold value type in a new value in the Threshold box and press the Enter key The raw table is updated instantly and rows with a close bead reaction are highlighted in
153. a Inc HLA Fusion Software Version 3 x x User Manual The sample is flagged in the System Comments as having a low Positive Control if any positive control trimmed mean in the current sample falls under the threshold you ve set On the analysis Bead Tab the bead bars for samples below the threshold you ve set are colored GRAY Minimum Bead Count Set Minimum Bead Count NMDP Code No Code Local Code P Grouping G Grouping Cross Code Bw4 Bw6 in Serology Demographic Information Minimum Positive Control k Minimum Bead Count gt Set Sure Reaction Bead View OC Low Positive Threshold The default Minimum Bead Count value assigned by the system is 100 If desired enter a new value in the Minimum Bead Count Value field The sample is flagged in comments as having a low bead count if any bead count in the current sample falls below the threshold you set Set Sure Reaction Bead 1 Click the Set Config button upper right and select the Set Sure Reaction Bead option in the configuration menu to enter Bead IDs for which to force positive or negative values The Force Sure Reaction dialog box is displayed Cross Code Bw4 Bw6 in Serology 2 Here you can enter bead IDs for which you want to force positive false positives are considered true positives or negative false negatives are considered true negatives Demographic Information Minimum Positive Control gt Minimum Bead Count
154. a aaaea 240 ACCESS NOR CAOS MINO A ias 240 Select REDOC TYDE O SO AA A A ee roe 241 Refine Repr NP Ec TE Ni 241 Sesslon Sample Selec A A A a te 242 VIEW PEDO EXPO ROD aii 243 EXPO RCD OM tana AA ii 245 Accessing Reports from the My Favorite MENU anaes eaen caste eee 245 REMOVING REDOMS LON My Favore ai 246 REPORTS TOO rocosa Eo Raccoon earn Eres 247 CUSTOMIZING REPORT APPEARANCE sara iia aa 247 Creating Custom Data Export Templates aia 248 Creatina CUSTOM REDOT iii adobo 249 Custom Molecuiar and Antibody Report Setup A c 250 SAMPLE SUMMAR Ci Gar anaes tal uct A A T E NEE N au til iced deltas are S see seat a ea emeu aes 251 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 10 One Lambda Inc HLA Fusion Software Version 3 x x User Manual MOLECULAR TYPING SAMPLE SUMMA Vat A id 251 ANtIDOGY SGCTECNING Sample Sumay icaeoeii i a a E a as 252 VIEW RECORDS corintio A AAA AAA AA AA AAA 253 PATIENTIN FO lidad dd aida nao 254 AUDIT TRAE REPO Ta A Ai dias 255 REPORT TYPES ia 257 DATA MANAGEMENT uta 261 O A A A A AE Eaa 262 MANAGE SESSIONIDATA WINDOW sas AAA AAA A AA AA A 262 SAMPLE MANAGEMENT ae 264 IMPORTING SAMPLE LISTS anaana E REA 265 INFORMATION FORMATS FOR SAMPLE LISTS seeoenseeseoseoseossossossoscoscsscseoseoseossossossoseoscoscssoseoseossossossoseoseoscosesesssossossossoseoe 266 Newpackind MISE TOMA A A T a 266 P cklist Old Standard X Samples srnce e e E i a A A E 266 Old packing lis
155. a sample By right clicking on either a session or a sample in the Navigator window you access menu options that allow you to affect your LAT analysis sessions before or during analysis Navigator Session level menu options Reanalyze with New Catalog Allows a session to be reanalyzed using a new or updated catalog gt Select New Product o 1 Right click on the session in the Fusion Navigator and select Reanalyze using New Settings Catalog New Catalog ID Lar 288 004 01 bl 2 Rename the session givingit a new Session ID 3 Click the drop down arrow in the New Catalog ID field and select a new catalog from the list 4 Click the Analysis button The session on which you right clicked is reanalyzed using a new Session ID with the catalog you just selected HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 219 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Sample Level Options The Related Records and Side By Side Analysis options are displayed if you right click on an active sample in the Navigator first select the sample with a left click Related Records A related record is a record that is associated with the current sample by patient or sample ID Side By Side Analysis Note This option is also available by using the Related Records toolbar button e Select this menu option to load all records related to the current sample in
156. aa Inc HLA Fusion Software Version 3 x x User Manual e Right click on a sample from the Navigator and select Side By Side Analysis Select a previous sample analysis from the displayed list to compare to the current one The current sample is displayed with a light brown background e The two analysis windows are then displayed together in a comparison window e Each pane of the window can be resized and moved independently by dragging and dropping Click the Side by side Analysis toolbar t button to cancel the comparison display HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 190 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual LAT Analysis The LAT analysis feature of the program analyzes CSV output files manually entered reaction patterns or ELISA results as a new session and can continue the analysis of a previously unfinished session Analysis results are based on catalog specifications provided with the software There are a few things that should be completed or verified before you start an analysis session e Make sure you have the latest catalog files before you analyze You can download or update catalogs from the LAT Home Page by clicking on Download e View and modify global product configuration settings before starting analysis Global settings are displayed and be can be modified on the LAT Home Page by clicking on or through the Utilities Menu Global set
157. actions has been reached or a solution is found The false reaction setting allows you to set the number of allowable false reactions Minimum setting O Maximum setting 4 Sample Date False l2 Forcei Ron Reset e Inthe False Rxn field click the up or down arrow a to change the number of allowable false reactions Note Regardless of the maximum false reactions set here sample analysis stops at the first false reaction found Force One False Reaction When a sample has a result with no false reactions exact match result the Force 1 feature forces HLA Fusion to re analyze the reaction to allow for one possible false reaction in any well This feature is used to search for results for which one additional reaction can change the results 1 From the analysis window click the Force Ibutton to force the program to analyze the sample with one false reaction Click the Reanalyze button to reset the analysis to the original results Click the Rxn Reset button to return the Rxn Pattern table to the default settings HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 134 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Micro SSP Combined Analysis The HLA Fusion software supports a combined analysis feature In a combined analysis the reactions from two tests of the same sample are combined together in a single analysis The previous test must either have the same S
158. ae Sample somero e e le e qe qe de de de po in BLUE Positive alleles have a shaded background An y indicates a positive emoa hk k fx O reaction 47H i E Click in this area to search by reaction 81 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual The Default configuration e Beads are sorted by sample reaction e The current sample appears on top line of the table in a blue font e Positive alleles are listed below the sample row and have a shaded background e Salmon coloring indicates a false positive e Green indicates a false negative Positive reactions are displayed as an X on the table Blue for the current sample and Black for the rest PC NC and excluded beads are displayed as a zero 0 on the table OR Set Config Type an allele into the field and click the Find Allele button to display the allele and its reaction pattern in the first row below the sample Double click on an allele name to bring that allele to the top of the table You can bring all of a certain allele group to the top by entering an allele group e g DRB1 03 ac Rxn Rec Site Local QC Patient Sample F Fea Ola M o o Ww los gt pa os o pe oe oe oe pe oe 90 lot los os os os Tos
159. ake the change in the General Configurations section of the Fusion Explorer Home page Note Some of the above tasks require you to have supervisor user privileges You may have to verify with your supervisor that these tasks have been completed HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 118 One Lambaa Inc Start Micro SSP Analysis Note HLA Fusion Software Version 3 x x User Manual Click the Micro SSP button on the home page panel orthe Micro SSP icon on the Fusion toolbar or select Analyze Data gt Micro SSP The Micro SSP Home page is displayed HLA Fusion Click to open the Catalog Management screen Micro SSP Product and Catalog Active Catalogs 160 Serology Equivalent 2012January 10 11 2012 Last Updated Date 12 14 2012 NMDP Update 10 11 2012 Details Download Reference file Updates Micro SSP Configuration Code NMDP V3 Cross Code Enabled No Active Demographic Allele Frequency Number of False Reaction 1 Bw4 Bw6 Information No Micro SSP Product Documents SSP1 01 001 14 Catalog Description Edit Micro SSP Allele Specific HLA Class DNA Typing Tray A 01 A 36 Lot 001 Worksheet 8 5x11 Worksheet 11x17 Probe Primer SSP1 01 001 WS SSP1 01 001 PRI SSP1 01 002 06 Micro SSP Allele Specific HLA Class DNA Typing Tray A 01 A 36 Lot 002
160. al Custom Query Report Setup Custom Antibody Scr gening Report Setup HLA Fusion Y Enter Select Custom Report Name My Custom Antibody Report y aya FAR Overall Results Assignments EX a i Uncheck Al Overall Pos Neg Y Other Assignments IF Approved By F PRA FZ Donor PRA Z Sample ID REQUIRED 7 Antibody Assi M Patient info M Patient ID and Local ID Possible Epitope IO IZ Sample ID Local ID V BarCode V Sample Session Info IV Patient Name MV Barcode Epitope Analysis Results Ps IV System Comments Y User Comments IV Antibody Specificity REQUIRED for this group Session Information x a Y CREG Analysis Details Y Saved Confimed Info Dias TP FN Mean Raw of Positives gt IZ Session ID Date REQUIRED for this Tail Analysis Results F Mor Testing Needed gu Check an Uncheck At w I Session Details 7 False Runs Ambiguity Exists Tak Peden Culla WY Laces Ripe I Antibody Specificity REQUIRED for this group FF System Comments Y User Comments Dime 4 More Tests and Tests Remarks L gi tone R M Postive Beads Wells Summary Test Configuration Inclusion Strength Index TN nee Dele IV Close Reaction Beads Y Manual Tail Assignment I PC NC Values V Rm Score V Sort Alphanumerically Test and Catalog Details IV Bead ID or Test Well REQUIRED for this group V NMDP Local code update date
161. allele Audit Trail Log a log with all specified activity for a selected users in the current Fusion da tabase My Favorite any of the above reports saved in a favorites list Reports listed depend on what you have stored under this menu HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 260 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Data Management When you select the Data menu item a wndowis displayed that allows you to manage session files as well as create log files of session data From this menu you can delete archive activate and move sessions to a different database You can also map the alleles in a session to the new nomenclature format HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 261 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Session Management To manage your data at the session level use the Data option from the HLA Fusion main menu When you select the Data main menu the Manage Data wndowis displayed Select patient records to archive or delete Sort Select display options E A A l Select A Sesso Date TestDate C Sesen Samcie C Patent 1D View Set Session Search L data and Criteria add comments Catalog ID F Test Date Exit the Manage Data AAT Copy Patent Love Sessions Jazronsiate Mictes Pregsession Log arctwve unargtuve Osiete cor win
162. ambaa Inc HLA Fusion Software Version 3 x x User Manual Select a product catalog from the Catalog ID drop down list Edit threshold values For LABScreen Mixed catalogs the threshold values can be set at the bead level Click Save to save values Click Close e Changing Antibody Screening Analysis Configuration Changes in the antibody screening analysis configuration are made by product type and apply only to sessions analyzed after the changes were made 1 From the LABScreen FlowPRA LAT or LCT home page click Edit or select Utilities gt Antibody Product Configuration from the HLA Fusion main menu Click Set Analysis Configuration to open the Analysis Configuration Settings menu Select a product type from the Product Type drop down list Change values as needed Click Save to save values Click Close HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 316 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Importing NS Files Negative Serum NS files can be imported to be referenced during analysis 1 From the Main Menu select Utilities gt Antibody Product Configuration 2 Click NS File Import to open the NS File Import menu NS File Import di NS File Import Import NS File MAHLA Fusion 3 0 0 Testing NS File Import LS NC6_RevODRAFT csv Catalog LS1A01_006 LS NC 6 1 LS1A01_007 LS NC 6 1 LS1A02_006 LS NC 6 1 ILS1AD2_007 LS NC61
163. ample information into the database for use in analysis sessions Sample lists may be in xls CSV or txt file format From the Sample List Import menu you can import sample lists or edit sample lists prior to importation Note Please verify all data you import as HLA Fusion performs minimal data validation upon import HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 264 One Lambaa Inc Importing Sample Lists HLA Fusion Software Version 3 x x User Manual Sample lists are an easy way to input an extended list of sample ID s and other sample information into the database for use in analysis sessions 1 From the Main Menu select Sample gt Import Sample List Select Sample List to Import C OL FUSION data session Data Reference Files Sample List New_Standard_Date_SDF_FormatFile List Format Sampie List csv Import Sample List Screen Search Sample List Sample List Details import Order Location Sample I Remove from SamplelD LABiContract ID No z ontr Ic one 7 Autogenerate Local ID Local ID Category I Use Sample ID as Patient ID I Create Test Luminex List on Import Import All M Apply Current Date Turnaround DON Patient ID Date Test List Name 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 QIIIA AA A A aa KI KI KI KI 1 70509 2113 9AB DR14 21028 1 80509 2111 3AB DR14 21028 1 90509 2106 3
164. ample ID or be associated with the same Patient ID To combine results for a sample you need to start or continue a Micro SSP allele specific test and have a previously saved Micro SSP or LABType session to combine with it After combining sessions the possible typing assignments are displayed and the reaction pattern table changes to reflect the reaction pattern of both tests 1 From the analysis window click on the Analyze Combined button below the reaction pattern table The Combined Analysis window displays a list of previous sessions that have used the current sample and share the same Sample ID a Combined Analysis loj x Current Sample ID 60231 Patient ID 11332 Session Well Mis Catalog ID Position Locus Analysis Date Combine Sample ID Note For Combined Analysis the sample must be saved Select the desired previous session s by selecting the associated Combine check box on the far left Click the Analyze button at the bottom of the pop up window Note If you combine one sample in the previous nomenclature format with a sample in the newer nomenclature format the possible and assigned allele pairs and code will be displayed in the new format If the sample with the previous nomenclature format contains an allele that is not included in the new nomenclature that older allele is dropped To rerun the combined analysis click the Reanalyze Combined button HLAF MAN V3 x x EN 00 Rev O HLA Fusi
165. ample screen 2 Usethe filters to find samples and click View Sample Note Wildcards can be used in the Sample ID field to widen the results 3 Edit sample information Note You can rename a sample by modifying the name in the Sample ID field Sample IDs are listed alphanumerically with all IDs beginning with numbers listed first 4 Click Save to save Or click Delete to delete the sample 5 Click Close to return to the Main Menu Note You are not allowed to delete a sample that is part of a session that has already been analyzed HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 268 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Test Lists A Test List is a list of Sample IDs that can be used repeatedly to automatically write the sample IDs into a session analysis that can be read by Luminex It is a useful tool when you have a group of samples to be run on multiple tests From the Test List menu you can e Create new Test Lists e View and edit existing Test Lists e Delete Test Lists e Export Test Lists to a txt file Creating New Test Lists Test Lists must be created in the order in which the samples are to be analyzed 1 From the Main Menu select Samples gt Manage Test List Manage Test List Screen Create Edit Test List Select Test List Or Enter new Test List Name he Delete List Sample IC Search Sample ID Local ID Patient
166. analyzed using the catalog file you selected Navigator Sample Level Options Group Product C Test Date C Catalog Session Date There are two menu options that are displayed if you right click on la an active sample in the Navigator select the sample first with a BB He left click Related Records and Side By Side Analysis gt PIGE m a e P k Related Records e Side By Side Analysis B sj HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 114 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Related Records A Related Record is a record that is associated with the current sample by Patient ID or Sample ID Note This option is also available when you use the Related Records toolbar button Ll Select this menu option to load all records related to the current sample into the Sample drop down list lt Summans I I Patient Sample Da Session Catalog ID Local ID a B el 5 Singles LS1A04NC7 AG_002 4 D1 5 Singles LS1A04NC7 AG_002 5 E1 5 0406workshop_A_Lot RSSO1A_007_05 B1 E2 5 0406workshop_B_lot RSSO1B_009_06 5 E2 5 0406workshop_B_lot RSSO1B_009_06 5 E2 5 0406workshop_B_lot RSSO1B_009_06 B El 5 0406workshop_C lot RSSO1C_006_05 5 E2 5 0406workshop_dpb1_l RSSO2PB1_002_05 Sample Drop Down List for Related Records e Use the sample navigation arrows to display the analysis of each related record one by one e Togo back to viewing the
167. ary link to the left of the Sample ID field at the top of the screen Note This function can be also accessed by right clicking a sample in the Fusion Navigator Review the product specific sections of this manual for more information about using this feature Side by Side Analysis From any Analysis Screen click the Side by Side Analysis button on the Fusion toolbar to compare the current sample analysis with a brown background with previous analysis sessions for the same Sample ID Select Side By Side Analysis Sample Micro SSP_20121226085334_SSPMLO2_003_07 SSPMLO2_003_07 Micro SSP_20121526085334_SSPML02_003_07 SSPMLO2_003_07 VNONE LAMBDA 000 Begin Side by Side Analysis e Select a previous sample analysis from the displayed list to compare to the current one The two analysis windows are then displayed together for comparison e Fach window can be resized and moved by dragging and dropping Click again on the Side by Side Analysis button to cancel the comparison display HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 38 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Ot rtam mes Se Locator Putient sampte Renata _Setconta Sead pares toad into Mead jouw k Des Lamban OC 10501 Probe DE OLRAH vax cae Lis s gt ot 0 mash E rnas an PEA Current Analysis 15 Local Oc Patientisumpin Bensa Set Conia
168. as current as possible it must be delivered well in advance of the software in order to allow for translations Generally product update information such as new features and issue resolution is located in the HLA Fusion Release Notes If a software release is minor and the release notes are not updated a README file is provided with a list of changes to the software and pertinent information that is not yet included in the user s manual In addition you can always access the most current product update information from the Help gt Product Update Notes menu option within the HLA Fusion Software application or from the OLI download site HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 15 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Program Updates Note For best results always make sure you are using the latest version of HLA Fusion Software HLA Fusion will automatically detect if there is a software update patch available and inform you of the availability You may also obtain updates of HLA Fusion by request Please contact your One Lambda Inc representative for a copy of the software or see the Technical Support section below for more contact information Product information updates catalog files etc for HLA Fusion are available through your One Lambda Inc representative or from the One Lambda website http download onelambda com HLAF MAN v3 x x EN
169. ation Settings Changes to product analysis settings apply only to samples not previously analyzed Previously analyzed samples must be re analyzed for the changes to be applied From the Product Configuration menu you can e Change Micro SSP product configuration e Change LABType product configuration e Change product settings for LABScreen Mixed analysis e Change antibody screening analysis settings e Change default negative serum values for LABScreen analysis Changing Molecular Product Configuration Changes to LABType and Micro SSP analysis settings apply only to samples that have not yet been saved or confirmed To change analysis settings for previously saved or confirmed samples you must change the settings from the product analysis window and re analyze the sample 1 From the LABType or Micro SSP home page click Edit or select Utilities gt Molecular Product Configuration gt Molecular Analysis Configuration from the HLA Fusion main menu 2 Select either LABType or Micro SSP from the Product Type drop down menu a HicreSS P Anahi Configuration HLA Fusion 10000 Pedra Type Moras HLA Fusion Product Type LABType El Code NMDP Local Code P Group G Group Fo ga C Local Code C Pro C Gap s C Mo Code No Code roii Code D abe Cross Coda Derogatis Tes Ex rr tee i FT wb PanE Information E Tepe ange aeinn Cross Code T Enable Cross Code Demographic none y
170. ation option in the Utilities menu HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 61 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Control Value Tab This tab allows you to review the quality of the Control Values for each sample This tab is divided into three graphs all of which have the following elements in common Sa aE e The X axis indicates the samples sorted by well position A a R Raw Data 19 e The Y axis indicates the raw data values specific to each graph e g positive or negative control values e From any graph right click to select either Exclude Sample or Analyze Sample Summary Control Value Bead Analysis e Double click on any marker to go to the analysis screen for that sample Exclude sample e Hovering your cursor over any marker displays the sample s MAN annotation The Positive Control Summary The Positive Control Summary graph top displays the positive control value for each sample e The x axis indicates the Sample ID names sorted by well position e The y axis indicates the positive control raw data values The horizontal bar indicates the configured value for the minimum positive control This value can be configured through either the Utilities gt Molecular Product Configuration menu or by configuring sample specific settings from the analysis wndow e Each exon is represented by a different col
171. ay or Navigator and Field dis j a i Session Name plays O Session Date kA Test Date i Search by Session Date O Catalog LE Choose which Date range OS e El tae Te information Session Sta sores 3 tole a you want to be tus or Cata Catalog Type i Sample Name shown log type C Well Position Patient ID C Sample Date O Well Status DOGMAS After choosing your search criteria click the Find button to begin the search Note The date range set here in the Session Date field is used as the default date range throughout HLA Fusion such as in the Navigator and Reports windows Each time you change it and click the Find button the default changes for the rest of the application Print Report From any Analysis Screen you can click the Print Generic Typing button to display a list of the reports that you can print the a reports listed are specific to the product you are currently analyzing so what you see in the example here may be eee o different If you have set up a default printer configured Allele Summary through Utilities gt Printer Setup the selected report is Allele Code automatically sent to the specified printer Otherwise a dialog box is displayed from which you can select a printer Molecular Typing Summary Example of Print Report Options HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 34 One Lambaa Inc HLA Fusion Software Versi
172. b code 2 Edit lab code information 3 Highlight a lab code to be deleted 4 Click Delete Lab Code to delete the lab code 5 Click Save to save changes and return to the main menu or click Cancel to discard changes and return to the main menu without saving HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 295 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Utilities HLA Fusion uses a variety of reference files for data analysis that need to be updated for new products lots and revisions You can also change many global product settings to customize analysis for your lab and you can modify default system settings to reflect your personal or network file system Warning Always use the latest reference files for analysis Otherwise analysis results may not be accurate HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 296 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Managing Catalog Reference Files Catalog reference files contain all of the reaction specific information needed for analysis including the following e Bead and well specificities e QC information e Cut off values e Bead and primer information Fach new lot or revision of a product needs its own catalog file for analysis results to be accurate Updating Catalog Files from a Local or Network Drive Lab supervisors can input new catalog
173. circled in the specificity field Clicking on the labels for Tail Analysis Results Epitope Analysis Results or Final Assignment creates circles around the specificities listed in the results area Clicking on the Exclude Antigen label circles the excluded antigens Note If you use the Find Antigen feature while the window is displaying molecular specificities you cannot see the circled antigens until you deselect the DNA check box 1 From the analysis window type antigens or CREG groups e g 1C or 2C into the field next to the Find Ag Antigen button 2 Click the Find Ag button Find 4s to circle the entered antigens or CREG groups Click the Find Ag button again to remove the circles form antigens in the specificity field CREG Table The CREG groups are displayed at the top of the table with the specificities for the group displayed below Specificities are highlighted in one of the following colors Note If you want to hide the display of the CREG bar click the CREG title at the top of the window A dialog box displays asking if you want to hide the CREG bar Click Yes to hide it To re display it click again on the CREG title and click the Yes button to show it e Purple positive assignments from the Epitope Analysis Results box e Pink Tail assignments that are masked by Epitope analysis e Blue Cwassignments e Green Bw4 and Bw assignments HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x Fo
174. cisio gt gt oo 0009 lt els um a m m mal m ala ja ln n al a m m al ala ala a ao STANE TA SLANA MYI i I Ct E PEPA SSS MINSNELAMBDA 000 7 Fusion automatically associates Exon 4 samples with generic samples of the same locus The row background color indicates the following e Nomenclature mismatch different dates Pink e Nosamples could be found to associate with the specific Exon 4 sample Orange e More than one sample associated with a single Exon 4 Cyan Blue e Sample has false reaction or no solution Light Gray Make sure the samples you want associated for the supplemental analysis are selected Note Only one sample can be associated with each Exon 4 per locus If there is more than one generic sample available for association with the Exon 4 of a particular locus the system by default selects the most recently created sample You can select an older sample if desired Micro SSP data can be combined with Exon 4 data only after it has been combined with LABType data LABType combined with Exon 4 cannot be combined with Micro SSP data 11 Click the Import button The supplemental session and all associated samples are displayed in the Fusion Navigator where you can select them to analyze in the LABType analysis window HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 58 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual LABType Session Sum
175. ck the X remove button to remove it Or select and assign a different one to replace it c p4 01 01 02 C 06 05 Related C 04 01 01 01 C 06 05 Allele C 04 01 01 03 C 06 05 Assign pairs C 04 01 01 04 C 06 05 button Serological assignments Remove button Translate noncurrent nomenclature format only The Translate button is displayed if your alleles format is displayed with older nomenclature Clicking the button does the following e Displays all assigned except from the Other Assignment field and possible allele code pairs in the latest nomenclature format If a matching allele in the new format cannot be found the allele remains displayed in the old format e You can view and print this display but results cannot be saved or reported in this new nomenclature format e Togo back to the older allele format you can navigate to another sample and then return to this sample Adding Comments to Samples Comments you or Fusion adds to the Comments field are displayed with the sample results in the current analysis session data look up and reporting functions in HLA Fusion 1 In the analysis window type sample comments into the User Comment field below the Assignments area HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 144 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Or double click in the User Comments field to open a larger writing space
176. confirmation only by a Lab Supervisor e From the analysis window click the Save button located in the bottom right corner of the analysis window to save analysis results for all the specificities currently listed in the Final Assignments results box Fusion automatically moves to the next sample For confirmation a Supervisor needs to access the sample for which you saved the assignments You can return to the sample any time prior to confirmation If you need to make changes click the Reanalyze button and then the Save button again HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 203 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Confirm Assignments Only Lab Supervisors can confirm analysis results When they do so samples are marked as Confirmed The Confirm button is Purple when you view a confirmed sample e From the analysis window click the Confirm button Confirm gt located in the bottom right corner of the window to confirm all analysis results You automatically move to the next sample to continue confirming results When you first return to a confirmed sample you see that the Confirm om button is now shaded purple to let you know it has been confirmed before Adding Comments to Samples Comments you or Fusion add to the Comments fields are displayed with the results in the current analysis session data look up and reporting functions in HLA Fusion e In
177. ction pattern in the first row Double click on an allele name to bring that allele to the top of the table You can bring all of a certain allele group to the top by entering an allele group i e DRB1 07 Click on the blank row header to either the left of an allele name or the sample reaction to move all the beads with that reaction to the left Click the Rxn Reset button above the Max button to reset the table to its original configuration When a column header is clicked the table is sorted by reaction criteria for that well or bead if combined with LABType The first click sorts in ascending order from top to bottom The second click sorts in descending order If you use the Analyze Combined button from the analysis window to analyze a LABType test and a Micro SSP test the Bead IDs from the LABType test are displayed in the Well ID row on the Rxn table These are recognizable by the bead ID followed by an underscore and a 0 HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 133 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Number of Allowable False Reactions If HLA Fusion cannot determine any results that exactly match the reaction pattern entered it analyzes the reaction assuming that there is one false reaction in the sample If a solution still cannot be found the system continues to search through additional false reactions until the number of allowable false re
178. d 3 again Or click the Maximize Minimize m button ae To view the Delta data the difference View Delta J ET between the signal generated and the cutoff point for each bead click the View Delta button Quadrant 3 Delta View HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 94 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual To go back to the normalized view click the same button which now says View Normal view normal Would you prefer to make View Delta the default view so that it automatically displays each time you bring up a sample in the LABType Analysis window Assign gt gt e Save the layout while this quadrant is in the View Delta mode by clicking an the Save Layout tell button After you exit Fusion and login again your LABType sessions will display Quadrant 3 in View Delta mode Quadrant 4 Test Results Quadrant 4 displays the typing results for the current sample In general the typing results include possible results and user assignments for allele pairs coded results serological equivalency results and other assignments The left side shows various pair tab assignments suggested by the software You must make all final assignments by bringing a suggested pair into the final assignment area or by typing in an allele pair There are five tabs here e The Pairs tab displays the possible allele pairs results that matc
