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LC1115RUO.3 MATCH IT! Antibody v1.2.1 User`s Manual.book

1. 2 Click Save pai Ni 3 The new assignment will Csen om display in the drop down menu of Class I and II Assign Delete Flag ments when reviewing Life is JL Screen Deluxe data Once an 2 Negative m Assignment Text is in use 4 Bead Fadure iz highlighted the text cannot 36 LCR la be cleared or edited Manage Luminex Systems x The user may enter multiple Luminex instruments when in the Manage Luminex Systems window Ser a Num ber Luminex ID and Luminex Server should be entered and then saved Serial Number Luminex ID Luminex Server When the software is first installed it will search the network for existing Luminex maza ae TEETE databases The Luminex instrument to gt 12345679 LMK1234 TST SAR which the batch is to be submitted may be a Fe E selected from the dropdown list when in 1 Automated Batch Setup If the name of the computer to which the instrument is attached does not show up in the list it may be typed in See Chapter 3 Automated Batch Setup Manage Users The MATCH IT software allows users to have unique log ins The login fea ture will prevent access to the software unless a user has been granted access during the activation process or if ab Supervisor adds a user profile at a later date FOR RESEARCH USE ONLY 2 10 LC1115RUO 3 2 15 To create a user Note The first time the software is installed the login information is username supervisor
2. 4 Data from LSA IgG and C3d must be paired to generate an LSA C3d combined report a Select the data set to be paired from the batches listed Hold down the CTRL key to highlight both LSA and the C3d As batches are selected they will be highlighted in blue TestType RunDate DrawDate PRA min Sample ID Lot ID Batch ID PS Graph Copy Grid s Assign IgG C3d Pair Export ntigens Generate Report Po b Right click and select Assign IgG C3d Pair from the pop up c Assigned pairs will be highlighted The first assigned pair for a sample will be highlighted in light blue The second assigned pair for a sample will be highlighted in red Any subsequent paired data sets will be highlighted in yellow Test Type list Sample ID Batch ID Run Date Draw Date PRA NGLE ANTIGEN II Test Type Lot ID Sample ID Batch ID Run Date Draw Date PRA FOR RESEARCH USE ONLY 9 9 LCITISRUO 3 2 15 8 By EA CHEG biin E fa Test Type Note IgG C3d pairs must be assigned in order to use the Export IgG C3d pair function in Exports Reports Graphing LSA IgG C3d paired data The MATCH IT software allows the user to generate a graph that gives a direct comparison between LSA IgG and C3d 1 Select LSA IgG and C3d data to be graphed Click on the LSA IgG sam ple to select Hold down the CTRL key and click on th
3. Column Customization Columns can be customized to meet the user s needs by right clicking a column header The customization will be saved for the user for future A O E do 1756 24 Sert Ascending 1503 Seat Descendi a a ing 1 gs Clear Sexting a Group Ey This Column 859 Fe Show Group Ey Box Remove This Column guage Column Chogser Best Fa Best Fat all columns Filter Editor ahh Show Find Panel E Ie FOR RESEARCH USE ONLY 5 4 LC1115RUO 3 2 15 Changing Sort Order The sample by default will display beads in descending order of Raw MFI This can be changed two different ways 1 Right click a column header and choose Sort Ascending or Sort Descending The sort order will be saved when viewing future batches 2 Left clicking a column header will also sort Once the column is clicked a downward or upward triangle will appear showing the direction of order descending or ascending in value respectively Column Removal Addition and Column Width 1 To remove a column right click the column and choose Remove This Column 2 To add a column that has been previously removed right click the col umn and choose Column Chooser The Column Customization window will appear displaying the columns that have been removed Right click the column to add and choose Show This Column The Column Customization window also allows the user to drag and drop columns into the windo
4. 11 To submit the batch to Luminex click Submit Batch to Luminex In order for the batch to be submitted the Luminex Template for the particular product lot must be present in the Luminex database as described above At this point the batch will be ready for selection in the Luminex Software FOR RESEARCH USE ONLY 3 4 LC1115RUO 3 2 15 12 To submit a batch to an Automated Liquid Handler choose the Liquid Handling Mapped Drive and then click Submit Batch to Liquid Handler A dialog box will appear If the liquid handler will be submitting the Luminex run to the Luminex Instrument the user must select Yes After selecting Yes or No a mes sage will indicate that the batch was submitted successfully This process generates two files a configuration file and a sample list file that are used by the liquid handler to submit a batch to the Luminex Instrument NOTE Specialized Luminex Templates have been developed by LIFECODES for use with liquid handlers These templates must be used in order for the integration of the Luminex and liquid handler to function properly Running a Batch in Luminex Running a Single Batch in Luminex IS 2 3 Once an Automated Batch is created and submitted to Luminex the user must give the command for the Luminex software to acquire the samples within a batch 1 On the tool bar at the top of the Luminex IS 2 3 Software click Open Batch 2 Any batches that have not been acquired i
5. 888627R Caution For Research Use Only Not for use in diagnostic procedures FOR RESEARCH USE ONLY TOC 1 LC1115RUO 3 2 15 Immucor Transplant Diagnostics INC 550 West Avenue Stamford CT 06902 Luminex is a trademark of Luminex Corporation LIFECODES MATCH IT IMMUCOR and associated logos are trademarks and or registered trademarks of Immucor Incorporated and or its subsidiaries in the United States and or other countries FOR RESEARCH USE ONLY TOC 2 LC1115RUO 3 2 15 TABLE OF CONTENTS Chapter 1 Chapter 2 Chapter 3 Introduction System Requirements 1 1 Computer Requirements 1 1 Software Requirements 1 1 Luminex Requirements 1 1 Networking 1 2 Networking Client Computers to a SQL Server 1 2 Networking Client computers to a SQL Server Express 1 2 MATCH IT Menus Menus 2 1 File Menu 2 1 Settings Lab Settings Menu 2 1 Tools 2 9 Exports Reports 2 12 Automated Batch Setup Lot Information Import 3 1 Importing Template files into Luminex 3 1 Importing EDS files into MATCH IT 3 1 Automated Batch Setup 3 2 Setting Automated Batch Preferences 3 2 Creating a Sample List optional 3 2 Creating a Batch 3 3 Running a Batch in Luminex 3 4 Batch Status 3 6 FOR RESEARCH USE ONLY TOC 3 LC1115RUO 3 2 15 Chapter 4 LifeScreen Deluxe Analysis Importing LifeScreen Results into MATCH IT 4 1 Importing EDS files 4 1 Manually Importing CSV Files 4 1 Opening a Batch 4 2 Direct Selec
6. FOR RESEARCH USE ONLY 6 17 LC1115RUO 3 2 15 Once the analysis of completed results has been reviewed click Approved Once clicked changes can no longer be made except by a Lab Supervisor by clicking Approved again Approving results will list the batch as Approved on the home page Reporting and Printing After the sample has been analyzed automatically or manually the user has the ability to customize a report Customizing a Final Report 1 Once the results for a sample have been Approved go to Print Reports tab ReacthityAduetments Groupings Hestocy ES rte Final Report 1 True Positives Tru ives Tare Graph Val EC Quick Print Graph Sort Rua Value DESC E Report Type i Print 2 Click the drop down arrow next to Fina Report and select the items to include in the Final Report Sample Info Reactivity Adjustments E Include Graph Final Report True Positives Tru a Graph value R L Assignment Detail v True Positives L False Positives True Megatiwes False Negatives Bead Ranking mn a 17 07 OK Cancel A a A aed Er Batches 3 A graph can be included in the report as well by checking the box next to Include Graph Graph Value y axis and Graph Sort x axis may also be customized by clicking the drop down arrow and selecting the appropriate choice Reactivity Adjustments Pres Histo Print Reports d Indude Gra
7. Yellow and Checked Antigens are Positive in the First batch and Negative in the Second Batch FOR RESEARCH USE ONLY 9 5 LC1115RUO 3 2 15 era bea LION Note Double click the batch to get to the original analysis tab 3 If an Antibody History was created previously for a particular sample the history will display in the Antibody History tab Edits to the history can be made here as well See Creating a History for LMID See for LMSA Graphing Antigens across Several Batches for LSA and ID A graph can be created with combined results from multiple batches 1 Choose to either Graph by Antigen or Graph by Date Graph Options Graph by Antigen Graph by Date E Positive Assignment Assignment Change 2 Go to the Antibody Batch Results Hold the ctrl key while selecting each batch to be included in the graph _ Select All Antena Antibody Batch Results Antibody History A CLASS TID 06 02 2010 FOR RESEARCH USE ONLY 9 6 LCITISRUO 3 2 15 3 Assigned antigens to be graphed will appear in the Antigen column on the right Differences in assignments between the two panels will be high lighted in Yellow Additional antigens can by added by selecting manually DOB1 02 01 DOB1 02 02 4 To include the CON value in the graph mark the box for COM To include all Antigens in a graph mark the box for Select All 5 Right click the highlighted batches and choose Gen
8. 11 A 02 12 A 02 13 A 02 14 A 02 16 A 02 01 A 02 02 A 02 03 A 02 04 A 02 05 A 02 06 A 02 07 A 02 08 A 02 09 A 02 11 A702 12 A 02 13 A 02 14 A 02 16 A 02 17 F A 02 10 A 02 17 A 23 01 A 23 02 A 24 02 A 24 03 A 24 04 A 24 05 A 24 06 A 24 07 A 24 08 A 24 10 A 24 13 A 24 20 A 24 22 109L AF3201 A 32 02 A 32 03 A 74 01 A 74 02 A 74 03 A 74 05 B 08 01 B708 02 B 08 04 B 08 09 B 14 01 B 14 02 B 14 03 B 14 05 B B 07 02 B707 03 8 07 04 B 07 07 8 07 09 8 07 12 B 15 01 B 15 03 8 15 04 B 15 05 B 15 07 B 15 08 B15 10 B15 11 B 15 12 B L B 51 14 B 07 05 B707 06 B 08 01 B 08 02 B708 04 B 08 09 B 13 01 8 13 02 8 15 09 B 15 30 B 27 07 B 35 02 B 35 04 B 35 06 B 35 09 B 3 B 07 14 B 15 02 B 15 06 B 15 13 8 15 21 B 15 25 B 15 31 B 27 06 8 40 09 B 44 02 B 44 03 B 44 04 8 44 05 8744 06 B 44 08 B54 A 02 01 A 02 02 A 02 03 A 02 04 A 02 05 A 02 06 A 02 07 A 02 08 A 02 09 A 02 10 A 02 11 A 02 12 A 02 13 A702 14 A 02 16 B 14 01 B 14 02 B 14 03 B 14 05 B 14 06 B 37 01 B 45 01 B 49 01 8 50 01 B 50 02 B 57 05 B 73 01 C 01 03 C 04 01 C 04 03 05 A 25 01 A 25 02 A 26 01 A 26 02 A 26 03 A 26 05 A 26 08 A 26 09 A 31 01 A 32 01 A 32 02 A 32 03 AS33 01 A 33 03 A 34 01 A 01 01 A 01 02 A 01 03 A 01 06 A 03 01 A 03 02 A 03 05 A 03 08 A 11 01 A 11 02 A 11 03 A 11 04 AS11 05 A 29 01 A 29 02 mener The Joo
9. 15 moved to the Print right column choose the LSA tab in the Reporting Options Choose the items to include in the report 8 Select desired Printing Option Send to Printer Save to PDF Save to Excel or Save to RTF Multiple options may be chosen If Save to PDF Save to Excel or Save to RTF is chosen choose a Save File Path 9 Click the Printicon A dialogue box will appear stating that reports have been generated Click OK to continue 10 If an Audit Report is desired click Audit Report This report can only be generated in pdf format Exporting Reports PDF HTML MAT RTF Excel CSV txt or Image File 1 Generate a report from the Print Reports tab in the LSA Analysis tab Sample Navigation g 2993171 POD 14 Sample Info Reactivity Adjustments Tail Adjustment Groupings History Print Reports Include Graph m Prime Final Report Tail Antigens Tru E Graph Value Raw Value Quick Print g Print Sample Audit Graph Sort Raw Value DESC Report Type Prink 2 Once a report appears on the screen click the Export Report icon in the upper right toolbar 3 The dialog box that appears provides several different options for exporting saving the report Sample ID 1708 Donor 60151 Lot IO 0520 3F OPEN SAT FOR RESEARCH USE ONLY 6 20 PDF File A ee
10. 2 15 Batch Reports 1 Click the magnifying glass to display a calendar 2 Choose the date or range of dates when the batch was imported 3 Batches will display on the left under Batch Select the batch of choice All samples within the batch will display under the Sample column 4 Use the arrows to move the samples to the Print right column which will include them in the batch reporting 5 Once all desired samples have been moved to the Print right column choose the appropriate 7esttab and Reporting Option for the test Select Send to Printer Save to PDF Save to Excel or Save to RTF Multiple options may be chosen If Save to PDF Save to Excel or Save to RTF is chosen browse to choose a Save File Path 6 Click the Print icon Dialog box will appear when printing is complete or reports have been generated Note The Antibody button on the homepage will display the same win dow Repertng yi Antibody Export Export C3d Results 1 Click the Calendar Icon to select a run date or range of run dates to be displayed 2 A list of C3d Batches with Paired results from the date range selected will appear in the left window 3 The user can select individual batches or Select All C3d batches by click ing the appropriate box FOR RESEARCH USE ONLY 2 15 LC1115RUO 3 2 15 He Export IgG C3d Paired Results Date Range 5 9 2014 1 21 2015 C3d Batches with Paired Results Samples with Paired Results Mect A
11. 27 calco Bg COME 16 1531 asai 000 n E a ME 2 Peatveden NAN CO O ie Pri 1 UseHFiCutoif I cons MIE MEE Exdude Patent Type OFF Comte 1 Custis Control Vales Corner ta Quick Print eAssign Adjust sets the positive threshold for all adjusted values Once the value box is selected the up and down arrows can be clicked to the desired value or the up and down arrow keys may be used A value can also be typed directly into the white box 7he default setting Is 0 eAssign Cutoff is a score of 1 to 4 It indicates the number of calcula tions against different controls that must be positive for the sample to be assigned as positive This allows the user to show samples positive with only 1 out of 4 controls positive 2 out of 4 controls positive 3 out of 4 controls positive or all 4 controls positive 7he default setting is 2 FOR RESEARCH USE ONLY 5 9 LC1115RUO 3 2 15 If the parameters are changed the user must save the change prior to manual tail analysis To save the changes Click Save If AutoTail is checked then the tail is automatically calculated Note If Eplets are assigned and reactivity adjustment changes are made using Assign Adjust or Assign Cut off the Eplet assignment will clear To assign eplets using the new cut offs click Eplet Analysis By MFI Cutoff Beads can be assigned as positive or negative by manually assigning an MFI cutoff There are three ways to assign an MFI cut
12. 3 LC1115RUO 3 2 15 eWithin the Batch List completed samples will be highlighted with bold text completed and approved samples will be bold and italicized ja areas i Faan de ETES L 7 a L Korn 57926 206 Donor 60139 L 1767 Donor 60131 eThe upper arrows can also be used to move from sample to sample Overall Antibody Assignments Automatic Assignments The software will automatically assign antibody specificities for antigens that are 100 positive The automatic assignments will appear in the Sin gle Antigen Results window Calculations and Displayed Values Calculations for LSA To determine the adjusted value for a bead first subtract the Background MFI from the RAW MFI to generate the BCM Background Corrected MFI Value for each individual bead The Background MFI is the background noise due to bead variation and can be found on the lot specific Recording Sheet provided with the kit Divide the BCM by the MFI of the Calculated Control CalcCON of its respective locus to generate the BCR Background Corrected Ratio The CalcCON for each locus is the Raw MFI value of the lowest ranked antigen bead for that locus BCM CalcCON MFI for locus 1 BCR for antigen x from locus 1 BCM CalcCON MFI for locus 2 BCR for antigen y from locus 2 BCM CalcCON MFI for locus 3 BCR for antigen z from locus 3 FOR RESEARCH USE ONLY 6 4 LC1115RUO 3 2 15 To generate the AD
13. A message box will appear to confirm the override This wall calculate the statistics for this sample as he consensus besd s did not fail This can nat beundene r impoering batch 12 the only resolution Do you wish to continue Sample Information Patient Name 1495 Donor 49588 HLAType Lotto 032036 02283A SA1 E FOR RESEARCH USE ONLY 6 16 LC1115RUO 3 2 15 elf a sample fails to meet the minimum bead count for a particular result the bead will be flagged as FAZLED To override the failure dou ble click the message and select the failed beads to include in the analy Note If a sample has both CON failures AND bead failures the CON fail ure must be overidden before the failed beads can be included Approving the Results of the Analysis Saving Results When Save is clicked the analysis for the sample is saved but can be ana lyzed again When Restore is clicked the sample will revert to the most recently saved data assignments Once analysis is complete and no additional changes need to be made for a particular sample click Completed Only a 7echnican or Lab Supervisor may make changes to a sample by clicking Completed again Once all samples in a batch have been completed the batch will be listed as Com pleted on the home page and signify they are ready for sign off Sample Information Patent Nimes 1286 nor GOL31 Hype Lott OSCR andae satan Sve ese
14. Analysis EN 3000703 DOCOPOZAMO 06 24 2013 11 13 2003 OPIO 30007033000 MAMO Pending Anses MI 2000703 3000 POZA MD_ 06 24 2013 11 23 2003 5 3000703 IMIM SOOT ZOO ADAMO Pending Ansty 2 Double click the batch name found on the Antibody Home tab under DSA 3 The batch results are displayed in a tab above the sample navigation ribbon All sample results appear in the middle section of the tab Individ ual sample IDs within the selected panel are listed in the left section of the tab under the batch name Arabe 2000703 30007024MD_1150_ CE 2000703 2000702450 LEO Assign Cutoff Ruan Date 05 2420153 Assign Adjust 0 0 Lot Hamber S00 703 Soa ees Expiration Date L 15 2004 Class 1 Burs 120 30 CON LSS Be PONE CERN 329531 Ce ee 665 7500 OON 1 0 2530 DO ae Oe OL HIS D SO CONS AL 2370 Comments Well Position 1 ET Date Range Selection Rather than selecting an individual batch a range of dates can be selected which will result in all batches run in that range being selected 1 Right click the antibody symbol as shown below FOR RESEARCH USE ONLY 7 2 LC1115RUO 3 2 15 2 A pair of calendars with a start and end date will open Select the desired range and click OK Sekce Date nor E a Near ES 5 M TVYWITEFES ES 56 0 213 5 a4 ae I Lo coma 3 The batch results are displayed in a tab above the sample navigation ribbon All sample result
15. BCR Antigen Density Background Corrected Ratio normalize BCR by dividing this number by the relative amount of antigen on each bead as found in the lot specific Recording Sheet Refer to the lot specific Recording Sheet provided with the kit for the list of the antigens present on each bead and the suggested cutoff for estimating the positive negative result The bead is considered positive if two or more of the adjusted values are above the cutoff values Higher or lower sensitivities can be obtained by adjusting the cutoff Note For LSA MIC there is only one CalcCON which ts defined as the Raw MFI value of the lowest ranked antigen bead Calculations for C3d The Negative Control Sample VC Raw MFI serves as the Background MFI for C3d calculations To determine the adjusted value for a bead subtract the Negative Control sample MFI from the RAW MFI to generate the BG Adjusted Background Adjusted MFI Value for each individual bead Individual Bead MFI MFI of NC bead BG Adjusted Divide the BG Adjusted by the MFI of the Calculated Control CalcCON of its respective locus to generate the BCR Background Corrected Ratio The CalcCON for each locus is the Raw MFI value of the lowest ranked antigen bead for that locus BG Adjusted CalcCON MFI for locus 1 BCR for antigen x from locus 1 BG Adjusted CalcCON MFI for locus 2 BCR for antigen y from locus 2 BG Adjusted CalcCON MFI for locus 3 BCR for antigen