179. date and time to the local regional code if a regional code is specified in the CSV file A regional code cannot be specified for CSV files created with Luminex software versions 2 2 or earlier If the first date field is highlighted yellow it indicates a regional code mismatch In this case it is recommended that you use the drop down selector in the second date field to choose the appropriate date taking into consideration regional date format differences 3 Select an HD session from the CSV File Name list to display its associated samples in the Current Sample Patient Details table france_HD_new france_HD_RUO i as shown below HD Session 1_HD HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 50 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual HD Samples in the current Sample Patient Details table Currert Luminex Luminex 100 IS 2 3 Session ID 0406workshop_A_Lot 7_1D402 HD Date 11 20 2012 11 20 2012 y Samples ES File Path le OLI Fusion data session LABType 0406workshop_A_Lot 7_ID402 csv Catalog ID RSSO1A_01 1_08 NOM Imat January 2012 3 3 0 I Set empty Patient ID to Sample T Auto Analysis MS Date 4 Last Name Ethnicity Farggotti Caucasian Bloodstone Chavez Hispanic Monkeyward Asian Stone Chung 5 3 i 12 22 2012 2391 2412 10 11 2012 10 11 2012 i ah 3
180. de Local Code or Cross Code e No Solution is listed if there are no results that match the sample s reactions within the allowable number of false reactions Allele Code Assignment 1 Double click the possible allele code or select the suggested code and click the V assign button Select an allele code and click the X remove button to remove an allele code assignment Manual Allele Code Assignment 1 Type an assignment into the text field just below Assigned Allele Code Make sure you type the assignment in correct allele code format e Newnomenclature format X 444 HHHH X HH FHA HHHH where X locus type and code number e Previous nomenclature format X HHHEX HHHE where X locus type and code number Otherwise the system does not accept it and prompts you to make corrections Note If you click on the Translate button to display alleles in the new nomenclature format you Cannot enter a manual allele code unless you reanalyze the sample and alleles are again displaying in the previous nomenclature format HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 140 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Press the Enter key to move the allele code you typed in to the Assigned Allele Code field DRB1 07 JKZH DRB1I 07 JKZW DRB1 07 JKZH DRB1 07 JKZW Note If you have a homozygous result the assigned code can be edited in the Manual Allele Co
181. de field to show the homozygous coded results once Unknown Allele Codes Unknown allele codes are marked with XX followed by a sequential number The numbers are reset to 1 for each sample and locus When you see unknown codes you should first make certain you have imported the latest NMDP file If you have the latest code file and are still seeing XX codes you can store these unknowns for later submission to the NMDP in a txt file named nmdp_code_ report txt By default the text file is stored inC OLI Fusion data NMDPExport but the location can be changed by modifying the Interface path Code information is appended to the end of this text file as it is added the newest additions are at the bottom Possible Allele Code C O4 XX1 C D4 XX2 Select XX C 04 XX4 C 06 05 ee code here C O04 XX6 C O08 z C D4 XX7 C 12 28 y C O04 XX8 0C 15 25 1 From the Possible Allele Code field og m i select the XX code to enable the NMDP z Code Report buttons at the ende O rr bottom of the screen the NMDP report button here Click the X button to cancel HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 141 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Right click the Report button and choose one of the following To send the unknown code information to NMDP select m Direct Request NMDP Save in text file To add the unknown code information to a text file ae
182. ded Allele Code Assignment Allele code assignment is performed on the far right panel of Quadrant 4 e The Possible Allele Code field displays possible coded results for all pairs that fully match the sample e The type of code used is dependent on your selection when you configured Fusion for LABType analysis or for this sample NMDP code default local code user defined or no code e The possible coded result is listed at the top section of the field e The code definition is listed below it e Ifthere are no codes for suggested alleles then the suggestion is listed with XX meaning the code is undefined e For multiple XX suggestions each suggestion is distinguished from the others by numbering such as XX1 XX2 and so forth Possible Allele Code A O2 127 A 11 XX1 10101 511 0111 02 11 03 11 07 11 12 11 7218 11 22 11 2911 30 1 Undefined Allele Code EJ Undefined Allele Code e The allele codes displayed in the Possible Allele Code field are condensed by the system based on suggestions from the list of possible allele pairs displayed under the Pairs tab HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 102 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual e The allele code is based on the current NMDP code or local code installed in the system By default the system assigns NMDP codes to the alleles You can optionally change these codes
183. dow Copy patient Move Translate Prints details Archive Restore an Delete data to sessions session about which the archived selected another toa alleles tests were selected Session and record database different to the done by session make it database new format whom etc available for use Manage Session Data Window e When you click Translate Alleles 122s all final allele pairs and code for the selected sessions are converted to the new nomenclature format and stored in the database e When you click Move Sessions LM Sessions you can select another Fusion database to which the selected sessions are moved HLA Fusion allows you the capability to create log files of your selected analysis e cr sessions which you can then print or HLA Fusion archive pevos pa ee E Family ID DOO O First Name P 1 Provide all necessary session input FaN information by using the drop down menus and search buttons on the left side of the Data window Camie Once a session is selected its information is dis played on the right side of the window the Session Info pane where you can add infor umseteciar ok cca mation ONE LameDa ooo HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 262 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 2 Once you have all information you want to include in the log click Save Once
184. drop these diamonds up or down to adjust a bead cut off setting When a cutoff adjustment has been made the diamond changes into a Delta Arrow 4 that points in the direction the cutoff was moved The tip of the arrow points to the location of the new bead cutoff value along the x axis Bead Cut off Delta Arrow Cut off Change Flag HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 93 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual You can hover your mouse pointer over any bar and details for that bead are displayed for the sample HE Sample Comments Type your own comments in this area You can add comments to the sample by typing in the Comment field at the bottom Double clicking in this text box opens a much larger window to type your comments in The Magenta and the white or non colored bar on the right represent the raw data values for the positive and negative control beads of a LABType assay Magenta Positive Raw Control X axis Beads in numeric order Data Value Y axis Raw data value trimmed mean on Data points Bars represent the raw data value of a bead vs the Control Sample reaction Beads Bar colors display e Positive control Magenta e Negative control Waite To expand the histogram double click in the area between Quadrants 1 and 3 To resize the histogram to its original size double click between Quadrant 1 an
185. e select Assign Possible Allele Code to bring the highlighted Possible Allele Code into the Other Assignment field 2 Select Assign All to bring the Possible Allele Code Assigned Serology or Assigned Allele Pairs assignment s into the Other Assignment field You can also choose to modify any of the copied code if desired Entered alleles are assigned and included in reports that are run which include this sample but allele assignments made this way are not listed in the final assignment field for this sample Reanalyze If you have imported a new NMDP code local code or serology equivalent file into the system or you change the number of false reactions allowed for a no solution sample you can click the Reanalyze button to analyze the data using the new reference file s or to reflect false reaction changes Reanalyze Button m aeonsives anat comine hamon gt Seve gt gt corno Note This reanalysis replaces only the NMDP local or serological codes or analyzes with different false reactions settings All other setting changes generally result in an automatic reanalysis of the sample immediately following the setting change Analyze Combined LABType Sessions HLA Fusion supports a combined analysis feature for both LABType and Micro SSP analysis sessions In a combined analysis the reactions from two tests of the same sample are combined together in a single analysis that may generate a higher resolution result
186. e 8 red f pma gaf jojn jo Grane CARRERE ee fola e 4 gold 2 E D a A A SEE e 2 light blue fa a 0 E E GG a a Go 4 El El El El El El o e 0 gray e Ifyou change a reaction button the focus shifts to the next button You can also manually type in reactions instead of clicking buttons e This panel launches the analysis of the current sample using the latest changes in reaction e Ifthe sample has not been analyzed yet the button is labeled Analyze If analysis already exists for the sample then the button is labeled ReAnalyze This button is only enabled when a Sample ID has been entered If a sample ID has not been entered when this button is clicked the sample ID field is flagged with and no analysis is performed Adding Tray Information You can add information about the current tray such as expiration date by clicking the Info button Lr The following dialog box is displayed when you click this button allowing you to add information about this sample tray Add Tray Information screen More Test Information x Reader BSmith Viability Q Clear ad 11 15 2012 y Compl Mfr Compl Lot AHG Lot HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 228 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Find Antigen To enter multiple antigens use a space to separate antigen entries All entered antigens are
187. e Version 3 x x User Manual Associating a Patient Donor ID with Sample IDS ccsscccseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 280 Translating Associated Patient Donor Results to New Allele Code ccccccccececccccsccccscsusecsseeeeeeeeeeecesessssssesuuuueeeeeseeesesssess 280 Associating Patent ONG Donor RECO AS ccs ssticccsaagensanaids ERE BROAD OARS 281 Associating a Donor WItTDONOl PRA RCSUIES a A AA AA A 281 PRATS Patent DONO ECOG Sine di A A A OO AE O 282 Exporting POLEN Donor RECO Sa ad 282 Archiving Patien Donor Records lt a IAS 282 Deleting Patient Donor RECOS rai das 283 Creatina Patient Donor Sn A TA T TNTA A T NOOT 283 PATIENT ANTIBODY TRACKING vician aE AEE ENSEN EEE E 285 PROFILE MANAGEMENT Zaoa E E E A E E E 289 USER MANAGEMENT rat io E AAAA EA A 290 MEW TIC I A ee olla ee 291 A O A A A 291 EIA User PRO eS diia diia 291 CHANGING Y A A O OO o O ate tebe ac E eres pile ea cr La Gat Cok 292 Resetting POSS WOIOS A AS A A A A aia iia aed Panos 292 changing User PUVNEGES ii toa 292 TIO CTI VOI MY SOUS a E E T T o T T 293 LAB PROFILE ooo aA A A AA E 294 EIN EGC EOD PrO lE oin A a A AA Runes tang uaNeeiaa bes 295 MAnagina Lao COLES rn E N ere Ter tr tere reer ee 295 ES NESA oa wos oats EEO 296 MANAGING CATALOG REFERENCE FILES oie a E A a E T 297 Updating Catalog Files from a Local or Network Drive sssessccccssesseecccnesecessausseceseaunsecesssuseesssaunsecessaua
188. e Version 3 x x User Manual Reports available for preview printing Data Reports Data Sample Patentinfo ProMe Ub IEPS TA 4B Patient Summary Patient Custom Antibody Screening ID Antibody Screening Results Antibody Custom Product Compare Note If you select Antibody Custom you are not be able to create a new custom report at this point The only custom reports available from the analysis window are ones you previously created through the Reports window Making Final Assignments Final assignments can be made from either the Tail not applicable to LABScreen Singles samples or Epitope results fields Note If you want the Mean Normal of positives to be used for Epitope analysis instead of the Mean Raw of positives check the setting Use the Mean of Normal on the LABScreen PRA Single Antigen and Singles product configuration screens From the analysis window do one of the following to make assignments e Double click an antigen specificity in the Tail or Epitope Analysis results box to assign the specified antigen to the Final Assignment list e Click to highlight the specificity and click the Assign Single lt button to move it to the Final Assignment list Click the Assign All L button to the right of the Tail or Epitope list to move all the current results on that list to the Final Assignments area e Right click on a specificity or CREG group on the CREG Table to assign it to the Final Assignments area
189. e histogram in Quadrant 3 to make it easy to locate and look at bead data HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 98 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Click a plus sign to Pais Force Type SubType Match Sero display the suggested FPIFN 7 allele pair assignments associated with the bead Click to sort by False Positive or False Negative 21 50 items and reaction type TATALA N FPIFN FN 024 61 items l Allele Allele Locus Click a minus sign to A201 01 07 4 11 14 A shrink it back A 01 31N A 11 14 A A 01 60 4 11 14 A Click here to A 01 64 A 11 14 A open all allele A 01 01 02 A11 14 A pair results for Click this button to copy ee oer A all the beads and save data to the nen a A clipboard which can be J le pasted into an Excel spreadsheet Results are grouped by bead and reaction type False Negative FN or False Positive FP You can change the order by clicking Allele 1 Allele 2 or the FP FN button until the results are displayed in the order you prefer e Click any Plus Sign to display the suggested allele pair assignments associated with the bead and reaction type Click the Expand All button to open all allele pair results for all the beads simultaneously Click the Collapse All button to close all results for all beads simultaneously e Click Copy Data to send a copy of this data to
190. e or more tests by selecting the check boxes for the tests you want to run on the samples listed under LABScreen Tests and or LABType Tests Once you are done assigning tests to all the selected samples click Save to save the work list Create Plate Design Note The Plate Designer feature is available only if you have SQL 2005 and above installed Plate Designer functionality in HLA Fusion software gives you the flexibility to organize and plan your samples in a plate format that is ready for processing through the Luminex system You must first create a sample work list Create a plate design Search by Sample Search by sample Search by test list External File Tesk meseros Sample ID al bestest bestest teiks hesthet heathet betes betis bet beetle bekri beatka bekti bekti bestit belt beiit Sarmple List 40a 2 11 23 4h 4 1022 11 29 4M 4102012 TAM 4 10 2012 11 23 44 40 2012 11 23 4M 40 2012 11 23 4M 40202 11 23AM 410202 11 23AM 40 2012 11 23 4102012 11 23AM 441042012 11 23AM 44102012 11 23AM 441042012 11 23AM 410212 11 23AM 410202 11 23AM 4A 0 a0 2 11 23 4M 000000000000 0000000000009 OO00808OO08E0 00000000000009 0000000000009 0000000000009 0000000000009 000000000000 Tests astsgned fo B C DRABI Wa DOA DOB DOA DOB DRB345 A HD Blue AtigredAleady Black Mol Astigned 1 Select Sample gt Create Plate Design from the main HLA
191. e starting analysis Global settings are displayed and be can be modified on the LCT Home Page Global settings apply across all newly imported sessions e Save time importing catalogs and files by verifying that the default URLs and paths are pointing to the locations where these files are commonly stored on your system or network These settings can also be modified in the General Configuration section of the Fusion default Home page Note Some of the above tasks require you to have Supervisor User privileges You may have to verify with your supervisor that these tasks have been completed HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 221 One Lambaa Inc Starting LCT Analysis Acquiring LCT Data HLA Fusion Software Version 3 x x User Manual 1 Select LCT button from the home page panel or the Fusion toolbar IE The LCT Home page is displayed Note If you are not using the default Fusion user interface the data and links shown on the right side of the window are not displayed Click to open the Catalog Manager Click to open the Update window Reference File window HLA Fusion Analyze Data Reports Data Sample PatientInfo Profile Utilities Help Exit IES oll 2 A AS Click to open the LCT HLA Fusion 000000 Available Reference Batch Entry eee Update window Details Dow
192. e tasks require supervisor user privileges You may have to verify with your supervisor that these tasks have been completed HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 153 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Starting LABScreen Analysis Note If you want to set W632 Normalization as the default for LABScreen Single Analysis select the check box next to Use W632 Normalization as Default in the LABScreen Single Analysis product configuration page Acquiring LABScreen Session Data Select the LABScreen button from the Home Page panel or the Fusion toolbar e The most recent Click to open the catalog update catalog manager Click to import Current number updated of downloaded H LA F usion 0 00000 reference files catalogs LABScreen Product and Catalogs available for Active Catalogs 194 Last Update Date 6 11 2012 Details Download each product LABScreen PRA 52 Reference file Updates 0 Information A a E on available Select a tab Mixed PRA Single Antigen Singles Edit reference file Y updates to display the current configuration Seng err ne eee Click to modify your LABScreen settings global settings Waming Message Displays Current A a Suppress waming messages No warning Swap bead if NC is higher than all beads message Swap bead if NCis high settings LABScreen Product Documents
193. ead Count SA IDA 16 75 4 68 02 01 01 A O KDPH A2BRKDA ya N P m 5 D1 2493120 2 nee 20 ow Bead Count 838 4 69 01 4 02 KHBB 1818 lo ls 1 24931 21 2499121 Low Bead Count 2746 A 31 KDUK A O3 JPEV 1978 O 94 F1 2492941 2492941 Low Bead Count 3119 4 26 KDSZ A 02 KDEA 1557 n 95 G1 500 500 Low Bead Count 3053 431 KEYX A 02 KFFA 2506 O 96 H1 NC NC Low Bead Count Low Positive Control 9 22 M CCU AAA User Comments gt Auto Accept All Apply P G Code Replace XX Code System Comments ERA LABType Session Summary Page The Session Summary Field Chooser Click here to open the Field Chooser HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x mu ra s p hea A HAM 2499029 L24302 Analysis Dote Analysis Lees Assigned Allele Code Assigned Allele Pair Astigned Seto a a 18183 2433046 Click the Field Chooser button on the far left side of the table headings The Field Chooser appears This allows you to select or clear the check boxes next to column headings to include or exclude those columns from the Summary Table Selecting or clearing check boxes in this window instantly updates the table You can also rearrange the order of the fields by using your mouse pointer to drag and drop any field name to a
194. ecificities are displayed only in the specificity field of the analysis window The CREG Table and screening results are displayed and saved as serological specificities 1 Inthe Analysis Window select the DNA check box to display molecular specificities 2 Clear the check box to return the display to serological specificities Select Minimum Positive Threshold You can change the minimum positive threshold using the pull down menu e From the analysis window select a new positive threshold from the Threshold drop down list next to the analysis tools near the top of the window The sample is re analyzed according to the new threshold The effects of the threshold change are displayed in the result boxes Exclude Antigen from Analysis To enter multiple antigens use a comma to separate the antigen entries All antigens entered are excluded from analysis 1 From the analysis window click the Excl Ag button The Exclude Antigen pop up box is displayed A Exclude Antigen loj x Antigens to be Excluded e g 41 423 855 Exclude Patient Typing ox dear HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 212 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Statistica 2 Typein antigens to be excluded separated by commas and click 3 OK Data Entry Order Sample Count Strength Index The sample is re analyzed and the excluded antigens are lis
195. ed 9 1172243566 73 93 47 63 2N Y bb NMAMWDEDAA DHA OE WANONNDO 00 53 1007 95 65 64515 G24 37 42 3 92 39 23 10 49 9 SGU Poe eb han ee eo oe O ODO OOOO OO ODA O OA DO OO OOO OOOO OO ORO tani E IO OR OO DOOR te Teale CCOO E DOMO OO OO OO OO DC MO OA ict OOOO O Cnt sot etn 7 21 67 74 CA 35 34 37 59 19 551 29 J3Jo0ooa o 99 45 41 31 85 90 75 amp 57 59 15 63 17 50 65 62 ae S E AC E oo Peart E butt a A A A A A E eet a 23405 556012 A Poe an o DNA Adjust Cut offs You can change a threshold cut off value for each sample You can only change one threshold cut off at a time 1 In the analysis window click on the threshold bar you want to adjust 2 Dragand drop the cut off bar to adjust the cut off and re analyze the sample Adiusting Threshold Cut offs 30 41 58 12 A A E A HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 175 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Select Minimum Positive Threshold You can change the minimum positive threshold by using the pull down menu above the bead graph From the analysis window select a new positive threshold from the Threshold drop down list next to the analysis tools near the top of the window The sample is re analyzed according to the new threshold The effects of the threshold change are displayed in the result boxes
196. ed 5 DP5 3942 37 excluded eE rc e A S antigens ES Systeme o A A Prove ao eS ed For a user Selecta Click to open the Comment fields Check if more For results as Save Confirm defined cutoff normalizatior donor selection tests are raw data assignments formula here screen reauired If you prefer to make Graph Raw the default view when you access the LABScreen analysis window go to the LABScreen product configuration settings and select the check box next to Display Graph Raw by Default CREG Table The CREG Groups are displayed at the top of the table with the specificities for the group displayed below Specificities are highlighted in one of the following colors Note If you want to hide the display of the CREG bar click the CREG title at the top of the window A dialog box displays asking if you want to hide the CREG bar Click Yes to hide it To re display it click again on the CREG title and click the Yes button to show it e Purple positive assignments from the Epitope Analysis Results box e Pink Tail assignments that are masked by Epitope analysis e Blue Cwassignments e Green Bw4 and Bw assignments HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 172 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual CikaCREGgoupor TBerhge Br aterstg to gg antigens to circle the corresponding specificities e Right click an antigen to move the specificity to the Final
197. ed sample e From the analysis window click the Confirm button confrm gt gt located in the bottom right corner of the window to confirm all analysis results that have been saved in the Final Assignments results box You automatically move to the next sample to continue confirming results When you first return to a confirmed sample you see that the Confirm button is now shaded purple to let you know it has been confirmed before HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 236 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Navigator Right Click Menu Options for LCT Sessions Analysis options are available through the Navigator whether you are in the LCT session summary view or on an analysis screen for a sample By right clicking on either a session or a sample in the Navigator window when either a session summary or analysis window is displayed you access menu options that allow you to affect your LCT analysis sessions before or during analysis Right click Sample level options Right click Session level options Navigator Product Test Date C Catalog Session Date Group Product Test Date Catalog Session Date eee eee 98 LCT_20120329165923_LCT 8 LCT _20120329165547_LCT 8 LCT _20120329164926_LCT 8 LCT_20120329164853_LCT 8 LCT 20120329155126_LCT AE LCT 20120329164853 LCT SH LCT_20120329155126_LCT
198. edit the template and add code definitions 3 Followthe example format using a Tab to separate each field and a slash to separate multiple values within a field e letter code lt tab gt numeric allele extension to which the code applies 4 Savethe fileas local_code txt See the next section Updating the Local Code File to import the file HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 302 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Updating the Local Code File After a Local Code file has been created it must to be updated in HLA Fusion 1 From the main or any of the product home pages click the Download link or from the main menu select Utilities gt Update Reference gt Update Reference File The Update Reference File dialog box displays Update Reference File Local Code Update Reference File HLA Fusion m Import Directory Directory Folder tree Local Code E C Catalog C NED P Group GGroup Serology Equivalent Option T Import Local Code MEAT Ready 2 Select the Local Code option 3 Use the Import Directory tree to locate and select the Local code file to be imported 4 Click Import Local Code to import the selected file s 9 Click Close to return to the Update Reference menu Updating Serology Equivalent File from One Lambda Website The Serology Equivalent file can be
199. ee eee e After the unknown code has been saved Fusion displays a confirmation message that the text file has been saved EA e To add unknown code information to an Excel file by default stored in c oLI Fusion data export NMDPExport right click on the Rpt button and select Save in Excel File xi Fusion Vata export WMDPExportiymdp_code report J32 7 A_9 D3915 csv After the spreadsheet file has been saved Fusion displays a confirmation message a When you re done click the Close button on the right of the Rpt button to remove the buttons from the display Note The Rpt button retains the last selection you made direct text or Excel so it can be used as a shortcut Unless you want to change your selection the next time you report XX code simply click Rpt Other Assignment The Other Assignment field may be used to make a sample assignment that is not restricted to any format In addition you can highlight and add serology or allele pair or code assignments and add them to the field for modification You can make other code assignments in one of two ways e Type an allele pair or allele code into the Other Assignment field e Click the V assign button and select one of two options 105 HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual L To assign just the possible allele cod
200. ent report Report Page Navigator If the report has multiple pages these buttons allow you to move to the first page the next page the previous page or the last page Find Text Clicking this button opens a text box which allows you to search and find text throughout the report Zoom Click the down arrow on this button to choose a zoom setting view an entire report page or view by the report page s width To close the Report Viewer window click the Close button 4 in upper right corner of the viewer HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 244 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Export Report 1 Click the Export Report button when you want to export a report in one of several standard formats The Select Output Directory and Save Type dialog box is displayed Exported report destination file save as type screen xi we 1 Enter a name for the current exported report or browse for a report file to export 2 Select a format from the Save as type drop down list Excel Acrobat Word or Rich Text format 3 Click OK By default the file is saved inc OLI Fusion data report Accessing Reports from the My Favorite Menu The My Favorite menu is a convenient way for you to access and generate the reports you use most You can make as many as 18 report types available from the My Favorite drop down including custom reports Adding to or
201. er H means the catalog is HD 6 Following catalog file validation the system may ask if you d like to associate the template name with the specified catalog file If you associate the two all new sessions with the same template will automatically select this catalog Catalog Template Association Catalog Template Association HLA Fusion Do vou want to associate the following template name and catalog Template asso20 Catalog RSSOH2345_01 0 Do not show this form any more POCNE LAMBDA HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 53 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Note If the incorrect catalog and template are associated as in the above example review the section Associating Product Catalog Files and Luminex Templates for instructions on removing the association Check to see if there are any samples that have been flagged as having a low Positive Control PC or low Bead Count the rows of low PC or low bead count samples are highlighted AEN You may want to delete these samples because they often slow analysis However such removal means you can no longer track these samples Take the following steps if you want to delete any of these samples 7 Click in the Gray border area to the left of the Well position column to highlight the entire row for the sample I Set empty Patient ID to Sample Auto Analysis Pp
202. er Manual Note If you right click in the black area of the test gel pane you can select a different order for the reactions when you click on a well 0 gt 1 gt 8 or 8 gt 1 gt 0 etc After you analyze a tray you can no longer add any Es 1 8 more sample information to that tray 8 gt 1 gt 0 If the sample has not been analyzed the right most 3 gt 6 gt 4 gt 2 gt 1 gt 0 button on the bottom of this pane is labeled Analyze 2 24 gt 8 If analysis already exists for the sample then the button is labeled Re Analyze This button is only enabled when a Sample ID has been entered If a Sample ID has not been entered when this button is clicked the Sample ID field is flagged with as being empty and no analysis is performed If other than the first well 1H reaction is set to zero 0 a message displays allowing you to see system suggested reaction information to help you decide if you want to analyze the non amp well with a positive or a negative score If more than one well is set to zero the message does not display but the suggested reaction information can still be viewed E Do you wish to analyze the Non Amp Well with Positive and Negative Score De To see the possible reactions if the well was positive or negative click Yes and scroll down the Possible Allele Pairs list to the headings Neg Reaction Pos Reaction If neither type of result can be suggested the heading is No Solution and it will
203. er text field System comments automatically added here to open the larger comments window Flagging a Sample for Further Testing You can indicate the need for further testing of a sample by selecting the More Tests check box and saving The More Tests indication is displayed in results data look up and reports for the sample e Inthe analysis window select the More Tests check box below the Assignments area if more tests are needed Printing the Current Analysis Window The Print Screen button on the Fusion toolbar sends the currently displayed analysis window to the default printer e From the analysis window click the Print Screen button on the toolbar to print the current analysis screen me e Itis printed to the default printer you have selected for this computer Previewing and Printing Reports To view or print an Antibody Screening Mixed Data report for the current sample use the Preview Report button on the toolbar e In the analysis window click the Preview Report button or Print Report button to display a list of reports you can print or preview for the current sample HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 169 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Reports available to preview or print Patient Summary Patient Custom Antibody Screening TD Antibody Screening Results Antibody Custom Product Compare HLAF MAN v3
204. file A regional code cannot be specified for CSV files created with Luminex software version 2 2 or earlier If the first date field is highlighted yellow it indicates that Fusion detected a regional code mismatch In this case it is recommended that you use the drop down selector in the second date field to choose the appropriate date taking into consideration regional date format differences Select a file from the list of CSV files to import or click the Folder L icon above the list to browse to LABType CSV file s on your system network If samples in a session have a positive control value below the minimum setting they are flagged so you can easily select and delete them from the session You may see CSV files for products other than LABType or other CSV files This means that you must first click on a sub folder for LABType or that your LABType session files are not contained within the directory to which HLA Fusion is pointing HLA Fusion assigns a Session ID the CSV filename automatically Optionally you can edit the Session ID field The ID can be alphanumeric contain letters and numbers and will be listed alphabetically with any other LABType session files in your database Session ID CI11269L51404Lot1_ID330 Session I D field A Session ID must be unique to the Fusion database If the Session ID already exists HLA Fusion prompts you to rename the session It is also highly recommended that you do not use any
205. files Analysis results are based on catalog specifications NMDP or Local codes and serology equivalent reference files All of which can be downloaded and used with the Fusion software A few things should be completed or verified before you start an analysis session Note Make sure you have the latest catalog files as well as NMDP code local code if used or serology equivalent reference files before you analyze You can download or update existing catalogs from the LABT ype Home Page View and modify global product configuration settings prior to starting analysis Global settings are displayed and be can be modified on the LABType Home Page or through the Utilities menu Global settings apply across all newly imported sessions Save time importing CSV files by verifying that the default URL s and directory or folder paths are pointing to the locations where these files are commonly stored on your system or network These settings can also be modified in the General Configurations section of the Fusion Explorer Home page You can set HLA Fusion to remain on a sample that you ve just saved or confirmed rather than automatically moving to the next sample by changing this setting in the General Configurations section of the Fusion Explorer Home page Some of the above tasks require Supervisor User privileges You may have to verify with your Supervisor that these tasks have been completed HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion U
206. files for use in analysis when new products lots or updates become available Catalog files are also available on the One Lambda download site 1 From the main or any of the product home pages click the Download link or from the main menu select Utilities gt Update Reference gt Update Reference File The Update Reference File dialog box displays x o EN HLA Fusion eeee8 m Import Directory TT FL1HD01_010_00 si de Bin FL1HD01_011_01 E FL1HD01_012_00 CO 4f3a6f385f4c38dc8e4244a6d8bcd058 FL1HDO2_010_00 Config Msi FL1HD02_011_00 File 3 Documents and Settings FL1HD02_012_01 C Downloads FL1HD03_010_00 o FL1HD03_012_01 usic FL1HD04_010_00 tree Y MSOCache FL1HD04_011_00 Catalogs FL1HD04 012201 O a e FL1HD05_007_01 ata FL1HD05_008_00 gt AppData FL1HD05_009 01 E catalog FL1HDO5_010_00 apat FL1HD06_007_01 a FLIHDO6_009_00 repat FL1HD06_010_01 session FLIHDO6_011_00 C temp FL1HD07_007_01 y Catalo ae 108 mb Catalog C NMDP C Local Code PGroup C GGroup C Serology Equivalent Options Catalog Folder Last Update Date Aun02 2012 Go to OLI F ONELAMBDA 0 0 0 Ready HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 297 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual If your serology information is outdated or you have not imported it yet a message like the one shown below is dis
207. fimDate ConfimUser MinBeadCnt Class IDondClass llDone FALSE FALSE JFIF FF blli ili m m m m m EEEEE Ready 23 e Click Print to print out a report of the Summary Table e Click Preview to view a report of the Summary Table Q Print Preview E oj xj File View Tools 100 v fH BS Close E Session LATMIXEDTest01 14201 a met mesta EA mi oo jmest2 IES Ci ms O TESTS IE O Ek papis resta C 1 5 TEST 5 1 6 TEST 6 C 1 7 TEST 7 mis LLC O tC Ci me EC E O k E 1 10 TEST 10 a ne Click and drag up to zoom in or downto zoom out a io rm a o h M Print Preview Summary Table e Inthe print preview window the page view slider on the left allows you to select different pages of the report e The session summary table columns and order can be modified You can save any modifications you make to the layout by clicking the Save Layout button Your changes are saved for all future LAT session summaries on the same computer until further modifications are made and saved If you want to exclude a sample from an analysis session select the Exclude check box next for that sample The sample is still displayed on the Reports sample list to prevent it from being included in report data do not select that sample during report creation HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x
208. ft of a user entry to view the profile Click Close to return to the main menu Adding New Users Supervisors can add new supervisor or technician level users Technicians cannot add new users Fields marked with an are required 1 From the Main Menu select Profile gt List User 2 Click Add User to add a new user 3 Enter new user information 4 Select the Active check box under the Role field to activate the user account Note If this is a lab tech profile and you want to allow reference file update and or data management privileges for this user select the appropriate check boxes 5 Click Save to save the new user information and return to the main menu or click Close to discard changes and return to the main menu without saving Editing User Profiles Supervisors can edit the user profile of any user Technicians can only edit their own profiles Fields marked with an asterisk are required 1 2 To edit your own profile select Profile gt My Profile To select from a list of users to edit select Profile gt List User and double click to the left of a user to select that profile Edit user information HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 291 One Lambda Inc HLA Fusion Software Version 3 x x User Manual 4 Click Save to save user information and return to the Main Menu 5 Click Close to discard changes and return to the Main Menu without savi
209. g p 1 Return to the Main Fusion Home Page by clicking either the Home Page button on the left of the screen or gt a the Home Page button at the top left of the screen on the Fusion Toolbar n Setup 15 x gt Fusion Setup O O OOOO oo HLA Fusion o General Setting Printer Setup URLs Paths Enable Audit Trail Logging err renee air 2 On the Home Page click Edit on the right side Det Patiert Donor Type Pate El of the General Configurations section ELISA Reader Serial Port y Auto Donor PRA Calculation f Donor Groups for PRA n OR L Stay Curent Sample After Save or Conf 7 Click the word Utilities on the Fusion Taskbar On the General Settings tab click the drop down arrow and select from the drop down list in the Default Home Page field to select your default home ENIT page 3 Click Save and then Close HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 26 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Launching Navigator If the Navigator tab is not already displayed on the right of the application window click the mE Show Navigator toolbar button to activate the Navigator function Or f Product TestDate Catalog Session Date Group Move your cursor over the Navigator tab on the right border of the application window to slide the Navigator into view The Fusion Navigator Tree Product
210. ge Me d to page Thumbnail tate te review a Page 1 of 12 The Print Preview Screen Clicking the Print button on the Print Preview Screen will send the images you ve chosen directly to your printer HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 60 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual LABType Session Summary Tabs Summary Tab The LABType Session Summary Tab displays a Results Summary Graph The graph displays the quality of batch analysis results for each sample e Match M indicates multiple matched results Orange e Match S indicates a single matched result Red e False indicates a false reaction in results Pink e Miss indicates that there are no suggested results Grey Summary Control Value Bead Analysis a an m a o a OO OOD OOOO CO0 Cccc DODOOCOCO OD0OCO ODO O DOOOO DO O 000 O00 00 Results Summary Graph Summary Tab e Click any of the squares in the Results Summary graph to display the corresponding sample analysis wndow e Ifthe Auto Accept All button is enabled at the bottom of the Session Summary screen you can click it to assign the possible results as final results for all samples except those with ambiguous results ASMA EE This feature is not activated unless you select it through the 7 Allow Auto Accept Al Molecular Product Configuration gt gt Molecular oa 1 Paa Analysis Configur
211. ges and lab information There is also an option for switching between the home page options depending on your system and List User Lab Profile navigation preference Menu Bar Profile Utilities The options under this menu item pertain to importing catalog code and serology files configuring the molecular and antibody products you analyze setting up your HLA Fusion system and system validation Help HLA Fusion Help Product Update Notes Check For HLA Fusion Updates Fads About HLA Fusion Menu Bar Help Utilities Update Reference Catalog Template Association Antibody Product Configuration General Settings Products Selection Validation Switch User Switch Database Menu Bar Utilities Molecular Product Configuration Create Combined Products Set Default Negative Value Set Mixed Product Configuration Set Analysis Configuration MS File Import This menu item allows you to access the following HLA Fusion Software information e Online help which provides guidance in using HLA Fusion Software e Links to tutorial Show Me videos e Notification of updates and a description of new features in the latest HLA Fusion software HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 31 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual e Dynamically updated Frequently Asked Questions
212. gnment and may not be 100 accurate We suggest that you review these assignments and make appropriate changes to obtain the expected assignment A Click Save to save changes 5 Click Close to return to the Update Reference menu HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 313 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Creating a Combined LABScreen Session Catalog To run a Class I and Class II combined LABScreen analysis session create a combined catalog to use for your session You must use a Class I catalog file and a Class IT catalog file that have the same positive and negative control beads but do not have any other beads in common 1 Select Utilities gt Antibody Product Configuration from the HLA Fusion main menu 2 Click Create Combined Products to open the Combined Products menu Combine LABScreen catalog files Combine Products 000000909 Select products to create new products Product List New Product CataloglD LS1ADANCE 002 03 LS1A04NC10_007_02 LS2A01NC11_008_06 LS2A01NC11_009 03 LS1A03 NC7_007_03 LS2PRANC10_012_06 LS1A04NC11_007_02 LS1A04NC10_006_05 LS2PRANC8_012_05 LS1PRANC8_013_05 LS1PRANC10_014_03 LS1A02NC7_008_02 LS2PRANC3_013_03 LS1PRANC10_015_00 LS1PRANC6_012_03 LS2PRANC8_011_03 LS1PRANC7_011_02 LS PRANCS 013 M3 ClassID NcBeadID PcBeadlD AddedDate 002 002 4 2 2012 10 30 07 CataloglD Clas
213. gnostic Use 242 One Lambaa Inc Note RSSO2345_008_03 Select All Deselect All Analysis Select LABType Micro SSP Category Select gt 20080117_LSM_LOT13_ID49 20080116_PRA2_LOT10_ID43 20080116_LSM_LOT13_ID41 120408 Cll SA 006_ID2288 120408 CI SA 003_ID2287 A 120408 CI SA 003_ID2287 06302011 DRASHI6064 Y TestDate Prod 04 30 2009 03 14 2012 02 22 2010 LAT LCT FlowPRA Quantiplex Beads LABType QC SSO HLA Fusion Software Version 3 x x User Manual e Select All select all sessions and samples for inclusion in the report e Deselect All deselect all sessions and samples from inclusion in the report e Analysis Select specify the analysis product report type LABType Micro SSP LABScreen etc e Category Select choose the report category molecular or antibody To create a separate report for each selected sample select the check box next to 1 Sample per Report View Print or Export Reports e Once you have the report type and all the samples selected click View Report The report is displayed in a separate window the Report Viewer Example of a report viewed in the Report Viewer rin Molecular Custom Reporl a Tie E MA Main Repent Smith s Custom Report Lal Mami Cine Lahde Eme Institut Gn Linbda Enshitube sire 21200 Canard Sires EN cise e fi ial i x Lab Cade Conta Di Emilia Fobaso
214. gt Force Sure Reaction d view QC Forced Positive Bead ID eg 001 002 005 etc Low Positive Threshold Enter the bead D s you want to force POSI TI VE Set Sure Reaction Forced Negative Bead ID eg 001 002 005 etc Enter the bead D s you want to force NEGATI VE OK Cancel _0K Corea ie Force Sure Reaction HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 74 One Lambaa Inc View QC NMDP Code No Code Local Code P Grouping G Grouping Cross Code Bw4 Bw6 in Serology Demographic Information Minimum Positive Control Minimum Bead Count Set Sure Reaction Bead Low Positive Threshold HLA Fusion Software Version 3 x x User Manual This pop out list displays the Alternate QC panels that you created which are available for the current Catalog file which can be displayed as histograms in Quadrant 1 of the Analysis Window When clicked you can select from this list rather than use the OLI OC QC panels can also be created by right clicking a saved LABType Session on the Navigator tree and selecting Create Local QC R55020 003 05 1L4B20120130155556 Rs55020 003 05_LAB120120131081215 Configure Alternate QC Panels Low Positive Threshold Setting Set Low Positive Threshold No Code Local Code P Grouping G Grouping Cross Code Bw4 Bwe6 in Serology Demographic Information Minimum Positive Control Minimum Bead Coun
215. gt Dacia Soren Meses K sewn Cones Parei a Fe 1d Vew Toe ep Change the appearance of your Sr play HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 23 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Select the Make text and other items larger or smaller see previous 2 Select Smaller sized text Windows Selecting Smaller 3 Display Fife o x a Jo E All Control Panel Items Display K Search Control Panel 2 File Edit View Tools Help 12 Control Panel Home Make it easier to read what s on your screen You can change the size of text and other items on your screen by choosing Adjust resolution one of these options To temporarily enlarge just part of the screen use the Adjust brightness Maanifier tool A Calibrate color Change display settings Smaller 100 default Preview Connect to a projector Adjust ClearType text Set custom text size DPI Medium 125 See also Personalization Devices and Printers File Permissions All HLA Fusion users must have read and write permissions to the following directories and files e OneLambda Fusion Interface exe config e ReportMap xml e C XOLI Fusion and all the sub directories and the files in these directories HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 24 One Lambaa Inc HLA Fusion Software Ver
216. gt Manage Test List Use the pull down menu to select a test list and click Continue gt gt Click Export to export test list details to a txt file HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 270 One Lambda Inc HLA Fusion Software Version 3 x x User Manual 4 If prompted to save the test list before export click Yes to save and continue 5 Select a location to save the test list and enter a file name for it 6 Click Save 7 When prompted to create a Luminex Patient List input click No 8 Click Close to close and return to the Main Menu 271 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Luminex Lists HLA Fusion can create a Luminex List from a new or existing test list You can use this list to quickly add information such as sample ID before you create a Luminex CSV output file From the Create Edit Test List wndow you can create a Luminex list Creating Luminex Lists Luminex List files can be edited after they are exported but changes are not reflected in the test list from which they were created From the Main Menu select Samples gt Manage Test List Use the pull down menu to select a test list and click Continue gt gt Click Export to export Select a location to save the test list to and enter a file name Click Save When prompted to create Lum
217. guration for each product e g low bead count for LABT ype 2 Choose to save the report preview it print it or export it to Excel HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 321 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Example IQ Report FrmIQ Operation System Service Pack English United States Installation Qualification Type HLA Fusion Database Version Fusion Database local FUSION FUSION_BSmith Fusion Database size and usage 47 161 MB of 4096 MB DB size Audit Database Audit Database size and usage SW Regional Bio Lab Typical IQ Report IQ Installation Qualification The IQ process assists you with the installation qualification by providing a built in functionality This can be performed only if you have completed the IQ process as explained above The installation qualification goes through a series of QA process to analyze pre loaded batch and catalog and compares them with pre defined results Once the Installation validation completes a results report is generated that you can choose to save print or export to Excel If the results concern you export them to an Excel file and email this file to OLI Customer Support e From the Main Menu select Utilities gt gt Validation gt Installation 1Q The validation test runs When it is complete a report is displayed with data regard
218. h the reaction pattern for the sample e The Force tab displays a list of alternate possible allele pair results for each bead if an additional false reaction is allowed e With the Type Subtype tab when an allele from one list is selected the matching allele s are highlighted on another list to show the possible match ups e The Match tab displays the coded format of the actual allele pairings for the sample e The Sero serology tab displays all suggested serology equivalent data for the sample based on the possible allele pairs The right side shows possible allele code assignments for the sample as well as close bead reactions HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 95 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Pairs Force Type SubType Match Seo Close Bead Ran El 020 411 01 z02N 48211 01 02N A 11 01 Possible Allele Code 02N A 11 XX1 A 11 XX2 02N A 11 A 03 18 A 11 AFTF A 11 AEPJ A 36 04 AEPJ 38 39 AFTE 17 40 XX1 01 01 01 01N 01 04N 01 0901 11N 01 15 XX2 oso cos F 02N A 11 01 020 A 11 D02N A 11 D2N A 11 D02N A 11 z020 A 11 201 01 01 01 A 11 01 12 24 01 01 01 01 A 11 64 fa 01 01 01 01 A 11 64 Other Assignment v Quadrant 4 Test Results The Pairs Tab The Pairs Tab displays the possible allele pairs results that match the
219. he Force ve button to analyze the sample as positive The sample is re analyzed Graph Raw The Raw Data Graph shows the raw Mean Fluorescent Intensity MFT value of each bead overlaid with the imported NC Serum MFI 1 In the analysis window click the Graph Raw button to display raw data graph with background values Click the Normal button to return to normalized graph HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 178 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Raw Data Table Positive beads are displayed in red text Rows highlighted in yellow have normalized values that are above the value in the Min Value box Changes made to the normalization formula and minimum normalized value apply only to the raw data table and not to analysis 1 From the analysis window click the Raw Data button on the bottom right of the analysis window to display Raw Data Table Raw Data Table Sample 1559 07 Patient Well Pos 5 Session 20120117_SAG2_LOT4_1D53 Current Formula Test Date 11 3 2012 11 11 02 AM Catalog LS2A01 NC6_004_02 Min Region Threshold Formula Baseine bd NC Bead 1 Negative Control Sample Min Value 2323 95 mE NC Baseline 3 Molecular Specificity 7518 98 105 33 2900 15 7771 27 105 33 3743 94 1913 81 105 33 318 48 5281 38 105 33 2384 55 4014 41 105 33 1604 58 1 D041 05 01 00A1 02 01
220. he View Gel button at the bottom left of the gel image screen If no image is currently linked to this sample you ll see this message 2 Click the Yes button and Fusion opens the Select Gel Image screen 3 Browse to a new gel image and click the Open button 4 Fusion opens the Gel Image window and displays the gel image you ve selected The window can be resized if needed HLA Fusion Software Version 3 x x User Manual Select Gel Image x e E m v Data Reference Files Micro SSP v Search Micro SSP a Organize y New folder y fil YX Favorites hy a E A Libraries i Documents A Music Pictures Micro SSP Gel dna 149 dr15 jpg z Videos Image a Homegroup jm Computer Ec ami miin nannan ie 3 File name fana 149 dr15 jpg Z jepeg image jpg z If you want to link this image to this sample click the Link Image button e To zoom in click the button e To zoom out click the button e To turn the image click the Rotate button Zoomin Zoom Out Gel Image Viewer Click to close the Gel Viewer Click to rotate To link the image to the gelimage the current sample HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 129 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual To Unlink an image already associated with the current sample 1 Click the View Gel button 2 When the image i
221. hood friend Po Wihatis the name of the city vou were born Po W NONE LAMBDA IE HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 22 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Key System Settings Screen Resolution HLA Fusion software requires a screen resolution of 1280 x 768 The software displays a message if your current resolution is less than the expected settings Note You can choose to suppress this message through the Edit link on the General Configurations section of the Home page lolx The minimum required screen resolution is 1280 X 768 Please use display settings to change the screen resolution Do you wish to continue l Don t ask me this again _Yes_ No Minimum Screen Resolution You can select Yes to have the system attempt to make the adjustment It will continue to start the application even if it could not adjust the resolution Or you can select No and adjust it manually In addition if your computer is running the Microsoft Windows 7 operating system the text display setting must be set to Smaller 100 default Take these steps if you need to adjust the screen text display size 1 Right click on the computer desktop Select the Screen Resolution option The Screen Resolution window displays Windows 7 Screen Resolution window 2 erren Hecwohettion aimi x GE A Corta Pare tees
222. hrough the Utilities menu If you have selected the Computer Assigned Serology check box for LABType product configuration adjusting the sample cutoff values automatically results in serology assignments Only one serology assignment can be made at a time per locus for the sample Therefore a current serology assignment is replaced if you assign a different one HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 100 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Pairs Force Type SubType Match Sera me Serology Equivalent 14 A 11 Allele pairs 01 01 1 te associated Ge ena 214 A 11 with the Sero z 01 01 14 211 Equivalent A 01 01 14 A 11 214 A 11 01 Assign Button Assigned Allele Pairs 2 01 01 05 A 11 215N 3251 01 05 A 11 29 24 01 01 05 A 11 16 A Other Assignment Assigned Sero Serological Assignment Suggested Serology Equivalent Tab 1 In Quadrant 4 click on the Sero Tab to display the Serology Equivalents for the current sample in the top pane of the tab above its associated allele pairs 2 Double click an equivalent or highlight it and click the V assign button to copy it to the Assigned Sero field 3 Click the X remove button to delete a serological assignment or to select and assign a different equivalency to replace it Note To set auto assigned serology results select Computer Assigned Serolog
223. i aes vast NOs 1306 O 021672012 Batch imp Bamit F S 7960 C08 0 Gogoi Weed es e A 04 ti ee 100 03 18 2017 Batch Imp Bamir y 0 cs Ds l Ta l 1353 1243 Corbi sea a F 012 CA661 l l cues ec 100 03 18 2012 Satch imo Semn en 2486 C07 0G CO 1571 103 01 XX1 06 02 06 07 06 10 06 1 06 1 ane FAEN CI rege F naet EOOD 14 06 1506 1706 18 Le ibe 0062 62 wed herra leen teta EET x1 09 0 02 06 9191032107 F 049 4 6T 03 44004 Batching Ber a User Comments Auto Accent Az Appi PIG Code Ea System Comments Pont Prenew export _ Session Summary Table e You can double click a sample in the Summary Table or single click a sample marker on the Summary Graph to go directly to the Analysis Screen for that sample e Double click in the User Comments field to add or edit your remarks System generated comments cannot be modified e Click the Field Chooser button to the left of the table headings The Field Chooser is displayed This allows you to select or clear the check boxes next to column headings and include or exclude those columns from the Summary Table e Selecting or clearing check boxes in this window instantly updates the table Note If you do not see a particular field available through the field chooser and you are sure it should be there go to C HLA Fusion temp and delete the file named Labtype_Layout xml HLAF MAN V3 x x EN 00 Rev O
224. ia da ConceiA A o B de Lima13 04 06 74475 08 21 2012 de Lima13 Maria de Lima Hispanic l Patient x KE LaBType Fees m em GGD If a sample is already associated with a patient the Patient ID and any existing related patient information is displayed To add patient information do one of the following 1 To add data from the system click the Patient List button The Import Patient windowis displayed allowing you to import the patient information file HLA Fusion LEKKER First Name Middle Name Laa Mame SSN impar Local Patient ID Category Gro Fary ERBLAINE pesas uso F s vine UR li ji E jus w ju Ferppuni ms ewe F a od K mi Chaves ra same F mem per odias P4 Morir 3 w e fa gt Ww int nom ra m ma hona roc maes ezo m Beanies At Simca MJ _ Ffae tpt cio HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use Click the Browse Button to locate Patient Information 196 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual To manually add Patient Data simply type data into the patient related fields of the table e You can have Fusion assign the Sample ID to empty Patient ID fields by checking the box for assigning the Sample ID to empty Patient IDs 2 Thesystem assigns a Session ID by default Optionally you can type in a different Sess
225. iagnostic Use 307 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 1 Select a catalog file 2 Edit existing template name s 3 Click Save to save changes 4 Click Close to return to the Main Menu Importing Allele Frequency Files Demographic Frequency You can import allele frequency files to use in analysis based on demographics 1 From the Main Menu select Utilities gt Update Reference Allele Frequency 2 Select the Create Demographic Group option Allele frequency import Demographic Allele Frequency x z gt Pe Pa HLA Fusion eeceeee gt Create and Update Demographic Allele Frequency C Create Demographic Group Update Alleles and Frequency Delimiter y Z Skip First Row Allele Column 1 E loe soon Demographic Group and Frequency in Database __ Allele Sero Frequency fd Allele Test 1 gt A 01 01 A 01 01 01 A 01 01 01 01 A 01 01 01 02N A 01 01 02 A 01 01 03 A 01 01 04 Y ONE LAMBDA 3 Click the browse button and locate Allele Frequency files 4 Click Import When an Allele Frequency file is successfully imported the groups it contains are listed in Demographic Group and Frequency in Database 5 Click Save HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 308 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual If the header f
226. ickthe button located to the upper right of the j Final Analysis results box to display tail analysis values in Final Assignments results field e LAT Single Antigen samples imported after this configuration change do not display the tail analysis assignment area on the sample analysis window HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 217 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Navigating Between Class amp Class II PRA Class I and Il Combined For Combined Class I and II LABScreen PRA sessions each HLA class is analyzed separately and needs to be saved separately for combined results to appear in the database Make sure that you have already created a combined Class I and Class II LABScreen PRA catalog file before you import the combined sessions e From the analysis window click Run Class I and Run Class II buttons located in the upper left part of the analysis window to switch between Class I and Class II results for the current sample HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 218 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Navigator Right Click Menu Options for LAT Note These options apply to all LAT sessions and samples There are analysis options available through the Navigator depending on whether you are in the LAT session summary view or on an analysis screen for
227. ie ean 211 VIEW IVI OIE CULOS DECIME SA AAA AAA A AE A AA AR 212 Selec MIDIMUNT POSITIVE TESNO e dl le de e Ml O 212 Exclude Antigen FIOM ANAYSSI A A lead 212 Pea ECU Cia taa E lbs 213 NAVIGATING BETWEEN CLASS TE CLASS M orreri ani e E a S 213 PRA CIOS S ES COMIC daa 213 POW DOTO TODE erian E E E ET NOTT E ETTE 214 ROW DOTO REPO A AA AA A A E E 214 EXPOFUNO SESSION Dal Aeee E a a a a 214 PONOT O 214 Adang Comments CO SOMO CS A A iaa 215 FIGQOING A SOMPIC TON Further TESTO AN A A A ad 215 Previewing and Printing REODOTES a AAN AAA AA ias 215 WIAKING FIN ACASSIGNMENTS aeren iio aa a a a aa A 215 Manua Ass INMENSA a Ae 216 Assigning NEO OLIVE SQINDICV QUES as 216 REMOVING ASSIONIMNCINS aia ASA ti 216 SOVEASS ONMEDA A Ia 217 CONFIRM ASSIGNMIENTS sscurssn sd taa 217 CREA TAN ANGIUSIS V UUE S e des ae teles DUES 217 NAVIGATING BETWEEN CLASS I Ge CLASS Maca o 218 PRA Class tand Tl COMDINCGS iris AAA A ci 218 NAVIGATOR RIGHT CLICK MENU OPTIONS FOR LAT sscsscssccsscssccsscnscnsccsscnscnsccnscnscnsccnscsscesccnscnscossonscnscesscsscnscssonsonsees 219 Renale WALID IN CW COLOIOG A ona 219 SAMPLESEEVEIROPTIONS Sta A A oi daalde desley de 220 REI tea RECUS aiina Re ont aed PERE Pe Ona A ic 220 SEBV SIGCANCIVSIS oe ee eee 220 LCECTANA SD Ea 221 STARTING ECT ANALYSIS o tn oi aa 222 ACOVIRNG CET O 222 LET SESSION SUMMARY SCREEN aid accio 224 USING THE LCT ANALYSIS WINDOW costs ncitedsvucccatsssustansedcvacacntatenscngseacentaataaccacawateaee
228. ient donor lists you attempt to import to verify that all characters contained in the data are supported by Fusion If your list contains unsupported characters a message is displayed to let you know and the list is not imported Newly imported patient records display alleles in the new nomenclature format Existing patient records display alleles with the existing allele format HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 277 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Managing Patient Donor Records The Patient Donor Management menu allows you to manage one record at a time From the Patient Donor Management menu you can e Add new patient donor records e Search existing patient donor records e Edit patient donor records e Associate patient donor IDs with sample IDs e Associate patient and donor records e Assign a donor to the Donor PRA o Print export and archive patient records Adding New Patient Donor Records You can add patient information using the Patient Donor Information menu This is the best option for adding a small number of patient records 1 From the Main Menu select Patient Info gt Manage Patient Click to display a list of patients donors in the Fusion database which you can search through by using numerous criteria 8 Patient Donor Information General Info HLA Tests Creatinine Tests Transplant History History
229. iew of the same sample The quadrants are all linked to one another a change you make to Quadrant 2 cutoff for example affects the display in Quadrants 1 3 and 4 Each quadrant can be re sized vertically and horizontally e Hover your cursor between the quadrants until the cursor image changes to Click and drag the graph to resize it e Or click the Quadrant Maximize I button to modify the quadrant display HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 79 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Keyboard Shortcuts for LABType Analysis Navigation The following table defines some computer keyboard combinations you can use to quickly navigate through a LABType sample during analysis Keyboard Combo To Do this To Do this Navigate to the next bead from bead analysis amp sample analysis screens Navigate to the previous bead from the bead analysis sample analysis screens Assign and go to the next sample from the sample analysis screen Quadrant 1 QC Histogram There are several tabs in this quadrant as explained in the following sections QC Tab The QC Tab displays a histogram of the reaction profile for the current bead against all samples of the QC panel used in the analysis Fach bar represents a QC sample and its height represents the normalized reaction value Rxn Rec Site Local QC Patient Sample Res
230. ifying glass and enlarge any section of the window Use your mouse to move the magnifier and use the arrow keys on your computer keyboard to increase or decrease the height and width of the magnified area Click anywhere on the screen to deactivate the magnifying glass Cross Loci Sample Foon A 010103 A 010104 A 0102 Magnify an Area Show Navigator If the Fusion Navigator normally displayed on the right side of the application window is not visible click the Show Navigator _ button on the toolbar Once the Navigator tab is displayed move your cursor over it to slide the Navigator panel open Navigator f Product Test Date Catalog Session Date Group IOVEDIAE fy EM LABT ype U4t0bworkshop dgb _ lot 6 U40bworkshop Blot 9 104 U40bworkshop A Lot 1014 The Fusion Navigator HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 36 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Patient Donor Information From any Analysis Screen click the Patient button to display the Patient Donor Information Screen where you can enter or edit information related to a patient or donor and associate it with the current sample PatientDonor Information General Info Enter new patient donor information or search patient donor to edit Search Patient Donor V Enforce ISBT format for Patient Donor ID T Archived M Patient
231. ile s on your computer or network Browse to Find LABScreen Session Files Note Note E yo aE Data Reference Files LABScreen v KZ Search LABScreen E Organize New folder a y E Documents a 2 as 0407 514004_001_1D328 csw a Music a Microsoft Office Excel Comma Separ b Pictures 7 123 KB Vi ES Videos 02131 1SM12 011 01 1D3214 csv a icrosoft Office Excel Comma Separ Microsoft O 2 Homegroup 7 16 3KB ag aap lot g_ID69 csv 1 Computer a Microsoft Office Excel Comma Separ E c Z 463 KB Ga D Bal ls a _010XM_ID1050 csv a Separ Cu Network da poa 042007LS2A01_004_ID329 csv y gl Microsoft Office Excel Comma Separ A File name CSV Files csv y Open Cancel Select a CSV session file s and click the Open button to display its associated samples in the Current Sample Patient Details table You may see CSV files for products other than LABScreen or other miscellaneous CSV files This means that you must first click on a sub folder for LABScreen or that your LABScreen session files are not contained within their own folder in the directory to which HLA Fusion is pointing HLA Fusion converts Luminex generated CSV file data such as date and time to the local regional code if a regional code is specified in the CSV file A regional code cannot be specified for CSV files created with Luminex software versions 2 2 or earlier If the first date field