16. Class I or Class II bead the Class I or Class IT result respectively will be reported as bead failure To override the failure review the bead count and then choose the appropriate assignment from the drop down menu Bead Failure Y Positive dl Pos Ctrl Lys Ctrl a 320 l d 17354 4546 LE f 56 114 4535 94 f 117 4230 64 13794 43 F elf a CON bead fails to meet the minimum bead count the software will report bead failure for both Class I and Class II Positive or Negative Control Failure eA Negative Control is considered as failed if any bead fails to meet the minimum bead count or if the Negative Control has a positive assign ment for Class I or Class II eA Positive Control is considered as failed if any bead fails to meet the minimum bead count or if either of the Class I or Class II assignment is negative The source of the failure is listed in the DSA Header Overriding an Assignment While the software performs analysis according to the product insert all results should be reviewed During this review process an assignment can FOR RESEARCH USE ONLY 7 5 LC1115RUO 3 2 15 be changed manually by clicking the arrow on the right side of the text box and selecting one of the choices that appears Bead Counts T 3 CT 525 17354 4546 22 E 114 TESTZ 4535 54 E TESTS 4230 64 Positive Le Overriding Default Parameters The default parameters Assign Adjust and Assign Cuto
17. Date Range Selection Rather than selecting an individual batch a range of dates can be selected which will result in all batches run in that range being selected FOR RESEARCH USE ONLY 4 2 LC1115RUO 3 2 15 1 Right click the antibody symbol as shown below LifeScreen J sano Cit ll 2 A pair of calendars with a start and end date will open Select the desired range and click OK 3 The batch results are displayed in an L feScreen Analysis tab All sample results for the highlighted batch appear in the middle section of the tab Individual sample IDs within the selected panel are listed in the left sec tion of the tab under the batch name Antibody LMX Analysis l Sample Navigation lt gt Batches nia Ll LMX Analysis o y Batch Name 100713 LMX SI2 Assign Cutoff iil EN Run Date 07 13 2010 Assign Adjust 0 0 Lot Number 041310 LMX Supplemental Assign Cutoff 22 a 100713 LMX SI2 Expiration Date 12 13 2010 Supplemental Assign Adjust 0 0 DM 6645 8134 Reviewed By MN 16 672 013 7 CON Ranges s me 55730226 CON1 24 308 CON2 27 841 CON 3 24 2527 Save Assignments Complete Approve 6 605 839 7 i PA a 5 702 356 6 Sample 6 645 813 4 Well Position 1 T Locked vBAF Bead Counts gt le 674 9011 Patient 6 645 813 4 Ne EE pm 3 eee Donne Class I Assignment Negat
18. HTML File I a MO lt lt co FR MIHT File LIFECODES Technical Support RTE File 550 West Avenue a Sismtord Connecticut 06851 ASL XLSX File CSV File PC iPatient Name 1708 Donor 60131 Text File Image File LC1115RUO 3 2 15 Exporting Summary Results Many Laboratory Information Systems require simple export files that list only the samples and results This file can be generated directly from the Exporttab See Export Results Reporting Export FOR RESEARCH USE ONLY 6 21 LC1115RUO 3 2 15 CHAPTER 7 DSA ANALYSIS This chapter contains information on the tools available to analyze LIFE CODES Donor Specific Antigen results DSA Importing DSA Results into MATCH IT If an Automated Batch was not created and data needs to be manually imported into the software the appropriate EDS file must first be imported fol lowed by the csv file Importing EDS files Before importing DSA data the information Lot Information Import necessary for analyzing the data generated by the Luminex instrument must be imported The information is provided in lot specific EDS files 1 Click Lot Information Import found on the Home tab of MATCH IT The Open dialog box will appear 2 Navigate to the location e g desktop of the EDS file s Select all appropriate files that need to be imported Use Ctrl left mouse button to select more than one EDS file at one time 3 Click Open A message will appear
19. I amp II ID kits also employ a fourth negative control calculation CalcCON based on performance of the non reacting antigen containing beads Individual Bead MFI CalcCON BAF Adjusted Ratio 4 FOR RESEARCH USE ONLY 5 8 LC1115RUO 3 2 15 CalcCON MFI lowest ranked antigen bead 20 eBy default a positive value for two or more of the four calculations indi cates a positive bead reaction This setting can be changed by the user See Preferences For LIFECODES Class I ID The percent PRA Panel Reactive Antibodies is calculated by PRA of pos bead reactions of beads in the assay x 100 of beads in the assay does not include control beads For LIFECODES Class II IDv2 PRA of pos reacting DR containing beads of neg reacting DR containing beads that also contain an assigned DQ antigen that is 100 pos in the enriched beads Total of DR containing beads X 100 of beads in the assay does not include control beads Making a Positive or Negative Assignment A bead is assigned as positive or negative based on user defined analysis parameters or by manual MFI cutoffs By Standard Mode If preferences have not already been set for these parameters or an over ride is necessary for a particular sample they can be changed in the Reac tivity Adjustments tab See Preferences sms lt room 27 Carole rra con SO Hey PA _ us dE Me D
20. Number 888627R Computer Requirements eMicrosoft Windows XP SP3 Vista or Win 7 32 64 bit version operating systems ePentium 4 or Core 2 Duo e10 GB hard disk space e4 GB RAM e24 bit graphics adapter and display eXGA display with 1024 x 768 eMouse or other windows compatible pointing device Software Requirements eMicrosoft SQL Express 2008 Included with software eMicrosoft NET Framework Version 3 5 Included with software e Optional Microsoft SQL Server 2008 or 2012 for increased storage capacity Luminex Requirements eThe LIFECODES MATCH IT Antibody Software is designed to import csv files created by the Luminex 2 3 and xPONENT software versions eThe data present in the csv file must be generated using an unmodified Luminex template provided by LIFECODES FOR RESEARCH USE ONLY 1 1 LC1115RUO 3 2 15 Networking Networking Client Computers to a SQL Server For Standard or Enterprise editions 1 From the Start Menu Open the MATCH IT database management utility drop down Choose the application and log in required for this utility 2 Click Choose Server 3 Click Available SQL Instances dropdown to display known SQL instances 4 Choose the SQL instance that contains the database 5 Once the connection is established a list of available databases will be displayed Choose the database and click Ok to connect 6 Open Matchit Software Troubleshooting If the SQL instance does not
21. Show All Batches A pending batch may be deleted by clicking Delete Note Deleting completed batches from the Batch Status will prevent them from appearing in the home screen Only Pending batches that will not be run should be deleted from this window 4 Upon completion of a Batch acquisition in Luminex the batch will be automatically imported into Matchit It is neccessary to refresh the home screen to view newly imported automated batches FOR RESEARCH USE ONLY 37 LC1115RUO 3 2 15 CHAPTER 4 LIFESCREEN DELUXE ANALYSIS This chapter contains information on the tools available to analyze LifeScreen Deluxe results LifeScreen Importing LifeScreen Results into MATCH IT If an Automated Batch was not created and data needs to be manually imported into the software the appropriate EDS file must first be imported fol lowed by the csv file Importing EDS files Before importing LifeScreen data the informa Lot Information Import tion necessary for analyzing the data generated by the Luminex instrument must be imported The information is provided in lot specific EDS files 1 Click Lot Information Import found on the Home tab of MATCH IT The Open dialog box will appear 2 Navigate to the location e g desktop of the EDS file s Select all appropriate files that need to be imported Use Ctrl left mouse button to select more than one EDS file at one time 3 Click Open A message when all lots have successful
22. a Database 8 3 FOR RESEARCH USE ONLY TOC 8 LC1115RUO 3 2 15 Chapter 9 Sample View Sample Search 9 1 By Sample ID Name 9 1 By Run Date 9 1 Advanced Sample Search 9 1 Merge Sample IDs Sample Names 9 2 Viewing Antibody Batch Results 9 3 Patient Information 9 3 Manually Entering Patient Data 9 4 Entering HLA Type 9 4 Displaying Batches 9 4 Graphing Antigens across Several Batches 9 6 Creating Paired Data Sets and Graphing LSA IgG and C3d 9 8 Graphing LSA IgG C3d paired data 9 10 Generating LSA IgG C3d Reports 9 11 Appendix A Error Conditions Patient as defined in this manual is synonymous with subject sample as in the person or thing that is being discussed or described FOR RESEARCH USE ONLY TOC 9 LC1115RUO 3 2 15 CHAPTER 1 INTRODUCTION Welcome to LIFECODES MATCH IT Antibody Software LIFECODES MATCH IT Antibody Software is an accessory for the evaluation of test results from LIFECODE s antibody products The LIFECODES MATCH IT Antibody Software is an aid to assist qualified laboratory personnel by suggesting the presence or absence of HLA antibodies Due to the complex nature of HLA Testing qualified laboratory personnel must review any result to assure correctness The software is a laboratory aid and not meant to be the sole source of a definitive result System Requirements The following is required to successfully install and use LIFECODES MATCH IT Antibody Software version 1 2 1 Part
23. a bead the individual bead MFI is divided by the MFI for each Negative Control Bead CON1 CON2 CONS From these quotients the Background Adjustment Factor BAF for the appropriate bead CON combination is subtracted The BAF is a pre deter mined MFI ratio for each bead CON combination to compensate for back ground noise due to bead variation See the lot specific Recording Sheet provided with the kit for BAF values Individual Bead MFI CON1 MFI BAF Adjusted Ratio 1 Individual Bead MFI CON2 MFI BAF Adjusted Ratio 2 Individual Bead MFI CON3 MFI BAF Adjusted Ratio 3 For I 01 and II 01 a positive value for any one of the calculations indi cates a positive bead reaction eFor all remaining beads a positive value for any two of the calculations indicates a positive bead reaction eA negative value for all three calculations indicates a negative bead reaction eThe Score shown in the Results Table is the number of above calcula tions that exceed the Assign Adjust value By default the Assign Adjust values are set to zero See Preferences Class Assignment eA sample is considered to be positive for class I HLA specific antibodies if at least one of the seven 7 class I HLA beads is positive eA sample is considered to be positive for class II HLA specific antibod ies if at least one of the five 5 class II HLA beads is positive eA sample is considered to be negative for HLA specific IgG anti
24. assay Each assay specific tab includes analysis settings The software is installed with default values for analysis The default settings should only be altered by personnel knowledgeable in the field of HLA Antibody Analy sis Changing these values will result in altered specificity and sensitivity of the assay The values may be changed using the up and down arrows next to the value or by manually entering the value of choice Once the FOR RESEARCH USE ONLY 2 1 LC1115RUO 3 2 15 values have been entered they can be saved by clicking Save Settings If at any time default settings need to be restored click Restore Defaults iS Preferentes Leb Information Antibody Date Format Setting Page Layouts Report Settings Lab Mame Lab Address SaveSettngs The specific functions of these settings are as follows Antibody Parameters a The Assign Cutoff L feScreen Deluxe ID LSA C3d and DSA is a score of 1 to 4 for ID and DSA or a score of 1 to 3 for Screen LSA and C3d It indicates the number of calculations against different controls that must be positive for the sample to be assigned as positive This allows the user to show samples are positive with only 1 control 2 controls 3 controls or all 4 controls 7he default setting is 2 for Screen supplemental beads ID LSA C3d and DSA The default setting is 1 for Screen pooled bead Changing this number will allow the u
25. be stored at C ProgramData Lifecodes Backup If the software is running on Windows XP Backup files should be stored at C Documents and Settings All Users Application Data Lifecodes Backup FOR RESEARCH USE ONLY 8 2 LC1115RUO 3 2 15 This feature is only available on the PC housing the database Choosing a Server In order to connect to a SQL database on another computer select Choose Server From here the SQL Instance and database can be selected If the SQL instance does not appear in the drop down it can be entered manually Connecting to a Database To choose the database to be used first highlight the database and then select Connect FOR RESEARCH USE ONLY 8 3 LC1115RUO 3 2 15 CHAPTER 9 SAMPLE VIEW This chapter contains information regarding view AE Rr ing data for a particular sample All batches can a ne be displayed graphically compared from one batch to another and antibody history viewed Sample Search By Sample ID Name Type the sample ID or sample name into the search box and click the mag nifying glass As the ID is typed into the box the auto complete feature will activate All batches containing that sample ID will display Click the batch for it to appear in Antibody Batch Results aa rose D 3 Pos Con tot 3000953 7 Eh Pat Con Les 3000677 EY Pos Con Let 2000753 53 Pos 20130911 By Run Date Click the
26. bead the MFI value of each capture bead is compared to three cutoff values background adjustment factors BAFs The three cutoff values are calculated from the background measured on the three CON beads in each test well Each CON bead has an equation for calculating the cutoff value for the Class 1 HLA capture bead and a separate equation for calculating the cutoff value for the Class II HLA capture bead The two equations for each CON bead are lot specific and can be found on the Recording Sheet The cutoff value calculated for a CON bead is subtracted from the MFI value of the capture bead The pro cess is repeated for each of the remaining two CON beads to obtain three results Adjusted MFI Values Example Class HLA BAF for CON1 49 465 C0N1 9372 Class HLA BAF for CON2 34 622 CON2 67 Class HLA BAF for CON3 29 615 CON3 0 65 2 FOR RESEARCH USE ONLY 7 4 LC1115RUO 3 2 15 Example Class HLA Capture Bead MFI BAF for CON1 Adjusted MFI 1 Class HLA Capture Bead MFI BAF for CON2 Adjusted MFI 2 Class HLA Capture Bead MFI BAF for CON3 Adjusted MFI 3 Class Assignment eA sample is considered positive for donor specific antibodies if two or more adjusted MFI values are positive eA sample is considered negative for donor specific antibodies if two or more adjusted MFI values are negative See Preferences Batch Failures Bead Count Failure elf a sample fails to meet the minimum bead count for a
27. calendar and choose a range of dates or specific date All sam ples from batches run within the range or date will display Click the batch for it to appear in Antibody Batch Results i Select Date Range November gt s 013 gt SM TW T F S i 5 6 7 amp 9 10 11 12 13 iiA 16 17 18 19 ai 21 2 23 210222330 Advanced Sample Search Selecting the Advanced Sample Search button will allow the user to search for samples by multiple identifiers FOR RESEARCH USE ONLY 9 1 LC1115RUO 3 2 15 To Use this feature first select the Advanced Search button from the Advanced Search Window Then click the first drop down to search by Assignment Patient Name Donor Center Donor Number or HLA Type Select the appropriate qualifier Equals Starts With Contains from the second drop down Enter the specific search term in the window Up to three fields can be included in a single search c Advanced Search Pomme g psw po Field to search ee Sorters ad 9 A A SS Once all desired fields have been chosen click Search All Samples that fulfill the search requirements will be listed on the left under Patient List Merge Sample IDs Sample Names 1 To merge sample IDs or sample names first find the sample ID or sam ple name by searching by date 2 Highlight the first ID Hold the Ctrl key as the other IDs are selected FOR RESEARCH USE ONLY 9 2 LC1115RUO 3 2 15 Once
28. can be included Tools for Making an Assignment Groupings The Groups drop down box is a list of user defined HLA Groups By selecting a particular group the antigens present within the particular FOR RESEARCH USE ONLY 5 11 LC1115RUO 3 2 15 group will be highlighted in the bead ranking See Antibody Reactivity Groups Color Coded Antigen s The user can color code antigens or groups of antigens to provide easier viewing This feature is intended as a visual aid The xm file provided on the Immucor website contains color coded antigens but they may be changed Eplet Analysis Added Epitope Analysis can be run at a sample level If epitopes are not calculated upon import click the Eplet Analysis button to assign available epitopes Eplets will be calculated based on Positive beads Eplets are not calculated on assigned antigens Note Eplet Analysis feature will not work if Use Serology is checked in Preferences If the user un checks Serology in Preferences after a batch has imported the batch must be closed and then re opened for those changes to take effect y aapsnen IEEE MFI Cutoff 3000 ia ata Cutoff Pi Use MFI Cutoff Cal Con 387 CONE 16 1561 l Positive Con 16689 CON2 36 450 PRA sel CONS 31 1725 IT e CON 1 36 COM 125 fustments Cut Tail Analysis Note Tail Analysis is by default a s
29. de garant as impl citas o de restricci n de responsabilidad civil por da os y perjuicios incidentales o consecuentes de tal manera que la exclusi n o limitaci n de m s arriba quiz no le sea a usted pertinente Sin embargo en las jurisdicciones competentes Immucor Transplant Diagnostics Inc hace valer sus l mites de responsabilidad con arreglo a las estipulaciones de este Convenio hasta el alcance legal permisible 6 DERECHOS RESTRINGIDOS DEL GOBIERNO DE LOS EE UU El Software y o la documentaci n del usuario se proporcionan con DERECHOS RESTRINGIDOS Y LIMITADOS El uso reproducci n o divulgaci n por parte del Gobierno de los EE UU se sujeta a restricciones como se consagra en la FAR 53 027 14 Junio de 1987 Alterna con f g 3 Junio de 1987 FAR 53 027 19 Junio de 1987 o DFARS 53 027 7013 c ii Junio de 1988 seg n proceda La contratista fabricante es Immucor Transplant Diagnostics Inc 550 West Ave Stamford CT 06902 EE UU En caso que el Gobierno procure obtener el Software de acuerdo con pr cticas comerciales ordinarias este Convenio para Uso de Software en lugar de las cl usulas reglamentarias anotadas arriba normar las condiciones de la licencia del Gobierno 7 CONDICI N GENERAL Ning n intermediario distribuidor agente o empleado de Immucor Transplant Diagnostics Inc est autorizado para hacer modificaci n o adici n alguna a este Convenio Para efectos del uso del Software en Am rica
30. indicates the number of calculations i e BCM BCR and AD BCR or BG Adjusted BCR and R Strength that must be positive for the sample to be assigned as positive This allows the user to show samples positive with only 1 out of 3 adjustment values positive 2 out of 3 adjustment values posi tive or 3 out of 3 adjustments values 7he default setting is 2 By MFI Cutoff LSA and C3d Beads can be assigned as positive or negative by assigning an MFI cutoff There are three ways to assign an MFI cutoff PEN Groupings History PrintReperts ar Paes so d lLomestal E CON 1 Positive Con 16956 Ea w konesta 232 CONZ 1 LonestC 37 CONS s17 Cutoffs Control Values A e 5 1 Under the Reactivity and DA tab click the box next to Use MFI Cutoff 2 The MFI Cutoff value box is now available Select the value box The up and down arrows can be clicked to the desired value or the up and down arrow keys may be used A value can also be typed directly into the white box Once the value is entered click the graph to view the new cutoff FOR RESEARCH USE ONLY 6 6 LC1115RUO 3 2 15 3 An alternative to step 2 is to right click anywhere on the graph and choose Graph Edit The Cut Off bar will then be visible and can be moved to the desired value Once the cut off has been set click Save 4 To apply an MFI cut off to all samples for Class I or Class IT a user may select MFI mode in the LSA or C3d tab of Pre
31. of the Software will void this limited warranty EXCEPT AS SPECIFICALLY PROVIDED HEREIN Immucor TRANSPLANT DIAGNOSTICS INC MAKES NO WARRANTY REPRESENTATION PROMISE OR GUARANTEE EITHER EXPRESS OR IMPLIED STATUTORY OR OTHERWISE WITH RESPECT TO THE SOFTWARE USER DOCUMENTATION OR RELATED TECHNICAL SUPPORT INCLUDING THEIR QUALITY PERFORMANCE MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE 5 LIMITATION OF LIABILITY Because software is inherently complex and may not be completely free of errors it is your responsibility to verify your work and to make backup copies IN NO EVENT WILL Immucor TRANSPLANT DIAGNOSTICS INC OR ANY OF ITS LICENSORS BE LIABLE FOR INDIRECT SPECIAL INCIDENTAL TORT ECONOMIC COVER OR CONSEQUIENTIAL DAMAGES ARISING OUT OF THE USE OF OR INABILITY TO USE IMMUCOR TRANSPLANT DIAGNOSTICS INC OR ANY OF ITS LICENSORS PRODUCTS OR SERVICES INCLUDING WITHOUT LIMITATION DAMAGES OR COSTS RELATING TO THE LOSS OF PROFITS BUSINESS GOODWILL DATA OR COMPUTER PROGRAMS EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES IN NO CASE SHALL IMMUCOR TRANSPLANT DIAGNOSTICS INC OR ANY OF ITS LICENSORS LIABILITY EXCEED THE AMOUNT PAID BY YOU FOR THE SOFTWARE OUT OF WHICH SUCH CLAIM AROSE This limitation on monetary damages will not apply to claims relating to death or personal injury which arises out of products deemed to be consumer goods under applicable law Some states provinces and other jurisdictions do not allow
32. or 3 the lot number not being indicated on the CSV file 4 CSV Import Lot Import Ce jis Template Mame 542091910 Lotinotin database Please select bot from st Opening a Batch Direct Selection 1 Click the arrow to first expand the Single Antigen section Af Single Antigen Batcn ID n Un Date 1 J0rt Date Number UT Samer LOT Mu er Tr x me y status e m 2014 11 03MC LSA1 1 IgG ESTERO E 01 21 2015 24 042348 TSTMAM SA1 042348 TSTMAM SA1 v Pending Analysis 2014 11 04MC LSA1 11 04 2014 01 21 2015 24 04234BTSTC3d SAL 04234BTSTC3d SA1 Pending Analysis CheckOut C3d SA1 C3d 09 05 2014 01 21 2015 Ooo 04234B TSTC3d SA1 03203F 02283A C3dS Pending Analysis Checkout LSA 1v2 08 21 2014 01 21 2015 2 1 03203F 02283A SA1 03203F 02283A SA1 Pending Analysis 2 Double click the batch name found on the Antibody Home tab under Single Antigen Note C3d batches will display in Bold type on the home screen 3 The batch name will display on a tab above the Sample Navigation rib bon All sample results appear in the middle section of the tab Individual sample IDs within the selected panel are listed in the left section of the tab under the batch name a Komesar os y Sample Navigation PEN PT235655 AAA ample Information TEE AE atient Name PT 233636 HLAType LotiD 042348 TSTMAM SA1 RunDate 11 03 2014 Save Restore Complete Approve Reactivity Adjustments o MFI Cutoff C
33. password lifecodes 1 Type a User Name First Name and Last Name LS gg xi Lser Marre First Marre Last Marre Ro 2 Choose the role Lab Supervisor Technician or User A User Users can only create other users A User does not have the abil ity to save complete or approve samples and is only in a read only mode A Technician Technicians can create other users and other 7echnicians A Technician is able to make changes add comments save and complete samples A Lab Supervisor Lab Supervisors can create all levels previously described plus other supervisors A Lab Supervisor is able to perform all the roles of a 7echnician in addition to the ability to Approve samples and run Audit Reports 3 Click Add 4 Close the software To login or reset password 1 Open the software Type in the user name created in the steps above The default password is lifecodes 2 Go to the User x tab and type the old password and then a any new password 3 Click Change Password 4 Clicking Reset Password will set password to lifecodes Available Assays This menu item allows the user to choose what to display on the Antibody home tab For example if the user does not wish to display L feScreen data uncheck the L feScreen choice found under Antibody FOR RESEARCH USE ONLY a LC1115RUO 3 2 15 Exports Reports The Exports Reports Menu item allows the Export Design Wizard user to export results and create reports E
34. the exclusion or limitation of implied warranties or limitation of liability for incidental or consequential damages so the above exclusion or limitation may not apply to you However in appropriate jurisdictions Immucor Transplant Diagnostics Inc limits its liability according to the terms of this Agreement to the extent permissible at law Nothing in this Agreement operates to exclude restrict or modify the application of any of the provisions of the Trade Practices Act 1974 Cth or any equivalent state or territory legislation the exercise of a right conferred by such a provision or any liability of Immucor Transplant Diagnostics Inc for a breach of a condition or warranty including but not limited to a condition or warranty in relation to goods or services of a kind ordinarily acquired for personal domestic or household use or consumption implied by such a provision 6 U S GOVERNMENT RESTRICTED RIGHTS The Software and or user documentation are provided with RESTRICTED AND LIMITED RIGHTS Use duplication or disclosure by the Government is subject to restrictions as set forth in FAR 53 027 14 June 1987 Alternate III g 3 June 1987 FAR 53 027 19 June 1987 or DFARS 53 027 7013 c 1 ii June 1988 as applicable Contractor Manufacturer is Immucor Transplant Diagnostics Inc 550 West Ave Stamford CT 06902 In the event the Government seeks to obtain the Software pursuant to standard FOR RESEARCH USE ONLY SA 2 LC1115
35. the positive and negative assignments for beads based on the settings for Assign Cutoff and Assign Adjust See Preferences eThe MFI Cutoff displays a graph with positive and negative assign ments for beads based on the MFI value the user sets as the cutoff 77a 10 15000 12000 E sooo aoe ds to wt a ee ee ee ee ee A DEAR RTT SE zF ERP 5 HB TE ATRAEN NES INIA ITENEN HEHH SHERT Eee ee eR dpi EEL Ga HENRI HHIH E F Mati 5z2 EX EE FMH AGG Gad pii de 5 Saeed i ii i ada Cada O Tesi ee Control Graph A graph of Raw MFI vs Controls Positive control and 3 negative CONS is displayed next to the Antigen Graph only when Raw MFI vs Bead Anti gens is chosen as the main graph ID Graph Main Graph Secondary Grapt BAO EC 1601 Cm 1001 D 63002 83501850011 Em ECO D 150785001 ENS ona cos il ISI BONE El pam EME COIN NCA fil NBA Br caca i 3 A 3100 AZ ED NBA Ca Y Abra Bram cvien ll AO BOTANA BSAS Br rca cra i 1554401181501 8611312 40201425011 809011 8 220 51 Bl Br 51001021004 7 4 3001V4800148 1901187901 Em 6 Cm 0202 1601 1 7901 aessa BOMBO caco i 4 4 3101433001 8550 030470 RODIN BATON Brico cien 1304110108400 850011861 wo102crazos 157 A 24025201 85901 BAIN BA BCO fl A 2801 SON BANA BARON BOLA cas 139 4 3601 6501 BAZON BSAA Bra Ber COSLA Cw 1701 20 50 A250 10 10 3 A ANAA BO ES bacacar ll ARAN BAIN BAUME MEME CATON Cw fll A PA
36. when all lots have been successfully imported Manually Importing CSV Files 1 Click Batch Import from the homepage This will open the Open dialog box 2 Navigate to the location of the CSV file s If importing from the computer connected to the Luminex CSV files can be found in C My Batches Outputon IS 2 3 sys tems and at C ProgramData Luminex xPONENT31 Output on xPONENT systems t 1 Batch Import 3 Select all CSV files to be imported Use Ctrl left mouse button to select more than one CSV file at one time 4 When the file is selected the analysis is done automatically during the import process Once the csv file has been imported it will appear on the Antibody Home tab under DSA Note A CSV Import Lot Import may appear after selecting a csv file This can be due to 1 the appropriate EDS file not being imported 2 the FOR RESEARCH USE ONLY 7 1 LC1115RUO 3 2 15 EDS file not being available See Lot Availability or 3 the lot number not being indicated on the CSV file 4 CS Import Lot Import E Sesson Name LSAZ Colombia 201202727 Template Mame 542091910 Lotinotin database Please select bot from list Opening a Batch Direct Selection 1 Click the arrow to first expand the DSA section T Donor Speafic Antibody Batch ED Run Bate O ImprtDate OO Nomba Of Samples Product sme Fl 201309130542 0812013 LIRA 6 3000703 200070240 3000703 2000702 UMD Pending
37. z from locus 3 To calculate the relative strength R Strength of an antigen divide the BG Adjusted values of the individual bead by the corresponding MFI value of the bead in the LSA Negative Control NC serum R Strength BG Adjusted MFI of Antigen Raw Value MFI of Antigen in NC Higher or lower sensitivities can be obtained by adjusting the cutoff Making a Positive or Negative Assignment A bead is assigned as positive or negative based on user defined analysis parameters or by MFI cutoffs Weak assignments are made based on pre set values that are lot specific FOR RESEARCH USE ONLY 6 5 LC1115RUO 3 2 15 By Standard Mode LSA and C3d If preferences have not already been set for these parameters or an over ride is necessary for a particular sample they can be changed in the Reac tivity Adjustments tab See Preferences 0 Lowest 968 Con o F 16956 286 Lowest 2 1610 se a eAdjustment Values for LSA and C3d BCM BCR and AD BCR or BG Adjusted BCR and R Strength set the positive threshold for BCM BCR and AD BCR LSA or BG Adjusted BCR and R Strength C3d Once the value box is selected the up and down arrows can be clicked to the desired value or a value can also be typed directly into the white box 7he default settings are lot specitic and part of the EDS file used for analysis eAssign Cutoff LSA and C3d is a score of 1 to 3 It
38. 1 Open SQL Server Configuration Manager 2 Click SQL Server Services 3 Check that the SQL Server Browser is stopped If it is not then right click the service and choose stop Checking TCP IP state 1 Open SQL Server Configuration Manager 2 Click SQL Server Network Configuration 3 Click the correct protocol This will be the name of the instance that holds the database 4 Verify the status of TCP IP It should be enabled If it is not then right click TCP IP and choose Enable If the SQL instance does not appear in the dropdown then there are two options 1 Type in the name of the SQL instance if the instance is valid and Match IT can connect to it then the databases it holds will be listed 2 Click Refresh Server List to scan the network for Match IT instances If the SQL instance appears but Match IT can not connect to it 1 Check to see if a port for the instance has been specified 2 Open SQL Server Configuration Manager 3 Click SQL Server Network Configuration 4 Click the correct protocol This will be the name of the instance that holds the database FOR RESEARCH USE ONLY 1 3 LC1115RUO 3 2 15 5 Double click TCP IP 6 Choose the IP Addresses tab 7 Scroll to the bottom to find IPAII 8 Check the TCP Port field If a port has been specified then add the port number to the SQL instance in the dropdown Example lt Computer name gt lt port number gt MatchITserver 1500 Note Imag
39. 10710 LMX Deluxe 010710 LMX Pending Analysis Y 1 Click the arrow to first expand the L feScreen section nn A D t i A 9 3 DET samo so O o o wean eed O mx iiilenin 12 11 28 n2 11 2n1n 71m925N8R I MY NFI IIYF NAPSNAR I MY Pendinn dnalveic 2 Double click the batch name found on the Antibody Home tab under LifeScreen 3 The batch results are displayed in an LMXAnalysis tab All sample results appear in the middle section of the tab Individual sample IDs within the selected panel are listed in the left section of the tab under the batch name EN Batch tare Lon ROOTS Asap Cutedt 1 3 Quad Fast antes LE Assen diz ao d Lettre SOS TS Degen Epee Assen tal D 2 ARS Exgearem Date CHLIS BHA Suppor Asset Aficio D 5 po Bl Revcacd Ep dl Hap Don Lol 000759 CO Ranges eget es ESPERE SERES Save sasigments complete Apee i ag tow 49933 J y naa Sampe Py Combes HOTTE Well Posten 3 O id Best Counts m g E A N A Pos Contes 3000715 a 3779 Peras 54599 Draw Dale Class LAsignneentt Postre Ej Class Il Assignment Poste a ON pel 1836 Derer 59537 ia LA ener s i oF A COS Pos cercon l Donor 57575 CODEN Ee E LE EEES A ES emit MRR A A o fark En 75 asa 875 Ee 102 10 61 727 1147 zor is l ATOA oc AIR TA AT TN D ET AE le nee EE A menti aor sal Unes sara liz rar ASIN EU EMS E TIA FR
40. 54 Cancel OK EDS file already exists in database Existing Lot The lot referenced in the file 3001302 30015302 3001288 LMX eds already exists Qverwrite ns mn FOR RESEARCH USE ONLY Appendix A 5 LC1115RUO 3 2 15 EDS file s imported successfully No paired C3d sam ples found within specified dat range C3d Batch Export Warning Mo C3d Batches containing Paired Results were found within the A specified date range Please try again bag EP i a aa ES LV ban pee E Spe Se TAs a Jon de CIO cl 1 1 cl z r r a 16124 21418 365 Bead Failure 66 15598 20704 373 MN so INE SEO EA Bead Fa ure 6305 FOR RESEARCH USE ONLY Appendix A 6 LC1115RUO 3 2 15 SOFTWARE AGREEMENT IF YOU DO NOT AGREE WITH THESE TERMS AND CONDITIONS DO NOT INSTALL THE SOFTWARE AND RETURN THIS ENTIRE PACKAGE WITHIN 30 DAYS OF SALE WITH YOUR RECEIPT FOR A FULL REFUND 1 USE You an entity a Site An Institution or a person may use Immucor Transplant Diagnostics Inc MATCH IT Antibody Analysis Software the Software either on a standalone computer or a network in the quantity purchased if you meet the following conditions In addition you may make one 1 archival copy of the Software STANDALONE COMPUTER USE You must acquire one copy of the Software for each Site or Institution on which the Software will be installed You may use the applications on more than one computer at a time provided these multi
41. 58 3 5 54 449 4 76 4 7 38 3 05 3 48 2 2 98 2 43 2 42 FOR RESEARCH USE ONLY 4 3 LC1115RUO 3 2 15 Changing the Sort Order The samples within a batch are loaded in order of their location in the batch By selecting the sort tab located in the upper right the results can be ordered by Sample ID Well Location default CON1 CON2 CON3 or Pos Ctrl Bead 1 Name 100713 LMX SI2 Assign Cutoff 1 1 Options Reports Sort Date 07 13 2010 Assign Adjust 0 0 lumber 041310 LMX Supplemental Assign Cutoff 2 2 A Well Location 3 ation Date 12 13 2010 Supplemental Assign Adjust 0 0 _ gt awed By Sample ID ON Ranges FETES CON 1 24 308 CON 2 27 841 CON 3 24 2527 Save Assignments Complete Approve TRS Pos Ctrl CON1 al CON2 mple 5 702 356 6 Well Position 5 T Locked vBAF Bead Counts v CONS Ln 3 Fionk C 7N72664 T Displaying BAF Values To display BAF values click BAF on the right tab LMX Analysis Batch Name 100414_EL_DELUXE Assign Cutoff 11 Options Reports Sort Run Date 04 14 10 Assign Adjust 0 0 Lot Number 091609 LMX Supplemental Assign Cutoff 2 E Li view VBAF Calc Expiration Date 05 16 10 Supplemental Assign Adjust 0 0 Reviewed By CON Ranges CON 1 50 332 CON 2 16 505 CON 3 23 641 Displaying Phenotypes To display the list of antigens on th
42. 5RUO 3 2 15 oO r Oo QG 0000000 AA Lak fen eaa ea D RRA OME 4 Sorting The data can be sorted by any of the headers in the ID Tail Window Click the desired header and the data will sort in o descending or ascending order 7he default 37 02 ranking is descending by RVa A sort order su q Change here does not impact the AutoTail 02 sorting or the function of the Next button o Default sort order can only be changed in ren Preferences See Tail Parameters ID only ISR RRR Eo tS RREME MI Hj l S45 OA e D D 5 Highlighting Groupings A particular group can be highlighted within the Available Tail Antigens by selecting the appropriate group in the dropdown menu found in the Tail Adjustment Grouping tab The antigen s included in the group that meet the Tail Parameters set will be highlighted in gray under Remaining Antigens To bring the antigens within the selected group to the top of the Remain ng Antigens turn Sort by arene ON A Ag AO O AD A AS AT Sho AMO ANDS ADEM ADEE ANDE ARI AMIS 490103 6 If Sampie Antigens were not eied into the empl list they can still be excluded from the tail analysis FOR RESEARCH USE ONLY 5 14 LC1115RUO 3 2 15 To add or exclude antigens to from the tail right Click an antigen within the grid and choose Exclude Antigen X from Analysis owe lei cz Bia Bw Cwl I A EPSPS cs EM cus ace ME 2 LA
43. AA BAA BON Daca ca ll 3 40 10045901 BONN BSN a caca i 143 425020 BZAR 2400280180 cnaz fll AA AO ONANAN BSO NESTA Ba Br COB Cw fll A 202 BSN ES A a cAc fl 4 S AAPAN BLASIN A a Ac i 2 40 AMALAN BISAN Cc 2012501 BLAA B LSIN Br CAAC fil 9 42 AMAIN ANNIN A CAC D 7 4 11010002 BADIN BSN cAc fl A 2A032501 BOTOA B LAA Ba CaCa fl A222 A691 BASON BARON Bret Ba CaCa VORB ASI BAON Bat cacas DION E1501 85201 Ecos fl VAIS Bra Em EC AAA C NO VASON BOTOA BZ Ent En caco I VADO BLSZ ESA Ecco 4230102501 80702181401 EM EC 107021010902 21 42300 6902 80702 BAM Br BE CN Ca A 2202 3000 B LAA BAD Bret Bosco 145 40 1011469011 20901 87301 8610070111505 AAN BASI BAD Br Br COPLA CIO 7 40 1014680181402 841021 8610090211201 3 4 3 10145905 83205 24002 Ba CAHN CAAT E A 2812 4300 815018510 A 29021459011 815018510 120 139 129 161 166 126 154 150 121 155 132 162 115 10 153 123 culation ID Graph FOR RESEARCH USE ONLY 5 6 LC1115RUO 3 2 15 eTo change the y axis for what is displayed in the graph click any of the column headers in the bead ranking view Adjust 1 Adjust 2 Adjust 3 or Adjust C where within the graphing area and choose Sort By A selection of anti eTo change the bead order antigen order of the x axis right click any gen sorting options will appear Additional Graphing Features a ee AS A T d i AS PL DATE RO EE de I A A AA TARTA
44. DU AE Move Antigen AS to Tail Antigens Grid El Highlight antigen AS in Analysis Grid Remove highlight of antigen AS in Analysis Grid Copy Gnd kchuded antrgen As m Analysis Grid Pas o a rd e a id Pa a e a a Td 7 To add an antigen to the tail double click the antigen found in the Remaining Antigens window or double click the antigen in the Bead Rank ng grid The antigen is added to the tail The remaining antigens not included within the tail are then re calculated and listed for further selec tion 8 The following Tail Actions can also be used when adding to the tail a Next moves the top ranking antigen into the tail b Right click within the grid and choose Move Antigen X to Tail Antigens Grid c Move Group to Tail will move all antigens within the selected Group into the tail d Undo Tal Will remove the most recent tail addition e Save will save any antigens placed into the tail analysis for the report f Resef returns the tail to the previously saved tail g New returns any antigens moved to the tail to the antigen list and allows the user to start again 9 Continue loading tail until complete or until all antigens desired are added to the tail Antigens will be bold and italicized in the bead ranking screen 30 0s Os on oe Os Oe Oe La Le Le h EP FOR RESEARCH USE ONLY 5 15 LC1115RUO 3 2 15 10 Click Save before moving to the next sample Comp
45. Diagnostics Inc se reserva todos los derechos que no se hayan cedido expresamente 4 GARANT A LIMITADA Durante noventa 90 d as a partir de la fecha de su compra Immucor Transplant Diagnostics Inc le garantiza que i el Software se ajusta s lidamente a la documentaci n aplicable del usuario y ii los soportes magn ticos sobre los que est distribuido el Software y la documentaci n del usuario si la hay son libres de defectos en materiales y mano de obra su opci n Immucor Transplant Diagnostics Inc le har la devoluci n del importe que usted haya pagado por el Software o le proporcionar los art culos correctos sin costo siempre que el o los art culos defectuosos sean retornados a Immucor Transplant Diagnostics Inc dentro de los noventa 90 d as despu s de la fecha de compra Cualquier maltrato o modificaci n no autorizada del Software anular esta garant a limitada Como excepci n a lo estipulado en la presente Immucor Transplant Diagnostics Inc no hace garant a declaraci n de hecho o promesa ya sea expresa o t cita reglamentaria o de otro car cter con respecto al Software documentaci n del usuario o apoyo t cnico inherente incluso respecto a su calidad funcionamiento comerciabilidad o idoneidad para un prop sito especial La garant a y recursos estipulados en la presente cl usula son exclusivos y en sustituci n de todos los dem s verbales o escritos expresos o t citos Esta garant a le
46. EW 040109 5 Batches will display poor in the Batch column e Double click the batch 20090511 1654230 DSA D of choice All samples DM 17 07 08 LSA EF Within the batch will C DSA Lysate Test 090810e Y display in the Sample ae colunmn Reporting Options per Test Save File Path LM DSA E ID C Documents and Settings tc07011My Docum Lu 6 U se th e arrows to REE dec Eisen ote move the samples to True Negatives J save to POF the Print right col False Positives Ill umn which will include False Negatives Lave to Excel udi _ Bead Ranking Save to RTF Lau EL the m In the batch L Statistics re po rti n g f E 7 Once all desired samples have been moved to the Print right column choose the ID tab under Reporting Options Choose the items to include in the report 8 Select desired Printing Option Send to Printer Save to PDF Save to Excel or Save to RTF Multiple options may be chosen If Save to PDF Save to Excel or Save to RTFis chosen choose a Save File Path 9 Click the Print icon A dialogue box will appear stating that reports have been generated Click OK to continue 10 If an Audit Reportis desired click Audit Report This report can only be generated in pdf format Exporting Reports 1 Generate a report from the Print Reports tab in the D Analysis tab Reactvity Adjustments Tail Adjustment Groupings History Print Repo