232. inex List input click Yes Click OK on the confirmation message to return to the Test List wndow OND oF Wn gt Click Close to return to the Main Menu Create Sample Worklists Note The Sample Work list feature is available only if you have SQL 2005 and above installed Create a Sample Worklist Sample Worklist Search by sample Search by test list Gear Finer Search LABScreen Tests LABType Tests F A oa LE Sample Work list functionality in HLA Fusion software gives you the flexibility to assign various tests to selected samples This information is used in designing plates for Luminex processing DAB1 rT owe V 87 m F _ DQA F por M paapar r or M ORDS HRG HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 272 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 1 Select Sample gt Create Sample Work list from the HLA Fusion main menu Do one of the following to search for samples D a Click the Search by sample tab use the search criteria to specify the samples that you would like to assign tests to and click Search b Click the Search by test list use the search criteria to specify the test lists that you would like to assign tests to and click Search Select one sample or select multiple samples by holding and dragging the mouse The selected samples are highlighted Now assign on
233. ing e Set up and connected to an audit trail database see the HLA Fusion Database Utility User Manual e Enabled Audit Logging from the HLA Fusion default home page Once you have completed the above and wish to view audit log data take the following steps HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 255 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Access the Reports window in one of two ways e From the home page click Create Reports e From the Fusion main menu options select Reports Select Miscellaneous gt Audit Trail Log The Audit Trail Log dialog box displays Audit Trail Log Screen Audit Trail Log HLA Fusion Modules User actions Bob Smth y C Antibody Tracking Manage Patient C Sample Analysis C Analyze C Login C Retrieve C Batch Analysis C Manage Profile C Sample Summary C Create C Logout C Search Date from To C HLA Fusion O Manage Sample C Update Reference C Delete C Other O Update ri728 2012 5 23 2013 2 C Import Session Product Configuration O Epot F Report Export C Manage Data C Report C Import C Report Run Epot cose e Use the drop down arrow to select the User for whom you want to see database actions e Select the date range and options you want the report to include Click List J to see the report If you want to export the audit trail report to Excel click Export l
234. ing the operation of HLA Fusion in your computer environment HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 322
235. int button to see A ie a list of available reports en ee ee Allele Code Allele Summary Molecular Typing Summary Panel Summary QC Overview Note If you select Molecular Custom you are not be able to create a new custom report at this point The only custom reports available from the analysis window are ones you may have previously created through the Reports window HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 109 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Assign Coded Results Usethe Assign button to assign and save all unambiguous possible coded results those results for which there is only one coded result For the assignment of Serological or Allele pairs or when you want to choose in the case of ambiguous results you must manually move them to Assigned and click the Save button Translate noncurrent nomenclature format only The Translate button aste js displayed only if the sample allele format is in the older nomenclature Clicking the Translate button does the following e Translates and displays all Assigned except from the Other Assignment field and possible allele code pairs haplo in the latest nomenclature format e Ifamatching allele in the new format cannot be found the allele remains displayed in the old format e You can view and print this display but results cannot be saved or reported in this new nomenclature format
236. ion exporting and printing you can create a report containing raw data information for the current sample Once the Raw Data Table is displayed click the Report button at the bottom right portion of the Raw Data table window to display a report of the raw data Click the Exit X button at the upper right corner of the table to close the window and to return to analysis Click the Print Screen button to display a preview of the currently visible portion of the Raw Data Table Click the Printer button at the top left of the window to send the image directly to the printer Click either the Exit X or Close buttons to close the window and to return to analysis HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 206 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Printing the Current Analysis Window The Print Screen button sends the currently displayed analysis wndow to the default printer for your computer e From the analysis window click the Print Screen button on the Fusion toolbar to print the currently visible portion of the analysis screen Previewing and Printing Reports To view or print an Antibody Screening Mixed Data report for the current sample use the Preview Report button on the toolbar Reports Data Sample Patent Into Profle aHB8 A AA B Patent Summary Patient Custom e Inthe analysis window click the Preview Report Antibody Screening
237. ion ID Current Session ID LAT 1240 2012101 Date 10 2 File Path 20 FUSION data session Data Reference Files LAT Vat 1240 csv Catalog ID LAT1240_005_01 y NOM Imat Note A session ID must be unique to the Fusion database If the session ID already exists the software prompts you to rename the session It is highly recommended that you not use any special characters in this field since they may serve a specific purpose as field separators 3 Accept the displayed Catalog file or select a Catalog file from the drop down list in the Catalog ID field Note If you need to import more catalogs click the Download Download link on the LAT Home page The catalog drop down list may not be immediately updated if you downloaded the catalogs during the current import session You may need to click the Home button and then click the LAT button again to return to the import process Product Test Date Group Catalog Session Date G LAT1240_002_00 88 LATO1112008 E LAT140 004 01 E LAT_20120109130107_LAT MM LAT_20120109130203_LAT E LAT140_005_01 E LAT_20120109130451_LAT 4 When session and sample information have been verified click the Import button The session is now displayed in the Fusion Navigator tree on the right side of the analysis screen for subsequent analysis NS AS LAT_20120109143957_LAT BS LAT 20120109144234_LAT E LAT140_006_01 89 LAT 20120109125117 _LAT
238. irs are grouped by demographic frequency groups e G1 itis frequent on both alleles e G2 itis frequent on one of two alleles e G3 itis not frequent on either allele Fach allele pair group is identified by G at the end of each allele pair to indicate demographic frequency If the closest matching results include a false reaction the false reaction bead is also listed No Solution is listed if there are no results that match the sample s reactions within an allowable number of false reactions When this occurs increase the number of false reactions and reanalyze Assign an Allele Pair from the Suggested List Double click on an allele pair under the Pairs tab to assign it to the final allele pairs assignment area Alternatively you can click to highlight an allele pair on the list under the Pairs tab and click the down arrow V assign button next to the Assigned Allele Pairs title to add it to the final assignment area Multiple allele pairs can be assigned To remove an assignment click and highlight the assignment on the Assigned Allele Pairs list and click the X remove button Assigning and Removing Allele Pairs Pairs Force Type SubType Match Sem Close Double click on a pair to Select and move them i click the X to the final button to assignment remove an area i assigned pair Or Click the Assign Button here HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitr
239. is window to confirm all analysis results You automatically move to the next sample to continue confirming results When you first return to a confirmed sample you see that the Confirm button is now shaded purple to let you know it has been previously confirmed HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 147 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Micro SSP Session Summary The summary table can be launched by clicking on a session in the Navigation Tree on the far right of the screen It lists each sample in the session and any saved analysis results e Double click a sample in the Summary Table to go directly to the analysis screen for this sample The Field a o E Catalog A Chooser ee Click on the Field Chooser _ button to J i the left of the table headings to display the Field Chooser In this window you can select or clear the check boxes next to column headings to include or exclude those columns from the Summary Table a Selecting or clearing check boxes in this aa ae window instantly updates the table Note If you do not see a particular field available through the field chooser and you are sure it should be there go to C HLA Fusion temp and delete the file named SSP_Layout xml e Click on any column header of the Summary Table to sort the table by that column The small Up 4 or Down v arrow in the column header indicates the sorting
240. isk are required Click Add New to save the data and add the patient donor information to the Fusion database Click Close to close and return to the main menu Lookup Patient Donor Records This option allows you to browse through records or search for specific ones 1 2 From the Main Menu select Patient Info gt Manage Patient Enter a patient donor ID and click Retrieve to display patient information Or click Search to browse patient records and lookup by name patient ID whether it is active or archived etc Highlight a patient record and click OK to display Editing Patient Donor Records Note You must be a Supervisor in order to edit a patient donor record All patient donor information except patient donor ID can be edited 1 Zz From the Main Menu select Patient Info gt Manage Patient Select a patient donor record Select the check box next to Edit Mode There is the same Edit Mode check box on both tabbed forms Edit patient donor information on one or both tabbed forms Fields marked with an asterisk are required Click Save to save your changes Click Close to return to the Main Menu HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 279 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Associating a Patient Donor ID with Sample IDs A Sample ID cannot be associated with more than one patient or donor record b
241. iven results field by holding down the Ctrl key and clicking multiple specificities From the analysis window do one of the following to make assignments e Double click an antigen specificity in the Tail or Epitope Analysis results box to assign the specified antigen to the Final Assignment field e Click to highlight the specificity and click the Assign Single button gt to moveit to the Final Assignment field e Click the Assign All button to the right of the Tail or Epitope list to move all the current results on that list to the Final Assignments field e Right click on a specificity or CREG group on the CREG Table to assign it to the Final Assignments area Manual Assignments Manual assignments can be entered in the field below the Final Assignments results field Enter multiple manual assignments by leaving a space between each specificity 1 From the analysis window type a manual antigen specificity assignment in the field under the Final Assignment box HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 235 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual E Click the Assign button L just above the Manual Assignment field to add the assignment to the Final Assignment results field B13 poe Assigning Negative Sample Values You can assign a negative value to a sample even if analysis shows some positive results e From the analysis window click
242. l v3 x x For In Vitro Diagnostic Use 63 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual The Bead Analysis Tab This tab allows you to review the global session information for each bead This tab displays three graphs which are described in the following sections Summary Control Value Bead Analysis One Lambda QC Bead ID A125 Max Scale Bead fos2 y lt gt Dai Exclude Bead False Reaction Summary N WO a ODN w 001 003 D09 011 013 017 020 022 024 026 029 031 033 036 038 040 043 046 048 054 057 059 061 063 065 067 069 071 073 075 077 034 036 083 002 D04 010 012 015 019 021 023 025 027 030 032 035 037 039 042 044 047 052 056 058 060 062 064 066 068 070 072 074 076 078 085 087 099 Auto display next highest False Rxn Bead upon cutoff adjustment Bead Analysis Tab False Reaction Summary With the graph in the lower panel you can review the number of False Reactions both positive and negative associated with each bead in the entire session False Reaction Summary o Pate ello edo o ad pd Y a a PL mta fea fea a Ya a Gee for AAA AAA aa as e e A e Ta da el ib Ban pue A ied HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 64 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual The color of the bar represents the type of false reaction that exists e Green false negative e Red false positive The height of the colo
243. lete the batch information or until you want to save and complete the batch later Each Micro SSP batch session can consist of as many samples as you wish to analyze with the same or with different catalog information HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 121 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Take one of the following actions once you are ready to stop creating the batch e Click the Next gt _ 2_ button to open the Micro SSP analysis window e Click the Save button to save the current batch information and return to it later e Click New Batch to start creation of a new batch e Click Close to exit the Batch Entry window HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 122 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Configure Micro SSP Data Analysis Global defaults for Micro SSP product configurations can be set from one of two places e The Micro SSP Home Page e The Utilities menu on the main HLA Fusion home screen In addition configurations can also be set from within the analysis window for the current Micro SSP sample by right clicking anywhere on the analysis wndow to view a pop up list of configuration options After an analysis has begun you ll need to right click in the area just to the right of the Find Allele button to open the Micro SSP Configuration Menu Micro SSP Sample
244. llele pair 05 DEBIDA or pairs and click z 7 this button to send them to the final assignment area The Final Assignment area Click the X button to The Manual remove allele Entry Box pairs Match Tab This data grid displays the coded format of the actual allele pairings for the sample A Matched Reaction Pair is a pair of alleles or group of alleles with a reaction pattern that completely matches the reaction pattern of the current sample Hover your mouse pointer over an allele to see its code definition e This result differs from the Possible Allele Code results The Possible Allele Code condenses the results into a single code where possible e Hovering your cursor over a coded allele format displays its code definition HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 138 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Manual Allele Pair Assignment 1 Make sure you type the assignment in the correct allele code format e Newnomenclature format X 4 44 HHHH X HH HH HHHH where X locus type and code number e Previous nomenclature format X 4H H X HHHH where X locus type and code number A manually entered assignment DRB1 O7 01 01 01 DEB1 07 03 Type an assignment into the text box directly below the Assigned Allele Pairs list Press the Enter key on your keyboard to move the typed allele upwards into the A
245. llele pair under the Pairs tab to assign it to the final allele pairs assignment area 97 Manuali y As TON ADAN ROU nara suid E T T E T a EA E ado TE 98 A E E A E eee 98 PVC SCY Oe TAD AAA IS TOTEE T E T NEO 99 Maten TOD A A A A A A E R eee 100 A E Ene terre ree ete ener ne eee tr tone etree ener ere ee eee ere tree ere eee eee ee eve 100 EXGIIOC EXON 3 PODS TOALLA donas 101 Allele Code Assignment id AA A AAA AAA AAA A A OO 102 Anele COGEASSIGIIIICIE aia EEE dra 103 Manta Allele Code ASTON e dra e O 103 EMC AS SONED iia 105 RENO IZ NN oe Cee RC RCE Tee it 106 Analyze COMDINEG LABTV De SESSIONS a sa 106 Adaing User Comments to SGM pies 107 EIGOGING as amp FOr Further TESTO AAA a hee alia EA AE AE ple cares areal Vie tages aad 108 Assigning Serology and Allele Code Results to a Patient cccccsssecccsseecccseseccnsuseccsuesccsauseccsausecssuecesauneessauseessunecesauasessaes 108 PRCVICWCOR FINT RE DOS AAA vitae esis AAA AAA A Ai 109 ASSIGN COGCO RES O a ee Ll ON 110 A Meeps A I ned esas waiees aane ates oe cae E tana eae ce ees 110 SOVE ASSIOMM CUS tidad eanietaebdagtantassentohauourad TOTA TNS 110 CONTIN Assignment SA ie eo 111 NAVIGATOR RIGHT CLICK MENU OPTIONS FOR LABTYPE sscsscssscsscssccsccsscnsccsscsscnsccsscnsccsscnscnscesscsscnscsccsscnscessonsoesees 112 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 5 One Lambda Inc HLA Fusion Software Version 3 x x User Manual
246. llil ode Liari DRR C DAMA 104 0104 3304 3504 Ee aa a a 49 04 4 004 44 04 46 04 A A T od 500040 5104 523 04 5 a Allele Code bary C OAT C DOBI 2 Lisl Nomenclature Vorsion You may request allele cc 2 XX code saved as a spreadsheet csv file OF 59 FILS TEF FF I if aT rer ee ee ee ea E ER 2471512775427 1 55 47 Fa t 100210521152 128025 1 31 27 39 27 Ca ee ra es ar te ys ar ees F a a i eo 2 19542714527 l Stampa pea 1027115273282 17 LA ere r927 ALATTA Sa aG 2 Pee 2 rae 2 O Ar 195121 135427 ISS SS A A A TEA o rA E E A T A AO AO e TT TT XX code saved as a text txt file t Tad ALTO 493087 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 142 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Other Assignment The Other Assignment field can be used to make a sample assignment that is not restricted to any format In addition you can highlight and add serology or allele pair or code assignments and add them to the field for modification Assign Possible Allele Code Assign All You can make other code assignments one of two ways e Type an allele pair or allele code into the Other Assignment field e Click the V assign button and select one of two options 1 To assign just the possible allele code select Assign Possible Allele Code 2 Choose Assign All to bring the Possible Allele Code Serology or Assigned Allele Pai
247. lowing e To add patient data which is already stored in the system double AG click in the Patient ID column of the Sample Patient Details table or alzada Manage Patient Ab Tracking e Click Patient Info on the Fusion Menu Bar and select Import Patient List to import the patient information file e To manually add patient data type data directly into the patient related fields in the table You can automatically assign the Sample ID to empty Patient ID fields by selecting the check box for Set empty Patient ID to Sample IY Set empty Patient ID to Sample 11 Select a Catalog file The catalog file selection method varies depending on the CSV file and the catalog files you may have previously imported for LABType Note If you need to import more catalogs click the Download link on the LABtype Home Page The Catalog drop down list may not be immediately updated if you downloaded the catalogs during the current import session You may need to click the Home button and then click the LABType button again to return to the import process e Ifthe CSV file specifies a template name only applies to CSV files from Luminex 2 2 and later and one of the available catalog files is associated with that template then all new sessions with the same template will auto select that catalog Catalog Listing i sees a As shown here you can also select a different catalog file from the one that Fusion has selected by using the dr
248. mary The session summary page can be launched by clicking a session in the Navigation tree It presents a preview of the analysis results listing each sample in the session and corresponding batch analysis results The Summary Graph displays data points for each sample The Field Chooser Click to include or exclude columns Summary Control Value Bead Analysis Session Summary tabs Session 132_7_4 9 ID3915 Catalo Click to assign the analysis results as the final results for all samples To apply P or G grouping to samples in the session that have not yet been saved g ASSO14_011_08 NOM January 2011 3 3 0 Wocus A Session Date 11 28 2011 Nu Search the samples for XX codes and replace them with updated NMDP O 1 41 2493029 Patient 2493029 Low Bead Count 4021 Possible aber of Sample 96 Possible lel le Allele i Exon3 NC Ae Definition A 01 01 01 01 A 24 02 01 02L AJD 01 01 0 16N 01 17 01 1 2 B1 2493030 2493030 Low Bead Count 3394 19 4 D1 A4725 01 02 FN 087 3 C1 2493031 2433031 2995 Low Bead Count A 24 XK2 17 63 4 24 02 01 01 Od 02 01 702 02 166 02 202 1 4 D1 2493032 5 E1 2493033 2493032 2493033 Low Bead Count 2670 4 68 KCUP Low B
249. mmended that you do not use any special characters in this field since they may serve a specific purpose as field separators 2 Use the browse button at the bottom of the window to search for and import one or more Micro SSP csv files or follow the steps below 3 Use the drop down menu in the Locus Filter field to select a locus by which to filter the catalog listing This will limit the catalog list in the next field to only those catalogs that include the selected locus 4 Use the drop down menu in the Catalog field to select a catalog file Note If you need to import more catalogs click the Download link on the Micro SSP Home Page for instructions on how to add new catalog files to the database The catalog drop down list may not be immediately updated if you downloaded the catalogs during this import session You may need to click the Home button and then click the Micro SSP button again to return to the import process 5 Accept the session name in the Session field or modify it 6 Enter a name in the Sample Name field If this is an existing sample name other fields such as the Patient ID and Ethnicity are populated with existing data You can also double click in the Sample Name field to display the Select Sample window from which you can select a sample HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 120 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 7
250. n Labim Oxnard Seats Drain CA Emi id Falso Ragion Mew Zip Poitel Cede 9136 Plone HLS 53535 0212 Coo USA Nom Semple 25465 Fan 010 333 1212 Local Dy Tampir Dino Ten Daim Feb 1 201 Sendoa Te 212 3010 DAE Lenu DE bgp 0A tlt 09 Lore DRB Tew Pox 1 Lomo Lumina 10 25 Comment Lew Bead Cou Control Values Exa ABE 1916 DAL Excal ABE EA Fil A B Fred E Interpretation Amigosd S5eralos La DPAL DF DAL DPAI DPB Tear Kaarti MIMLLMLLLALA EMER DREADED EL ERE LLC HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x Xx m ee PA k k p Ma rr r e PA a E Ys a wie A aa me sismi DEB 1 01 0700 20040507147 1012540350 e 150 idem Yak DEBI050401 07 090401440801417977998 16 90 41 5374 ja d 104540 14 01 0050 10 10701 0414161703081 3473 54044444 ed E ed a O A Pd For In Vitro Diagnostic Use 243 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual The Report Viewer contains various toolbar buttons to allow you to export print and navigate through your report The functionality of these buttons is described in the following table Report Viewer Toolbar Export Report Exports reports in one of several available formats including Crystal Reports PDF and Microsoft Word Print Report Sends the current report directly to the printer Toggle Group Tree Opens a tree panel on the left side of the Report Viewer window which lists all the samples included in the curr
251. n Software Version 3 x x User Manual Note You may see CSV files for products other than LAT or other miscellaneous CSV files This means that you must first click on a sub folder for LAT or that your LAT session files are not contained within their own folder in the directory to which HLA Fusion is pointing 4 Click on a CSV file to display its associated samples in the Current Sample Patient Details table Current Sample Patient Details Table A E FRAO Soman File Path Ic LI FUSION session Data Reference Catalog ID a y T Set empty Patient ID to Sample CSV File Name LATO1112012 LATO1142012 LAT01142012b lat 1240 Sain Sample i Patient 1D aSXISO 1 Vania Cler Meyer Goldbaum31 03 06 73983 09 12 2012 Goldbaum31 x vi 2 Emilia de Souza A Vieira 13 03 06 73694 08 09 2012 Vieira 13 Emilia de Souza Hispanic y Patient xl 3 Maria Laurinda dos Anjos13 03 06 73654 09 12 2012 dos Anjos13 Maria dos Anjos Hispanic I Patient x 4 Wison Zani 06 03 06 73299 09 06 2012 Zani 06 Wilson Zani Caucasian I Patient x 5 Jolo Rodrigues da Silva29 03 06 73916 08 27 2012 da Silva29 Jolo da Silva Hispanic i Both xl 6 Catarina de F Hermenegildo31 03 06 73952 10 01 2012 Hermenegildo31 Catarina Hermenegildo Hispanic Patient x 7 Joan Rodrigues da Silva 29 03 06 73916 10 03 2012 da Silva 29 2 Joan da Silva Hispanic Donor y 8 Mar
252. n Vitro Diagnostic Use 149 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Navigator Right Click Menu Options for Micro SSP Session Level Options There is a menu that displays if you right click on an active session in the Navigator select the session first with a left click Product Test Date Catalog i Session Date E 12 22 2012 Reanalyze using New Settings Catalog EP Micro SSP_20111222095547 12 20 2012 BB Micro SSP_20111220114141 Reanalyze with New Nomenclature l0 xi Allows the session to be reanalyzed using a new or updated HLA F usion catalog 1 After right clicking on a session the Select New Product screen opens A A 2 Rename the session 3 Click the drop down arrow w in the New Catalog ID field and select a new catalog from the list Ly 4 Click the Analysis button The session on which you right clicked is now re analyzed with the catalog you ve selected HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 150 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Sample Level Options E 12 19 2012 B Micro SSP_20121219085 DA Or Po Two menu options are displayed if you right click on an active sample in the Navigator select the sample first with a left click Related Records A related record is a record that is associated with the current sample by Patient ID or Sample ID
253. n change the ID LABScreen Session ID field Session ID 2008011 _LSM_LOT13_ D49 Note A session ID must be unique to the Fusion database If the session ID already exists the software prompts you to rename the session It is also highly recommended that you do not use any special characters in this field since they may serve a specific purpose as field separators 4 Select acatalog file Your catalog selection method is one of the following depending on the CSV file and the catalog files you have imported for LABScreen Note If you need to import more catalogs click the Download link on the LABScreen home page to add new catalog files to your database The catalog drop down list may not be immediately updated if you downloaded the catalogs during this import session You may need to click the Home button and then click the LABScreen button again to return to the import process If the CSV file specifies a template name applies only to CSV files from Luminex 2 2 and later and one of the available catalogs is associated with that template then that catalog is automatically selected HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 157 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual You can also select a different catalog from the one the system has selected by using the drop down list in the Catalog ID field and selecting any catalog listed If there is no template match
254. n is displayed 254 HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Patient Information Screen General Info HLA Test Result Fatient Donor Info Patient Donor ID 1 First Name Elizabeth Middle Name J SSN 111 000 1998 Ethnicity Caucasian Address 7109 Washington Street City Washington State Province DC Country USA Email Address Test Test org Employer Beckman Instruments Donor Center ID 795 Division KIDNEY Transplant HospitalName SEVERANCE Hospital Spouse Info Spouse Name Joasson Emergency Contact Info Name Jon Archived Family ID Farggot Last Name Farggotti Birthdate 12 30 2012 Gender Male 2 Female UNK CategorGm 3 Human Animal Region SSW Postal Code 20019 Phone 201 345 0198 Mobile 201 345 4333 Work 201 340 2134 Fax 201 341 0777 Disease Renal UR BloodType B Rh PabentiDonor Patient Blood Type Phone 3 Click the Test Info tab to see that information for the current patient donor If more than one information card is displayed use the arrow buttons to navigate through the patient records 4 Click the Close button ted in the upper right corner to close and return to the Reports window Audit Trail Report You can view and print a report of user activity for the current database This data is only available if you have done the follow
255. n opens October 2012 Mon Tue Wed Thu Fr Sat 12 3 4 G 7 8 9 W 11 12 13 14 15 17 18 19 20 21 2 23 24 2 26 27 28 23 30 31 C Today 10 16 2012 wn Unlike Manual Entry which is limited to just one session Batch Entry allows you to enter a group of sessions with the Session Summary screen This allows you enter data in a tabular format with each row representing one session 2 Enter a unique name for this batch or accept the default batch name which Fusion suggests 3 Manually select and or enter session data beginning with the HLA class I II Class I PRA Class II PRA Gass ne and Single Class I at the left side of the Session Summary Screen and continue to the right until all the available data for a session has been entered E E The fields with an asterisk are required This includes the fields that are completed by using drop downs Catalog Name and Test Date and the Session ID HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 194 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Continue entering session data as needed Note that once you ve entered data for a session and have started entering data for the next session you cannot return to the previous line of session data However after a batch has been saved it can be reopened and edited 4 When all data for a batch of sessions has Sine etches AUF been en
256. nc HLA Fusion Software Version 3 x x User Manual Patient Information HLA Fusion can store patient information and associate sample IDs with patients and donors You can store all typing and screening information in one location for each patient Note Please verify all data you import as HLA Fusion performs minimal data validation upon import HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 276 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Importing Patient Donor Lists After creating a Patient Donor List you can import the information into HLA Fusion 1 From the Main Menu select Patient Info gt Import Patient List The Patient Import wndow displays Import Patient 7 x Vn a INI N PN a HLA Fusion e5o5eoeee r I9I1 gt First Name Jossie Ethnicity Address hispanic 3097 Runnin 3098 Runnin 708 Josephin 1111 Bug Ro 90 Cloudy Str 7109 Washin 20 Bloodston 167 Lagoona 11600 Pennysl z n n ed mina 8 31 2007 10 31 2004 12 7 2005 11 45 1777 1216 2005 11 23 4511 12 2 2005 ee Import Patient Window 2 Select the check box in the Import column for each patient you want to import 3 Click the Import button to import checked patients 4 Click Close to return to the main menu Note The HLA Fusion system checks the pat
257. nd drag and drop it up or down the bead graph to re analyze the sample with a new cut off value Positive cutoff lowered to 0 9 Negative cutoff line ATA an ia Positive cutoff lowered to 1 3 A A A sa mont gf OD Dn Dn tert o E 11 E sl ls gt E E an Cos N nr ooo i in is Ln o as Red A 326 HE tHE wo weet eH e224 gg s 5 eet tv teset ges es Aa 8 en TERE TEREE AA CACAO i fie go prtazak e Bu th yf OA ae Ae AR ARA e E E ESE 0 ee EAE Ll frites AZ ARP 42285 Se 2 eas aS Negative Bw m m gt e A T La om a a e ALAS TA OE R b Lg o A RI E aa y A O a A d g A OS A LALALA mon le a a a SRA UE ROAR AREA ee me cutoff linee lx lt 2 a A ee A A AAA AA AA Green Po Op ge bo ee ae A O oe fac a a aras a eee cass 4 me HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 164 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Cutoff colors e The Positive cutoff threshold is colored Red e The Negative cutoff threshold is colored Green Reset All Options to Default Any changes made can be returned to default values e From the analysis window click the Use Default button in the upper right portion of the window to return all changed settings to default values The sample is re analyzed with the default values that were used when the sample was selected for analysis Se Ca g Graph Raw
258. negative and undetermined results User may select the highest or lowest bead ratio found for each sample LAT data from analyzed LAT samples e LAT Mixed Raw Data results of multiple samples on an LAT Mixed analysis tray including a tray layout of the original raw data input and test results e LAT Mixed results of a single sample on an LAT Mixed analysis tray including a tray layout of the original raw data input and test results e LAT Specificity Raw Data Raw data results for LAT specificity or HD trays including a tray layout of the original raw data input and test results e LAT Specificity complete specificity report for LAT specificity and HD trays including over all tail epitope manual tail assignments and test details LCT data from analyzed LCT samples e LCT Specificity test details of a single sample on an LCT analysis tray FlowPRA data from analyzed FlowPRA samples e Flow PRA Specificity test details of a single sample on a FlowPRA analysis tray HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 258 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Specialty reports created for specialized purpose e Antibody Reaction summary table of computer specificity assignments based on reaction scores e SCORE export report used by SCORE software e LABType export report covering LABType results e LABScreen export report covering
259. nfirm button located at the bottom right corner of the wndow to confirm all analysis results that have been saved in the Final Assignments results box e You automatically move to the next sample to continue confirming results e When you first return to a confirmed sample you will see that the Confirm Co button is now shaded Purple to let you know it has been confirmed previously HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 111 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Navigator Right Click Menu Options for LABType Session Level Options There are three menu options that are displayed if you right click on an active session in the Navigator select the session first with a left click Session Level Navigator Menu Options Create Lab QC Allows you to save the catalog file and the QC parameters from the selected session as a Lab QC panel e The local QC is set up similarly to a catalog file where the user can upon launching a new analysis select the local QC from the catalog list The local QC information is then used in the analysis session instead of the One Lambda QC e When selected a dialog box displays and prompts you to name the new lab QC default name current catalog ID _LAB HLA Fusion J Base Catalog ID A550281_015_06 MS 8 amp 8 3 3 gt 6 O The lab QC was created successfully Lab Catalog ID R