47. History 5 16 New History 5 16 Applying a Previously Created History to a New Sample 5 16 View Current Assigned History for a Sample 5 17 FOR RESEARCH USE ONLY TOC 5 LC1115RUO 3 2 15 Chapter 6 Approving the Results of the Analysis 5 17 Approving Results 5 17 Reporting and Printing 5 18 Customizing a Final Report 5 18 Quick Print 5 19 Batch Reporting 5 19 Exporting Reports 5 20 Exporting Summary Results 5 21 LIFECODES Single Antigen Analysis Importing Single Antigen Results into MATCH IT 6 1 Importing EDS files 6 1 Manually Importing CSV Files 6 1 Opening a Batch 6 2 Direct Selection 6 2 Date Range Selection 6 3 Viewing a Sample within a Batch 6 3 Navigating to a Particular Sample 6 3 Overall Antibody Assignments 6 4 Automatic Assignments 6 4 Calculations and Displayed Values 6 4 Calculations for LSA 6 4 Calculations for C3d 6 5 Making a Positive or Negative Assignment 6 5 By Standard Mode LSA and C3d 6 By MFI Cutoff LSA and C3d 6 Move Remove Exclude Antigens to from the Assignment LSA and C3d 6 7 Tools for Making an Assignment LSA and C3d 6 8 FOR RESEARCH USE ONLY TOC 6 LC1115RUO 3 2 15 Chapter 7 Creating a History LSA and C3d 6 11 Applying a Previously Created History to a New Sample 6 11 View Current Assigned History for a Sample 6 12 Column Customization LSA and C3d 6 12 Changing Sort Order 6 12 Column Removal Addition and Column Width 6 13 Displaying Selected Bead Va
48. IAEA HT 2 eo ia a a 4 m E a i a ree eA ye i Ma TPR Pe RA RA 07 1 SS eT CEE a OT TO EUX VU r a p ee tie te yori es LEP re eq CT NA CRT L DO a ON Paba ica Pea o O AL MS Ee ata AA A A O AA VE Ap ET eee E MA irrita cat LOS TA aana OA A O CO A E ACA A A TA Ei LC1115RUO 3 2 15 El li A i ey a hie EAA E a F l MO e AS WG AS AA CA DA ee Fr sal Cc CU a Da E LUS sain ANO A CL DL CE e Ci A MAA AAA rl a ee EI MI sesion ia tocante cal MI erro TE ENT QE LICE SR ie le ir aiii ere very i i e from a bar graph to a line graph right E A a Il ee O DL a 191 5 7 ie AA A ANA ABN AAA E TACTO ETT r VAL a a hp A ii VA TA LU EM E A i l A E Le WI worries WI earn a i MO Seen eens EN ke ee oe TE CE erste eet D eerie yar DI tose RANIA Del eee wove DG eisai DI oe D SSS EA m aT a A E FOR RESEARCH USE ONLY E Ae TA oon T iir E eee fore eee A ete RT eisai DE te ee A HAA 1 Re SL a a der O AAA DL DR ieee dE right click anywhere within the graphing area and choose Zoom Use the mouse to make a box around the area to zoom DO iinn rs vase oda iTi I Done ns A en me oi e Andri click anywhere within the graphing area and choose Gallery A selection of graph types will appear elf a Group is selected the graph will highlight the bars for the beads containing an antigen
49. LA type then antigens entered into this field must match an antigen listed on a product worksheet and be sep arated by commas Example A2 A24 B56 B51 or A 02 01 A 24 02 B 56 01 B 51 01 Displaying Batches 1 To view all batches containing a specific sample double click the sample name or click the icon All batches containing that sample will display under the Antibody Batch Results tab alle Fr Fi ie LMIi_WKS_20130828 5 LMI WES 20130828 55 E LL LM D WES WFU_ CH 391 FOR RESEARCH USE ONLY 9 4 LC1115RUO 3 2 15 2 Click any of the batches listed for the selected sample for all results to appear in Antibody Batch Results wee er ET LAINE AS EAn 4 EA Void OHA CL EHE LT ii tal ah bed COLE LEA 3 The antigen specificities for the chosen batch will display once the batch is selected itt nn es OOo Gait iy ange ah Der ETC al e Ore aces ess ALES Hanson Leire ALE BOLE ii brei Cem b TE GAS TT ON aces eh A isd Hainan Liria PAIS dl besos Coder he Note C3d batches will display in bold type If two batches have been run for a chosen assay and both batches are selected by holding down the ctrl key any differences of antigen assign ments between the batches will be highlighted Red and Checked Antigens are Positive in all batches Red and Un checked Antigens are Negative in the first batch and Positive in the Positive in the second batch
50. Notepad document FOR RESEARCH USE ONLY 3 2 LC1115RUO 3 2 15 2 Enter all column information Each piece of information must be delim ited by a comma regardless of whether the information is present or not PB Untitled Notepad File Edit Format View Help 1234 John Smith 10 23 78 4690 08 07 07 1235 Rex Jones 10 23 78 1236 Mike Jones 3457 1237 Leslie Jones Do not hit return after the last sample is entered 3 Save the file Note Enter the Sample HLA Type in the same serological format used in the LIFECODES worksheets In order for antigens to be excluded they must match an antigen listed on the product worksheet For example if Al is entered it will be excluded Entries such as AOL A01 02 etc will not be excluded For Single Antigen the allele must be entered such as A 01 01 This allows those antigens to be excluded during the analysis of the HLA antibody No commas should be entered between antigens Draw Date must be in the format selected in Preferences Warning When creating patient lists for LSA C3d the name used for the Negative Control sample MUST match exactly the name listed under C3d settings If this condition is not met auto import of this batch will fail Creating a Batch In order to create an automated batch the EDS file for the particular prod uct and lot must be imported into the LIFECODES MATCH IT software See Importing EDS files into MATCH IT and the correct Luminex Templat
51. R Assign Cutoff 28 EET ee 5 PU ied o a a ee PO PE RES RE RS PRE PET PRE EE PRE PSE En Lowesta 72 CON1 Positive Con Epet Analysis Update By Lowest B CON 2 A ii im Exclude Patient Type OFF Comments TL A C3d Analysis FOR RESEARCH USE ONLY 6 2 LC1115RUO 3 2 15 Date Range Selection Rather than selecting an individual batch a range of dates can be selected which will result in all batches run in that range being selected 1 Right click the antibody symbol as shown below Single Antigen Batch ID Run Date SA1_20100129 01 29 10 2 pair of calendars with a start and end date will open Select the desired range and click OK Sekre Date eine T Member 2011 gt habo 1 BOLE gt SE TNT F 5 SMIWTES E 9 3 4 6 60s 10 11 12 13 24 35 56 10 11 12 13 14 15 16 43 17 18 19 2 21 22 25 A M abo 6 AT EE CE 2925 2 3 The batch results are displayed in an LSA Analysis tab All sample results appear in the middle section of the tab Individual sample IDs within the selected panel are listed in the left section of the tab under the batch name Viewing a Sample within a Batch Navigating to a Particular Sample eTo go to a particular sample in the batch left click the sample ID in the left hand pane The software will open this sample alsar Pos Sera ed j D je FOR RESEARCH USE ONLY 6
52. RUO 3 2 15 commercial practice this software agreement instead of the noted regulatory clauses shall control the terms of the Government s license 7 GENERAL No Immucor Transplant Diagnostics Inc dealer distributor agent or employee is authorized to make any modification or addition to this Agreement For use of the Software in North America and Latin America this Agreement will be governed by the laws of the State of Delaware For all other countries this Agreement will be governed by the laws of the country in which the Software was purchased For customers Should you have any questions concerning this Agreement or Immucor Transplant Diagnostics Inc software use policies write to Inside Sales and Service Immucor Transplant Diagnostics Inc 550 West Ave Stamford CT 06902 CONTRAT DE LOGICIEL IMMUCOR TRANSPLANT DIAGNOSTICS INC SI VOUS N ETES PAS D ACCORD AVEC LES PR SENTES MODALITES ET CONDITIONS N INSTALLEZ PAS LE LOGICIEL ET RENVOYEZ LE EN TOTALITE AU PLUS TARD 30 JOURS APRES L AVOIR ACHETE AVEC VOTRE RECU POUR VOUS FAIRE TOTALEMENT REMBOURSER 1 UTILISATION Vous une entit ou une personne pouvez utiliser Immucor Transplant Diagnostics Inc MATCH IT Antibody Analysis Software le logiciel en quantit autoris e si vous remplissez les conditions suivantes En outre vous pouvez faire une 1 copie d archive du logiciel Pour les mises a jour et les changes Si le logiciel est une mise a jour ou u
53. Ranking Report during export The user can select individual columns by placing a FOR RESEARCH USE ONLY 2 3 LC1115RUO 3 2 15 check next to the item Once all items have been selected click Save Settings Preferences ab Information LMX ID LSA DSA Settings dy ab T aforr zH Ti s Bead Ranking Default Epitope Settings Bead Bead Bead Count Bead Count Donor ID Donor ID RawValue i Adjust1 Adjust e Adjust3 AdjustC Assignment DR1 RawWalue Adjustl Adjust2 Adjust3 AdjustC Negative Control Sample Name C3d ONLY It is a requirement of the C3d assay that a negative control sample be included in every batch The user must designate a Negative Control Sample Name that will be referenced for all C3d batches upon import If the Negative Control Sample Name in the batch does not match what is listed in Preferences the user will be prompted to select a negative control upon import FOR RESEARCH USE ONLY 2 4 LC1115RUO 3 2 15 Select Heg tive Control A Negative Control was not identified for the C3d Batch 03203F 2P05 541 C3D Please designate a sample as the Negative Control or Cancel the import Cancel The user must click on a sample from the list displayed in the dialogue box and then click OK Tail Parameters 7D only Preferences Tail Par Adjustments RVal Cutoff o apos cua 9 sera assin Adu M Use Default Parameters D Positive Use De
54. TWARE Y DEVUELVA ESTE PAQUETE COMPLETO DENTRO DE LOS 30 D AS DESPU S DE LA VENTA JUNTO CON SU NOTA PARA EL REEMBOLSO TOTAL DE SU DINERO 1 USO Usted persona f sica o moral laboratorio o institucion podr usar el MATCH IT Antibody Analysis Software de Immucor Transplant Diagnostics Inc el Software en la cantidad establecida siempre que re na las condiciones que siguen Adem s usted podr hacer una 1 copia de archivar del Software Para Modernizaciones y Sustitutos Mejores Si se trata de un Software de modernizaci n o sustituto mejor se le autoriza para que use el Software s lo en caso de que sea usuario autorizado de un producto de aprobaci n seg n lo determinado por Immucor Transplant Diagnostics Inc y siempre que usted i o suprima el producto de aprobaci n o instale el producto nuevo en la misma computadora o red tal como el producto de aprobaci n y ii no transfiera el producto de aprobaci n a ninguna otra persona 2 RESTRICCIONES Salvo lo que se estipule expresamente en la Cl usula 1 usted no podr alterar fusionar modificar o adaptar el Software de ninguna manera incluso la ingenier a inversa el desensamblaje o la descompilaci n Usted no podr vender distribuir prestar arrendar alquilar otorgar licencia o transferir de manera distinta el Software o cualquier copia del mismo excepto que s podr transferir el Software de FOR RESEARCH USE ONLY SA 5 LC1115RUO 3 2 15 manera defi
55. abase Pease select lot from ket Opening a Batch Direct Selection 1 Click the arrow to first expand the D section Number Of Samples Product Name gt L091029 IDII Pending Analysis 0506091M1 Class I 050609 MI 1204200910 _CF 1 M1216094 los 17 09 12 16 09 9 0506091M1 Class I 0506094MI Pending Analysis 1D1_083109_MAC 08 31 09 30 09 8 0227094M1 class 1022709 Pending Ana ysis M113009A 06 17 09 11 30 09 9 0506091M1 Class I 050609 LMI Pending Analysis M1124096 los 16 09 11 24 09 9 0506091M1 class I 050609 LMI TPending Analysis M1123094 los 17 09 11 23 09 9 05060941 class I 0506094MI Pending Analysis 4 4 2 Double click the batch name found on the Antibody Home tab under JD 3 The batch name will display on a tab above the Sample Navigation rib bon All sample results appear in the middle section of the tab Individual sample IDs within the selected panel are listed in the left section of the tab under the batch name rer coma Cal Con 59 ct CONZ 52 Positive Con Boaz et We HFI Ca C coma al IS Cuates Tot Voies Date Range Selection Rather than selecting an individual batch a range of dates can be selected which will result in all batches run in that range being selected FOR RESEARCH USE ONLY 5 2 LC1115RUO 3 2 15 1 Right click the antibody symbol as sh
56. able VBAF Calculation ZMX only allows the logged in user to activate this feature By default this feature is inactivated VBAF or Variable Background Adjustment Factor is designed to be used by personnel knowledgeable in the field of HLA Antibody analysis when the samples being analyzed have negative control bead values that do not conform to expected values This calculation uses the following formula MFIciasst VBAF AVGcon1 BAFconi VBAF 256 The Variable Background Adjustment Factor VBAF is calculated as the difference between the observed MFI for a CON bead and a predetermined average AVG value based on a set of negative sera The VBAF is then subtracted from the MFI value of the CON and the Class 1 Class II beads VBAF makes the assay less sensitive when the negative control bead values are low and more sensitive when the negative control bead values are high Once this feature is enabled the calculation can be applied to an entire batch or to individual samples If the VBAF calculation is used the sample header will indicate this By default this feature is inactivated e Import Mode JD and LSA allows the user to choose to apply either the Standard Assignment adjustments Assign Cutoff and Assign Adjust or BCM BCR and AD BCR or to set cut offs based on an MFI value for ID and LSA files upon import f Bead Ranking Default tab 7D and LSA allows the user to define the columns that will be included on the Bead
57. aining antigens within the selected Group eTo overlay a particular sample i e the negative control onto each sample graph select the sample of choice and right click to choose Set as Negative Control Now when viewing any of the sample graphs within the batch the sample and the set neg ative control sample will display FOR RESEARCH USE ONLY 6 15 LC1115RUO 3 2 15 Batches Bead Bead Count AC 79 gt s0 al esooriosrraca OOOO os i 6 mn pus os mn E EE 73 D e a e MS Note The user may select one of the samples within the batch to be des ignated as the Negative Control Once this option has been turned on for a batch it cannot be turned off This feature is NOT available for C3d Note When making reactivity adjustment changes to a sample with Weak antigens Weak Antigens will remain Weak To change a Weak assignment to Positive MFI mode must be used Note If Eplets are assigned and changes are made to Reactivity Adjust ments then Eplet assignments will clear To assign Eplets using the new cut offs Click Eplet Analysis Batch Failures LSA and C3d Bead Count Failure The source of all failures is listed in the Single Antigen Analysis header By clicking the FAILED message the user has the option to included failed beads in the analysis e If a CON bead fails to meet the minimum bead count the software will report all beads as failed To override the failure click the message
58. all IDs are highlighted right click and choose Merge Patient e Patient List Patient De A A rr Merge Patient ES 400 ito2 Test Ty 3 Name the new Sample Now the sample ID or sample name can be found as they were originally named as well as found under the new merged name Viewing Antibody Batch Results Patient Information If Patient Name Date of Birth Draw Date HLA Type Accesstion Number Donor Number or Donor Center Number were included in the auto batch set up they will be displayed in the Patient Details tab of Patient View for each individual sample Patient Details EZ T Ce PR __ Er Donar Number Donar Center Number 13 141587 FETTE The user can also manually enter this data in to any one of these fields FOR RESEARCH USE ONLY 9 3 LCITISRUO 3 2 15 Manually Entering Patient Data 1 Select the batch from the Patient List window 2 Enter the Patient Details 3 Click Save Note The user will be prompted to save Patient Details for the single batch or for all batches containing the sample If the user chooses to save for All Batches the draw date if entered will be applied only to the selected batch Entering HLA Type Patient HLA Type can be is manually entered in the Patient Details tab Once saved it will display in Patient Information in the Analysis screen and on reports generated for that sample If a user wants to Exclude the patient H
59. ame OD MissingBatchName csv Batch Name is missing from file Please correct and then reimport FOR RESEARCH USE ONLY Appendix A 1 LC1115RUO 3 2 15 CSV file contains Batch name is longer than 30 characters CSV File Import Status 3001075 LM20 LongBatchName csv Batch Name LongBatchName 123456789 123456789 10 is longer than 30 characters Please correct and then reimport CSV file contains sample name s is longer than 30 char X acters CSV File Import Status 30013502 LMX_LongSampleName csv Batch 3001302 LMX_LongSampleName contains one or more sample names longer than 30 characters Please correct and then reimport Batch Import Can celled CSV File Import Status 30012094M1_FlexMap Exp FM STD_ 20131219 131835 csv Import cancelled Lot could not be CSV Import Lot Import found in database session Name 042314 KIR 2 FOC 04194H Template Mame 041944 03283C KIR 2 Lot notin database Please select lot from list mm 03203F 02283A 5A 1 1032042 022834 C3D5A1 042348 TSTC3d SA1 1042348 TSTMAM SA1 AAA OU A A A A A E mn No samples are entered Submit Batch to Luminex A You must enter at least 1 SamplelD for this Batch FOR RESEARCH USE ONLY Appendix A 2 LC1115RUO 3 2 15 Missing Fields Invalid Field s i Please fix the following fields Operator Duplicate Sample Names Submit Batch to Luminex E3 A You must enter at a unique SamplelD for
60. appear in the dropdown then there are two options 1 Type in the name of the SQL instance if the instance is valid and Match IT can connect to it then the databases it holds will be listed Click Connect to establish the connection 2 Click Refresh Server List to scan the network for Match IT instances If the SQL instance appears but Match IT can not connect to it 1 Check to see if a port for the instance has been specified Ask the database administrator to check the port settings in SQL Server Configuration Manager 2 If a port has been specified then add the port number to the SQL instance in the dropdown Example lt Computer name gt lt port number gt MatchITserver 1500 Networking Client computers to a SQL Server Express For 2008 editions 1 From the Start Menu Open the MATCH IT database management utility drop down Choose the application and log in required for this utility FOR RESEARCH USE ONLY 1 2 LC1115RUO 3 2 15 2 Click Choose Server 3 Click Available SQL Instances dropdown to display known SQL instances 4 Choose the SQL instance that contains the database Click Connect to establish the connection 5 Once the connection is established a list of available databases will be displayed Choose the database and click Ok to connect Troubleshooting On the computer that holds the database verify the SQL Browser is off and TCP IP is enabled Checking the SQL Browser state
61. appears on the screen click the Export Report icon in the upper right toolbar 3 The dialog box that appears provides several different options for exporting saving the report o EE had LL ASES PDF File a HTML File IMMUCOR Es MHT File UFECODES Prone 203 328 9597 Er 550 West Avenue Fax 203 328 9599 Stamford CT 06902 USA XLS File Class III LMX Re XLSX File Batch ID LMX 30008 73 Wa CS File Run Date 082013 Assignment Cutoff 11 ae Lot Number 3000875 3000855 Assignment Adjust 0 00 0 00 Text File LHEX Image File Expiration Date 04 15 14 Exporting Summary Results Many Laboratory Information Systems require simple export files that list only the samples and results This Antibody maama E asa file can be generated directly from the Export button on the homepage See Export Results Antibody Export FOR RESEARCH USE ONLY 4 10 LC1115RUO 3 2 15 CHAPTER 5 LIFECODES ID ANALYSIS This chapter contains information on the tools available to analyze LIFE CODES ID results ID Importing ID Results into MATCH IT If an Automated Batch was not created and data needs to be manually imported into the software the appropriate EDS file must first be imported fol lowed by the csv file Importing EDS files Before importing ID data the information nec Lot Information Import essary for analyzing the data generated by the Luminex instrument must be imported The informat
62. ase is deleted it cannot be retrieved and all data is lost If the current database in use needs to be deleted the user must connect to another database by highlighting and clicking Connect or create a new database and connect to it Once a new connection has been established the former database in use can be deleted Attaching a Database To attach a database select Attach Database A dialog box will appear where the user selects the database to be attached This feature is only available on the PC housing the database Detaching a Database Detaching a database removes it from the server list but does not delete the database It can be attached later if needed To detach a database highlight the database and select Detach Database The database that is currently in use cannot be detached This feature is only available on the PC housing the database Backing Up a Database To backup a database select Backup Database Next navigate to the location where the backup is to be kept If the software is running on Windows 7 Backup files should be stored at C ProgramData Lifecodes Backup If the software is running on Windows XP Backup files should be stored at C Documents and Settings All Users Application Data Lifecodes Backup Restoring a Database To restore a database select Restore Database Next select the loca tion where the backup to be restored is kept If the software is running on Windows 7 Backup files should
63. ation Import essary for analyzing the data generated by the Luminex instrument must be imported The information is provided in lot specific EDS files 1 Click Lot Information Import found on the Home tab of MATCH IT The Open dialog box will appear 2 Navigate to the location e g desktop of the EDS file s Select all appropriate files that need to be imported Use Ctrl left mouse button to select more than one EDS file at one time 3 Click Open A message will appear when all lots have been successfully imported Manually Importing CSV Files 1 Click Batch Import from the homepage q This will open the Open dialog box csv Batch Import 2 Navigate to the location of the CSV file s If importing from the computer connected to the Luminex CSV files can be found in C My Batches Output on IS 2 3 sys tems and at C ProgramData Luminex xPONENT31 Output on xPONENT systems 3 Select all CSV files to be imported Use Ctrl left mouse button to select more than one CSV file at one time 4 When the file is selected the analysis is done automatically during the import process Once the csv file has been imported it will appear on the Antibody Home tab under Single Antigen FOR RESEARCH USE ONLY 6 1 LC1115RUO 3 2 15 Note A CSV Import Lot Import may appear after selecting a csv file This can be due to 1 the appropriate EDS file not being imported 2 the EDS file not being available See Lot Availability
64. ation of the first batch in your multi batch Add the second batch to the correct location according to the instructions above then Remove the first batch You can now add this batch back to the correct location following the steps above Batch Status The status of a batch can be verified in the MATCH IT software 1 Click Automated Batch Setup from the homepage 2 Choose the Automated Batch Status tab lol xi Automated Batch Setup Automated Batch Status Automated Batch Preferences f batchID batchName a batchotatus server crestebE T A b i LABSTM38F25K1 pan 18 Isal 080110_lum Pending LABSTM38F25K1 2 9 2010 Delete 19 Isal 080110_lum2 Pending LABSTM3SF25K1 2 9 2010 Delete 20 Isal 080110_lum3 Pending LABSTM38F25K1 2 9 2010 Delete 21 Isal 080110_lum4 Pending LABSTM38F25K 1 2 9 2010 Delete 25 SFTest Pending LABSTMDK 7P4D1 2 11 2010 Delete 26 SFTest2 Pending LABSTMDK7P4D1 2 11 2010 Delete nm 27 SFTest3 Pending LABSTMDK P4D1 2 11 2010 Delete 28 SFTest4 Pending STMWWS 6M4NCF1 2 11 2010 Delete 29 SFTests Pending STMWS 6M4NCF1 2 11 2010 Delete pan 30 SFTest Pending STMWS MA4NCF1 2 11 2010 Delete pa 31 SFTest Pending STMWS 6M4NCF1 2 11 2010 Delete PE er LACET MARA 24 zakia ie Print Liquid Handler Report I fete ee 3 Pending batches those not yet acquired in the Luminex IS 2 3 or xPO NENT software will be displayed To see completed batches as well check
65. bodies if all the HLA beads are found to be negative Batch Failures Bead Count Failure elf a sample fails to meet the minimum bead count for a Class I or Class II bead the Class I or Class IT result respectively will be reported as Bead Failure To override the failure review the bead count and then choose the appropriate assignment from the drop down menu FOR RESEARCH USE ONLY 4 5 LC1115RUO 3 2 15 elf a CON bead fails to meet the minimum bead count the software will report Bead Failure for both Class 1 and Class II Positive or Negative Control Failure when using a liquid handler The software can be set so that the results for the entire batch are tied to the performance of the Positive and Negative control when a liquid handler is used All samples will be listed as failed if either the Positive or Negative Control samples fail eA Negative Control is considered as failed if any bead fails to meet the minimum bead count or if the Negative Control has a positive assign ment for Class I or Class II eA Positive Control is considered as failed if any bead fails to meet the minimum bead count or if either of the Class I or Class II assignment is negative eThe source of the failure is listed in the L feScreen Header Bead fail ures will only be listed within the panel not in the header The feature that ties the performance of the batch to the performance of the nega tive and positive controls can be enabled or di
66. ce the sample tray has been placed into the XY Platform of the Luminex system Note It is possible to change positions when creating a multi batch As the batches are added drag the first sample of the batch to the desired location Running a Single Batch in Luminex xPONENT 1 Open the xPONENT software and sign in as admin 2 Select the Batches Tab at the top of the screen Sid a DB Q XPONENT his Protocols 3 3 All batches that have not been acquired will be listed under Pending Batches 4 Select a batch by clicking on it To Review batch contents select Plate Layout To run click the Run button at the bottom of the screen Running a Multibatch in Luminex xPonent 1 In the batches tab select Create a New Multi E Batch i j 2 Select the first batch to be included and click OK s Create a New Multr Baich 3 To add another batch click on the well where that corresponds with the first sample in the batch and select the Add button at the bottom of the screen To delete batches select the batch and click Remove 4 Repeat step 3 until all desired batches have been added 5 Verify that the plate is a direct representation of the Multi Batch screen in the software FOR RESEARCH USE ONLY 3 6 LC1115RUO 3 2 15 6 Click Run to process immediately or Save to process at a later time Note The first batch in a multi batch will by default be added to well A1 If this is not the loc
67. ct All mn f Le mai pa an ed gt SINGLE ANTIGEN II T patient 4 PR FA cee GE ea ES an Sas pe EA IM Patient 5 TestType LotID Sample ID BatchID RunDate DrawDate PRA FinalRe DPA1 01 03 0PB1 01 01 ds Patient 6 SINGLE 030548 AR4533 Checko 09 09 14 26 DQA1 0 Y DPA 1 01 03 DPB1 02 01 INN g3 Patient 7 SINGLE 030548 AR453306 checkout 08 21 14 25 DQA1 01 x DPA1 01 03 DP81 03 01 M pat EE A Y DPA 1 01 03 DPB1 04 02 MN amp patient 9 TestType LotID SamplelD BatchID RunDate DrawDate PRA FinalRe x IF iv DPA 1 01 03 DPB1 18 01 gt SINGLE 042348 AR4527 CheckO 09 05 14 3 A 02 02 Y DPA1 02 01 DPB1 01 01 SINGLE 09203A AR452711 Checkou 08 21 14 22 B 07 02 RL SE hs Y DPA1 02 01 DPB1 04 01 FOR RESEARCH USE ONLY 9 8 LCITISRUO 3 2 15 3 Selecting an individual batch will Emme y display the assigned antigens for O DPA1 01 03 0PB1 04 01 LJ DPA1 01 03 DPB1 04 02 Lei DPA1F01 03 DPB1 18 01 that batch in the antigen column on the right The user can select an LSA IgG batch and a C3d batch by hold ing down the CTRL key when the Jprarozo1prsitonon second batch is selected Differences E DPA1 02 01 DPB1 04 01 in assignment between the two DPA1 02 01 0PB1 05 01 batches will display in yellow Addi 2 tional antigens can be selected man z ually o A DPA102 01 0PB1 14 01
68. d in any of the Calculation tabs can be customized to meet the user s needs Sort Ascending a El Sort Descending Clear Sorting Group Ey This Column e Show Group By Box Remove This Column 1584 12 68 13 99 paa UE Column Chooser 116 99 5 p Best Fit 933 Best Fit all columns Changing Sort Order For LSA samples will display beads in descending order of AD BCR by default For C3d samples will display beads This can be changed two dif ferent ways FOR RESEARCH USE ONLY 6 12 LC1115RUO 3 2 15 1 Right click a column header and choose Sort Ascending or Sort Descending The sort order will be saved when viewing future batches 2 Left clicking a column header will also sort Once the column is clicked a downward or upward triangle will appear showing the direction of order descending or ascending in value respectively Column Removal Addition and Column Width 1 To remove a column right click the column and choose Remove This Column 2 To add a column that has been previously removed right click the col umn and choose Column Chooser The Column Customization window will appear displaying the columns that have been removed Right click the column to add and choose Show This Column The Column Customization window also allows the user to drag and drop columns into the window to customize the layout 3 To change the width of a column right click the column and choose Best Fit or Best Fit all col
69. del Norte y Am rica Latina este Convenio se regir por las leyes del Estado de Delaware Para todos los dem s pa ses este Convenio se regir por las leyes del pa s en el que fuera adquirido el Software Para clientes Si llegaran a tener alguna pregunta respecto a este Convenio o a las normas del uso de software de Immucor Transplant Diagnostics Inc escriban a Servicio y Ventas Immucor Transplant Diagnostics Inc 550 West Ave Stamford CT 06902 FOR RESEARCH USE ONLY SA 7 LC1115RUO 3 2 15
70. e 2 Right Click and select Generate Graph from the menu Select whether or not to include a graph in the report from the sub menu a Lot ID SampleID BathID Run Date Draw Date PRA Final Results Lali RS EA A E CEE Generate Grap i Copy Grid Assign IgG C3d Pair Export Antigens Generate Report With Graph Without Graph 3 The LSA IgG C3d report will populate a new window Class I Single Antigen Results for IgG and C3d Igt Batch ID Checkout LSA lw2 Cid Batch ID CheckOut C3d SA1 C3d Patient Name ARARATI Patient DOS Dorner Number Accession E Sample lO ARSS2711 Draw Date Donor Center E PRA 23 Loti 092034 061438 541 Expiration Date 03 31 14 Patient HLA Type Report Parameters IgG Method Standard Calculation Positive COM MFI CON 1 MFI CON 2 MFI CON 3 MFI 16744 219 14 2169 Assignment Cutoff ECM Cutoff BCR Cutoff AD ECR Cutoff 2 1500 4 5 3d Method Negatve Control Sample Calculation Positive CON Cad MFI 17218 Assignment Cutoff BG Adjusted Cutoff BCR Neg Cutoff R Strength Cutoff 1 1500 a 4 All reports will include IgG and C3d Report Parameters and data will be sorted as follows e Positive IgG Positive C3d ePositive IgG Negative C3d eNegative IgG Positive C3d eNegative IgG Negative C3d FOR RESEARCH USE ONLY 9 11 LC1115RUO 3 2 15 4 Once a report appears on the screen click the Export Report icon in the upper ri
71. e must be imported into the Luminex Software See Importing Template files FOR RESEARCH USE ONLY gee LC1115RUO 3 2 15 into Luminex To create a batch Automated Batch senip Batch Name Operator Locus Name Lot iD Assay Name C g a g Qisas Start Peton Current Lumine Cornecton Lummex Connection Statis Liquid Handing Mapped Drive E PONENT Hum 3 Submit Batch To Liquid Handler Submit Batch To Luminex 1 Click Automated Batch Setup on the Home Screen 2 Go to the Automated Batch Setup tab 3 Select IS 2 3 or XPONENT 4 Enter a Batch Name Note Session names cannot be reused and cannot exceed 30 characters including spaces Session names cannot contain apostrophes or commas and will not be imported and ana lyzed until the panel name Is changed 5 Enter user initials in Operator 6 Choose a est Type LifeScreen Deluxe Class I ID etc 7 Choose the appropriate Lot ID Assay Name should automatically popu late with the Lot ID 8 Enter a Start Position well location on plate 9 Choose the Luminex instrument to which the batch is to be submitted from the dropdown list under Current Luminex Connection and verify that Luminex Connection Status is Available If the name of the computer to which the instrument is attached does not display in the list it may be typed in 10 To load a pre saved Sample List click Get Sample List File The user may type directly into the columns as well
72. e C3d sample As samples are selected they will be highlighted in blue SINGLE ANTIGEN I CS CR Re EL bed 1 Test Type Lot ID BatchiD RunDate DrawDate PRA Final Res ET ee CheckOut C 09 05 14 7 A 02 0 Generate Graph ETT y es za SIAP SINGLE ANTIGEN ct ae Eau m a A a EC SINGLE ANT SINGLE Al n Generate Report checkout LSA 2 08 21 14 32 DOB1 02 E All ALU TAROT ASE DAA Copy Grid Remove IgG C3d Pair Batch ID RunDate DrawDate PRA Final Res Export Antigens checkout LSA 2 08 21 14 26 DPB1 03 2 Right Click and select Generate Graph All assigned antigens from the antigen window will appear as data points on the graph Note IgG vs C3d Graphs will display Background Corrected MFI in the y axis and antigens in the x axis IgG vs C3d Graph Legend E LSA IgG assigned positive E C3d assigned positive E 2 amp 2 E 2 2 YX E 2 F amp F 2 2 E NA A A A PEEEEEPEEEEREEEEEE LE ELOTE TEE A C3d assigned negative 5 8 8 8 8 8 FE EE EE GB FOR RESEARCH USE ONLY 9 10 LC1115RUO 3 2 15 Generating LSA IgG C3d Reports The user can generate a report with LSA IgG data and C3d data from the Sam ple view screen 1 Select LSA IgG and C3d data to be reported Click on the LSA IgG sample to select Hold down the CTRL key and click on the C3d sample As sam ples are selected they will be highlighted in blu
73. e Weak or Exclude Weak is used no changes to the Anti body Assignments can be made Note Weak antigens are only assigned for LSA Tools for Making an Assignment LSA and C3d Groupings The Groups drop down box is a list of user defined HLA Groups By select ing a particular group the antigens present within the particular group will ADI ARED ATOI ATO A ZOLI A2402 y 4 24 03 22902 ASOT AIO 4035001 ASOD Ad A1 2 Color Coded Antigen s The user can color code antigens or groups of antigens to provide easier viewing This feature is intended as a visual aid Eplet Analysis Added Eplet Analysis can be run at a sample level If epitopes are not cal culated upon import click the Eplet Analysis button to assign available epi topes FOR RESEARCH USE ONLY 6 8 LC1115RUO 3 2 15 Fo UD 5 History ee Ba L wl mt JL LE Eplets can also calculated in the Eplet Analysis tab located at the bottom of the analysis screen In the Eplet Analysis Tab the user can refine the list of Eplets displayed by excluding Antigens based on BCM BCR AD BCR or MFI values Antigens excluded by these parameters will be listed in the Excluded Antigens window FOR RESEARCH USE ONLY 6 9 LC1115RUO 3 2 15 Antigens that are known or predictive Negatives can be selected from the Negative drop down These Antigens will be removed from the grid and
74. e beads click Phenotypes LMX Analysis 5 Batch Name 100414_EL_DELUXE Assign Cutoff Li Options Reports Sort Run Date 04 14 10 Assign Adjust 0 0 2 Lot Number 091609 LMX Supplemental Assign Cutoff 22 L View VBAF Calc a Expiration Date 05 16 10 Supplemental Assign Adjust 0 0 Reviewed By CON Ranges CON 1 50 332 CON 2 16 505 CON 3 23 641 Displaying Bead Counts To display the bead counts for a sample click the down arrow next to Bead in the sample header Sample 2577465 Well Position 2 T Locked VBAF BE g e Patient 2577465 an can Draw Date Class I Assignment peste 1d Class II Assignment Negative 1 79 ne GS cios chas eros Ja Pos C Raw 99 925 as 7 h foe ho fadival2 4 72 su se ass ss 457 l 51 oo el mel el me mL el me mel mel 1 05 80 Ls 67 I 01 69 Sample 3763683 Well Position 5 T Locked vBAF 11 02 96 Patient 3763683 Fe iene eee Class I Assignment Positive 8 Class II Assignment Positive 1 05 101 Pos Ctrl 66 TE CI 01 CI 02 cCI 03 a a CI 05 CI 06 CI 07 En s le ss less hoss ws Le fr avan 118 lose faor joa lose aor fo Adi al2 3 81 1 5 Do ea FOR RESEARCH USE ONLY 4 4 LC1115RUO 3 2 15 Assignments Displayed Values and Calculations Bead Assignment To determine the adjusted value for
75. e chosen If Save to PDF Save to Excel or Save to RTF is chosen choose a Save File Path 9 Click the Print icon Either one report containing all chosen samples will be generated or individual reports for each chosen sample will be gener ated 10 If an Audit Reportis desired click Audit Report This report can only be in pdf format Exporting Reports PDF HTML MHT RTF Excel CSV txt or Image File 1 Generate a report from the Reports tab in the DSA Analysis tab DS Analysis Ly Batch Name 20091013 D54 Assign Cutoff 2 2 e Trex En A Run Date 10 13 09 Assign Adjust 0 0 dior Bis Lot Number 102009 L MD Expiration Date 06 12 10 seme rene Class I BAFs Class I BAFs Class II BAFs Class II BAFs ON Reviewed By 2 Once a report appears on the screen click the Export Report icon in the upper right toolbar FOR RESEARCH USE ONLY 7 8 LC1115RUO 3 2 15 3 The dialog box that appears provides several different options for exporting saving the report E le E SE Lo Pp 7 aa 100 BEATA Ci dy Nl est g _ POF File IMMUCOR MHT File LIFECODES Phone 203 328 9597 RIF File 550 West Ave Fax 205 328 9508 XLS File Stamford Connecticut 06902 USA XLSX File Class I II pores SENS Batch ID 3000703 3000702 L CSV File Run Date 06 24 2013 Text File io Assignment Cutot 2 2 Image File 1 Adj Val Cutoff 0 00 0 00 ClassIBAF 126 Exporting Summary Results Many Lab
76. e montant que vous avez pay pour le logiciel ou bien de vous fournir les produits corrig s gratuitement si vous renvoyez les articles d fectueux au plus tard quatre vingt dix 90 jours apres votre date d achat Toute mauvaise utilisation ou modification non autoris e du logiciel annulera cette garantie limit e l exception des modalit s contenues dans le pr sent contrat Immucor Transplant Diagnostics Inc ne donne aucune garantie ne fait aucune d claration promesse ou garantie expresse ou implicite statutaire ou autre sur le logiciel la documentation de l utilisateur ou le soutien technique connexe y compris sur leur qualit leur rendement leur commercialit ou leur utilisation a une fin particuli re Cette garantie et les remedes expos s dans le present contrat excluent et remplacent toutes les autres garanties verbales ou crites expresses ou implicites Cette garantie vous donne des droits juridiques particuliers et vous pouvez galement avoir d autres droits qui varient d une juridiction a l autre 5 LIMITE DE RESPONSABILITE Comme le logiciel est fondamentalement complexe et peut contenir des erreurs vous tes responsable de verifier votre travail et d en faire des copies d archive En aucun cas Immucor Transplant Diagnostics Inc ou l un de ses donneurs de licence sera responsable de dommages indirects sp ciaux incidents civils economiques couverts ou cons quents occasionn s par l utilisation ou l impossib
77. each patient record Invalid date format Submit Batch To Luminex Draw Date must be a valid date and match the Preferences Date Format Setting MM dd yyyy Luminex Connection not available E 7 Submit Batch to Luminex j 1 Luminex Connection not available Ader Please check Luminex connection and re submit batch FOR RESEARCH USE ONLY Appendix A 3 LC1115RUO 3 2 15 Invalid Database Name Database Name is Invalid ER Cannot use the following character in a database name P Please enter a valid database name Successful Database Creation EVOLUTION Database MATCHITO20414 MatchIT04 212014042538 Created Successfully Detach in use data base Detached Unsuccessfully ma then detach functionality will work Detach database Confirmation _ Confirm Database Detach Are you sure you want to detach the database MATCHITdatabase eden Detach database suc cessful message Server local EVOLUTION Database MatchITOLO82015020712 matchit Detached Successfully FOR RESEARCH USE ONLY Appendix A 4 LC1115RUO 3 2 15 Database Backup successful message pa Server loca EVOLUTION Database MATCHITO20414 Backup Successful Invalid Login Warning A Invalid username or password Batch has already been imported into 4 CSV Import Lot Import Jha Ja database This batch 30012094M1 FlexMap Exp FM STD has been previously imported Please specify a new batch name MO1251
78. erate Graph 300107524 3001075 3001 Copy Grid SINGLE ANTIGEN E E ss Bs Se CCC Ba Y A a PEE Se Pr A BBSBR2E 25255252525 252525 2525 2556S SESESBEBESBSEEE REE Aix in FOR RESEARCH USE ONLY 9 7 LC1115RUO 3 2 15 By default the graph will be a bar graph with Antigens listed on the X axis and MFI on the y axis To modify the style of graph or to graph by an assay specific calculated value ADJ1 BCM etc right click anywhere in the graph and select from the menu that appears Edit title Point Labels Font Properties Creating Paired data sets and Graphing LSA IgG and C3d Creating LSA IgG C3d paired data sets 1 Search for the sample by name or by run date in the Patient List Search Window 2 Click any of the batches listed for the selected sample for all results to appear in Antibody Batch Results C3d batches will display in bold type mw Patient Details Patient Ab Graph Options mao Ps Patient Name Date of Birth _ Draw Date 8 Graph by Antigen TT remaniement dl ad lO paz J AA Graph by Date Checkout C3D SA2_ C3d EE 3 GS EN E checkoutLSA 2 a M Positive Assignment CheckOut C3d SA1 C3d e DM E ie Checkout Lsa 1v2 Antibody Batch Results Antibody History LA select CON MN patient 2 F TestType Ei J Z Sele