260. nflict on nomenclature dates a warning message is displayed that gives you the option of continuing or canceling the combined analysis The nomenclature of the sample test you selected to combine with the current one will be used if you continue Adding User Comments to Samples Comments you or the system add to the Comments Field are displayed with the results in the current analysis session data look up and reporting functions in HLA Fusion They are separated into user and system comments You can only add or edit the comments in the user comment field 1 Inthe analysis window enter your comments into the User Comment field below the Assignments area maximum of 255 characters HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 107 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual n 10 x wax scale _Wiew Dette To open the larger Double click comments area anywhere in this area User Comment System Comment Comment Field Comments are saved only after you click the Save or Confirm buttons Flagging a Sample for Further Testing You can indicate the need for further testing of a sample by selecting the More Test check box The More Test indication is displayed in results data look up and reports for the sample Vl More Test m C Patient Assign Assigning Serology and Allele Code Results to a Patient Note This feature is available
261. nfo button The More Test Information dialog box is displayed when you click this button allowing you to add information about this tray Add Test Tray Information A More Test Information x Plate ID 12204701 1 Reader Bsmith Date Read Tray Expire eZ 22 Clear Secondary Ab Substrate HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 209 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Using the ELISA Reader To import analysis data directly from the Biotek ELX 800 NB ELISA reader the computer on which you are running HLA Fusion must be connected to the ELISA reader Connect and calibrate the ELISA reader according to product specifications HLA Fusion can analyze only 96 well Terasaki trays ELISA reads the trays and transfers the raw data to HLA Fusion e From the analysis window click the Read From ELISA button to import data from the ELISA reader Note The Read From button is displayed only when your computer is connected to the ELISA reader and you have not yet entered any manual reactions for the current test LAT PRA Single Antigen Histogram Displays the reaction of the sample Histogram for LAT PRA Single antigen BYaRARE _ o e Y axis reactivity X axis well position and sample order e By default the histogram is sorted from highest reaction to lowest You can also click the Sort by Well Position button to sort
262. ng Changing Passwords Supervisors can change passwords for any user but they must have the user s old password Technicians can change only their own passwords 1 From the Main Menu select Profile gt My Profile 2 In the user profile click the Change Password button 3 Enter the current and new passwords 4 Click the Save Password button to change the password Or click Close to close and return to the main menu without changing the password Resetting Passwords If a user loses or forgets their password HLA Fusion can reset the password The new password is the same as the user s user name Only Supervisors can reset a user s password 1 From the Main Menu select Profile gt List User and select a user 2 Intheuser profile click the Reset Password button 3 Click Close to return to the main menu Changing User Privileges Only Supervisors can modify a user s privilege level 1 From the main menu select Profile gt List User 2 Double click to the left of a user to open their profile 3 Inthe user profile select the check box next to either Manage Data or Update Reference Files or both to give the selected user privileges for those activities within the Fusion application 4 Click Close to return to the Main Menu HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 292 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Inactivating Users Supe
263. nload Last Update Date 2 3 2012 catalogs display Active Catalogs 33 Reference file Updates 0 nomenclature date LCT Configuration and revision notes Threshold X6 Cw Included Yes Popup messages enabled Yes Click to modify E eee LCT Global LCT Product Documents sett i ngs Catalog Catalog Description Worksheet LCT 1W30_019 02 Lambda Cell Tray 1W30 Lot 019 LCT 1W30_019 WS LCT 1W30 020 00 Lambda Cell Tray 1W30 Lot 020 gt Home LCT 1W30_021 00 Lambda Cell Tray 14430 Lot 4 021 LCT 1W30_021 WS LCT 1W30 022 00 Lambda Cell Tray 1W30 Lot 022 LCT 1W30 022 WS Click these links LCT 1W30_024 00 Lambda Cell Tray 1W30 Lot 024 LCT 1W30_024 WS to display the LABType LCT 1W30_ 025 00 Lambda Cell Tray 1W30 Lot 025 LCT 1W30_025 WS sse Micro SSP LCT 1W60 019 01 Lambda Cell Tray 1W60 Lot 019 LCT 1W60 019 WS selected catalog LCT 1W60 020 00 Lambda Cell Tray 1W60 Lot 020 LCT 1W60 020 WS worksheet or Leisis LCT 1W60 021 00 Lambda Cell Tray 1W60 Lot 021 LCT 1W60 021 WS probe primer LAT LCT 1W60 022 00 Lambda Cell Tray 1W60 Lot 022 LCT 1W60 022 WS documents LCT 1W60 023 01 Lambda Cell Tray 14 60 Lot 023 LCT 1W60 023 WS m LCT LCT 1W60 024 00 Lambda Cell Tray 1W60 Lot 024 LCT 1W60 024 WS 4 FlowPRA LCT 1W60 025 00 Lambda Cell Tray 1W60 Lot 4 025 LCT 1W60 025 WS User Name Esmith Server Name ocal FUSION Database Name MyDatabase Ver 3 0 0 The LCT Home Page Note Open worksheets and probe prime
264. nostic Use One Lambda Inc HLA Fusion Software Version 3 x x User Manual 3 Select create a Sample Date 4 Click the Analyze button View Gel Within the Serology Analysis window you can view the gel for the current sample This tool finds the gel file J PEG format associated with the CSV data file and displays it in the Analysis window 1 Click on the View Gel button A picture of the gel for the current sample is displayed as a new window 2 Click the Close button or click on X to close the gel Modify the Session Start Position For multi test trays you can skip tray positions to match your gel photos by clicking the Add New Sample button until the correct test start position is displayed HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 131 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Rxn Reaction Tab The reaction pattern table displays the positive reactions for each well or bead if combined with LABType x axis versus every allele y axis defined in the current catalog e The Reaction Pattern Table is displayed in the right pane of the Micro SSP analysis window Double click anywhere in this The Max area to expand the table button Search by Allele to half the analvsis window expands the reaction table Click to sort the table by the AT selected oci Semple an well korono reactions wororo Search by A 01 01 02 A
265. nostic Use 7 One Lambda Inc HLA Fusion Software Version 3 x x User Manual ERE aE a A atacar tados 178 R w Da ta Table mierenia cies E E E E E E 179 ROW Data REPOTI sranie a i A A eee 179 Displaying DSA Donor Specific Antigen Match Mismatch cccccccccccccccccccecccecceccceecesesssesseseeeeeeeeeeeseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 180 AG GING COMMENTS TO Sample S A OAO 181 FIGGGING a Sample for Further Testing ia 181 PHATING the CUENCA O Y SIA A E A 181 Previewing ana POUNG REDOT S 00 A A dao 181 Makma FNUASSIINMEN S ta A ais 182 Manual ANS 01 1 66 od fee ee Ee aE e AEAN a 182 ASSIGNING Negative samble Values iaa taa 183 FREMIOVIING ASSIO NIN CIES TA AAA A A 183 SVING ASSIM Saa aa 183 CONAN O ASSIM ES Li EA AAA A E 184 Getting Tail Analysis Values EXCEP Singles ieii a T a AA Ad 184 POTION PRA EXCESOS a os 184 Choosing Minimum Positive Threshold Cutoffs Except Singles ccccccccsseeeseseeceeccccnuesececseecceusseeeceseseaueeeeeesesseuuneseeeeseneas 185 Hiding Tail Analysis Values Single ANI da ii 185 Navigating Between Class and Class II PRA Class and Il COMDINCA ccccccccssseesseecececcseeeseeceseeeasusseceeseesaueeseeeessssaaaeess 186 Sort Antgenis male ANTIG CI a tai Ei 186 NAVIGATOR RIGHT CLICK MENU OPTIONS FOR LABSCRE N sccssccssccssccssccssccsscnsccnsscnssccsscesscssscsssesscsccesssessoessoseoess 188 Reanalyze WILINGW SCULINGS COLGIOG A A AA A A A A tt 188 sample Level OGIO Sc 1 A AAA A tt N
266. not be followed by results HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 127 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Possible Results for One Non Amp Well Possible Allee Fairs l dey Reaction 0061 0606 DOBL OGOS FMF DORON DOBI 030103 D061 0205 DOBL OZOS FMF DORIA DOBITOGIADZ P Headings to look D061 0323 DOBLTDIZS FAN for when viewing DQ61 030202 DOBIT0F0202 P D061 03020 D061 030204 F possible non amp DQ61 030204 DOBI 030204 1 D061 0504 DOBLTOS04 FMF 36 well results DQ6170314 DOBITOJLA FEF p061 0514 0081 030504 FHE d IQ61 030504 DB1 030504 FMi A Pos Reaction View Well Details You can view comprehensive details about the current sample by hovering your cursor over a well in the test gel area of the analysis window View Well Details with your mouse over a well Well Position 4H Recg Site 45745 82LR83 Specificity B 18 09 54 B 27 52 B 37 01 01 04 02 07 10 12 27 B 38 Working with Gel Images e Ifyou have a gel image already linked to the current sample you can view it or unlink 1t OR x You can search for and link another gel O Gel Image does not Exist Click Yes to Browse for an Image image to the current sample e we HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 128 One Lambaa Inc Here s how you can link a gel image to the current sample 1 Click t
267. nter reactions and analyze data For details see the individual product analysis sections in this user LABScreen manual LAT LCT FlowPR 4 Reports Menu Bar Analyze Data When you select this menu item the Reports Page is displayed allowing you to create reports of your analysis data Data When you select this menu item a Data Window is displayed that allows you to manage i e delete archive activate or move sessions and samples map session alleles to a new NMDP nomenclature and view print log files of session data Sample Import Sample List Options under this menu item pertain to importing creating managing Manage Sample Info and exporting sample information This is also the menu to use for A E managing Luminex test lists and for creating sample work lists and plate Create Sample Worklist designs Create Plate Design Menu Bar Sample HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 30 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Patient Info Patient Info i E Import Patient List Options under this menu item pertain to importing patient donor lists managing individual patient donor information and tracking patient antibody data Manage Patient 46 Tracking Menu Bar Patient Info Profile Profile My Profile There are options under this menu item for creating and managing your own user profile lists of system users and privile
268. ntigen A Not Tested T ar 3LS1AO4LOT 2_1D305 Ls1404_002_00 45 Cwi DGI bok L5 e test kits 3LS1404LOT 2 10305 L51404_002_ 00 46 Das 3L51A04LOT 2 10313 LS1404_002_00 36 include Allele SLS1 AO4LOT 2 10325 Ls1404_002_00 39 DRE1 0401 DRB1 0404 3L51 AO4LOT 2_1D329 L51404_002_00 30 E OREH O405 3151 404LOT 2_1D335 L51404_002_00 31 v DRB1 0402 3LS2401LOT 6_ID306 LS2401_006_00 45 Z DREM D403 3L52401LOT 6_ID306 LS2401_006 60 46 Include Antigen tel rit ne Donor Antibody Information e Optional Select the DQA DPA check box to include these in Class IT tracking e Optional Manually enter the donor typing in the Sero Typing field 11 Click the Data Table button to display a raw data table CSV file with the patient antigen signal over a period of time The table can be printed or exported HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 288 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Profile Management HLA Fusion tracks all changes to analysis data made by users and allows added data security with a two level analysis result confirmation Save and Confirm HLA Fusion also stores general laboratory information to be used on reports including multiple contract lab codes HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 289 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual User Management F
269. o Diagnostic Use 97 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Manually Assign an Allele Pair Manual assignments must be entered in the Manual Entry Field in standard allele nomenclature format Separate alleles with a space Assigned Allele Pairs 1 Enter an assignment into the text field below the a Assigned Allele Pairs area Assignment area 2 Press the Enter key to display the typed allele on the Assigned Allele Pairs list above N2 01 01 01 01 A 11 01 w You can also make an assignment into the Manual Entry field by selecting a suggested allele pair and clicking the Assign button V to move the pair into the Manual Entry field followed by pressing the Enter key Note If you highlight more than one allele pair from the Pairs List only the first one highlighted iS assigned to the manual entry field Force Tab The Force tab displays a list of alternate possible allele pair results for each bead if an additional false reaction is allowed In other words when there is a full match result the system evaluates the sample with a single false reaction e This list is applicable for only one 1 forced false reaction e All results are grouped by order of the beads and reactions the default is to list beads in ascending order with false negative reactions listed first e Use this tool for homozygous or rare allele assignments e False reactions are shown in light blue bars in th
270. o the analysis screen for this sample e Scroll left or right to view all of the Summary Table fields e Click the Field Chooser button to the left of the column heading row The Field Chooser windowis displayed In this wndow you can select or clear the check boxes next to column headings to include or exclude those columns from the Summary Table Selecting or clearing check boxes in this window instantly updates the table HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 224 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Note If you do not see a particular field available through the field chooser and you are sure it should be there go to C HLA Fusion temp and delete the file named x_x_x antigen type Layout xml Analysis Date e Click on any column header of the Summary Table to sort the table by that column The arrow in the column header indicates the sorting order up for ascending and down for descending Columns can also be dragged and Class Il PRA SA Ce aa PRA dropped to change their order e e The session summary table columns and order can be modified When you Confim Date close the Field Chooser a pop up message displays to let you choose _ whether or not to save any changes you made If you click Yes your changes are saved for all future LCT session summaries on this same MIC Donor PRA computer until further modifications a
271. ociated SamplelDbs Associated Ponorlls ALA1 _4 HLae A HLA1 B HLAZ E HLA1 Bu HLi2 Ew HLA1 HLae C HLA1 DRE1 HLAe DRE1 HLAl DRE3 HLAZ2 DREES HLA DRE4 HLAZ _DRB4 HLA1 DRBS HLA2 DRBS HLA1 DOB1 HLAz DQB1 HLA1 DPOQ41 HLAz DOA1 HLA1L DPB1 HLAz DPB1 HLA1 DPA1 HLAZ DPA1 HLA1 MICA HLAZ NICA HLA1 NICH HLAe _MICE HLA KIR Class AbSpec ClassiII ibSpec MIC AbSpec Unacceptabled ntigens Acceptahbledntigens Notes 5HLAl 4 5HLAe _4 5HLAl B SHLae 6 SHLAl Cw HLA Cw 5HLAL DR SHLAZ DR SHLAl DE345 SHLAZ DR345 5HLAl DO SHLAe DO 5HLAl DP SHLAZ _DP DonorType IncludeInDonorPRa 36450 Human Neely Jason Neely 021 09 2987 2 17 2001 4 caucasoid 560 Waiting Street CA NWN USA 91022 ineelyf yahoo com 213 567 0997 213 567 0987 213 567 0987 213 567 0997 MIT Research Evvonne AE Evvonne 2135 509 0196 101 5t Judes s Hospital MARROW Transplant 2 BOME MARROW PACLENt yep ere rere reer errr ere tet ee etree eee pees bo Bo6 00 DO DP 14 DP9 27614 Human Martinez Daniel DM Martinez 032 11 1934 97 1271996 M hispanic 40 Driveland Road Fast Li CA NWN USA 90222 mdanielfaol net 324 489 1430 324 482 1430 324 459 1450 324 489 1450 Joba Juice Maria BE Maria 324 469 1430 103 East Li Hospital MARRON Transplant 0 Marrow Patlelt rrrrrrrrrrrsrrrrsrrrasrrrasarcaar rr A r r bb yg DOB Doe DP 19 36557 Human Phannudet Keodone PE Phannudet 111 41 5432 1230 2000 F oriental 1009 Special
272. offs to use with any LABScreen PRA or Single Antigen sample To set the cutoffs for X8 X2 review the section Changing Antibody Screening Analysis Configuration You can then switch between the OLI provided cutoffs and the ones defined through Fusion by doing the following e To choose user defined cutoffs select the check box next to User e A Cutoff la H User Cutoff E e Togo back to using the OLI cutoffs clear the User Cutoff check box Hiding Tail Analysis Values Single Antigen You can choose to hide the display of Tail analysis values from Single Antigen sample analysis but these values remain stored for look up or reporting 1 Select the Utilities gt Antibody Product Configuration gt Set Analysis Configuration menu O Auto Accept Al option Hide Tail Analysis Window 2 Select LABScreen Single Antigen from the Product Type drop down menu at the top of the display 3 Select the Hide Tail Analysis Window check box located at the bottom of the Single Antigen product configuration dialog box 4 Click the Save button at the bottom of the menu HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 185 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual LABScreen Single Antigen samples imported after this configuration change do not display the tail analysis assignment area on the sample analysis window Navigating Between Class I and Class II PRA Clas
273. ologist x T VONE LAMBDA The Security Login dialog box is displayed The Fusion Security Login Screen dE HLA Fusion Security Login HLA Fusion Server used Cancel Database that Fusion is using Version 3 0 0 13925 Created on 4 27 2012 Used 3 333 MB of 10240 MB DE size Regional Settings Client English United States Database DB Server ys english SQL_Latin1_General_CP1_CI_AS Collation an l Fen i B j la a rs pao Enter your HLA Fusion User Name and Password Click the Log In button to open the program Note The Database field displays the database to which you are currently connected HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 21 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Retrieving a Forgotten User Name or Password e Ifyou forget your HLA Fusion User Name click the Forgot User Name link enter your first and last name and select your lab role supervisor or technician The system displays the user name matching the data you provide e Ifyou forget your HLA Fusion password click the Forgot Password link and answer the two security questions you were asked when you set up your user profile e The password is displayed when the questions are answered correctly REE HLA Fusion 000 LiserlD DETA ESAE E Forgot User ame Security Questions What ie the last name of your best child
274. on M Auto Analysis However such removal means You can continue importing Luminex Session Files or you can click a session in the Navigator to start a Batch Analysis Note import a session under a new name and or user HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use Once a CSV file has been imported it no longer displays on the Luminex Session Import list unless you select the Include Imported M Include Imported check box This may be used to re 49 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Acquiring LABType Session Data HD To display a listing of HD session s on the CSV File Name list Selecting HD Session Files Select CSV Files x TA a a B Search HD Sessions A E GM imeem 2 1 Click the Folder 4 icon The Select Organize New folder fil k n Docente EN E CSV Files screen opens Note that you one E 022708 CD HD A_ID1530 csv 9 27 2012 5 34P may need to open HD sessions from a E 022708 CD HD A_ID1530_HD csv 29 2 04 El vec EAR E eS location other than the default path for LABType files After clicking the Folder i teas icon browse to the location where the ca 0 HD Sessions LABType HD files are stored on your system network vid File name 022708 CD HD A 1D1530_HD1 csv y CSV Files csv 2 Click the Open button Cancel Note HLA Fusion converts Luminex generated CSV file data such as
275. on 3 x x User Manual Preview Report Patient Summary From any Analysis Screen click the Preview Report Patient Typing For Batch button to display a list of reports you can check out before printing reports listed are specific to the product you are currently analyzing The reports are displayed in a preview ocana Ue sath window Use the Print_2 land Export_2 _lbuttons in the Custom Typing Results by Sample preview window to output the report in the selected format Allele Code Patient Custom Click the Close button at the upper right of the screen to Allele Summary exit the preview window Molecular Typing Summary Panel Summary Ol Overview Example of Preview Report Options Print Screen From any Analysis Screen click the Print Screen button to open a new window containing a screen shot of the current analysis window Click the Print button top left corner to send the screen shot directly to the printer To close this window click the Exit IX button or the Close button gi Pea Sree Tee ee oe Se tees Camara fem bens Erica Toe Dens Lael chew 8 in PD oe o UD made ote A OO AO Example of Print Screen Results HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 35 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Magnify From any Analysis Window click the Magnify A button to activate the magn
276. on 4 LABType samples e g RSSO1E 001 00 cat 3 Select files from the list of CSV files on the left side of the LABType Home Page that you want to import for supplement with Exon 4 data e Or click the Folder L icon and browse to the LABType CSV file s on your system network to locate and select CSV files HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 56 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual The LABType Session Patient Details Table is displayed 10 LABType Session Import Exon 4 Luminex Luminex 100 IS 2 3 Session ID 0406workshop_A Lot 7_1D402 Date 8 22 2012 8 22 2012 y Samples ES File Path c ILI FUSION data sessio Catalog ID RSSO1E47_002_01 y NOM imat January 2012 3 3 0 Set empty Patient ID to Sample T Auto Analysis i Lo llo Lo lle bo le lolo ee lo le EJER A Import the sessions containing samples you want to supplement with Exon 4 data by following the same process you have used to previously import CSV files into Fusion Use the Fusion LABType analysis wndow to analyze the samples you want to use in analysis with Exon 4 Clickthe LABType button to return to the LABType home page Make sure you downloaded the Exon 4 catalog s e g RSSO1E_001_00 cat If you have not yet done so click the Download link on the upper righ
277. on User Manual v3 x x For In Vitro Diagnostic Use 135 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual e Ifthe nomenclature dates between the current one and the one s being combined with it conflict then the session s you selected is highlighted Red e Ifyou click the Analyze button and there is a conflict on nomenclature dates a warning message is displayed that gives you the option of continuing or canceling the combined analysis The nomenclature of the sample test you selected to combine with the current one will be used if you continue Note Notice that the Analyze Combined button in the analysis window changes to Reanalyze Combined button This is an indication that the selected sessions have been combined If sessions are combined a note is added to the system comments box HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 136 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Make Typing Assignments in Micro SSP Analysis HLA Fusion provides computer suggested allele pairs and coded assignments Final typing assignments can only be made by you or your supervisor From the analysis window you can do the following Pairs Tab Switch between code formats Apply Bw4 Bw6 to serology results Apply frequency filters Assign non coded allele pairs Assign a coded allele pair Assign serology equivalents Make manual assignments Remove assignments Save and c
278. on demographics 1 From the Main Menu select Utilities gt Update Reference gt Allele Frequency HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 309 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Allele frequency import Demographic Allele Frequency HLA Fusion Create and Update Demographic Allele Frequency Create Demographic Group e Update Alleles and Frequency Demographic Group and Frequency in Database C4653 G0244 A 01 01 A 01 01 01 A 01 01 01 01 A N1 01 01 02M VONE LAMBDA 2 Select the Update Alleles and Frequencies option 3 Click the browse LJ button and locate the Allele Frequency file you want to update 4 Double click on the file or click Open in the browser window 5 Do any or all of the following to modify the file e Add delete alleles e Delete existing demographics e Change the allele frequencies e Convert allele format 6 Click Translate Alleles 7 Click Update 8 Click Close HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 310 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Managing CREG List Information You can modify existing CREG lists or create new ones for use in PRA and Single Antigen LABScreen FlowPRA LAT or LCT analysis Take the following steps to create or modify a CREG list 1 Select Utilities gt Update
279. onfiguration FULLER UNOS EPITOPE 2 On the LAT Home page click the Edit link to 7 display the Analysis Configuration Settings dialog box this dialog box is _ O Display Graph Raw by Defaut displayed already if you are accessing it through the Utilities menu 3 Select a different table from the CREG drop down list 4 Click the Save button at the bottom of this screen Find Antigen All entered antigens are circled in the specificity field To enter multiple antigens use a space to separate antigen entries Clicking on the labels for Tail Analysis Results Epitope Analysis Results or Final Assignment creates circles around the specificities listed in the results area Clicking on the Exclude Antigen label circles the excluded antigens HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 211 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Note If you use the Find Antigen feature while the window is displaying molecular specificities you cannot see the circled antigens until you deselect the DNA check box 1 From the analysis window type individual antigens or CREG groups e g 1C or 2C into the field next to the Find Ag Antigen button 2 Click the Find Ag button to circle the entered antigens or CREG groups 3 Click the Find Ag button again to remove the circles from antigens in the specificity field View Molecular Specificities Molecular sp
280. onfirm assignments The Pairs Tab displays the possible allele pairs results that match the reaction pattern for the sample The pairs are suggested by the software The list identifies the pairs and groups them by either full match pairs no false reactions or the number of false reactions Results with false reactions are listed with the false reacting bead well identified DRB1 16 02 01 DRB1 16 07 The results display one allele pair per row DRB1 16 02 01 DRB1 16 08 DRB1 16 02 01 DRB1 16 09 DEB1 16 02 01 DRB1 16 11 Possible homozygous pairs are flagged in the Comment field DRB1 16 02 01 DRB1 16 12 DEB1 16 02 01 DRB1 16 13N DRB1 16 02 01 DRB1 16 14 DRB1 16 02 01 DRB1 16 a HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 137 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Assign an Allele Pair from the Suggested List 1 Double click on an allele pair under the Possible Allele Pairs to assign it to the final pairs assignment area Alternatively you can click to highlight an allele pair on the list under the Pairs tab and click the V assign button next to the Assigned Allele Pairs title to add it to the final assignment area To remove an assignment select the assignment on the Assigned Allele Pairs list and click the X remove button DRB1 04 05 DRB1 D04 7 m Double click aie i Len bes 05 DRB1 04 assign them j aaa oe Select an a
281. only to Lab Supervisors and for saved samples This check box is grayed out until the sample has been saved or assigned and can only be selected by those with Lab Supervisor privileges If selected serology and allele code results are then added to the patient s record e Inthe analysis window check the located below the Assignments area L More Test T pere prer Analyze Analyze Combined W Patient Assign e Click Confirm gt gt to preservethe setting HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 108 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual e Ifyou previously assigned results to the patient a message displays asking whether or not you want to overwrite the previous assignment The Print Screen button prints the currently displayed analysis wndow e From the analysis window click the Print Screen button on the Fusion Toolbar to print the current analysis screen Preview or Print Reports To view a LABType report for the current sample use the Preview Report and or Print Report buttons on the toolbar In the Analysis Window click the Preview Report button or the Print Report button to display a list of reports you can preview or print for the current sample e Data Reports Data Sample Patent into Profle MEAT IP B F Patent Summary Fatient Typing for Batch Patient Custom Or hover your mouse pointer over the Pr
282. onment Thus a laboratory performing HLA typing or antibody screening in another environment may need to reset cut off values to meet specific laboratory requirements From the Main Menu of HLA Fusion you can access the three major components of the program e Analyze Data e Manage Records e Manage Samples In addition you may also access the following features e Patient Information e Utilities o Help e Exit This manual helps you start using One Lambda s HLA Fusion It includes an overview of the system and then takes you into the process of analyzing data See the HLA Fusion Software Installation Guide for installation instructions HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 19 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Navigation This section describes the various ways to access the HLA Fusion software menus and functions as well as howto use the Navigator tool to access and move between sessions and samples HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 20 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Logging on to Fusion 1 Double click the HLA Fusion Icon 4 on your computer desktop You can also open the program from the Windows menu Start gt Programs gt One Lambda gt HLA Fusion P Forgot UserName a HLA Fusion LastName Your Last Name Fist Name Role Lab Techn
283. op down list in the Catalog ID field and selecting any catalog file listed If there is no template match the system then considers the closest bead match between the session and all available catalog files If only one catalog file is a close match it is automatically selected and you can check to see if there are any samples that have been flagged as having a low Positive Control PC or low bead a un un O aks lo do i lo oO a a y TD un 3 ala ab oo S S D wn wo O gt gt i N 3 in oH O be be D a i 2 a un wo O ale N oO mb 5 a a wn un O pa N co _ oH O ale N oo S a N TD uN uN O ole N co oe a ol RSSOMICA 004 03 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 47 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 12 If there is more than one match a catalog validation dialog box is displayed with the best bead matches You can confirm the selected Catalog file by simply clicking the Close button Or you can double click a catalog file name on the list of Suggested Catalogs Clicking the Detail button on the Catalog Validation screen opens the Mismatched Beads window which lists which beads were not found in the Session and or Catalog Click the OK button to close Catalog Template Association HLA Fusion Do you want to associate
284. options that are displayed if you right click on an Active Sample in the Navigator select sample first with a left click Sample level Navigator Options Z a 3 abserum 3 6 jaegerman al 7 den hartog EXETER a Related Records he Side By Side Analysis 8 Output_Classl_Singles Related Records A related record is a record that is associated with the current sample by Patient ID or Sample ID Note This option is also available by using the Related Records toolbar button E e Right click a sample in the Navigator and select Related Records to load all records related to the current sample into the Sample drop down list at the top of the screen Use the sample navigation arrows to display the analysis of each related record one by one e Togo back to viewing the samples in the current sessions click the lt lt Summary link at the top of the window Side By Side Analysis Use this option to compare the current sample analysis with one previously conducted Note This option is also available by using the Side By Side Analysis 4 toolbar button Side by side Analysis Selection List HLA Fusion Patient ID Session Catalog ID Sherber 08 12 012606_LS12_L9_ID861 LS1A04 NC6_001_02 012606_LS12_L9_ID869 LS1A04 NC6_001_02 012606_LS12_L9_ID862 LS1A04 NC6_001_02 NONE LAMBDA 000 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 189 One Lamb
285. or e Double click on any marker to bring up the analysis window for the sample Positive Control Summary Graph HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 62 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Negative Control Summary The Negative Control Summary graph middle displays the negative control values for each sample e The X axis indicates the Sample ID names sorted by well position e The Y axis indicates the negative control raw data values e Double click on any marker to bring up the analysis window for that sample Negative Control Summary Graph A E E EEE O O A are A A eS oli EE Bead Count Summary The Bead Count Summary graph lower displays the Lowest Bead Count per sample e The X axis indicates the sample ID names sorted by well position e The Y axis indicates the negative control raw data values The horizontal bar indicates the configured value for the Minimum Bead Count This value can be globally configured through the do e Utilities gt Molecular Product Configuration menu ae eee Min Bead Failure Threshold x entonado Min Positive Control You can configure Sample Specific settings directly from the Analysis Window Double click on any marker to bring up the Analysis Window for that sample Negative Control Summary Graph HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manua