79. erology tail analysis To change to a 4 digit tail analysis See Antibody Parameters When Exclude Patient Type is turned ON on in the Reactivity Adjust ment tabs if not already selected under Preferences excluded antigens FOR RESEARCH USE ONLY 5 12 LC1115RUO 3 2 15 will be listed under the Excluded Antigens window in IDTail and not available for Tail Analysis Automatic Tail The software will assign a tail automatically if Perform Auto Tail Analysis is chosen as a preference or if Do Auto Tai is checked in the Patient Informa tion key See Tail Parameters ID only The tail will then be automatically assigned when imported Manual Tail 1 Tail preferences should first be set in the preference window See Tail Parameters ID only 2 Go to the 7ail Adjustment Groupings tab Hen hirt Mowe Group to Ta en Y o ei ER Pons Bew pear bs 3 Click New Move Group to Tail UnBo Tail sort By Group OFF Mew Assignments The antigens listed are those that meet the Tail Parameters previously set for a particular sample See Tail Parameters ID only The following statistics are displayed a of true positives b of false positives c of false negatives d of true negatives e Chi f R Value g Positive h Strength Index Avg MFI of all beads containing the antigen FOR RESEARCH USE ONLY 5 13 LC111
80. es Save ad Complete Approve ad Printing an Individual Sample Report or Audit Report LMS Analysis Patient Draw Dat ca I di wali 1 Select the sample ID in the Batch Listing pane 2 Right click the sample ID to access the report options Report LifeScreen Sample or Sample Audit Report A Sample Audit Report will only be gener ated if changes to the sample have been made If no changes then no report will appear 3 Once a report appears on the screen click the Print icon in the upper toolbar Batch Reporting 1 Go to the Home Antibody tab FOR RESEARCH USE ONLY LC1115RUO 3 2 15 2 Click the Antibody icon Antibody pk 3 Click the magnifying glass to display a calendar x Choose the date or g BE ad pene range of dates of when roots tsa roqRondest me the batch was imported PA 011810MIRclassI5A 10QR000353 122209MJRclassIxSA 10QR000383 Minoren ogee CG z a br mr in pe D me 1008000590 choice All samples pa 10QR000691 LL i i i Pres within the batch will dis Reporting Options per Test Save File Path play In the Samp Il e col LMX DSA LSA MDN C Documents and Settings tc0701 My Docum ws umn Y Single Sample per Report _ Send to Printer _J Include Pos Neg Controls w Save to PDF 6 Use the arrows to seve to xc sm move the samples to sve tor rae the Print right col
81. es depicted in this manual may differ slightly from MATCH IT Antibody software Please contact LIFECODES technical support with any questions FOR RESEARCH USE ONLY 1 4 LC1115RUO 3 2 15 CHAPTER 2 MATCH 1T MENUS This chapter provides descriptions of the home menu functions Menu func tions which can be found on the main home screen are described in brief with a link to more detailed instructions Other functions found only in the menu are described in this chapter in full detail File settings Tools Exports Reports Help Menus File Menu The File Menu contains addtional access to com Lot Information mon functions found on the home screen It allows the user to utilize keyboard shortcuts Batch Import Exit Lot Information Import Access to importing specific lot information EDS file See Importing EDS files into MATCH IT Batch Import Access to manually importing a csv file from a specified location See Manually Importing CSV Files Exit Ability to exit the software Settings Lab Settings Menu Se The Settings Menu contains laboratory Ab Reactivity Groups defined settings for the various assays Eplet Epitope Management Preferences This menu item contains several tabs for personal laboratory settings 1 Lab Information tab The user can input personal laboratory informa tion This is required information 2 Antibody tab This tab contains an individual tab for each antibody
82. ets using the new cut offs click Eplet Analysis Batch Failures Bead Count Failure elf a sample fails to meet the minimum bead count for a particular result the bead will be flagged as FAJLED To override the failure doule click the message and select the failed beads to include in the analysis FOR RESEARCH USE ONLY 5 10 LC1115RUO 3 2 15 Ot Berd Failure Beads 104 113 115 on o o 0O sla Lotto Reniy Aian k j 5 7 Bin Babes 08 28 2013 COM 16 CONE i CONE 11 33 Calon 31 53 Positive Con 20151 6 PRA b elf a CON bead fails to meet the minimum bead count the aie will report all beads as failed To override the failure click the message Yo mi 20130828 cs LM2Q_201350828 edi 525 edi kJ SsmpleNevigstion Esos EA A couranene Sample Information Patient Name RCMD 864 HLAType Loup 3000775 300074 MFI Cutoff As sgn Cutoff 2 3 Lise MET Cutoff This wall calculate the statistics for this sample as if the consensus besd s did nat fac This can not be undone re imperting batch is the onky resolution Do you wish to continue The source of all failures is listed in the ID Analysis header By clicking the FAILED message the user has the option to include failed beads in the analysis Note If a sample has both CON failures AND bead failures the CON fall ure must be overidden before the failed beads
83. fault Adjustments Exdude Patient Antigens Show DQ by Default Class I MFI Cutoff Perform Auto Tail Analysis Class II MFI Cutoff A Use Serology for Tail eal Use Class I MFI Cutoff on Import S Use Class II MFI Cutoff on Import FOR RESEARCH USE ONLY 2 5 LC1115RUO 3 2 15 a The Rval Cutoff is a score of 0 to 1 In the tail analysis the software will display all antigens with an R value greater than or equal to the cutoff set 7he default setting Is 0 b The Pos Cutoff is a score of 0 to 100 In the tail analysis the software will display all antigens with a positive score greater than or equal to the cutoff set The positive score represents the percentage of beads containing a particular antigen that are positive 7he default setting Is 50 c The Tail Sort feature allows the user to define the parameter by which to rank the antigens 7he default setting is RVal d For the software to automatically perform a tail analysis when opening the batch for the first time check Perform Auto Tail Analysis e If a 2 digit Serology tail analysis is preferred as opposed to the 4 digit Allelic check Use Serology for Tail f To always have the DQ enhanced beads LM2Q displayed in the bead ranking report check Show DQ by Default Analysis Options The user has the ability to perform Auto Eplet Analysis ID and LSA in the Eplet Settings tab Once the Auto Eplet Analysis is selected the appropriate parameter
84. ferences window MFI cut offs can be set individually for Class 1 and Class 11 and MICA The up and down arrow keys may be used A value can also be typed directly in the white box The user must then indicate that the value should be applied to data upon import Move Remove Exclude Antigens to from the Assignment LSA and C3d eThe user may right click EEN 2302 an antigen within the Move Antigen 24 02 to Antibady Assigament Grid assignment grid and Remove Antigen A 24 02 from Antibody Assignment Grid choose to Move or A ie antigen in ter Remove Antigens from Remove highlight of antigen A 24202 in Analyse Grid Antibody Assignments Copy Grid A elf Sample Antigens were entered into the sample list they will be displayed in the Sample Information tab Sample information Patient Name Doe Jane LAT ype B 27 05 8 27008 A D bot 03203F O2283A GA1 Run Date When Exclude HLA Type is turned ON in the Reactivity Adjustments tab if not already selected under Preferences excluded antigens will be listed under the Groupings tab FOR RESEARCH USE ONLY 6 7 LC1115RUO 3 2 15 eTo change the assignment of all Weak beads to Positive and have all such Antigens listed in Antibody Assignments check Include Weak in the Single Antigen Results window eTo change the assignment of all Weak beads to Negative check Exclude Weak in the Single Antigen Results window Note Once Includ
85. ff should only be altered by personnel knowledgeable in the field of HLA Antibody Analysis Changing these values will result in altered specificity and sensitivity of the assay See also for details on changing parameters Approving the Results of the Analysis Saving Completing and Approving an Assignment The Save Assignments button saves any assignment edits that have been made Changes can be made and re saved The Complete button locks all the samples in the batch and signifies all samples have been analyzed and are ready for sign off When a batch has been completed and locked only a Lab Technician or Lab Supervisor may unlock the samples by clicking Complete again Completing the results lists the batch as Completed on the home page The Approve button signified the samples are finished When a batch has been approved only a Lab Supervisor may unapprove the samples by click ing Approve again Approving the results lists the batch as Approved on the home page DSA Analysis Batch Name O54 FINAL Assign Cutoff 2 2 Run Date 08 05 2010 Assign Adjust 4 0 Lot Number 050108 LMo Expiration Date 01 01 2009 Class I BAFs 10 6000 Com1 0 8149 8 5567 CON270 7416 23 7180 COM S30 6671 Class II BAFs 16 3710 CON1 0 6877 11 2740 CON270 6527 16 7610 COMN3 0 64 0 Reviewed By CON Ranges Comments Se CON 1 92 193 CON 2 159 347 CONS 36 102 OOO gt Save Assignments eS A Adj 3 319 19 11 4 Sco
86. ght toolbar HTML File ss MET File Fax RIF File ALS File Class 1 Single Antigen Results forlgGand L XFie IgG Batch ID Checkout LEA lw2 CSW File Cid Batch ID CheckOut Cod SA1 Text File Cid E Image File Patient Name ARGS 2711 Patient DOB Donor Number Accession Sample ID 4452711 Draw Date Donar Center E ii PRA Loi iD 053034 06143B 541 Expiration Date 023114 Patient HLA Type 3 The dialog box that appears provides several different options for exporting saving the report 4 Select and Save to the chosen location FOR RESEARCH USE ONLY 9 12 LC1115RUO 3 Q 15 APPENDIX A ERROR CONDITIONS CSV File successfully imported Esa TONY 07303Y SAM FlexMap Exp Stand 20131217 143042 csv File imported Lot selected for import is not correct d has invalid Fe an as INVall CSV File Import Status probes 092034 541_FlexMap wrong probe name csv Batch wrong probe name LSA1 contains invalid probe list for Lot Please associate the CSV witha different Lot and try again CSV file contains duplicate sample names CSV File Import Status OSA CAP dupSamplenames csv Batch DSA CAP dupSamples contains duplicate sample names Please correct and then reimport CSV file contains invalid or inconsis tent sample names MA oe eae CSV File Import Status EN LUMX 3000875 PosSeraED2 2 csv Sample names are not consistent within the CSY file check for discrepencies CSV file is missing batch n
87. gn Cutoff should only be altered by personnel knowledgeable in the field of HLA Antibody Analysis Changing these values will result in altered specificity and sensitivity of the assay See Antibody Parameters FOR RESEARCH USE ONLY 4 6 LC1115RUO 3 2 15 Optional VBAF Analysis a EE LMX Hea der Negative Control Sample has Failed Options Reports Sort Batch Name 052410 dixscreen Assign Cutoff Run Date 05 24 2010 Assign Adjust 0 0 L view VBAF Calc Lle SJUAUWOJ ajdues Applying VBAF to an Entire Batch To apply the VBAF calculation to the entire batch select View VBAF Calc from the Options tab Applying VBAF to a Single Sample To apply the VBAF calculation to a single sample select the VBAF Calc checkbox in the header of the individual samples Approving the Results of the Analysis Saving Completing and Approving an Assignment The Save Assignments button saves any assignment edits that have been made Changes can be made and re saved The Complete button locks all the samples in the batch and signifies all samples have been analyzed and are ready for sign off When a batch has been completed and locked only a Lab Technician or Lab Supervisor may unlock the samples by clicking Complete again Only a Lab Supervisor can unlock a single sample by clicking the Locked box Completing the results lists the batch as Completed on the home page The App
88. h A graph of Raw MFI vs Controls Pos and 3 CONS is displayed next to the Antigen Graph only when Raw MFI vs Bead Antigens is chosen as the GIA graph FOR RESEARCH USE ONLY 6 14 LC1115RUO 3 2 15 Additional Graphing Features eTo change the y axis for what is displayed click any of the column headers Raw BCM BCR or AD BCR or BG Adjusted BCR and R Strength eTo change the bead order antigen order of the x axis right click any where within the graphing area and choose Sort By A selection of anti gen sorting options will appear eggo sosy Raw ValueDESC Gil Gallery BCM DESC 4000 atl R Zoom sh fii Graph Edit AD BCR DESC j PEPPE Sh 1242 sue q PES ee PUTANA JAANI EEEE EERE EEE EE EE E toa Bead DESC PEER AAA it rr 2 AAE EE EE y vere X EEES za Ez Za Gab nes mid aha 124 oe Properties Antigen ATC Ta i E giit niga Antigen DESC Standard Cakulaton Segle antigen Graphs Eplet Analysis eTo change the graph type i e from a bar graph to a line graph right click anywhere within the graphing area and choose Gallery A selection of graph types will appear eTo zoom right click anywhere within the graphing area and choose Zoom Use the mouse to make a box around the area to zoom elf a Group is selected the graph will highlight the bars for the beads containing an antigen in the selected Group The gray bars represent beads cont
89. ilit d utiliser des produits ou des services Immucor Transplant Diagnostics Inc ou de l un de ses donneurs de licence y compris mais sans s y limiter aux dommages ou aux co ts relatifs a la perte de profits de contrats de reputation commerciale de donnees ou de programmes informatiques m me si Immucor Transplant Diagnostics Inc a t avis de la possibilit de tels dommages En aucun cas la responsabilit de Immucor Transplant Diagnostics Inc d passera le montant pay par vous pour le logiciel ayant occasionne une telle reclamation Cette limite sur les dommages mon taires ne s appliquera pas aux plaintes relatives a des blessures corporelles ou des d c s occasionn s par des produits consid r s comme des biens de consommation en veru de la loi en vigueur Certains Etats provinces et autres juridictions ne permettent pas l exclusion ou la limite des garanties implicites ou la limite de la responsabilit pour dommages incidents ou cons quents et par consequent l exclusion ou la limite ci dessus peut ne pas s appliquer a vous Cependant dans les juridictions pertinentes Immucor Transplant Diagnostics Inc limite sa responsabilit conform ment aux modalit s du present contrat dans la mesure permise par la loi FOR RESEARCH USE ONLY SA 4 LC1115RUO 3 2 15 6 DROITS LIMIT S DU GOUVERNEMENT DES TATS UNIS Le logiciel et ou la documentation de l utilisateur sont fournis avec des DROITS LIMIT S ET RESTREINTS L uti
90. in the selected Group The grey bars represent beads containing antigens within the selected Group eTo change the graph type elo zoom eTo overlay a particular sample e the negative control onto each sample graph right select the sample of choice from the batch window and right click to choose Set as Negative Control Now when viewing any of the sample graphs within the batch the sample and the set neg ative control sample will display Batches a METE 16 F4 FR 50 SH 20091 104PR4 c2 m 144 64 E me 7 o em s6 Poa MEA E Note The user may select different samples within the batch to be desig nated as the Negative Control Once this option has been turned on for a batch it cannot be turned off Calculations and Displayed Values Calculations To determine the adjusted value for a bead divide the individual bead median MFI by the MFI for each Negative Control Bead CON1 CON2 CON3 From these values subtract the Background Adjustment Factor BAF for the appropriate bead CON combination The BAF is a pre deter mined MFI ratio for each bead CON combination to compensate for back ground noise due to bead variation and can be found on the lot specific Recording Sheet provided with the kit Individual Bead MFI CON1 MFI BAF Adjusted Ratio 1 Individual Bead MFI CON2 MFI BAF Adjusted Ratio 2 Individual Bead MFI CON3 MFI BAF Adjusted Ratio 3 The Class
91. int Reports Be Edt Find Groups Se p Options Groups 2 Click New 3 The previously assigned antigens either automatically or manually will be checked and highlighted in the window which appears Additional antigens may be added to the DJI ss history by checking the box next to the antigen Note This will so not change the saved assignments 4 Click Save 5 Confirm the decision to make a history snapshot of the results and name the Antigen History Group AE A ON x Save Group As Cancel Applying a Previously Created History to a New Sample A previously created History can be viewed with a new sample 1 Go to the History tab of the new sample 2 Click Find 3 Type either the name of the Antigen History Group or a key component of the name i e first letter 4 The history of the sample will display FOR RESEARCH USE ONLY 6 11 LC1115RUO 3 2 15 View Current Assigned History for a Sample 1 Go to the History tab of the new sample 2 Select the History from the drop down 3 The Saved History Snapshot will be highlighted Delete History 1 Go to the History tab of the sample 2 Select a History from the dropdown or use Find to search for a History 3 The History Snapshot will be loaded 4 Click Delete then confirm deletion Delete Sample History Are you sure you want to delete this sample history Column Customization LSA and C3d Columns locate
92. ion is provided in lot specific EDS files 1 Click Lot Information Import found on the Home tab of MATCH IT The Open dialog box will appear 2 Navigate to the location e g desktop of the EDS file s Select all appropriate files that need to be imported Use Ctrl left mouse button to select more than one EDS file at one time 3 Click Open A message will appear when all lots have been successfully imported Manually Importing CSV Files _ 1 Click Batch Import from the homepage This will open the Open dialog box 2 Navigate to the location of the CSV file s If importing from the computer connected to the Luminex CSV files can be found in C My Batches Output on IS 2 3 sys tems and at C ProgramData Luminex xPONENT31 Output on xPONENT systems TF GI Batch Import 3 Select all CSV files to be imported Use Ctrl left mouse button to select more than one CSV file at one time 4 When the file is selected the analysis is done automatically during the import process Once the csv file has been imported it will appear on the Antibody Home tab under ID Note A CSV Import Lot Import may appear after selecting a csv file This can be due to 1 the appropriate EDS file not being imported 2 the FOR RESEARCH USE ONLY 5 1 LC1115RUO 3 2 15 EDS file not being available See Lot Availability or 3 the lot number not being indicated on ti the CSV file Soc 1 Template Mame 3000651 Lotnotin dat
93. ive D ass ssignment Negative iv 1 100713NEG CI 01 CI 02 CI 03 CI 04 CI 05 CI 06 CI 07 CH 01 Cu 02 CI 03 CH 04 CH 05 Pos Ctrl CONS Viewing and Changing the Results of a Batch Scrolling through a Batch If all of the data for the batch does not appear on the screen the scroll bar can be used to move among the different samples Navigating to a Particular Sample To view a particular sample in the batch left click the sample name in the left hand pane The software will jump to this sample and it will be high lighted in red l o nu Tl en Batches mJ LMX Analysis y E Batch Name 100713 LMX SI2 Assign Cutoff re Options Reports Sort E Run Date 07 13 2010 Assign Adjust 0 0 T AT Lot Number 041310 LMX Supplemental Assign Cutoff 22 Li View VBAF Calc a h 8 100713 LMX SI2 Expiration Date 12 13 2010 Supplemental Assign Adjust 0 0 3 ju 6645 8134 Reviewed By E on 6 672 013 7 CON Ranges les028 CON 1 24 308 CON 2 27 841 CON 3 24 2527 Save Assignments J Complete Approve J 4 6 605 839 7 al gt 5 702 356 6 B Sample 5 702 356 6 Well Position 5 TT Locked I VBAF Bead Counts y Li ol 6 674 901 1 ii a Patient 5 702 356 6 lt g OF 100713PO5 Draw Date Class I Assignment Negative Class II Assignment Negative En 4 100713NEG a CII 02 CI 03 CII 04 E 257 204 2
94. lass II BAFs 16 3710 CON1 0 6877 11 2740 CON2 0 6527 18 7610 CON3 0 6440 General Reviewed By Comments CON Ranges Adj3 319 19 11 4 125 Score 0 Bead Counts l FOR RESEARCH USE ONLY 7 3 LC1115RUO 3 2 15 Changing the Sort Order The samples within a batch are loaded in order of their location in the batch By selecting the Sort tab located in the upper right the results can be ordered by Sample ID Well Location default CON1 CON2 CON3 Pos ctrl or Lys Ctrl Bead DSA Analysis Batch Name 20091013 D54 Assign Cutoff 2 2 Reports Export Sort Run Date 10 13 09 Assign Adjust 0 0 S Lot Number 102009 LMD Expiration Date 06 12 10 Class I BAFs Class I BAFs Well Location J Class IIBAFs Class II BAFs Reviewed By pS Sample ID CON Ranges Comments Well Location CON1 0 0 CON2 0 0 CON 3 0 0 Y Save Assignments Complete Approve a Adj 3 16560 5 13202 68 12 A conz aj pos TEA a A Displaying Bead Counts To display the bead counts for a sample click the down arrow next to Bead in the sample header 14217 Adj1 4546 22 13956 2 Adj2 4535 54 13964 66 Adj3 4230 64 13794 43 II Pos Ctrl 100 TN Assignments Displayed Values and Calculations Bead Assignment To determine the adjusted values for a capture
95. lect the appropriate Sam antigen pet Positive strength g Waso CE ple ID or Batch Name from the ee 10 search results 42601 100 ne 4 Choose an Export type D 16802 100 Predefined Exports Antibody Tail Export includes antigens with their Postive score and Strength Antigens display based on the Positive setting in the Tail Parameters For example if the positive is set to 75 only those anti gens 75 and above will display in the export Antibody Tail ID includes PRA Tail Antigens and any user comments on individual samples LifeScreen Export includes all information from the LifeScreen data includ ing individual sample information raw data for each bead run date score assignment and reviewer information User Defined Exports The user has the ability to create custom Exports to include all appropriate data This is done through the Export Wizard as explained above 5 If a Sample Search was performed a list of Batch IDs will appear Choose the appropriate batch A preview of the Export will display If a Batch Name Search was performed a list of Batch Ds will appear that contain all or part of the search text entered Choose the appropriate batch A preview of the Export will display 6 Click the drop down next to Save Options and choose the file type Note The Export button on the homepage will display the same win dow Reporting Antibody FOR RESEARCH USE ONLY 2 14 LC1115RUO 3
96. leted Approved Creating a History The user has the option of creating a Snapshot of the History for a particu lar sample In the story tab a user has the ability to load antigens to create a reactivity group specific to the sample This will enable a user to monitor changes in antibody status across kits and over time New History 1 Go to the History tab 3 The previously assigned antigens either automatically or manually will be checked and highlighted in the win dow which appears Additional antigens may be added to the history by checking the box next to the antigen Note This will not change the saved tail results 4 Click Save 5 Confirm the decision to make a history snapshot of the results and name the Antigen History Group Save Group pes C63646_LM1_20131106 Applying a Previously Created History to a New Sample A previously created History can be viewed with a new sample 1 Go to the History tab of the new sample FOR RESEARCH USE ONLY 5 16 LC1115RUO 3 2 15 2 Click Find 3 Type either the name of the Antigen History Group or a key component of the name e first letter 4 The history of the sample will display View Current Assigned History for a Sample 1 Go to the History tab of the new sample 2 Select the History from the dropdown 3 The Saved History Snapshot will be highlighted Approving the Results of the Analysis Approvi
97. lisation le d doublement ou la divulgation par le Gouvernement est soumise aux restrictions expos es dans les lois suivantes FAR 53 027 14 Juin 1987 Alternate lll g 3 Juin 1987 FAR 53 027 19 Juin 1987 ou DFARS 53 027 7013 c 1 11 Juin 1988 en vigueur L entrepreneur fabricant est Immucor Transplant Diagnostics Inc 550 West Ave Stamford CT 06902 Si le Gouvernement a obtenu le logiciel conform ment la pratique commerciale normale c est le pr sent contrat de logiciel et pas les articles des reglements cit s qui r gira les modalit s de permis au Gouvernement 7 GENERALIT S Aucun revendeur distributeur agent ou employ de Immucor Transplant Diagnostics Inc n est autoris a faire des modifications ou des additions au pr sent contrat Pour toute utilisation du logiciel en Am rique du Nord et en Am rique Latine le pr sent contrat sera r gi par les lois du Commonwealth du Delaware Pour tous les autres pays le pr sent contrat sera r gi par les lois du pays dans lequel le logiciel a t achete Clients Si vous avez des questions sur le present contrat ou sur les politiques d utilisation des logiciels Immucor Transplant Diagnostics Inc crivez a Inside Sales and Service Immucor Transplant Diagnostics Inc 550 West Ave Stamford CT 06902 USA CONVENIO PARA USO DE SOFTWARE DE IMMUCOR TRANSPLANT DIAGNOSTICS INC SI USTED NO ESTA DE ACUERDO CON ESTOS T RMINOS Y CONDICIONES NO INSTALE EL SOF
98. ll Sd Batches L Select All Samples EXpang ollapse A 2014 11 04MC LSA1 1 C3d 2014 11 03MC LSA1 1 IgG gt gt 2014 11 04MC LSA1 1 C3d 4 Samples paired through Patient View from the selected batch es will populate the window on the right and will be sorted by name a The User can Expand or Collapse the batch information displayed for all samples sample by clicking the appropriate button b The user can Expand or Collapse the batch information displayed for an individual sample by toggling the box next to the sample name 5 The user can select individual samples to export by marking the box next to the sample name If all samples are required for export the user mark the Select All Samples box Samples with Paired Results VA au Samples Collapse 6 To Export the results click the Export Paired Results Button The user can then save the exported data to any desired location Note files exported will be csv format FOR RESEARCH USE ONLY 2 16 LC1115RUO 3 2 15 CHAPTER 3 AUTOMATED BATCH SETUP This chapter describes how to set up a batch Detailed instructions are described including creating a sample list choosing a Luminex connection and then creating the entire batch for submission to the chosen Luminex Lot Information Import Importing Template files into Luminex Before creating a batch the information necessary for identifying the appropriate beads to count must be impo
99. lor from the Anti gen s Color drop down menu 3 Place a check mark next to all the antigens to be colored one color 4 Click Save 1 Under the Group Managment tab choose either Class I or Class II 2 Choose an existing group from the drop down menu if edits are needed or choose Add New 3 If creating a new group type the name of the group in the box and click OK 4 Place a check mark next to all antigens that need to be added to the newly created group or the group being edited 5 Click Save 1 An already exisiting xml file can be imported by clicking Import This file is available on LIFECODES section of our website 2 Once a category of groups is created an xml file can be exported by clicking Export FOR RESEARCH USE ONLY 2 8 LC1115RUO 3 2 15 Eplet Epitope Management This menu item allows the user to import or export Eplet information The file containing the eplet information is a csv file Separate files must be imported for Class 1 Class 11 and MICA Eplet Epitope Management Q Class I B 07 12 B 13 01 B 13 02 B 15 16 8 15 20 B 27 14 B 35 01 B 35 02 8 35 03 B 35 04 B 35 05 B 35 06 B 35 07 B 35 08 B 35 09 B 3 B 54 01 B 55 01 B 55 02 B 55 07 B 59 01 C 01 02 C 01 03 C 04 01 C 04 03 C 04 04 C 04 05 0 05 01 C 06 02 C 06 03 C 06 04 C B 73 01 A 02 01 A 02 02 A 02 03 A 02 04 A 02 05 A 02 06 A 02 07 A 02 08 A 02 09 A 02 10 A 02
100. ls Menu gives the user access to man ee agement of certain properties in the software Lot Availability such as display of lots screen assignments to LifeScreen Assignments display and management of both users and Instruments Manage Luminex Systems Manage Users Available Assays Lot Availability The Lot Availability window displays all templates and expiration dates imported into the database The user has the option of which lots to make available by checking the box next to the lot under the Available column If a lot is checked as Available then this lot can be used to import data and to create a batch To search for a particular lot type a portion of the lot ID in the Lot Search box FOR RESEARCH USE ONLY 2 9 LC1115RUO 3 2 15 Left click any of the headers Lot ID Expiration Date Assay Name to sort the column LifeScreen Deluxe Assignments The LifeScreen Deluxe Assignment Management window allows the user to create assignments for use when analyzing LifeScreen Deluxe data Posi tive Negative and Failed are automatically assigned to samples High Background and ND Not Determined are default assignments but must be manually assigned when reviewing data Other user defined assign ments may be created or deleted in this management window Creating a LifeScreen Deluxe Assignment Text gt ifescrsen Assonments 1 Type the desired text in the A Assignment Text field ex can FE Delete Repeat
101. lues 6 13 Graphical Display LSA and C3d 6 13 Antigen Graph 6 13 Control Graph 6 14 Additional Graphing Features 6 15 Batch Failures LSA and C3d 6 16 Bead Count Failure 6 16 Approving the Results of the Analysis 6 17 Saving Results 6 17 Reporting and Printing 6 18 Customizing a Final Report 6 18 Quick Print 6 19 Batch Reporting 6 19 Exporting Reports 6 20 Exporting Summary Results 6 21 DSA Analysis Importing DSA Results into MATCH IT 7 1 Importing EDS files 7 1 Manually Importing CSV Files 7 1 Opening a Batch 7 2 Direct Selection 7 2 Date Range Selection 7 2 Viewing and Changing the Results of a Batch 7 3 FOR RESEARCH USE ONLY TOC 7 LC1115RUO 3 2 15 Chapter 8 Scrolling through a Batch 7 3 Navigating to a Particular Sample 7 3 Changing the Sort Order 7 4 Displaying Bead Counts 7 4 Assignments Displayed Values and Calculations 7 4 Batch Failures 7 5 Overriding an Assignment 7 5 Overriding Default Parameters 7 6 Approving the Results of the Analysis 7 6 Saving Completing and Approving an Assignment 7 6 Reports 7 7 Printing Standard Report 7 7 Printing an Individual Sample Report or Audit Report 7 7 Batch Reporting 7 7 Exporting Reports 7 8 Exporting Summary Results 7 9 Database management Creating a New Database 8 1 Deleting a Database 8 1 Attaching a Database 8 2 Detaching a Database 8 2 Backing Up a Database 8 2 Restoring a Database 8 2 Choosing a Server 8 3 Connecting to
102. ly imported Manually Importing CSV Files 1 Click Batch Import from the homepage q This will open the Open dialog box GI Batch Import 2 Navigate to the location of the CSV file s If importing from the computer connected to the Luminex CSV files can be found in C My Batches Output on IS 2 3 sys tems and at C ProgramData Luminex xPONENT31 Output on xPonent systems 3 Select all CSV files to be imported Use Ctrl left mouse button to select more than one CSV file at one time 4 When the file is selected the analysis is done automatically during the import process Once the csv file has been imported it will appear on the Antibody Home tab under L feScreen Note A CSV Import Lot Import may appear after selecting a csv file This can be due to 1 the appropriate EDS file not being imported 2 the FOR RESEARCH USE ONLY 4 1 LC1115RUO 3 2 15 EDS file not being available See Lot Availability or 3 the lot number not being indicated on the CSV file Y Cov Import Lot Import gt Len mot database Please select lot from ist NA A 3000573 A Le 2000651 3000626 1M1 ete AEF tee A MO parra A Pe S000 DOC a a a TAA ee E ae ie Opening a Batch Direct Selection LifeScreen Batch ID Import Date Number Of Sample Lot Number Product Nam A LMX 022709 PL 02 27 2009 06 17 2010 6 092508R LMX DELUXE 092508R LMX Pending Analysis MO617104 03 30 2010 06 17 2010 24 0
103. n change vous avez le droit de l utiliser uniquement si vous tes un utilisateur autoris d un produit vous qualifiant tel que defini par Immucor Transplant Diagnostics Inc et a condition i d effacer le produit vous qualifiant ou d installer le nouveau produit dans le m me ordinateur ou r seau que le produit vous qualifiant et ii de ne pas transf rer le produit vous qualifiant a une autre personne 2 RESTRICTIONS Sauf autrement pr vu en Section 1 vous ne pouvez pas alt rer amalgamer modifier ou adapter le logiciel de quelque maniere que ce soit y compris par r troing nierie d compilage ou desassemblage Vous ne pouvez pas vendre distribuer pr ter louer a court terme ou a long terme licenser ou autrement transf rer le logicier ou le copier l exception de transf rer de mani re permanente le logiciel y compris toutes ses versions ant rieures et de transf rer le contrat de logiciel et toute la documentation et les m dias et ne retenir aucun exemplaire Si le logiciel est un logiciel de d monstration et d valuation vous ne pouvez pas transf rer le logiciel a des fins commerciales Si vous avez acquis le logiciel pr charg dans un ordinateur en achetant l ordinateur logiciel MEO vous ne pouvez pas s parer ce logiciel MEO ou toute disquette l accompagnant de l ordinateur Si vous utilisez le logiciel dans un pays de la Communaut europ enne la d fense contre toute modification amalgamation alt ratio
104. n ou adaptation du logiciel ne modifie pas vos droits en vertu d une l gislation appliquant les directives du Conseil de la CE sur la protection juridique des programmes informatiques Si vous recherchez de l information d interface conform ment au texte de l Article 6 1 b de FOR RESEARCH USE ONLY SA 3 LC1115RUO 3 2 15 ces directives vous devez d abord contacter le service suivant Immucor Transplant Diagnostics Inc 550 West Ave Stamford CT 06902 USA 3 DROITS DE PROPRIETE INTELLECTUELLE Tous les droits de propri t intellectuelle sur le logiciel et la documentation de l utilisateur appartiennent a Immucor Transplant Diagnostics Inc ou a ses fournisseurs et sont prot g s par les lois sur la propri t intellecutelle en vigueur y compris les lois sur les brevets les marques de commerce et les droits d auteur et les modalit s des trait s internationaux Immucor Transplant Diagnostics Inc conserve tous les droits non express ment accord s 4 GARANTIE LIMIT E Pendant les quatre vingt dix 90 jours qui suivent la date d achat Immucor Transplant Diagnostics Inc garantit i que le logiciel se conformera substantiellement la documentation destin e a l utilisateur et ii que les m dias magn tiques sur lesquels le logiciel est distribu et la documentation de l utilisateur s il y en a une sont libres de tout vice de mat riaux et de main d oeuvre Immucor Transplant Diagnostics Inc choisira de vous rembourser l
105. n the reports and user interfaces the Date Format Settings may be changed in this tab It is also necessary to select a date format used in the Luminex system which specifies the run date format in the output files generated by Luminex 4 Page Layouts This tab allows the user to restore a specific page lay out to its default settings This only needs to be performed if changes have been made to any of the layout of a particular assay Select the layout and click restore 5 Report Settings This tab allows the user to choose paper size and address format Settings will be applied to all reports Antibody Reactivity Groups This menu item allows the user to create user defined antigen groups FOR RESEARCH USE ONLY gt LC1115RUO 3 2 15 Ab Reactivity Group Management To color y Export Color Management Group Management class 1 O Class II _ ees Antigen s Color gt lt i D To create or edit a group Ab Reactivity Group Management x Import Export Close Color Management Group Management Save Delete Class II Class I Group s 2c M IL Antigen gt D Ki To Import Export Group Data code _antigens 1 nder th lor Managment tab ch ither Cl I or Class II 2 Choose a co
106. n the Luminex IS software will be listed here Highlight the batch to be acquired and click Select 3 Verify the plate is a direct representation of the Run Batch screen in the Luminex software 4 To acquire the samples click Start Plate once the sample tray has been placed into the XY Platform of the Luminex system Note It is not possible to change positions when opening a single batch The correct position needs to be selected when Creating the Automated Batch Running a Multi Batch in Luminex IS 2 3 Once an Automated Batch is created and submitted to Luminex the user must give the command for the Luminex software to acquire the samples within a multi batch 1 Click Create Multi Batch found on the homepage of the Luminex IS software FOR RESEARCH USE ONLY 3 5 LC1115RUO 3 2 15 2 Click the Add Batch icon in the top left hand corner of the screen Any batches that have not been acquired in the Luminex 1S software will be listed here 3 Highlight the batch to be added to the multi batch and click Select 3 Repeat steps 1 and 2 until all desired batches have been added to the multi batch 4 Verify the plate is a direct representation of the Run Batch screen in the Luminex software 5 Name the multi batch and add the user s initials Click Save The multi batch will automatically load but could be saved for a future date if necessary by choosing Open Multi Batch 6 To acquire the samples click Start Plate on
107. ng Results When Save is clicked the analysis for the sample is saved but can be ana lyzed again ib Y UN Du Y Simple gui lt SN A COMPARE Se rar Postes ROSH Hate ue LOH paie ES Toon mete Ad copie Reactivity dajusnents Talctment Grops Hstry Pant Reports When Restore is clicked the sample will revert to the most recently saved data assignments Once analysis is complete and no additional changes need to be made for a particular sample click Complete Only a Lab Technician or Lab Supervi sor may make changes to a sample by clicking Complete again When all samples in a batch have been designated as Complete the batch status will be listed as Completed on the home page and signify they are ready for Approval Patent hares CMD 154 fschitydustnents Taladjciret Gros Hery rn apes Once the analysis of completed results has been reviewed click Approved Once clicked changes can no longer be made except by a Lab Supervisor by clicking Approved again When all samples within a batch FOR RESEARCH USE ONLY 5 17 LC1115RUO 3 2 15 are designated as Approved the batch status will list the batch as Approved on the home page Reporting and Printing After the sample has been analyzed automatically or by using the manual tail analysis features the user has the ability to customize a report Customizing a Final Report 1 Once the results have been Approved go to Print Reports
108. nitiva incluso todas las versiones anteriores a reserva de que transfiera el Convenio para Uso de Software y toda la documentaci n y soportes magn ticos y no retenga copia alguna Si el Software es un software de demostraci n y evaluaci n D y E no podr transferir el Software con prop sito comercial En caso que adquiriera el Software precargado en computadora como parte de su compra de la computadora Software del Fabricante entonces no podr transferir ese Software del Fabricante por un valor aparte del de la computadora Si est haciendo uso del Software en cualquier pa s de la Comunidad Europea la prohibici n de alterar fusionar modificar o adaptar el Software no afecta a sus derechos bajo ninguna legislaci n que aplique las Directrices del Consejo de la C E sobre la Protecci n Legal de Programas Inform ticos Si busca informaci n de interfase en los t rminos del Art culo 6 1 b de esas Directrices debiera inicialmente consultar Immucor Transplant Diagnostics Inc 550 West Ave Stamford CT 06902 USA 3 DERECHOS DE PROPIEDAD INTELECTUAL Immucor Transplant Diagnostics Inc o sus proveedores son titulares de todos los derechos de propiedad intelectual del Software y de la documentaci n del usuario y est n protegidos por leyes sobre propiedad intelectual vigentes incluso por leyes sobre patentes marcas registradas y derechos de autor as como por disposiciones de tratados internacionales Immucor Transplant
109. off Reactivity Adjustments Tal Adjustment Groupings History Print Reports ae scour 6m icaicon 87 cont 16 1581 Assign Adjust 0 00 g Assign Cutoff 28 D cON2 7a Postvecon 20461 conz 36 450 Ets 10 cons 67 PaA 42 CONS 31 1725 Cutoffs en Control Values 1 Under the Reactivity and Adjustments tab click the box next to Use MFI Cut off 2 The MFI value box is now available Select the value box The up and down arrows can be clicked to the desired value or the up and down arrow keys may be used A value can also be typed directly into the white box Once the value is entered click the graph to view the new cutoff 3 An alternative to step 2 is to right click anywhere on the graph and choose Graph Edit The Cut Off bar will then be visible and can be moved to the desired value 4 Click Save 5 To apply an MFI cut off to all samples for Class I or Class II a user may select MFI mode in the ID tab of Preferences window MFI cut offs can be set individually for Class I and Class II The up and down arrow keys may be used A value can also be typed directly in the white box The user must then select the box that indicates that the value should be applied to data upon import Note If Eplets are assigned and reactivity adjustment changes are made using MFI mode Eplet assignments will clear To assign epl