286. or the column of any allele frequency file you import is empty the entire column is not imported into Fusion regardless of any other data it contains If columns are duplicated Fusion gives you an error message and does not import the allele frequency file The data contained in the Allele Frequency file may look similar to this graphic ji 2 A 0101 3 A010101 0 2 0 012 0 73 A A 01010101 0 2 0 003 0 2 3 AUD 10 9 d 6 A D2010101 10 9 56 7 AS02006 0 01 3 BE AD20107 0 01 4 9 A 020110 0 01 4 LO A O20301 0 02 0 04 11 A020302 0 01 0 01 12 4 020601 10 4 10 4 13 A OZ0G02 0 01 14 A207 2d 3 4 15 A0210 0 1 0 1 16 A O2 156 0 01 17 A 0218 0 02 0 02 18 AS OLS 0 02 0 02 15 A0242 0 01 20 A D0L31 0 01 0 01 21 A 0253MN 0 01 0 01 22 ASUS 0 01 23 A4 0270 0 01 0 01 24 A0271 0 01 0 01 25 A022 0 01 26 A0201 0 8 0 3 27 AFO3010101 0 8 0 8 28 A OS02 0 02 0 04 29 A1101 2 1 8 1 30 A 110101 5 1 31 A 1102 0 1 32 A 110201 0 1 0 1 0 1 33 A 24020101 35 6 35 6 35 6 AT 2401 35 6 35 6 35 6 35 A 2404 0 02 0 02 0 02 36 ATAJE 0 02 0 04 0 02 37 A 2430 0 02 0 03 0 02 38 A 2425 0 01 0 01 0 01 39 ARIAS 0 01 0 01 40 A 2601 3 8 SE 41 A 260101 3 8 3 8 42 A 2602 2 2 e 43 A 236035 2 1 2 1 44 A 2604 0 01 45 A 2605 0 02 46 A 2606 0 02 47 A 2611N 0 01 Updating Allele Frequency Files Demographic Frequency You can modify allele frequency files before using them in analysis based
287. order up for Ascending and down for Descending You can also click on a header and drag and drop it to change the atient _ Cstalog OCUS column order Save Layout xj Do you want to save the Layout e You can save any modifications you ve made to the layout by clicking the Yes button in the message box when it appears a HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 148 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Your changes are saved for all future Micro SSP session summaries on this same computer until further modifications are made and saved e Click the Export button located at the bottom of the screen to save the Summary Table on your computer or network default location is C OLI FUSION datal report The file will be saved in the Excel spreadsheet XLS format e Click the Print button to create a hard copy of the Summary Table e Click the Preview button to view and or resize the Summary Table before printing Jal File View Tools ajm ASSES A 100 olHjE gt W O Og Patient Catalog Locus AB DRB1 DRB3 m Click and drag up to zoom in or downto zoom out Page 1of2 In the print preview window the page view slider on the left displays icons for each page of the report e Click on a page icon to display that page in the preview window HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For I
288. ored in your Fusion database Or click Search and search by Patient ID First or Last name etc 3 The Molecular and Serological Typing fields are automatically filled with available data for the specified patient 4 Select the start and end date range from which you want to view sample antigen data for this patient click the drop down arrows in the date fields to display a calendar 5 You can select Secondary Ab or enter one of your own This is a way to filter samples and it means that samples you want to bring up must have this secondary Ab Otherwise they will not be available when Find is clicked HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 285 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual e Optional You can display the percentage of PRA from available donors in the system or from selected donor groups who match the computer assigned antibodies for the current sample 6 Clickthe Donor PRA button to bring up the following dialog box from which you can select donor groups or All Donors The Donor PRA calculation is displayed next to the Donor PRA button lolx o M Donor PRA Calculation M All Donors 123 ABC CBA Available Donor Groups Selected Donor Groups 123 ABC Add Remove Donor Group Selection 7 Click the Find button to display a list of samples for this patient that are within the specified da
289. ostic Use 282 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 6 Click Close to return to the Main Menu Deleting Patient Donor Records Patient donor records can be deleted through the Manage Patient menu option 1 From the Main Menu select Patient Info gt Manage Patient 2 Click the General Info tab 3 Select a patient donor record 4 Click Delete to delete the patient donor record from the Fusion database 5 Click Save Creating Patient Donor Lists The following is an example of a patient list that can be created and the guidelines for doing so The patient list must be formatted for import via a program like Excel or Notepad and saved as a Windows compatible CSV file The first field section must contain the names of the patient list fields each separated by commas Note Creating a new patient list can be made easier by first exporting an existing list into CSV format and using the fields in that to build your new list Patient List Field Names and Format PatientIDName CategoryGrp FamilyID FirstName MiddleName LastName Ssn Dob Gender Ethni city Address City State Region Country ZipCode Email Phone WkPhone Cellular Fax Emplo yer SpouseName SpouseBloodType EmergencyContact EmrgncyTel DCN HospitalName Division BloodType Disease RnBloodType PatientDonorFlg Associated SampleIDs Associated DonorIDs HLA1L A HLA2 A HLA B HLA2 B HLA BW HLA2 BW HLA C HLA2 C HLA1 DRB1 H
290. ow to close and return to the Reports window Antibody Screening Sample Summary Any selected antibody screening records are displayed on the Antibody tab of the Sample Summary screen You can view screening information in a condensed format as well as display more details for any sample 1 Select samples using the Reports window 2 Click the Sample Summary button 3 Click the Antibody tab Semple Surenar y Moleculas Antibody CS TE AR e e ke Rp O Ce DAN I009 jiii 1512 19 mess LFLADMNCE 06 P Low NC Raw Value SSS eV ee CI Low NC Faw Vakse Low NC Raw Vakse Low NC Ryw Vaka t 3 rn ome e SPA mos 97 HR fea jr 7 7 HR a aran E VA na AH jara arar mw HH rara Tre Ho Jero C JT fas e E ai Jara PP e ee ee Low NC Faw Value Low NC Raw Value Low Bead Court Low NC Rae Vakan Low Bead Cort a HEN Te ces estao Jenna 1 HA TA aa ml INN NONI MO CO CEIC CET Neg O o O A l E els Reports Sample Summary Screen e Click the Export button to export the displayed data as an Excel file e Click the DNA button to export molecular specificities as an Excel file 4 Click the Close button L 1 in the upper right of the window to close and return to the Reports window HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 252 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual View Records The View Records feature
291. pdating NMDP Code HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 301 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 3 Navigate to the NMDP file on a local or network drive using the Import Directory tree 4 Click Import NMDP to import the selected file 9 Click Close to return to the Update Reference menu Updating NMDP Files from the NMDP Website Follow this procedure to import the NMDP list from the NMDP website 1 From the main or any of the product home pages click the Download link or from the main menu select Utilities gt Update Reference gt Update Reference File 2 The Update Reference File dialog box displays 3 Select the NMDP option 4 Click Auto Update which automatically imports the current NMDP file for use with HLA Fusion Or click Go to NMDP and follow the instructions for downloading an NMDP file from the website Note If Auto Update does not respond verify your network connectivity and that the URL you set for NMDP in Utilities gt URLs amp Paths is correct Creating a Local Code File Local code files are created by individual labs local codes are created to make ambiguous typing assignments easier to store and read For example ambiguities such as B 1501 1501N 1502 can be condensed with a code to B 15AB for simpler record keeping 1 Copy the local code template from the HLA Fusion CD to a local drive 2 Use a text editor to
292. played If you do not see this type of message go to the next step If you see the message click OK to open the Serology Import dialog box Serology equivalent file notice Serology Information E x The Serology information does not exist in the database Please import most recent Serology Make sure the Catalog option is selected 2 Using the file directory tree on the left locate catalog files to be imported Reference File Manager HLA Fusion Product E FlowPRA Filename Revision Nomenclature IMGT RevisionNotes FL1HD10_007_00 FL1HD10 FL2SP_011_00 FL2SP Product LABScreen LABType LAT The number F LCT of catalogs currently in your Fusion database Show these products nf oe jj Foon 08 f ates Revisions M stalogs Updated amp So i aa Latest aiaiai l Update Previously Downloaded Documents catalogs available for PONE LAMBDA 000 download Lists all Available catalogs which are available catalogs not in your Fusion database Note To determine which catalog is the most recent available HLA Fusion looks first at the lot number and then the revision number An updated lot number gets flagged as the most recent version of a catalog even if there is also an update to the revision number of the previous lot since you last downloaded catalogs 3 Highlight the files you want to import or click Select All to select all files listed HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion
293. ple for Further Testing Marking a sample for more testing displays the More Tests check box for the sample s results in the Current analysis session in all analysis data look up and reporting functions in HLA Fusion 6 N m e Inthe analysis window check the More Tests check box signment z More Test located below the Assignments area Printing the Current Analysis Window The Print Screen button prints the currently displayed analysis window e From the analysis window click the Print Screen button on the toolbar to print the current analysis screen HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 234 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Previewing and Printing Reports Preview or Print Reports 31348044 ada Aa To view or print an Antibody Screening Mixed Data report for r TEPEE the current sample use the Preview Report button on the E a toolbar i Patient Custom Antibody Screening ID e Inthe analysis window click the Preview Report button or Print Report button to display a list of reports you Antibody Custom can print or preview for the current sample LCT Specificity Making Final Assignments Final assignments can be made from either the Tail or Epitope results lists Once a specificity has been moved to the Final Assignments area it is no longer displayed in its initial results box You can select more than one specificity in a g
294. presents typing results and analysis details for each sample selected Sample information is shown for one sample at a time From the View Records menu you can view screening and typing records individually 1 Select data records using the Reports window Data Display Sample ID 1 Session ID 0407workshoprssoA_008_1D319 HLA Locus A HEEE ID RSSO1A_011_08 Operator Local ID Catalog ID RSS01A_011_ Test Pos 1 A1 Test Date Apr 04 2012 O More Test Notes HLAAllele Pairs Allele Code Serology Code A 03 02 A 68 01 02 A 03 XX1 A 68 XX2 A 03 02 A 68 01 06 XX1 03 02 03 10 03 31 03 73 03 76 03 106 FA 03 02 A 68 07 Pu A 03 02 A 68 11N 03 02 A 68 16 0 A 03 02 A 68 17 A 03 02 A 68 21 01 A 03 02 A 68 24 NC Bead 035 NC Raw 13 310000419616 Recognition S PC Bead 5 T 12 013 75 ES RI80 013 53 R 60 013 155 Q A 159 032 61 RN 65 013 75 VD 80 013 62E GK66 013 Positive Cont 013 032 8 013 013 013 i un un Sjejel e e Probe Specificity A 02 243 A 11 43 A 24 82 A 02 81 124 A 23 36 A 24 A 01 07 A 02 185 A 24 12 A 02 38 A 11 01 01701 20 A 02 55 A 26 03 01 03 02 A 01 13 28 A 02 01 01 01 A 02 46 48 129 A 03 30 A Positive Control Exon 2 A 02 52 A 03 43 82 A 24 6 A 02 81 87 112 124 129 136 A 02 05 01 05 04 06 01 06 A 01 01 01 01701 31 01 33 013 A 01 51 A 02 55 A 03 24 149TA E 153 032 A 02 03 017 03 04 38 117 13 A A
295. r HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 281 One Lambda Inc HLA Fusion Software Version 3 x x User Manual 4 Select the Include in Donor PRA check box Printing Patient Donor Records HLA Fusion prints both Record Management tabs regardless of which tab is currently being viewed 1 2 3 4 From the Main Menu select Patient Info gt Manage Patient Select a patient donor record Click Print to print Click Close to return to the Main Menu Exporting Patient Donor Records Patient donor records can be exported individually to a CSV file The file has the same format as a Patient List 1 From the Main Menu select Patient Info gt Manage Patient 2 Select a patient donor record 3 Click Export to export 4 Select a location to save the CSV file to and enter a file name 5 Click Save 6 Click Close to return to the Main Menu Archiving Patient Donor Records Archived patient donor records are not available for reporting or associating You can still view archived records and reactivate them by clearing the archive check box L 2D From the Main Menu select Patient Info gt Manage Patient Click the General Info tab Select a patient donor record From the Patient Donor List window select Archive from the drop down Active Archive list Click Save to save HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagn
296. r In Vitro Diagnostic Use 229 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Click any of these areas on the CREG bar to circle antigens in the specificity area above aca ae CA SG Mee a S 2 8 6 18 e gt 12 8 S E sis Sl 1 Click a CREG group or antigens to circle the corresponding specificities 2 Right click an antigen to move the specificity to the Final Assignments box Do the following if you want to use a different CREG table 1 Click the LCT home page button or select Utilities gt Antibody Product Configuration gt Set Analysis Configuration 2 From the Home page click the Edit link to display the Analysis Configuration Settings dialog box This dialog box is displayed already if you are accessing it through the Utilities menu CREG 7 Select a table from the CREG drop down list 4 Click Save ll Cw Include e Enable Pop up Messages OLI FULLER UNOS sa Sort by Well Position This button appears when the histogram is currently sorted by reaction When clicked it sorts the histogram in order of well position and the button is labeled Refresh 1 From the analysis window click the Sort by Well Position button setbvwerroston 2 To return to sorting by reaction click the Refresh button re Before Sort by well is selected in order of reaction o o N U A 4 O y OO Ww SE 1E 1c 54 3B 34 1D 28 de SF 2F 14 SF 50 sc 58 44 45 40
297. r bar indicates the number of false reactions to the indicated bead Double clicking on one of the bars in this graph changes the corresponding QC and Bead graphs to that bead Likewise double clicking one of the Bead ID s along the X axis changes the corresponding QC and Bead graphs to that bead The two graphs in the upper panel compare the bead profiles of the current session right graph with a histogram of the same beads run on a One Lambda QC panel left graph If a local QC is used for the session the local QC histogram is displayed on the left QC Panel and Bead Profile Graph One lambds QC Bead 10 7 Ot FLA e Hover your cursor over the bars on the histograms to display bead information e Right click a bead profile to select either Exclude Sample or Analyze Sample e Double click any bead to go directly to the Analysis Screen for that sample e Click the Bead Info button to see the allele specificities for the current bead seso ow lt p Bead Info Rec Site 10YSTS 16 DRB1 03 01 01 01 DRB1 03 01 01 02 DRB1 03 01 02 DRB1 03 01 03 DRB1 03 01 04 DRB1 03 01 05 DRB1 03 01 06 DRB1 03 01 07 DRB1 03 01 08 DRB1 03 01 09 DRB1 03 01 10 DRB1 03 01 11 DRB1 03 02 01 DRB1 03 02 02 DRB1 03 03 DRB1 03 04 DRB1 03 05 01 DRB1 03 05 02 DRB1 03 05 03 DRB1 03 06 DRB1 03 07 DRB1 03 08 DRB1 03 09 DRB1 03 10 DRB1 03 11 01 DRB1 03 11 02 DRB1 03 12 DRB1 03 36 DRB1 03 37 DRB1 03 38 DRB1 03 39 DRB1
298. r more testing You can return to a session summary from the analysis wndow any time by clicking the lt lt Summary link from the HLA Fusion toolbar next to the Sample ID HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 125 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual MicroSSP Analysis screen Sample ID 1216 11 07 Jair 672012 x Findallele srake i Force 1 Run Reset H D A A Axn PE NR R sa 10A 11H 11c 118 114 Cross Loci Je Net SampleRxn Oo li all o o i i La O SS Se ee a 4 31 01 02 A 31 01 03 The 4 31 01 04 4 31 01 05 reaction amp 31 01 05_ PE 4231 01 06 pattern A YAA O al oe 31 01 07 t bl 4231 01 08 apie Input and A 31 01 09 analysis ol saoao ane E A 31 02 E ea tables SS O sao i E i it A 31 05 san s fa Groups and Displays Condenses allele pairs with pairs A 31 XX1 A 33 XX2 the same gt XXL 31 01 31 02 31 04 31 05 31 06 31 09 31 11 31 i A 31 01 02 A 33 01 01 61 XX2 33 01 33 03 33 04 33 05 33 06 33 07 33 10 33 reaction A 31 01 02 A 33 03 01 61 A 31 01 02 A 33 05 G1 C O3 XX1 C 03 XX2 pattern A 31 02 A 33 01 01 G1 C0 03 XxX3 C 04 XX4 A 31 02 A
299. r sheets to verify the accuracy of revision numbers these documents do not contain a revision number in their filename HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 222 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 2 Clickthe Batch Entry Button The LCT Batch Entry Screen is displayed Batch Name LCT_20120314120500 Existing Batches Fina Batch Date 4 25 2012 y 11 13 2012 Catalog LCT 30D_031_00 can have 2 test s in the plate Class Catalog Session fate Test Date gt Sample Sample i i ost Date Class hal LCT 30D_031_00 LCT_201203141205 b25 03 14 2012 qe 10 25 2012 Smith 1025 Donor y Al sl E Notice that Fusion has automatically assigned a session name Optionally you can rename the session Note A session ID must be unique to the Fusion database If the session ID already exists the software prompts you to rename the session It is also highly recommended that you do not use any special characters in this field since they may serve a specific purpose as field separators 3 Use the drop down menu in the Catalog field to select a catalog file Note If you need to import more catalogs click the Download link on the LCT home page The catalog drop down list may not be immediately updated if you downloaded the catalogs during this import session You may need to click the Home button
300. re saved Min BeadCnt e Click the Export button to save the Summary Table on your computer or the network default location is C OLI FUSION data report The file is saved in Excel XLS format LCT Session Summary Field Chooser e Click Print to print out a report of the Summary Table e Click Preview to view a report of the Summary Table LCT Session Summary exported as a spreadsheet file Qa ld w C io v LCT_20120314120500_LCT 30D_031_00 xls Compatibility Mode Microsoft Excel cay Home Insert Page Layout Formulas Data Review View Add Ins C D E E G H J K L M N Oo p Q R S i U Sample LocalID Comment Class 1 SampleDate Family AnalysisUClass IlFinal Class ll Class llEpitope MoreTest ConfirmD ConfirmU Class IT MinBeadCnt PCNCRatio Class IDonorPRA Class llDonorPRA MICDonorPRA CSmith Oct 25 2012 Smith FALSE 0 Bun G Print Preview File View Tools N Ses Sample CSmith Page 1of2 LCT Session Summary Print Preview e Inthe print preview window the page view slider on the left allows you to select different pages of the report HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 225 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual e The Summary Table columns and order can be modified You can save any modifications you make to the layout by clicking the Save Layout button we Your changes are saved
301. reen Batch Analysis Report is displayed Results can be saved but they need to be confirmed individually Save Batch Analysis Lab technicians and supervisors can save batch analysis results for further review and approval Samples are marked as Ready 1 Click Save gt gt at the bottom of the report menu to save all samples to the database 1 Click Exit to close and return to the Main Menu Review Analyze Samples To let you view batch results in more detail after saving the Analyze button displays the session in the Analysis window Each sample needs to be saved individually if you did not save the batch analysis session before reviewing the batch results HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 187 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Navigator Right Click Menu Options for LABScreen Note These options apply to all LABScreen sessions and samples There are analysis options available through the Navigator depending on whether you are in the LABScreen session summary view or on an analysis screen for a sample By right clicking on the Current Session in the Navigator window you ll see menu options that allow you to affect your LABScreen analysis sessions before during or analysis Navigator iz Product Test Date Catalog Session Date Group El LAB Screen e MixedLot11 e Output_Class _Singles BE Zt 02 06 LSPRA1 amp 2 LOTOO
302. rom the Profile main menu you can Add new users Edit existing user profiles Change passwords Reset passwords Archive users HLA Fusion uses two user levels for added security and control of typing and screening results Supervisor can Lab Technician can Modify all product configuration settings except to Modify all product configuration settings enable Auto Accept All and Computer Generated Serology for LABType and Micro SSP products Save and Confirm analysis results Analyze data and save analysis results Update reference files such as catalogs Only if authorized by the supervisor Update reference and NMDP codes files such as catalogs and NMDP codes Archive catalogs Archive catalogs Only if authorized by the supervisor Modify and delete Modify and delete session and sample data session and sample data Modify own amp other user accounts Modify own account only Change the Lab Profile Manage sample and patient information HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 290 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Viewing the User List The List User option displays a list of all users currently in the database both active and retired You can look up and select user profiles 1 2 3 4 From the Main Menu select Profile gt List User Type in a name and click Search to search for current users Double click to the le
303. rs as signment s into the Other Assignment field e You can then choose to modify any of the copied code if desired e The entered allele is assigned and is included in reports that are run that include this sample e Itis not listed in any final assignment fields for this sample Possible Serology Field The serology equivalent field displays all serology equivalent suggestions for the sample based on the possible allele pairs When you select a displayed serology equivalent the allele pairs associated with it are displayed in the field below Note Make sure you have imported the current serology equivalent file through the Utilities menu If a zero 0 appears in the serology assignments this means you need to import the current serology equivalent file e Only one serology equivalent assignment for the sample can be made at a time Therefore a current serology assignment is replaced if you select and assign a different one HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 143 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Note If this is a multi loci test more than one locus can be assigned However for single locus tests only one locus can be assigned Possible Serology 1 Double click a serology suggestion or highlight it and click the V assign button to copy it to the Assigned Serology field Serology Equivalent Select the a serology equivalent and cli
304. rvisors can inactivate users who are no longer using HLA Fusion User information is still stored in the database but the user is not able to log into the program 1 From the Main Menu select Profiles gt List User and select a user to edit 2 Clear the Active check box to deactivate the user 3 Click Save to save user information and return to the main menu or click Close to discard changes and return to the Main Menu without saving Note If a User ID is still associated with analysis records the User ID cannot be deleted HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 293 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Lab Profile The Lab Profile menu displays the contact information for your lab network information used by HLA Fusion and NMDP contract lab codes Most of this information is entered during installation but can be updated at any time Only supervisors can change the Lab Profile From the Lab Profile menu you can Edit the Lab Profile Add edit and remove Lab Codes Change the Network Path Change the Email Server Name Lab Profile Information Screen i A HLA Fusion 0000000 Lab Name One Lambda Inc Ee Dr Emilia Johnson Institute One Lambda Institute email oli org Address 21200 Oxnard Street z 818 555 1212 818 555 1212 Note s Mail Server Name Postal Code 91 361
305. s and II Combined For Combined Class I and II LABScreen PRA sessions each class is analyzed separately and needs to be saved separately for the combined results to appear in the database Make sure that you have already created a combined Class I and Class II LABScreen PRA catalog before you import the combined sessions e From the analysis window click the Run Class I and Run Class IT buttons Run Class H located in the upper left part of the analysis window to switch between Class I and Class II results for the current sample Sort Antigen Single Antigen Single Antigen trays can be sorted in order of specificity instead of reaction value 1 For Single Antigen analysis click the Sort Ag Button The graph is sorted by bead number 6 27 13 14 31 23 70 2 55 A 22 ONNU Y 2200002 76 25 79 80 34 46 11 71 12 69 2 5 iat ea Lc E 2 Click the Refresh button to return to the default graph LABScreen Mixed Batch Analysis allows you to quickly analyze a session and save it for later review and final assignments You cannot view samples graphically during batch analysis and no final screening assignments are made e Batch analyze a session e View the Batch Analysis report e Save analysis results HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 186 One Lambda Inc HLA Fusion Software Version 3 x x User Manual Overview After batch analysis is performed the LABSc
306. s Jose JV Rivas 331 00 1908 3 29 2000 N hispanic 3202 Bio Court Orange FL S50 058 32133 rmejpl com 312 2350 1096 312 230 1096 312 230 1096 312 230 1095 EB Homes Terriana 0 Toula 3121 2350 1096 607 Miami Hospital BONE MARROW Transplant AB Marrow EDO spree ere erer eee ee eer Ti ADO BS7 DRIS DRS2 0P5 0P5 44715 Human Haigety Jimmy HJ Haigety 111 94 1212 11 22 2000 M caucasoid 7701 Christian Brothers Road Bellflower CA NNU USA 91314 jhe men com 323 981 0916 325 345 1234 323 506 7771 714 556 1289 Verizon Corporation Juanna O Juanna 3235 345 10295 103 5t Michael Hospital MARROYV Transplant 0 Tissue Patient ppsrrrrsrrrrsrrssrrrrrrrrrerrrerrrrrer DO DR DP roo 44716 Human Shoemaker Cheryl 5 Shoemaker 111 15 1234 11 22 2002 F black 1705 Brothers Road Canyonville OR NNU US4 97417 38chmen com 541 8399 4467 541 839 6509 541 299 1098 541 760 1966 Juniper Creek Elizabeth 0 Elizabeth 3235 345 1098 103 5t Michael Hospital MARRERO Transplant O Tissue EDO Errores AT rr DR Hees 44717 Human Dublin Nikitta D Dublin 1111 13 1234 1172272004 F asian 345 dAshilly Court Canyonville OR NNU US4 97417 schmen com 541 839 4467 541 839 6509 541 299 1098 541 760 1986 Juniper Creek Elizabeth 0 Elizabeth 323 345 109585 103 5t Michael Hospital MARROW Transplant 0 Tissue EDO Errores TA CU CUl DR DR DRS1 DRS2 DO DO6 26198 Human
307. s to reveal the RunFilelndex file In Windows Vista and Windows 7 open Windows Explorer and select Tools gt gt Folder Options Next click on the View tab and select Show hidden files folders and drives If you rename a session do not name it output as that is reserved for the original HD output file Note The Supplemental button can be used to add other sessions to the current one e g supplementing B locus sessions with B7 for analysis This does not work for combinations of different test types such as A locus and B locus If asample is already associated with a patient the Patient ID and any existing related patient information is displayed 4 To add patient information do one of the following e To add existing data from the system double click in the Patient ID column of the Sample Patient Details table or click the Patient List button on the toolbar The Import Patient window is displayed allowing you to import the patient information file e To manually add patient data simply type data into the patient related fields of the table e You can assign the Sample ID to empty Patient ID fields by selecting the check box for Set empty Patient ID to Sample M Set empty Patient ID to Sample 5 Select a catalog file Your catalog selection method may be one of the following depending on the CSV file and the catalog files you have imported for LABType Note If there are no catalog files available for selection
308. s are displayed in Red text Rows highlighted in yellow have normalized values over the minimum value Changes made to the normalization formula and minimum normalized value apply only to the raw data table and not to analysis 1 From the analysis window click the Raw button on the bottom right of the analysis window to display the raw data table Take one or more of the following actions e Click on a header at the top of any row to sort the table by that category e Click the Report button to create a Raw Data Table report e Click the Print Screen button to print what you see on the screen e Click the Close button to close the window and to return to analysis Raw Data Report You can create a report containing raw data information for the current sample e Once the Raw Data Table is displayed click the Report button at the bottom right portion of the Raw Data Table window to display a report of the raw data Exporting Session Data You can click the Export button to export sample data into a comma separated output file This file can be imported for analysis This feature is can be used if you have a separate workstation for ELISA and analysis Donor PRA You can display the percentage of PRA from available donors in the system or from selected donor groups who match the computer assigned antibodies for the current sample Note To select a donor group s select Utilities gt General Settings To create a donor group select
309. s displayed in the Gel Image viewer click the Unlink Untik button Add Samples There are two methods that samples can be added and analyzed in a session e Data Reports Data Sample Patient Into Profile Utilities Help Exit 1 Click the Add New Sample Latter sameie ES 2Sa AEA Smile 21 E button seme Lo eae A 2 Type a new Sample ID or Sample Name in the Sample ID field above the gel image we Data Reports Data Sample Patentinfo Profle Utites Help Ext 3 Select the Sample Date by clicking the Down peta A AE AK dh Arrow Vin the Date field to the right of the Sample ID field o 4 5 1 12 18 19 25 26 4 And dick the Analyze button __ Today 11 29 2012 OR Here s an alternate method to add existing samples for analysis in Micro SSP 1 Click the Sample Selection button to the right of the Sample ID field Select an existing sample from the list of Available Samples Rae want ad a Ga ele mp st E Select SampleID o x HLA Fusion Available Samples HLA Fusion You can use the text box at the cima Sad top as a search tool 2 Click the OK button at N the bottom of this window to move the sample from the A a list of Available Samples to the Sample ID text box above the gel image viewer You may use the existing Sample Name or create a new one DONE LAMEDA e eo 130 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diag
310. sID NcBeadlD PcBeadlD 4 2 2012 10 31 01 4 2 2012 10 30 39 4 2 2012 10 30 13 4 2 2012 10 30 28 4 2 2012 10 30 21 4 2 2012 10 30 50 4 2 2012 10 29 48 4 2 2012 10 30 21 4 2 2012 10 30 39 4 2 2012 10 30 24 4 2 2012 10 30 13 4 2 2012 10 30 26 4 2 2012 10 30 26 4 2 2012 10 30 15 4 2 2012 10 30 50 4 2 2012 10 30 44 4 2 2012 10 30 37 b New Catalog ID ONE LAMBDA 0 0 0 3 Select the first product catalog to be combined and click 4 Select the second product catalog to combine and click LA The new catalog file name appears at the bottom of the selection menu 5 Click Save to save the new combined catalog file for use in LABScreen analysis e Optional Click Clear to reset the selections and start over 6 Click Close Le HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 314 One Lambaa Inc Changing LABScreen Default Negative Serum HLA Fusion Software Version 3 x x User Manual Negative control sera can be adjusted or added for each product or lot You can change the trimmed mean fluorescence value for each bead individually 1 Select Utilities gt Antibody Product Configuration from the HLA Fusion main menu 2 Click Set Default Negative Serum Value to open the Default Negative Serum Value screen Setting default negative serum value Input User Default Neg Serum Control Value HLA Fusion 3 Select a catalog file Catalog ID LS1A03 NC7_0
311. se L button 2 Adjust the date range Use the drop down calendars in the Session Date fields to select a different start and end date 3 Enter or browse for specific sample or session characteristics or status see below 4 Once you set criteria and click the Find button on the left panel of the Reports window the session list in the right panel of the window filters accordingly For In Vitro Diagnostic Use Session Date 3 19 2012 wow 4 2 2012 C Indude all records for samples C Indude all combined samples Fma Local ID Catalog Type Catalog ID Locus Click to filter sessions by selected criteria TestType ECEE Tech ID Session Status Sample Profile More Tests Needed Yes No AI Notes Remarks Added O Yes No all Analysis Data Exists Yes No all Assignments Made O Yes No Al Generic Ambiguity Exists O Yes No Al False Reaction Exists O Yes No all LESW Generated Yes No Al Sample session status or other characteristics as search criteria 241 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Session Sample Selection e Inthe Samples Sessions list click the sign next to any session to expand the display to show its samples View by Sessions or by Samples A session with some but not all samples selected A5502345 008 03 04 30 2009 0L2000_DR_L16_10756 0314 2012 620201 1CLOC10149521D455 06
312. seesssaunseesssauaseeenes 297 UPDATING CATALOG FILES FROM THE ONE LAMBDA DOWNLOAD SITE iuuci niinni aid ii 299 UPDATING MOLECULAR TYPING REFERENCE FILES aenieei EEr ales 301 Updating NMDP Codes from a Local or Network Drive menirea ei A EE EA E A a e 301 Updating NMDP Files from the NMDP Website ui A A A aa 302 Creanga Lo CO COGS FIE AN AAA ito 302 Upaating ENE Local Code e aa 303 Updating Serology Equivalent File from One Lambda Website oococcocoocconnccoonononoccononnnnnnanonnnnnnonoonnnnnanrnnnnnnannnnnnnnanons 303 CATALOG MANAGEMENT AND INFORMATION co as 304 ACHIV ETORRI 304 UNA FCNVERNVOS a A A AA A ia 306 VIEWING Catalog Filen orma EOP au sols aa A a Ll ee 306 Deleting Catalog FIC TAL ormat Om a di 306 Reporting Catalog FIC GONNA OD in AN nnd cotta tuedautendoed E OAT 307 Associating Product Catalog Files and Luminex TeMplates cccooooccnccocnononononncnanononononnonanonnonarononnnnononanonnonanononannnnenaninnnns 307 Importing Allele Frequency Files Demographic Frequency oooncccncccncnooonccnnnnnnnnnnncconononnnnonarocnonnnnonnnrcononnnnnnnnarononnnns 308 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 12 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual UPDATING ALLELE FREQUENCY FILES DEMOGRAPHIC FREQUENCY ssscccccsssecccceesecceceueeeccsseueseccseeeesecesseuneecesseueeeesesuuneesesseueeesessugnesss 309 MANAGING CREG LIST INFORMATION sida 311 CHANGI
313. ser Manual v3 x x For In Vitro Diagnostic Use 41 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Overview of the LABType Analysis Process After importing session s check the Summary Table for low Positive Control and low Bead Counts Consider deleting those samples Check the lower left graph of the Analysis Screen for close reactions just above or below the cut off points Also check the Control and Bead Analysis Tabs Use the Force tab to help review homozygous and rare allele results lower right quadrant Look at the reaction table to review allele reactivity patterns upper left quadrant Check the Close Reaction Box to further finalize assignments lower right quadrant Make any necessary cut off adjustments upper right or lower left quadrants Make final allele pair serology and or coded assignments lower right quadrant HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 42 One Lambaa Inc Start LABType Analysis Importing LABType Session Data Non HD Analyze Data LABType Micro SSP LABScreen LAT LCT FlowPR 4 HLA Fusion Software Version 3 x x User Manual Click the LABType button on the Fusion Explorer Panel the LABTypel the toolbar and select LABType The LABType Home Page is displayed HLA Fusion LABType Product and Catalogs the version is listed here If the code being used is NMDP
314. sion 3 x x User Manual User Interface Fusion Home Pages Opens the Analysis Opens the Catalog Opens the Reference Product Selection Management window File Update window window HLA Fusion gt COC x Analyze Data Reports Data Sample PatientInfo Profile Utilities Help Exit Notification 101418 GUIA IA dendam n Y that new or updated HLA Fusion 0000098 x NX JOJeDIAR catalogs are J e M Products and Catalogs AA t available Last Update Date 37272012 Details Download Edit LABType 33 LABScreen 109 Reference file Updates 0 MicroSSP 158 LAT 5 LCT 9 A Fee Unies To check for a lt FlowPRA 27 Fusion soft S50 Quantiplex Beads 2 ware updates mFusion Database O h O th Fusion SQL locali SQLEXPRESS Database FUSION_New Used 10 75 MB of 1024000 MB DB size pens the pens the Settings us_englishiSQL_Latinl_General CPI_CLAS Version 3 0 0 Created on 1 12 2012 printer setup Users List Audit Log SQL localliSQLEXPRESS Database Audit Log 1 Used 5 4MB of 2000 MB DB size window Screen Users Printers z Number of Users 2 Show Print Screen preview dialog Edit Opens the Fusion AP ES Print Screen printer O ens the PoS 2 la l Show Print Report preview dialog setup window for a te igat Inactive 0 Technicians 2 Report printer genera l audit tr ail aviga or eneral Configurations a
315. sis results for further review and approval Saved samples are available for confirmation only by a lab supervisor e From the analysis window click the Save button located at the bottom right corner of the analysis window to save the analysis results for all the specificities currently listed in the Final Assignments field HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 183 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Fusion automatically moves to the next sample For Confirmation a supervisor needs to access the sample for which you saved the assignments You can return to the sample at any time prior to confirmation if you need to make changes Click the Reanalyze button and then the Save button again Confirming Assignments Lab supervisors can confirm analysis results When they do so samples are marked as Confirmed The Confirm button is Purple colored when you view a confirmed sample e From the analysis window click the Confirm button located in the bottom right corner of the wndow to confirm all analysis results that have been saved in the Final Assignments results box Fusion automatically moves to the next sample to continue confirming results When you first return to a confirmed sample you ll see that the Confirm ont button is now Shaded Purple to let you know it has been confirmed previously Getting Tail Analysis Values Except Singles Tail analy
316. sis values can be displayed in the analysis with the final assignments but are not stored for look up or reporting e From the analysis window click the T button located to the upper right of the Final Analysis results box to display tail analysis values in Final Assignments results box Get Manual Tail Results Donor PRA Except Singles You can display the percentage of PRA from available donors in the system or from selected donor groups who match the computer assigned antibodies for the current sample Note To select a donor or donor groups click the Donor PRA button You can also auto select groups by selecting Utilities gt General Settings To create a donor group select Patient Info gt Manage Patient select Donor in the Patient Donor field and fill in the donor group field HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 184 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 1 For Single Antigen or PRA analysis click the Donor PRA button A pop up box displays the percentage of matching donor PRA and the total number of donors that were considered in the calculation xi Click OK to close the box The percentage and number of donors O Sid remains displayed next to the Donor PRA button ofDonors 1 Donor PRA Comments System Choosing Minimum Positive Threshold Cutoffs Except Singles You can set the minimum positive threshold cut
317. sition SeepeeDee 1 2 2012 Reaction Input Pane tape A BE c D E F i Ao soo oe poe To Eff Bead iz OQ gt TF ere er __ FC Graph ALA A A AA hebrea gun Y mOnt ny PELTI EBBBYBELERRBE ESTE ERES RBVSRR S2KSSA SRE gt 2 Er har z e e e e SOSSSSSAIRSASSBIHAASISR Specificities BSSSssI asesRgosysssez gt oo a 5099595949 eee gt a whet gt Ba agag Gaz mw ite 9 00 gt bcs O ril 2 9 PES rice 9 ri G rool Analysis tools SC 2 EE Sle EEE BEER a do JE He bee be be ELE LB LE LS 5 BI CREG Bar Epitope Analysis Resulta Final oe Assignment Cf ele ds Comments Area Click to display Select if more Click to Rak and double click to expand it Donor PRA tests are display results Confirm buttons required as Raw data The LCT Analysis Window HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 227 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Reaction Input and Analysis Pane The pane in the upper left of the wndow displays each bead grouping of the test on a separate tab Each bead is listed with specificity and reaction button To switch between panes click on the tab of the selected bead group When clicked the reaction for the selected bead switches between the following numbers and colors Reaction Input e 1 green Analysis pane Sample Da 1 17 2013
318. ssesensdecasmuseaei eneiessaesvensesansancassesssesaussaessaesensesenaensaamssaresaueeseanaassensesenaensdesssaresaeessecsessvenmuseses 25 US LO Ft ONE AGE II e oO III II A 25 NN O EE EE EEE EE E E E E E EE AE EE E 27 NOV OOTO TEE e E E E E E E E nee teeeccam 27 RESUIETS GROUP coran E E EEE AT E E 28 GrOUD OY POQ UC oai naa REEE o A 28 Ege R 0 Gs E e PETEN S A I EE E Sere A E er rrr Tt tT Tee E E S E E T 29 MO OY CSU DATO na 29 ACCESSING HLA FUSION SOFTWARE FUNCTIONS ccccccsccosscsccesccsccssccssccssesecessccccsecsssccecsssccacssecsasesecessecacesacesesucesaceaceess 30 DOIN STATE NIN OPTIONS sta io gies Ascari sae teeta ee we wore cis baw oia 30 Anaye DIR 30 ROPOT 0 ECC R A 30 E A e Pr Po CE E A A 30 o An PP PP E ge 30 A PP e o In e e AAQ gn E aeancneeuoaee eee 31 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 3 One Lambda Inc HLA Fusion Software Version 3 x x User Manual PONE N A seca osteoma vedi cedaoas E A E 31 UA o E AE E E E EPE E E E EET E E EEEE ET E E EAE E 31 PICU S EE TE EE EEE A EEE E TE o S ETETE TE PEE On EEEE TENTENE E TERETE TE aI 31 A AT ME a A AA E E A o AE 32 Toolbar BUON SA AA AA AAA AAA AA OOO 32 A O O ET O 33 A OE soit ahaa caster aie acceh ceah ale tia ae ah aaa crear cr teat Salar tae ica lea a tac ance tee tastes aac ear Laan eau leases e E alee anes 34 PLEVICWORE DONE ad A A AAA A A daa 35 PINES CEN TREN nets E O Ia eee Nido 35 MAI A acid 36 A CtErer OR Cee
319. ssigned Allele Pairs text box Possible Allele Codes The Possible Allele Code field displays the possible coded results for all results that fully match the sample The type of code used is dependent on your configuration selection NMDP code default local code user defined or no code Possible Allele Code Possible EE allele code A a i JKZW DRB1 07 JKZW Allele code JKEZW 07 01 07 03 07 04 07 05 07 06 07 07 07 08 07 09 07 10N 07 lam definition 4 Assigned Allele Code Assigned DREB1 07 JEW DPR1 07 Je7W allele code DEB1 07 JKZW DREB1 07 JK l HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 139 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual e The possible coded result is listed at the top section of the field The code definition is listed belowit e Ifthere are no codes for a particular suggestion then the suggestion is listed with XX meaning the code is undefined For multiple XX suggestions each suggestion is numbered as XX 1 XX2 etc to distinguish one from the other e The allele codes displayed in the Possible Allele Code field are condensed by Fusion based on suggestions from the list of possible allele pairs displayed under the Pairs tab e The allele code is based on the current NMDP code or local code installed in the system By default the system assigns the NMDP codes to the alleles You can optionally change these codes to either No Co
320. ssignments area e Right click on a specificity or CREG group on the CREG Table to assign it to the Final Assignments area Manual Assignments Manual assignments can be entered in the field below the Final Assignments results box Enter multiple manual assignments by leaving a space between each specificity 1 From the Analysis Window type a manual antigen specificity assignment in the field under the Final Assignment box 2 Click the Assign button l just above the Manual Assignment field to add the assignment to the Final Assignment results box Assigning Negative Sample Values You can assign a negative value to a sample even if analysis shows some positive results e From the analysis window click the Assign ve button located just above the Manual Assignment field to assign all samples on the Final Assignment results box a negative value Removing Assignments Specificities can be removed from the Final Assignments results field You can remove more than one specificity by holding down the Ctrl key and clicking each specificity you want to remove e From the analysis window click to highlight specificities on the Final Assignment list hold down the CTRL key to select more than one and click the Remove LI button located below the Final Assignments results field HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 216 One Lambaa Inc HLA Fusion Software Version 3 x x User Man
321. subtypes Displays allele pairs HLA Fusion Software Version 3 x x User Manual Groups pairs Displays the sero with the same p ay reaction pattern ena Quadrant 4 Pairs Force Type SubType atch Sero Close Bead Ran 03 4 24 10 03 A e4diled Atag Atag Atag Atag Area Pair tab AFZA Assignments atzA suggested by 12 ated HLA Fusion atog ama Arad 10 leas 10 lus 10 lus 10 10 lus 10 lus Possible Allele Code A llixx1l A 24 4X2 Oe ee Ley A Oe dar 10 2d 1125 01 4 24 10 Dz 4 24 10 Atad Diza 10 124 Assigned Allele Pairs ME Assigned Sero wlx Assigned Code 4 11 01 04 A 24 125 All 2403 A LIAR A 24d Axe A 11 01 08 4 24 10 JA 11 01 14 A 2 4 10 Other Assignment Enter your own comments here System Comment Adjust Bead 001 52 65 To re analyze a sample after new NMDP Moves Unambiguous possible allele code to the Assigned Code List serology or changed To analyze Place a check mark Saves your current number of false reactions from here to indicate that window layout reactions allowed two tests Patient Assign ppssion gt gt Savg gt gt Confirn Read only notes Assign the results To assign and Save analysis Supervisor entered by Fusion at the patient level save all results for review and clicks here to approval confirm analysis results Each quadrant of the Analysis Window represents a different v
322. sults The LABType Analysis Window is divided into four main sections or Quadrants each providing specific data for analysis HLAF MAN v3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 76 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual The LABType Analysis Window ASBSRIaTtasaltaaavo Sp lt lt Summary 50099 FJI lt e DI Sample Date Ran Rec Site Local Qc Patient Sample Resutts Set Confia Bead Raw Bead info One Lambda QC ID 011 Probe ID A130 Max Scale on z E Exclude Reset _ Close Bead Rxn Possible Allele Code A 02 CDRH A 29 BPM0 01 01 01 A 29 01 01 01 G1 BPM 29 01 29 01N 29 02 29 04 29 06 29 08N 29 01 01 01 A 29 10 G1 CDRH 02 01 02 01L 02 07 02 09 02 15N 02 18 02 01 04 amp 29 01 01 01 G1 01 04 A 29 10 G1 07 A 29 01 01 01 G1 Assigned Code 4 02 CDRH A 29 BPM SOFOCAR EEN LO LUDI DOTA OOOO Jaroz O A 29 01 01 01 v Other Assignment User Comment O More Test ll temas tests contes Analyze Analyze Combined Patient Assign CDRH 02 01 02 01L 02 07 02 09 02 15N 02 18 02 20 02 24 02 29 02 30 02 31 02 33 02 34 02 42 02 43N 02 49 02 53N 02 59 02 62 02 66 02 67 02 PE Displays the Displays User QC Displays LAB QC Reaction Table for each probe if created Displays Recognition Displays Loci results for the Enter new values here Displays Site and Data for d current patient to modify the Y axis O
323. t Set Sure Reaction Bead View OC Low Positive Threshold gt HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x The default Low Positive Threshold value assigned by HLA Fusion is 200 If desired click the Set Config button and enter a new valuein the Low Positive Threshold field located at the bottom of the pop out menu Samples below this value are graphed as GRAY vertical bars in the upper right Quadrant 2 of the Bead Analysis screen For In Vitro Diagnostic Use 75 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Using the LABType Data Analysis Window The LABType Data Analysis Window provides detailed analysis information for each sample in the session You can review the allele assignments suggested by the program and modify and accept the typing assignments HLA Fusion suggests possible typing results but the final assignment must be made by you or your supervisor From the LABType Analysis Window you can do the following Switch between code formats Apply Bw4 Bw6 to serology results Apply frequency filters Show the delta between the signal generated and the cutoff point for each bead Display reaction recognition site raw and bead data Navigate between beads Exclude a bead from analysis Adjust cutoffs Assign non coded allele pairs Assign a coded allele pair Assign serology equivalents Make manual assignments Remove assignments Save and confirm your analysis re
324. t format 11 for AB DR sample S iii dd 266 CONTA DEN ea Fora rasore En a EE E EE T ETE T ET 266 TFOD DeHMITCG FORMO oean a E A A AA A A A o 267 SORTON Gee eer eee EPPO a PEON Tee AMEN FET E A A RA A AE a 267 EOCOI SaGMple PONCNCAD ONIS EA A A iS 267 VIEWING AND EDITING SAMPLE INFORMATION aiii 268 PS RS TS ys vain vac oan A N A 269 creatina NCW Fe SE LISTS 2 is A A AAA Rei Paeeudevebesanaeetecsde aunts auedisees 269 VIEWING and Editing EXISTING Test Liste cada 270 DICTION EXISTING TSE LISUS coast sec ares se seeandaicabienasad on eniocan Renee nan doe aad scisoaniu ened an Miwa a 270 EXPONO FOOSE IAS ES A A Deute wee Camee ou aoard 270 LOUMINEX Sc 2ciusccccsiseacseasnwadnnstion E S A EE deus sauesetas suneuasnwansoannesuinnssinnseraas duaesaat E suaaaganscanedanasaats 272 CREATING LUMINE X LISTS roo io tics 272 Create Sample WORMISES rd 272 Create Plate Des TOIT ears sia estes T E ET A TET ee eee viene aes ee ete a aoe anti hes Da ae 273 PATIENT INFORMATO N ec occsstessccscuiessaadssiens cons AAEE EEA AATE ASAE EN sas Seesvessveesaassueos eens seuss 276 IMPORTING PATIENT DONOR US Tucan o 277 MANAGING PATIENT DONOR RECORDS oia ada a aii ia 278 ADDING NEW PATIENT DONOR RECORDS aia aia 2 8 Lookup Paten DONO ROC ON AA ANA AAA AAN ica OEN OOR 279 Editing PATIENT DONOF RECOMGS astra iO iaa AAA AA a AA A AAA AA A 279 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 11 One Lambda Inc HLA Fusion Softwar
325. t side of the LABType home page and download the necessary catalog s After the Exon 4 catalog s have been added to your computer or network select Exon 4 sessions from the list of CSV files on the left side of the LABT ype home page e Or click the Folder L icon above the list to browse to the LABType CSV file s on your computer or network to locate and select Exon 4 CSV files This will display the Exon 4 samples in the Sessions Detail Table on the right side of the LABType window Click the Supplemental button please note that the Import button is not available for Exon 4 sessions The Supplemental Analysis window is displayed HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 57 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Supplemental Session Selection Exon 4 A Supplemental Analysis 00000009 m y Homerci n e Date Narusy WU Pedi Pa iN a Doe ee en Y IMGT Verson O Orange No eboble temple found to combine Ligi Bhue Mote than one remples from tame locust found Exon de orhi Loi Gray Sancie has laka reactor or no sobran Exon 4 onb Select Samples ke Supolementel Anabi No ol Relted Wels E1964 TERUGY Tc EROS TERUZ on Tero STOOAIDOGN ST DQAIO403N STODA1 0504 ST D0A1 0504 TOOAI 0602 ST DOA1 0502 Tenia TERI TER TENI TER236 2 TER2B TERO79 TEROTS TER252 E2 TER252 1ER175 2 1ERI75 12635 vi EI calada ala olin gt
326. ta for all supported products e Create custom reports for which you determine content type e Create reports for electronic submission such as NMDP HML reports e Store as many as 18 reports in a My Favorites list for convenient access e Modify the appearance of any report such as fonts formatting and background colors supervisors only In addition the following are a few considerations before you create reports in HLA Fusion e The report date is in a different font than the other report contents This is by design to allow the Crystal Reports date field to be displayed in PDF format in various language and regional settings e Please verify the reports and the data during the installation and validation process e All report files are made available to you so that you can arrange and size the fields to meet your needs Note To view reports your computer must have some form of printer driver installed If you do not have a printer driver installed you can download a free copy of PDF Distiller from Adobe com or Microsoft Office Document Image Writer from Microsoft com In addition you Can print and export these reports from the analysis or batch summary window Sample IDs Patient IDs Well IDs Alleles Serology and so forth are sorted alohanumerically in reports just as they are on other HLA Fusion forms and lists HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 239 One Lambaa
327. tanadeaceaas statanevnasuntee seabadecseounnassuawonbenncrs 227 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 9 One Lambda Inc HLA Fusion Software Version 3 x x User Manual REACTONINPUT AND ANALYSISPANE ot dd id 228 PODIO TEO TO OCIO aa 228 EIA NU 229 CREG TOD Sui lo id dot patios 229 SOME DY Well POSTOR Aa 230 Select MINIMUNT POSITIVE TNT CSIOIG dia 231 EXGIUIGC ANTIGEN Om ANOIVSIS 5G chs ee hese ia E oe ead os 231 ida E AAA A II II O neta tate 232 FOW DIT TOD RN Nana 232 POW GEG REDOT des 233 DONORARA tesina r a 233 Adano COMES OS E o a cutee Le geo 234 Flagging a SOMIDIE FOr FTE TESTING to 234 Printing the Current Analysis WINGKOW 1 ccccseeecccseseccsseseccaenecesausecssuueeesaneeesaueesssaueeesauseeesausesssauscssauseessausessauasessauseessgages 234 PREVIEWING AND PRINTING REPORTS usuario 235 NIAKING EINALASSIONMENTS sua da ati 235 Mantua A SINE E aan tico 235 ASSIGNING Negative Sample VAS ta 236 RETHOVING ASSIONINICNIS ti 236 SOVHIG ASS ONE ES AA EA SAA AAA IAEA ARA 236 Coning ASSINET S aranin EA T AAA AAA AAA a 236 NAVIGATOR RIGHT CLICK MENU OPTIONS FOR LCT SESSIONG csccsscsscsscsscsscsscsscsccsccsccsccscesccsssscsscsscsscescnscsscnscnsonsonss 237 Reanalyze With New Catalog viii ii ii at aii dai di ida di dicas 237 SAMPLE LEVEL OPTIONS a 238 Reate RECO A A E ici 238 Iae BVS UCANG td 238 REPORTS aeie E A E r a ia 239 USING THE REPORTS WINDOW iess aa a a a a e a a
328. te range Find Patient List Patient ID cd86 v Molecular Typing Sero A3 A11 B51 B13 Cw4 Cw12 DR4 DR15 DQ1 Da Typing Date 1905 2008 we To 19 06 2009 ae Formula Baseline we include Sample Date sample Index Sample ID Final Assignment 25 08 2008 1 CDSBL 2 Negative E 01 08 2008 2 CDEEM Negative 9 1509 2008 3 CDSEN 1 423 424 576 2809 2008 4 CDS6P 2 A23 B61 A24 876 B48 B7 7 06m0 2008 5 CD86 QC A23 B8 A24 548 87 576 E 1670 2008 6 CDB86R 1 423 024 881 876 B48 25 08 2008 P CDSS DO m 0109 2008 E CDBEM DG Note To add final assignments to a sample double click in the Final Assignment column for the sample to display the analysis window and add the assignment Also only samples with a date can be included in this tracking If the Sample Date column is empty for a sample click on the empty Sample Date cell and use the pull down date finder to add a date HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 286 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual 8 Select the check box in the Include column for the sample s you want to include in the Ab tracking graphs and data The graphs are displayed to display a specific type of graph click on the associated tab 9 Select the check box for the antigen s you want to include in the tracking tient ll Search fence iia FY Molecular Typing Moteatar A MODTA AF OO EMO MRTG DREPI
329. ted in the PRA 8 6 4 2 50 Excluded Antigens field in the Analysis Statistics box PRA B 6 4 FPRA 8 6 3 To include all these antigens again click the Excl Ag button again click Clear to remove antigens from the field and then click OK to re analyze with these antigens included Include Exclude Cw You can choose to include or exclude Cw antigen specificities from analysis e Near the top of the analysis window select the Cw check box to re analyze with Cw specificities Clear the Cw check box to re analyze without Cw specificities Navigating Between Class amp Class Il PRA Class I amp Il Combined For Combined Class I and II PRA sessions each HLA class is analyzed separately and needs to be saved separately for combined results to appear in the database Make sure that you have already created a combined Class I and Class IT LAT PRA catalog file before you import the combined sessions e Inthe Analysis Window click either the Run Class I or Run Class II buttons located in the upper middle part of the analysis window to switch between Class I and Class II results for the Current sample After you click on the Run Class I button and the analysis is completed the button changes to Run Class II and vice versa HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 213 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Raw Data Table Positive bead
330. tent of the actual application screens HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Table of Contents INTRODUCTION unit 14 WHAT Is HLA FUSION SOFTWARE vececccccecscssceccescescescessesscsecssssecsssessessesscsessecssssassassssesssessessessassussassssecsessessassussussasessssessecsacacnsens 14 PRODUCT DOCUMENTATION AND UPDATE FILES cccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccecs 15 PROGRAM UPDATES wicicccaicdadccradandcassdanneenatesdeanad saaceuadasneoundennsedatesaeamad sinasemodanneauddeuasedadesaceaadsiaceuodanneenndenacemadesoeeaadswacanoteateaneras 16 LIMITATIONS OF THE PROGRA Missiniiananiiaicanadiia ii is 17 TECHNICAL SUPPORT o eon danwuneesanesasatoessmsukesmeeus E dessuneesanesaaet esumaueonmeeuscers 18 SCOPE OF THIS DMANDA atadura caduca educa ceda 19 NAVIGATION uns az 20 LOGGING ON TO FUSION ccccscsccccsccccccccccccccccscsccccceccccccccccscscccccecececsccccsccccccsecececccccscccccesecececcccscscccccesecececscoscsccscsesececes 21 RETRIEVING A FORGOTTEN USER NAME OR PASSWORD cecececcececccccccacccencecencecencececcecencecencecencecencecencecencecenceeeaceeenceaeeseaeeseaeeceeeceaeess 22 KEY SYSTEM SETTINGS oa ia dior as eco oo cae ui acciona 23 SCREEN RESOLU ON a 23 FILE PERMISSION Sar a ia is pelados iii 24 USER INTERFACE ccs tc cccencccecaiacsaese
331. tered click the Save LAT 20120109125117 Samp button at the bottom of the screen The i LAT 20120109130107 batch has been saved and is included in the list of Existing Batches in the drop down list at the top of the screen 5 After you re finished entering session data for this batch click the Next button Similar to Manual Input of Session data as discussed previously the Data Input Menu and the main LAT Analysis window appears Importing CSV files in LAT 1 Click the Folder L Icon to open the Select CSV Files list CET Include Imported C OLI Fusion data session Li xi GU y m session Data Reference Files LAT y Search LAT 2 Organize New folder v fil YX Favorites A y lat1240 csv A Libraries 4 lat1288 csv Documents 5H AT01112012 csv y Ap A LATO1142012 csv y Pe 4 LATO1142012b csv lb LATExportSX15X2 csv 2 Homegroup y lathd csv y latmixed 10test csv j Computer Ep LATMIXEDTest01142012 csv E Cc G3 LAT TESTALATM10X5_009_02 csv aol 2 File name esv Files csv 2 Select one or more sessions from the Select CSV Files list 3 Click the Open button LAT01112012 LAT01142012 LAT01142012b The CSV Files are now displayed in the CSV File Name List lat 1288 LATExportSX15X2 HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 195 One Lambaa Inc HLA Fusio
332. that are no longer used The catalog information still exists in the database but is not included in the list of available catalog files for analysis Catalog files can also be restored for use in analysis 1 From the Main Menu select Utilities gt Update Reference gt Catalog Information Management HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 304 One Lambaa Inc f o 4 Note Catalog Management HLA Fusion _ S Status CataloglD CatalogType LocusType NOM Date HLA Fusion Software Version 3 x x User Manual 0 0 0 0 0 0 0 A RSSO1A_011_03 LABType A January 2010 2 28 0 Lja fasson fite A oao faao PE RSSO1A_011_08 LABType A January 2011 3 3 0 O fasson fite JA sanuaey2011 330 PE RSSO1A_12R_00 LABType A January 2011 33 0 A rssowe or3 07 tastyee Je ianua 2010 2280 Fla RSSO1B_014_04 LABType E January 2010 2 28 0 Ija rssowe 014 07 Labype fe poao faao AF RSSO1B_014_11 LABType B January 2011 3 3 0 IE fasson taBtype B fanova 330 ia RSSO1B_13A_04 LABType B January 2010 2 28 0 LIE A pssorc ooe 03 LaBType e vana 2010 fa RSSO1C_009 05 LABType C July 2010 3 10 EJE rsso1c_008 07 tastype e samueey 20m 330 AF RSSO1C_010_01 LABType c January 2011 3 3 0 Ija assores omo fiT fasc uy2010 310 m RSS01E47_001_03 LABType ABC January 2011 3 3 0 FI RSSO1E47_002_01 LABType ABC January 2011 3 3 0 ia R
333. the Assign ve button asson ve located just above the Manual Assignment field to assign all samples on the Final Assignment results box a negative value Removing Assignments Specificities can be removed from the Final Assignments results field You can remove more than one specificity by holding down the Ctrl key and clicking each specificity you want to remove e From the analysis window click to highlight specificities on the Final Assignment list hold down the CTRL key to select more than one and click the Remove 4 button located below the Final Assignments results box Saving Assignments Lab technicians and supervisors can save analysis results for further review and approval Saved samples are available for confirmation only by a lab supervisor e From the analysis window click the Save button saveza located in the bottom right corner of the analysis window to save analysis results for all the specificities currently listed in the Final Assignments field Fusion automatically moves you to the next sample For confirmation a supervisor needs to access the sample for which you saved the assignments You can return to the sample any time prior to confirmation if you need to make changes Click the Reanalyze button and then the Save button again Confirming Assignments Lab supervisors can confirm analysis results When they do so samples are marked as Confirmed The Confirm button is purple when you view a confirm
334. the analysis window enter sample comments into the Comment field below the Assignments area Comments System Type your own comments in this area Double click in either text field System comments automatically added here to open the larger comments window Comments are saved only after you click the Save or Confirm buttons Flagging a Sample for Further Testing You can indicate the need for further testing of a sample by selecting the More Tests check box and then Saving The More Tests indication is displayed in results data look up and reports for the sample 1 In the analysis window check the More Tests check box located below the Assignments area at the bottom right 2 Click Save or Confirm to preserve the setting HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 204 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Adding Tray Information You can add information about the current tray such as expiration date by clicking the Info e button The following dialog box is displayed when you click this button allowing you to add information about this sample tray A More Test Information x Plate ID 11212 4801 2 Reader oi Date Read 11 12 2012 Clear Tray Expire 12 12 2012 Y Clear Secondary Ab Substrate HLA Fusion xl i Save Complete Save Close Exporting Session Data You can click
335. the assignments You can return to the sample any time prior to confirmation if you need to make changes e Click the Reanalyze button and then the Save button again Confirming Assignments Lab supervisors can confirm analysis results When they do so samples are marked as Confirmed The Confirm button is Purple when you view a confirmed sample From the analysis window click the Confirm L amp 22_ putton located in the bottom right corner of the window to confirm all analysis results that have been saved in the Final Assignments Results box After confirmation Fusion automatically moves to the next sample to continue confirming results When you first return to a confirmed sample you ll see that the Confirm A button is now shaded purple to signify that it has been previously confirmed Adding Comments to Samples Sample comments are displayed for the sample s results in the current analysis session in all analysis data look up and reporting functions in HLA Fusion e Inthe analysis window type sample comments into the Comment field below the Assignments area e Or double click in either field to display a pop up window that allows more text characters to be entered HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 168 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Comments System Type your own comments in this area Double click in eith
336. the entered antigens or CREG groups Click the Find Ag button again to remove the circles from antigens in the specificity field Change the Lab Scale The maximum value for the bead graph scale per the baseline user or raw data formula can be modified from the analysis window To do so follow these steps e Right click in the background area of the analysis window just above the top value of the y axis of the bead graph Right click in the light blue area to change the Lab Scale sa ag sorag odao Acv Dom creo ou OG he ae adgu 40 e Select Set Max Scale e Type anew value in the Scale field and press the Enter Es key on your keyboard To return to the LAB Scale value follow the above steps but select the LAB Scale option HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 174 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual View Molecular Specificities Molecular specificities are displayed in the specificity field of the analysis window and can be used to make allele assignments Screening results are displayed and saved as serological specificities 1 From the analysis window select the DNA check box near the top of the Analysis Screen to display molecular specificities Clear the check box to return to the serological specificities 77 43 76 52 55 80 71 75 Bs o Molecular specificities are displayed when the DNA Check box is select
337. the following template name and catalog Template RSSO 281_012 Catalog RS 50281_015 1 Do not show this form any more ONE LAMBDA 0 00 f Catalog Association Catalog Validation Catalog validation E HLA Fusion ee Selected Catalog AS50151_004_06 Validation Results Bead mismatch exists Suggested Catalogs D ouble click to select and continue aa Catalog ID Nomenclature Date Imat Version Miamatched BE ASTM January 2012 3 3 0 as a E HLA Fusion AS50151_005_00 January 2012 Tha following sample beads are not found in catalog AS50154_004_07 January 2012 3 3 0 004 006 007 006 003 010 011 012 013 014 015 016 017 016 0190 20 021 022 024 025 026 027 028 029 030 034 036 097 033 039 04 0 041 042 043 MIONELAMBDA 0 00 Following Catalog File Validation Fusion may ask you if you would like to associate that template name with the specified catalog file If you click Yes to associate the two the system automatically selects this catalog file for future imports of any CSV files that reference this template Note If the incorrect catalog and template are associated review the section Associating Product Catalog Files and Luminex Templates for instructions on removing the association Check to see if there are any samples that have been flagged as having a low Positive Control PC or low Bead Count the rows of low PC or
338. the reaction pattern entered it analyzes the reaction assuming that there is one false reaction in the sample If a solution still cannot be found the system continues to search through additional false reactions until the number of allowable false reactions has been reached or a solution is found The false reaction setting must be between the minimum setting of l and the maximum setting of 4 Note Regardless of the maximum false reactions set here the sample analysis stops at the first false reaction found HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 89 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Raw Tab Displays the data for the current sample as a table of values From the LABType analysis window in Quadrant 2 click the Raw tab to display the Raw Data Table Set close bead reaction threshold sample specific if done here Bead Raw Ben Threshold 3 Negative Reaction ID i 002 a mo Jo ors moza oss n248 as 5a a ass o o3 1857 21 0o35 1248 45 45 157 oM na foots 1857 21 035 1248 50 50 127 Positive 824 o o3 1857 21 035 1248 20 20 130 Reaction aene e a e e e e 9 6 013 1857 24 035 1248 60 60 138 013 1857 21 035 1248 100 100 144 032 1414 53 035 1248 35 ee 013 1857 24 035 42 48 013 1857 24 035 1248 2 013 1857 21 095 1248 1414 55 035 12 46 a ME o bF a 013 os 11 1064 4 a
339. tings apply across all newly imported sessions e Save time importing CSV files by verifying that the default URL s and paths are pointing to the locations where these files are commonly stored on your system or network These settings can be modified in the Utilities gt General Settings section of the default Fusion Home page Note Some of the above tasks require you to have Supervisor Privileges You may have to verify with your supervisor that these tasks have been completed HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 191 One Lambaa Inc Starting LAT Analysis Acquiring LAT Session Data HLA Fusion Software Version 3 x x User Manual There are four basic methods to import session data for LAT Analysis in HLA Fusion 1 Ze 3 4 Manual Entry the data from only one session is manually entered from the keyboard Batch Entry the data from several sessions are manually entered in a series CSV file gt a properly formatted CSV file is directly imported into Fusion for LAT Analysis ELISAP read analysis data directly from the Biotek ELX 800 ELISA reader Click the LAT button from the Home Page panel or the LAT E4 icon on the Fusion Toolbar to open the LAT program The LAT Home page is displayed Click to open the Up date Reference File window Click to open the Catalog Manager Click to open the Available Reference File Update window 6 16 2012
340. tly to NMDP click the RPTL button If you re connected to the Internet Fusion will open the Bioinformatics NMDP Org webpage 2 DNA Type Lookup Tool Windows Internet Explorer y ioj x _ a LA E http www marrow donor org cgi bin DNA dnatyp pl nomversion V__ ive Search x File Edit View Favorites Tools Help E Convert F Select A 5 Sy gt We Se GNA Type Lookup Tool y E dh 1 Page Oj Tools Home CONTACT us STE ME BIOINFORMATICS NMDP ORG HLA RESOURCES SEARCH STRATEGIES PUBLICATIONS EDUCATION POLICIES Home gt HLA Resources gt Allele Codes gt DNA Type Lookup Tool a HLA Resources T tim M HLA Resources DNA Type Lookup Tool HaploStats Update to NMDP allele code nomenclature Allele Code Update to Version 3 WHO Nomenclature Haplotype Frequencies Instructions PDF Biannual Rare Allele Lists Allele Codes CA CB GE Allele Code Lists DRB1 C DRB3 C DRB4 DRB5 E EPE Al 5 oie internet o y HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 104 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual e To add the unknown code information to a text file by NT default stored inc OLI Fusion data NMDPExport ire NMDP right click on the Rpt button and select Save in text L file Save in Excel Fi x NMDP code saved in c OLI ene een
341. to either No Code Local Code or Cross Code e No Solution is listed if there are no results that match the sample s reactions within an allowable number of false reactions If the sample shows no solution increase the number of false reactions in the upper right quadrant for a suggested result Allele Code Assignment Possible Allele Code A 03 18 A 11 AFTF A 11 AEPJ A 36 04 AEPJ 38 39 AFTF 17 40 XX1 01 01 01 015NM01 04N 01 09 01 11N 01 15 XAA 0 511 01 11 02 1 03 11 05 11 07 11 05 11 4 Assigned Code iv x A 11 REBT AW367 04 Lv Manual Allele Code Assignment A 01 XXx1 A 11 XX2 a Pairs Force Type SubType Match Seo No Solution Double click the possible allele code or select the suggested code and click the V assign button Click the X remove button to remove an allele code assignment 1 Type an assignment into the text field just below Assigned Allele Code Make sure you type the assignment in correct allele code format e The new nomenclature format X 4 X HHH where X locus type and code number e The previous nomenclature format X X where X locus type and code number Otherwise Fusion will not accept it and prompts you to make corrections Note If you click on the Translate button to display alleles in the new nomenclature format you Cannot enter a manual allele code unless you reanalyze the sample and the alleles are
342. to the Sample drop down list Use the sample navigation arrows to display the analysis of each related record one by one e Togo back to viewing the samples in the current sessions click the lt lt Summary link at the top of the window Side By Side Analysis Use this option to compare the current sample analysis with a sample analysis previously conducted Note This option is also available by using the Side By Side Analysis toolbar button e Select asample to compare to the current one The two analysis windows are then displayed together in a comparison window e Fach window can be resized and moved by dragging and dropping Click the Side By Side Analysis toolbar button again to cancel the comparison display HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 220 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual LCT Analysis The LCT analysis feature of the program analyzes manually entered reaction values as a new session Analysis results are based on catalog specifications provided with the HLA Fusion software There are a few things that should be completed or verified before you start an analysis session e Make sure you have the latest catalog files as well as NMDP code local code if used or serology equivalent reference files before you analyze You can download or update catalogs from the LCT Home Page e View and modify global product configuration settings befor
343. toff bar and drag it up or down to a new cutoff setting Using your mouse pointer drag and drop this line up or down to adjust the probe cut off setting Adjusting the Cut off Bar HLAF MAN V3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 66 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual To reset the cut off click the Reset Cutoff button and select a reset option from the drop down list Reset Cut off Menu Reset Cutoff All Samples Current Bead Reset to OLI Default All Samples All Beads Reset to OLI Default Unsaved Samples Current Bead Reset to OLI Default Unsaved Samples All Beads Reset to OLI Default e When adjusting the cut off you can determine which bead is displayed after the adjustment by either selecting or deselecting the following check box at the bottom right of the Bead Analysis window e If the check box is selected the next highest False Reaction bead is displayed after the cut off adjustment e Ifthe check box is not selected the bead displayed before the cutoff adjustment was made remains displayed There are two Comments fields at the bottom a User one to record your own comments and a System field in which HLA Fusion records recent actions you ve taken in the Summary Window such as adjusting a cut off The system comments cannot be edited User and System Comments System Comments 67 HLAF MAN v3 x x EN 00 Rev O H
344. ty Patient ID to Sample V Auto Analysis cite PC Values ere P Patient ID First Name Last Name Ethnicity ald E C4905 l 7 31253266 347 00 i Y C4905 Earl Presley Caucasoid gt Tom Jones Caucasoid Lu m i nex Alfred Smith Black C SV Connie Black Caucasoid Carl Thompson Caucasoid Se SS i on home A E Darlene Pry Caucasoid A y Mar Carlson Caucasoid files E a i Guzman Hispanic LABTyp e Home Page button a A ee SS Sets the Double click the Lists Positive Select Auto Patient IDto Sample ID stosee Control PC analysis to analyze be the same as the LABType values foreach all session samples the Sample ID sample list sample sample when imported ID s can be edited Note Open worksheets and probe primer sheets to verify the accuracy of revision numbers these documents do not contain a revision number in their filename 2 Click the small Folder L Icon and select a session s from the Select CSV Files screen HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x Selecting Importing CSV Files For In Vitro Diagnostic Use 44 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Note Note Note To combine CSV files for applicable supplemental kit analysis D HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use HLA Fusion converts Luminex generated CSV file data such as date and time to the local regional code if a regional code is specified in the CSV
345. ual Button Name Other Buttons and Controls ee ee EI a e Product Data Analysis Find Sample Navigation Tools Only visible Print Report during sample analysis my A A IAS The lt lt Summary link returns to the Preview associated sample Report summary table Seran Displays the date of Sample Date 8 23 2011 the current sample in the analysis window B DO Show Navigator Find Patient Click the Find button to open the HLA Fusion Search Window to look for records using various criteria You can choose to search Related by Patient ID Sample ID Session ID Catalog ID and Records specificity or Other Side by Side Other allows you to provide multiple search criteria including date Analysis range session status and catalog type The Find dialog box also allows you to modify the Navigator Session sort and display criteria HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 33 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Fusion Search Screen ala HLA Fusion 00000090 Search Criteria Sort Navigator Se S10 23 Select these ff py patient ip T E gt es oe Set the order search criteria m ee that your C ys 1D O Tray Status for basic AS E search results O Session Name i searching By Session ID will be dis By Catalog ID ji played Select Other to Display Fields for Navigat enable the Sort spl
346. ual Save Assignments Lab Technicians and Supervisors can save analysis results for further review and approval Saved samples are available for confirmation only by a lab supervisor e From the analysis window click the Save gt gt button located in the bottom right corner of the analysis window to save analysis results for all the specificities currently listed in the Final Assignments results box You automatically move to the next sample For confirmation a Supervisor needs to access the sample for which you saved the assignments You can return to the sample any time prior to confirmation If you need to make changes click the Reanalyze button and then the Save button again Confirm Assignments Only Lab Supervisors can confirm analysis results When they do so samples are marked as Confirmed The Confirm button is purple when you view a confirmed sample e From the analysis window click the Confirm button located in the bottom right corner of the window to confirm all analysis results You automatically move to the next sample to continue confirming results When you first return to a confirmed sample you see that the Confirm button is now shaded purple to let you know it has been confirmed before Getting Tail Analysis Values Tail analysis values can be displayed in the Final Assignments results field but are not stored for look up or reporting AN ce ae e e ef A a g SO A e From the analysis window cl
347. ult cut off value Patient Sample Results Tab The Patient Sample Results tab details all of the results for all the tests done on a Sample ID or Patient ID As results are saved for each locus either the serology result or the allele code for each loci appears Daarroa301 DOATIEIOG in this all loci section ooo E DQB1 03 4 1 D001B1 04 04 X1 03 01 039 19039 22 Click on any of the labeled Gray tabs along the top of the grid to sort the results in either ascending or descending order The direction of the small triangles A indicates how the results have been sorted Hover your mouse over any Possible Allele Code to see the entire allele code HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 86 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual wee You can use your mouse to widen the grid or double click between the Res02P61 tabs to automatically increase the column width to accommodate all the rssozPe1 data presented ac Rxn Rec Site Localac Patient Sample Results Lag ac Session Date 5 1 2009 y fio 9 2012 y Assigned Assigned Assigned Other Well Session s Possible Allele Code Allele Pair Sero Assignment Position Date A 02 XX1 A 02 XX2 G0221 12 10 2011 RSSO1A_006 12 10 2011 RSSO1A_011_06 XX1 02 01 02 01L 02 04 02 0 ae ae ae eS a a es SSeS Ss SS ee E RP I A il bia 04 07 2009 RSSO1B_014_06_QC_244 10 11 2010 RSSO1B_014_06 y
348. ults Enter a new One Lambda QC ID 016 Probe ID OLR4401 Max Scale Max Scale aan value here 30 80 Sample ID Name C4680 50 Well Position 59 C8 Normal value 46 Raw Data Timmed Mean 1146 Hover your CT sl E 31 01 ey 40 E ping A 3 3 A view sample 30 details HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 80 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual e Hover your cursor over any sample and the sample details are displayed including typing results see graphic e To change the histogram scale click inside the Max Scale box type in new limits and press the Enter key The Max Scale feature defines the maximum Y axis range When you enter a new Max Scale value the QC and bead data histograms automatically refresh to display the range from zero to the new maximum value e The cut off line represents the One Lambda default cutoff value Rxn Reaction Tab The Reaction Pattern tab displays the Positive reactions for each bead X axis versus every allele Y axis defined in the catalog file From the LABType Analysis Window in Quadrant 1 click the Rxn tab to display the Reaction Pattern Table Double click to display the Click to sort beads selected bead in the Bead Click to expand or Search by by sample reaction Data graph Quadrant 2 contract the table allele oa ja 5 6 4 13 16 47 49 E a Current e
349. ut a patient or donor record can have more than one sample ID associated with it From the Main Menu select Patient Info gt Manage Patient 1 Select the HLA Tests Tab 6 Patient Donor Information General Info HLA Tests Creatinine Tests Transplant History Treatment History Crossmatch Result Edit ID TER259 Associate Sample IDs View Sample Summary Associate PRA Donor Groups TER259 HLA Assignments Molecular Class DRB1 DRB3 DRB4 DRB5 Only digits BLANK Low and are accepted in serology fields Class II DR DR 51 52 53 DQ DP Antibody Assignments Class Antibody Specificity Class Antibody Specificity MIC Antibody Specificity Unacceptable Antigens Acceptable Antigens Comments PONE LAMBDA 0 0 0 Patient Donor Information Screen HLA Tests Tab Click the Associate Sample IDs button In the Patient Donor Sample Association window highlight a sample ID and click gt to add it to the Patient Donor Sample List Click lt to remove a highlighted sample ID from the list Click Save to save the data Click OK to return to the patient record Click Close to return to the main menu Translating Associated Patient Donor Results to New Allele Code Patient or Donor results can be translated to update the allele code names to the new NMDP allele code format HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 280
350. uto download Sea rch Crite ria Navigator search setup Edit Audit logging enabled No Edit ena b le patie nt a E 2 window Default Patient Donor Type Patient A Reference files auto download enabled No Audit Logging Status ty p e etc pri nte r URL and file path setup Yes Auto Donor PRA Calculation No U RL s a nd directo ry Default Home Page Home Stay Current Sample After Save or Confirm No p ath S etup The Fusion Expl One Lambda Product Documents p orer LABType Nom ra Worksheet Worksheet E Green if Audit lick Catalog Catalog Description Probe Primer Datasheet A click any Date 8 511 11x17 Logging is on button to ASSO1A 12R_ 00 January 2012 LABType SSO Class A Locus Typing Test Lot 412R Red if it s off open the ASSO1B 014 11 January 2012 LABType SSO Class B Locus Typing Test Lot 014 ASSO1B 014 WS RSSO1B 014 BPI correspond ASSO1B 015 01 January 2012 LABType SSO Class B Locus Typing Test Lot 015 ing prod uct RSSOIC 009 07 January 2012 LABType SSO Class C Locus Typing Test Lot 009 RSSOIC 009 WS RSSOIC 009 BPI ASSOIC 010 01 January 2012 LABType SSO Class C Locus Typing Test Lot 010 RSSOVE4 001 January 2012 LABType SSO Class Exon 4 7 Supplement Typing RSSOIE4 001 WS ASSO1E47 001 RASSOIE4 002 January 2012 LABType SSO Class Exon 4 7 Supplement Typing A550151 004 January 2012 LABType SSO Class B7 Supplement Typing Test L R55015
351. utton you can display all the DSA match mismatch information for the patient associated with this sample and the donor s associated with the patient Note If you do not have a patient associated with this sample you will receive a warning message and will not be able to display any DSA match mismatch information until you associate a patient to the sample and at least one donor to the patient To display the information take the following steps 1 Click the M button next to the T button on the right If you have a patient associated with this sample the DSA Match Mismatch window opens co lt o Co amp DSA Match Mismatch Patient Info Patient i 120208 If necessary select another donor from the Donor Molecular po ID drop down list Use the or buttons to expand or collapse the table The colors on the table mean the following Final Assignment Drag a column header here to group by that column ad Green represents a matched antigen e Orange represents a mismatched antigen that has been confirmed in the final assignment e Yellow represents a mismatched antigen that has not yet been confirmed in the final assignment HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 180 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Adding Comments to Samples Comments you or the system add to the Comments field are displa
352. v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x No Code the results allele pairs assembled into a string with no formatted code are simply condensed without applying a coded format Local Code assigns user defined code definitions codes used by your Lab for suggested code results P Grouping Codes allele strings in P Grouping as HLA Fusion Software Version 3 x x User Manual Current Sample Configuration Options published by IMGT al Bw4 Bw6 in Serology Demographic Information Minimum Positive Control Minimum Bead Count Set Sure Reaction Bead View QC Low Positive Threshold G Grouping Codes allele strings in G Grouping as published by IMGT Cross Code allows allele combinations that cross serological groups e g EAPW DRB1 04 03 01DRB1 04 03 03 By default cross coding is turned off so that allele pairs are condensed only within the same allele groups NMDP Code No Code Local Code Cross Code Demographic Information Minimum Positive Control Mimnimum Bead Count Set Sure Reaction Bead Low Positive Threshold Serology has identified many pairs of HLA B alleles which appear to differ only at the Bw4 Bw6 region the two mutually exclusive serological epitopes If you select this option Bw4 Bw is added to the serology results For In Vitro Diagnostic Use Bw4 Bw 6 in Serology Type SubType Match Sero BG Bu B Bw6 BS Bw6 B41 Bw6 E Blank
353. vers July 2010 nomenclature update based on IMGT HLA database version January 2011 nomenclature update based on IMGT HLA database vers January 2011 nomenclature update based on IMGT HLA database vers January 2010 nomenclature update based on IMGT HLA database vers January 2010 nomenclature update based on IMGT HLA database vers July 2010 nomenclature update based on IMGT HLA database version January 2011 nomenclature update based on IMGT HLA database vers New lot Based on January 2011 IMGT HLA database version 3 3 0 a Archive Catalog Select the S select check box for the catalog files you want to archive and click Archive sse When a pop up message displays Data Saved click OK Click Close to return to the main menu When you import a new version of a catalog file the system auto archives the previous version HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 305 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Un Archive Files Archived catalog files display an A in the Status column when you view the catalog list and the check box for Show Archived Catalogs is selected JU Catalogs check box gt he trino 00307 LABT AS50154_004_02 LABT ut oe DP meme E LAMBDA 000 Archive and unarchive catalog files Na isc Da LAB Type Place a check mark here and YY 1 click the Unarchive button
354. w can be resized and moved by dragging and dropping 1 Click the Side By Side Analysis toolbar button to cancel the comparison display HLA Fusion The Fusion Explorer O a a a ar You may prefer to remove the Fusion Explorer along the left side of the screen also referred to as the Home Page Pane to increase the screen area available for analysis or for personal preference HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 116 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual To temporarily remove the Fusion Explorer do the following 1 Right click in the dark blue box at the top of the Fusion Explorer if it s gray click on it and it will turn blue 2 Click on Hide and the Fusion Explorer disappears To restore the Fusion Explorer click the Home Icon on the toolbar To temporarily float the Fusion Explorer over an analysis window do the following 1 Right click in the dark blue box at the top of the Fusion Explorer 2 Select Floating from the drop down menu and the Fusion Explorer becomes un docked Left click in the dark blue area to reposition the Fusion Explorer a You can position the Fusion Explorer anywhere on top of the analysis window b Or use your mouse to click drag and drop the Fusion Explorer along the top bottom or sides of the main screen to dock the Fusion Explorer at a new location To return the Fusion Explorer back to its
355. w template is added to available export templates from the Tools gt Export Data menu Export Data Select template Customize Report Setup Data Export hi Export Data 3 When you are ready to export data first select all the sessions you want to include from the available list Then select Tools gt Export Data and select one of the templates The Export Data dialog box is displayed Export Data file save location Export Data x OLI FUSION data export File name Fusion Data csv Save as type CSV format csv 4 Select the format for the exported data X ML CSV or Text The exported data file is saved by default inc OLI Fusion data export Creating Custom Reports Certain report types allow you to customize the types of fields to include Note For Molecular Custom or Antibody Custom reports you must make sure the Free 3 of 9 Extended font is installed on your computer otherwise the barcode is not recognized If needed you can download this font for free at http www free barcode font com 1 To create a custom report select a report type containing the word Custom in its name e g Molecular Custom under the Generic Typing report type menu 2 Click the Setup button in the Report Option section of the window HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 249 One Lambaa Inc HLA Fusion Software Version 3 x x User Manu
356. websites to download reference and catalog files and product updates This option also allows you to set the directory path where HLA Fusion by default stores catalogs session batch files reports etc Modifying URLs or paths ahead of time allows you to avoid having to browse for files each time you need them 1 Click Edit on the right side of the General Configuration panel of the HLA Fusion default home page or select Utilities gt General Settings from the HLA Fusion main menu HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 319 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Select the URLs tab or the Paths tab CEI NT 000000 http www OneLambda com haa One Lambda Inc Catalog Files URL http download onelambda com pubAray_info Windows HLA_Fusion_Catalogs pe One Lambda Inc Web Services URL http Inquiryform onelambda com oli_wsvc labdata asmx Lal One Lambda Inc Serological URL http download onelambda com pub Aray_info Windows HLA_Fusion_Catalogs Usa NMDP URL http bioinformatics nmdp org HLA Allele_Codes Allele_Code_lists Allele_Code_list_in_Numerical_Order aspx m NMDP Download URL http bioinformatics nmdp org HLA numeric v3 zip m HLA Fusion Software Download Update URL AOL FUS SION d st av e mp http download onelambda com pubAray_info Windows HLA_Fusion_Catalogs Document Software Update _ has Run files for MAHLA
357. when selected the Navigator will display only those samples or sessions which have been imported but not yet analyzed These sessions will appear in Blue HLAF MAN V3 x x EN 00 Rev O HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 113 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Miss only samples with no solution are listed samples displayed with gray square markers in the Results Summary graph on the Session Summary tab e False Reaction only samples with false reactions are listed samples displayed with pink square markers in the Results Summary graph on the Session Summary tab The samples in the session on which you right clicked are filtered based on the sub menu option you select The filtering criteria is then loaded into the batch navigation list Fusion then takes you to the analysis wndow where the samples are displayed in order of the batch navigation list Reanalyze with New Nomenclature Allows the session to be reanalyzed using a new or updated catalog file gt Select New product HLA Fusion Old Session ID A5502B1_008 New Session ID RSSO2B1_008_1 New Catalog ID RSSO2B1_015_06 ONE LAMBDA 1 Modify or rename the Old Session ID by giving it a New Session ID 2 Click the drop down arrow in the New Catalog ID field and select a new catalog file from the list 3 Click the Analysis button The session on which you right clicked is now re
358. x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 170 One Lambaa Inc Using the LABScreen PRA Single Antigen amp Singles Analysis Window There are several tasks you can perform from the LABScreen window for PRA Single Antigen and Singles product analysis Review data and assign specificities Circle antigens in the specificity table View molecular specificities Adjust cutoffs for the sample Graph raw data Exclude an antigen from analysis Sort antigens for Single Antigen samples Make tail or epitope analysis assignments Manually enter an assignment Assign a sample as negative Add comments mark for more testing and or view a report for the current sample HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use HLA Fusion Software Version 3 x x User Manual 171 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Click to go to Ab gt Temas sona Tesis JO iia Sova cacou Eten tracking a Specificiti e OR o e Tato ecifTicities ETA IA ar p ES a e K XX pers Le Le y Or o i z K Q O CREG a a mada Ma Bar E O wile TIPTREE Tail Analysis Results pitope Analysis Results EMOS ON ci n suec re ep eel em 2 tInclus PC NC 15 623 DQ 1 8566 22 Statictics 1 59 1 0 28 m 7806 44 1 59 pl 0 28 5535 51 Table a 1 59 1 i 4935 04 X6 1606 33 1942 28 DP18 1 60 0 4402 39 i X8 4714 51 3693 64 DPS T 60 0 4256 82 Lists HE peste i
359. y E p So a oe Se ooo 1 CITA SEC EA Pos 39 DOSDQZDRIZ E O Lee ee Pos 83 Low PC 00 Tierra erie JO ooa isas OOO eRace Pos 7 88709788785 gt Low PC lt 500 Low NC Raw Vale Press JO ooa isas gt SPRANCIOO Pos 80 87881867842 OOOO o o i i eer O ooa isas OOO eRace Pos 20 86081882788 i OOOO i i eee OOOO O O oaa isas OOO eoa Pos 71 B63CWwi2B568 Perrera O ooa rsippanis gt SPRANCIOO Pos 96 BESASGBSIAS ena A E a DE ol AAA O CE IRI GA OT Ga C V Molecular Typing Sample Summary Selected antigen typing records are displayed on the Molecular tab of the Sample Summary screen You can view typing information in a condensed format as well as display more details for any sample 1 Select samples using the Reports window 2 Click the Sample Summary button The default tab is Molecular 3 Select an option from the Select Type of Data to Display drop down list Reports Sample Summary Screen Select Tyra al Deba do Diapley SEITE Baie See a HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 251 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual The window displayed depends on the option selected e Click the Export button to export the displayed data as an Excel file e Click the DNA button to export molecular specificities as an Excel file 4 Click the Close button 4 in the upper right corner of the wind
360. y on the LABType product configuration page ea Exclude Exon 3 Probes for a Locus If you are analyzing samples from a DPA DPB or DQA DQB kit containing Exon 3 probes some of the samples may result in false reactions or no solution This is due to the limited sequence information available for Exon 3 probes For such samples you can choose to analyze without the Exon 3 probes DQB1 checkbox appears due to No Solution E A Esta tson 3 oot harry Abete Powe y x Assigned saro vix Messi ote ra HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 101 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual As the example shows if there is a false reaction or no solution for samples with these loci a checkbox is displayed to allow you to exclude the Exon 3 The checkbox only appears with false reactions If you exclude Exon 3 probes for a locus it has the following results e Acomment is included in the System Comment field Exclude lt locus gt Exon 3 probes e All Exon 3 probes are displayed as Gray bars on the Reaction Profile Quadrant 3 e The lt loci gt check box is displayed with a check mark Note If the false or no solution is corrected by making cutoff adjustments without having to exclude the Exon 3 probes the check box disappears All Exon 3 manual exclusions and or global adj ustments will be kept as is whether the Exon 3 probes are included or exclu
361. yed with the results in the current analysis session data look up and reporting functions in HLA Fusion 1 In the Analysis Window type sample comments into the Comment field below the Assignments area Comments are saved when you click Save Flagging a Sample for Further Testing You can indicate the need for further testing of a sample by selecting the More TestsMcheck box and saving The More Tests indication is displayed in results data look up and reports for the sample e Inthe analysis window check the More Tests check box located below the Assignments area e The Test Selection window is displayed e Select the check boxes next to the additional tests you want run e Entera name for the test list you are creating e Click Save to save the test list and return to the analysis window Printing the Current Analysis Window The Print Screen button prints the currently displayed analysis wndow e From the analysis window click the Print Screen button on the toolbar to print the current analysis screen Previewing and Printing Reports To view or print a report for the current sample use the Preview Report button on the toolbar e Inthe analysis window click the Preview Report button or Print Report button to display a list of reports you can print or preview for the current sample HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 181 One Lambaa Inc HLA Fusion Softwar
362. yellow e Click the Maximize button to expand the Raw Data Table Click the button again to minimize the Raw Data Table e Click on any column header to sort the Raw Data table by that column Double click a Bead ID to select that bead on the Bead Tab e The count values and corresponding Bead IDs in Red are those beads that have a bead count lower than the low positive control threshold The minimum Bead Count threshold may be set through the Utilities gt Molecular Product Configuration menu or by clicking Edit on the LABType Configuration portion of the LABType home page The default threshold is 100 Bead Pos PC HE OLI Sample 1D Ran PERS Normal CH Raw Maa Cutoff EMM o2 0 lors 2080 00 oss t087 2s 2s 103 oos 8 1326 51 44 fons 2090 08 035 1087 11515 ooa 8 200626 73 ons 2000 08 035 10 87 23 23 oos f1 21056 7 fons 2800 08 oss 10 87 20 20 oos e 3675 94 a23 ons 2890 08 035 10 87 30 30 2173 95 r2 o3 2080 09 035 10 87 25 25 o lose s0284 oss 40 87 60 60 a ons 2999 09 035 e fa Josz 250288 035 1438 235 69 1087 20 jo fn ow a rre 1087 a a fo om 6 2603 08 s7 ons 2999 09 035 10 87 20 20 os ons ie 2999 09 100 013 2080 09 035 10 87 100 100 124 wa 1 esos 2 032 2502 84 035 10 87 13 13 105 Bead counts lower than low positive control threshold Bead Info Bead Info Tab Bead ID 002 DGB1 020101 D B1 020102 D B1 0202 D B1 0203 D B1 0
363. you have displayed the session log you want use the Print Session Log Archive Active and Delete buttons at the bottom of the window to manage the log Note Samples can also be deleted individually without the need to delete an entire session The only exception are LABType or Micro SSP samples that have been combined HLA Fusion allows you to move patient records 1 Select Patient ID as the Sorted Select Level The Select Patient window is displayed 2 Select one or more patients The following wndow displays Copy Patients Session Date 4 4 2012 5 30 2013 y DIANEIVY DIANNE IVY Select V Patient ID Sample Name Y Well Position Y CatalogID Analysis Type Y DIANEIVY TERO85 MARCUS TERYLAUS M ERI W 5001206441 S4102101712 1 LCT 1W30_021 LCT Y AnalysisDT Y Confirm Date Y In Target Y LCT_20120330110145_LCT 1W30_021_00 04 02 2012 AIN NOS rr DNS ln FN Nm Select Al Tora Daabose dE oprto Target Database Bock 3 Select browse in the Target Database field to select the database to which you want to move the selected patient records 4 Once you have selected the target database click Send to Target Database HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 263 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Sample Management In HLA Fusion sample lists are an easy way to input a large list of sample IDs and other s
364. yzedDy AnehysisDT Con ilter sessions by selected List of criteria sessions y Filtered j 1 by report Catalog ID and alleles p a that match criteria alleles in Ove Ono Gu the allele on oe Ow J pair e In Required Ca arc review all HLA Typing and data in all dido for accuracy assigne allele field Criteria to Select a tab refine report to view either data filters by session the displayed or sample sessions HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x For In Vitro Diagnostic Use 240 One Lambaa Inc HLA Fusion Software Version 3 x x User Manual Select Report Type e Select a report from the report type menu options displayed at the top of the Reports window The list of sessions in the right pane of the Reports window is filtered to display only the ones related to the selected report type Report Types 214 83 ala E EE Ala amp Patent Generic Typing LABType MicroSSP Generic Antibody LABScreen LAT LCT FlowPRA Specdalty Statistical Miscellaneous My Favorite Tools J Refine Report Input If needed use the left panel of the Reports window to further filter the sessions you want to include in your report There are a number of criteria you can set Patient ID Session Sane Jm Spec ificity Test Date El e H HLAF MAN v3 x x EN 00 Rev 0 HLA Fusion User Manual v3 x x 1 Enter a Patient ID Session or Sample ID fields or browse for the information with the Brow

HLA Fusion IVD User Manual v3_0_EN

Contents

Download Pdf Manuals

Related Search

Related Contents