110. oratory Information Systems require simple export files that list only the samples and results This file can be generated directly from the Exporttab See Export Results Antibody FOR RESEARCH USE ONLY 7 9 LC1115RUO 3 2 15 CHAPTER 8 DATABASE MANAGEMENT This chapter provides information regarding managing databases including creating deleting backing up and storing databases To open the database management window you must first click on the Start button located at the lower left of the computer screen 1 Go to All Programs and then select Lifecodes 2 Select Database Manage ment 3 Select Antibody from the Appli cation dropdown 4 4 Sign in using the same Login and Password that are used to access the Matchit Antibody analysis software Login supervisor Pass word lifecodes and click Login 5 The Database Management window will open Choose Server Server local EVOLUTION Database MATCHITE Creating a New Database To create a new database select New Database A prompt for a name will appear A database name must start with a letter Once named click Ok Deleting a Database FOR RESEARCH USE ONLY 8 1 LC1115RUO 3 2 15 To delete a database highlight the database to be deleted and select Delete Database A prompt will appear asking if the database should be deleted Select Yes to delete the database Once a datab
111. otorga derechos jur dicos espec ficos y quiz usted tambi n disponga de otros derechos que var an de una jurisdicci n a otra 5 LIMITACI N DE RESPONSABILIDAD CIVIL Toda vez que el software es inherentemente complejo y no pueda ser libre de errores por entero es responsabilidad de usted verificar su trabajo y hacer el copiado preventivo En ning n caso Immucor Transplant Diagnostics Inc o cualquiera de sus licenciantes ser responsable por da os y perjuicios indirectos especiales incidentales extracontractuales econ micos de cobertura o consecuentes derivados del uso o la inhabilidad de uso de productos y servicios de Immucor Transplant Diagnostics Inc o de cualquiera de sus licenciantes entre los cuales figuran los FOR RESEARCH USE ONLY SA 6 LC1115RUO 3 2 15 da os o costos vinculados a la p rdida de ganancias negocios plusval a datos o programas inform ticos aun cuando se advirtiera la posibilidad de tales da os En ning n caso la obligaci n de Immucor Transplant Diagnostics Inc ser superior al monto desembolsado por usted en la compra del Software del cual derivara aquella reclamaci n Esta limitaci n sobre da os pecuniarios no ser aplicable a reclamaciones relativas a la p rdida de la vida o la lesi n corporal que surja de productos que se les d tratamiento de bienes de consumo conforme a la ley aplicable Algunos estados provincias y dem s jurisdicciones no permiten la exclusi n o limitaci n
112. own below ID Batch ID Run Date LM 2009 05 25 AM2 03 25 09 2 A pair of calendars with a start and end date will open Select the desired range and click OK 3 The batch results are displayed under the D Analysis tab All sample results appear in the middle section of the tab Individual sample IDs within the selected panel are listed in the left section of the tab under the batch name Viewing a Sample within a Batch Navigating to a Particular Sample To go to a particular sample in the batch left click the sample ID in the eted samples will be highlighted with bold text completed and approved samples will be bold and italicized LM1_20130828 gt H RGMD 658 4218 D05421 FOR RESEARCH USE ONLY 5 3 LC1115RUO 3 2 15 The upper arrows can also be used to move from sample to sample Antibody 10 Analysis Sample Hanged lt 093340004 44 gt Tabs in the Analysis screen Once a Sample is selected the Standard Calculation tab will display the bead ranking grids The user can select between Serology and Allelic phe notype displays by clicking on the tabs at the top of the grid Both tabs look similar and can be customized as described in the below sections Tail Analysis will only be available in the grid designated in Preferences See Analysis Options 153 HA 13 117 127 131 142 140 132 143 122 125 ga 39 13 i 1 1 i 1 aS Bis
113. ph a Print Final Report True Positives Tru B Graph Value Raw Value F Quick Print Print Sample Audit Graph Sort Raw Value DESC 3 gt t Typ Frint 3 Once a report appears on the screen click the Print icon in the upper toolbar FOR RESEARCH USE ONLY 6 18 LC1115RUO 3 2 15 Quick Print Either a Bead Ranking report or Graph can be printed by clicking Quick Print The Bead Ranking Report is sorted as it is sorted in the grid All anti gens associated with each bead will be listed as well as whether the bead was assigned as Positive or Negative Batch Reporting 1 Go to the Home Antibody Tab 2 Click the Antibody icon Antibody P EN a 3 Click the magnifying glass to display a calendar l Antibody Batch Reporting i Batch Reporting Options per Test Save File Path CUnjDsa LSA pi Assignmen mon C Documents and Settings tc017011Mwy ocur lud Send to Printer e Save to PDF L Save to Excel Save to RTF FOR RESEARCH USE ONLY 6 19 4 Choose the date or range of dates of when the batch was imported 5 Batches will dis play in the Batch col umn Double click the batch of choice All samples within the batch will dis play in the Sample column 6 Use the arrows to move the samples to the Print right col umn which will include them in the batch reporting 7 Once all desired samples have been LC1115RUO 3 2
114. ple computers are connected in a network with a computer acting as a File Server FOR UPGRADES AND TRADEUPS If the Software is an upgrade or a trade up you are authorized to use the Software only if you are an authorized user of a qualifying product as determined by Immucor Transplant Diagnostics Inc and provided you i either delete the qualifying product or install the new product on the same computer or network as the qualifying product and ii do not transfer the qualifying product to any other person 2 RESTRICTIONS Except as expressly provided in Section 1 you may not alter merge modify or adapt the Software in any way including reverse engineering disassembling or decompiling You may not sell distribute loan rent lease license or otherwise transfer the Software or any copy except you may permanently transfer the Software including all prior versions provided you transfer the Software Agreement and all documentation and media and you do not retain any copies If the Software is demonstration and evaluation D amp E software you may not transfer the Software for commercial purposes If you acquired the Software preloaded on a computer as part of your purchase of the computer OEM Software then you may not transfer such OEM Software or any accompanying disks for value separately from the computer If you are using the Software in any country in the European Community the prohibition against altering merging modif
115. ppropriate files that need to be imported More than one may be selected at one time by pressing Ctrl left mouse button 3 Click Open A message will appear when all selected files have imported successfully Automated Batch Setup Setting Automated Batch Preferences This tab customizes the information to be either entered manually or imported from a sample list To customize which import columns to include in a batch l gt Automated Batch Setup l Oj xj Automated Batch Setup Automated Batch Status Automated Batch Preferences Batch Preferences Select the Batch columns that you wish to import and track Batch Import Columns IV Sample ID Tl Donor Center IV Patient Name J Patient Donor Number IV Draw Date J Patient DOB M Accession Number M Patient HLA Type D Sex Update Batch Preferences 1 Click Automated Batch Setup on the Home Screen 2 Go to the Automated Batch Preferences tab 3 Place a check in the box next to each item to be included as an import column 4 Save by clicking Update Batch Preferences Once Batch Import Col umns are selected they will appear as columns under the Automated Batch Setup tab Creating a Sample List optional A sample list is a file containing a comma separated list of the data selected on the Automated Batch Preferences tab As a minimum the Sample ID is present in each list All other fields are optional To create a sample List 1 Open a blank
116. re 0 Bead Counts ead Faire a Postive 1 el boue tel A FOR RESEARCH USE ONLY 7 6 LC1115RUO 3 2 15 Reports Printing Standard Report 1 Once the results have been accepted a report can be generated The report for the batch can be ordered by sample or well location 3000703 30007024 M0_1ED Assign Cute 2 2 Far Research Use Only Reports Export Sort 06 24 2013 Assign Adjust 0 0 EX 3000703 3000707440 Expiration Dabe 01 15 2014 Sample D welLocaton 125 900 CORT 53 355 CON 430 52 853 2000430 660 51 500 COND 25S 220 400 CONSO ed 60 See CON CL 8 70 Comments Cc B Assignmen 7 am 2 The report is created by pressing the Generate DSA Report button 3 Once a report appears on the screen click the Print icon in the upper toolbar Printing an Individual Sample Report or Audit Report 2667S69 LCR conto co 1 Select the sample ID in the Batch NID ce Listing pane Adj3 17275 5 Score 3 Report Sample i 4611265 LCR Sample Audit Report 2 Right click the sample ID to access the report options Report Sample or Sample Audit Report A Sample Audit Report will only be generated if changes to the sample have been made If no changes then no report will appear i 7 L 5053415 LCR of JBH HTO i laimnaos in 3 Once a report appears on the screen click the Prin
117. rove button signifies that analysis of the samples is finished Only a Lab Supervisor can approve or unapprove a batch To unapprove click Approve again Lab Supervisors can also unlock individual samples by clicking the Locked box Approving the results lists the batch as Approved on the home page CON Ranges A CON 1 24 308 CON 2 27 641 CONS 24 2621 save Assignments Complete Approve Lo E FOR RESEARCH USE ONLY 4 7 LC1115RUO 3 2 15 Ci C5 Cl lase 87 seva ces ad Ft tren LE Reports Printing Standard Report 1065 tener issus Sample Pas Cen bet 3000753 Well Position A Patient Pos Con Lot MONTE e a Class JAssignencnt Postve C2 Class Tl Assignment Perme ad Cr cua QE OS CNA 2005 Postel ER 2147 IGN 131397 lea fas 1130 61 77 7 E p 1 Once the results have been approved a standard report may be run The report for the batch can be ordered by sample or well location 2 The report is created by clicking the Generate LMX Report button 3 Once a report appears on the screen click the Print icon in the upper Options Reports Sort Sort By N 18 Sample Well Location toolbar Batch Name 20100324 PRA S Assign Cutoff 1 1 Run Date 03 24 10 Assign Adjust 0 0 Lot Number 091609 LMX Supplemental Assign Cutoff one Expiration Date 05 16 10 Supplemental Assign Adjust 0 0 Reviewed By CON Rang
118. rted into the Luminex software The information is provided in lot specific template files Files with the extension idt are designed for use with the Luminex IS 2 3 software Files with the extension Ixt are designed for use with the Luminex xPonent soft ware Templates can be downloaded from the Immucor website To import an IDT file into Luminex IS 2 3 1 Go to File gt Import Template found on the Luminex software home tab 2 Navigate to the location of the IDT file s Choose the appropriate file to be imported Only one file may be chosen at a time 3 A message will appear for each successful file import To import an LXT file into Luminex xPONENT 1 Select the Protocols Tab at the top of the Luminex xPONENT screen 2 Click on the Import button on the bottom of the screen 3 Navigate to the location of the LXT file s Choose the appropriate file to be imported Only one file may be chosen at a time 4 A message will appear for each successful file import Importing EDS files into MATCH IT Before creating a batch the information necessary for analyzing data generated by the Luminex instru ment must be imported The information is provided in lot specific EDS files To import an EDS file t O LotInformation Import 1 Click Lot Information Import found on the Home Screen The Open dialog box will appear FOR RESEARCH USE ONLY si LC1115RUO 3 2 15 2 Navigate to the location of the EDS file s Select all a
119. rts Include Graph k Print Final Report Tail Antigens Tru 3 Graph Value RawVaue Quick Print m Print Sample Audit Graph Sort Raw Value DESC 3 p port Type 2 Once a report appears on the screen click the Export Report icon in the upper right toolbar 3 The dialog box that appears provides several different options for exporting saving the report FOR RESEARCH USE ONLY 5 20 LC1115RUO 3 2 15 2 E 100 E I M M U COR LIFECODES 550 West Avenue Stamford CT 06902 USA Patient Name C6s646 Sample ID C63646 Exporting Summary Results HTML File MHT File RIF File ALS File ALSA File CSV File Text File 30828_ Image File DA Many Laboratory Information Systems require simple export files that list only the samples and results This file can be generated directly from the Exporttab See Export Results FOR RESEARCH USE ONLY 5 21 LC1115RUO 3 2 15 CHAPTER 6 LIFECODES SINGLE ANTIGEN ANALYSIS This chapter contains information on the tools available to analyze LIFE CODES Single Antigen Class I and II C3d and LIFECODES Single Antigen MIC LSA Importing Single Antigen Results into MATCH IT If an Automated Batch was not created and data needs to be manually imported into the software the appropriate EDS file must first be imported fol lowed by the csv file Importing EDS files Before importing LSA data the information nec eo Lot Inform
120. s appear in the middle section of the tab Individ ual sample IDs within the selected panel are listed in the left section of the tab under the batch name DSA Analysis Batch Name DSA FINAL Assign Cutoff 2 2 Run Date 08 05 2010 Assign Adjust 0 0 Lot Number 050108 LMD Expiration Date 01 01 2009 Class I BAFs 10 6000 CON10 8149 8 5567 CON2 0 7416 23 7180 CON370 6671 Class II BAFs 16 3710 CON10 6877 11 2740 CON20 6527 18 7610 CON3 0 6440 Reviewed s Reports Ext Sort By 8 Sample Gen Comments Se Adj 3 13917 57 9896 12 11 soe S a E Bead Counts Viewing and Changing the Results of a Batch Scrolling through a Batch If all of the data for the batch does not appear on the screen the scroll bar can be used to move among the different samples Navigating to a Particular Sample To go to a particular sample in the batch left click the sample name in the left hand pane The software will jump to this sample and it will be high lighted in red Antibody DSA Analysis Sample Navigation lt gt Batches DSA Analysis Batch Name DSA FINAL Assign Cutoff 2 2 Reports Export Run Date 08 05 2010 Assign Adjust 0 0 Sort By Lot Number 050108 LMD Expiration Date 01 01 2009 sample ap DSA FINAL Class I BAFs 10 6000 CON1 0 8149 8 5567 CON2 0 7416 23 7180 CON3 0 6671 j C
121. s can then be chosen to analyze the data Note The Auto Eplet Analysis feature is not available for use if Use Serology for Tail is turned on Additional Preferences a Exclude sample antigens The user has the ability to Exclude Antigens on import if this information in entered during Automated Batch Set up ID and LSA To Exclude Antigens for ID the Exclude Patient Antigen box must be checked on the Settings tab in ID To Exclude antigens for LSA the Exclude Patient Antigens box must be checked on the Settings tab in LSA and the import Exclude Antigen CSV file available from the Immucor website must be imported in to the software FOR RESEARCH USE ONLY 2 6 LC1115RUO 3 2 15 Note 7 he samples HLA type must be entered into the sample list or added to the Sample Profile in Patient View in order to display on the report This feature is designed for batches submitted to Luminex through the MATCH IT software In order for antigens to be excluded they must match an antigen listed on the product worksheet and be separated by commas Example A2 A24 B56 B51 or A 02 01 A 24 02 B 56 01 B 51 01 b Override Default Adjustments 254 and C3d only allows the user to set new cutoffs and apply them to all future batches of a given lot When this box is left un checked lot specific cut offs will be applied when in Standard Mode This box is unchecked by default 3 Date Format Settings To change the date format that appears i
122. sabled in Lab Settings fea ture See Preferences Overriding an Assignment While the software performs analysis according to the product insert all results should be reviewed During this review process an assignment can be changed manually by clicking the arrow on the right side of the text box and selecting one of the choices that appears a sadAjouayd vg LMX Header Negative Control Sample has failed Batch Name 052410dlxscreen Assign Cutoff 11 Run Date 05 24 2010 Assign Adjust 0 0 Lot Number 010710 LMX Supplemental Assign Cutoff qua L view VBAF Calc Expiration Date 09 07 2010 Supplemental Assign Adjust 0 0 Reviewed By Devtest Supervisor Options Reports Sort CON Ranges CON 1 20 231 CON 2 21 789 CON 3 39 1942 Save Assignments Complete Approve 7 tarked M VRAF Bead Counts _ Sample Neg Well Position Patient Neg Draw Date CI 01 CI 02 CI 03 CI 04 CI 05 CI 06 CI 07 CII 02 CII 03 CII 04 CII 05 Pos Ctrl CONS 98 65 58 o 11894 1166 125 _ 116 128 M20944 3 27 3131 3 78 5 03 2 99 2 86 3 35 3 05 4 18 3 51 1 81 1 97 2 5 3 66 1 22 1 1 78 1 31 1 63 1 62 Class I Assignment Failed Y Class II Assignment Failed y SIUSWWOD ajdues 2 43 2 64 2 62 2 77 21 2 2 75 2 34 2 71 2 42 Score O To lo 0 0 i lo lo lo lo Overriding Default Parameters The default parameters Assign Adjust and Assi
123. ser to chose how many controls need to be positive in order for the bead or analyte to be positive b The Assign Adjust 1 2 amp 3 LifeScreen Deluxe ID and DSA BCM BCR and AD BCR LSA only and BGA BCM and R Strength C3d Only is the value used by the software to determine if a bead value is positive This value sets the positive threshold for the adjusted value 7he default adjustment is O for all but LSA and C3d which have lot specific default adjustments When an Adjusted Value Adj Val 1 2 and 3 or BCM BCR and AD BCR or BGA BCM and R Strength exceeds the Assign Adjust value the Adjusted Value is considered positive Thus by raising the Assign Adjust the assay sensitivity is reduced FOR RESEARCH USE ONLY 1 LC1115RUO 3 2 15 c The Pos Neg Control Override L feScreen Deluxe only when submitting batches to Liquid Handler allows the logged in user to decide if this function should be enabled When enabled the entire batch is tied to the performance of the Positive and Negative control All samples will be listed as failed if either the Positive or Negative Control samples fail eA Negative Control is considered as failed if any bead fails to meet the minimum bead count or if the Negative Control has a positive assignment for Class I or Class II eA Positive Control is considered as failed if any bead fails to meet the minimum bead count or if either of the Class I or Class II assignment is negative d En
124. t icon in the upper toolbar Batch Reporting 1 Go to the Home Antibody tab 2 Click the Antibody icon Antibody a Export Antibody FOR RESEARCH USE ONLY Ar LC1115RUO 3 2 15 3 Click the magnifying glass to display a calendar ibody Batch Reporting 4 Choose the date or QU PA range of dates of when _ nu i STR the batch was F TT 040109 d im ported x ae 5 Batches will display SAN O4218E 042408 in the Patch column RUSSES Double click the batch gt 20090511 9623910 DSA of choice All samples 17 07 08 LSA1 BF DSA Lysate Test 0308108 a within the batch will Reporting Options per Test Save File Path d ISP ay In th e Si amp Ly DSA A ID C Documents and Settings tcO701 My Docum P col unmn v Single Sample per Report Send to Printer 6 U se th e arrows to Include Pos Meg Controls e Save to PDF move th e sam p es t O _ Save to Excel aust Rent the Prin t M righ t col a RRT umn which will include them in the batch report A 7 1f individual reports of the samples moved to the Print right column are preferred choose the LifeScreen DSA tab under Reporting Options and check Single Sample per Report There is then the option to nclude Pos Neg Controls 8 Select desired Reporting Option Send to Printer Save to PDF Save to Excel or Save to RTF Multiple options may b
125. tab Approv ing the results is not a requirement to print indude Graph Final Report Tal Antigens Tru h Graph Value Rawvaue y Graph Sort Raw Value DESC 2 Click the drop down arrow next to Fina Report and select the items to include in the Final Report Reactivity Adjustments Tail Adjustment Groupings 3 A graph can be included in the report as well by checking the box next to Include Graph Graph Value y axis and Graph Sort x axis may also be customized by clicking the drop down arrow and selecting the appropri ate choice oie Graph Sort Raw Value DESC Report Type FOR RESEARCH USE ONLY 5 18 LC1115RUO 3 2 15 3 Once a report appears on the screen click the Print icon in the upper toolbar Quick Print Either a Bead Ranking report or Graph can be printed by clicking Quick Print The Bead Ranking Report is sorted as it is sorted in the grid All anti gens associated with each bead will be listed as well as whether the bead was assigned as Positive or Negative Batch Reporting 1 Go to the Home Antibody tab 2 Click the Antibody icon Antibody 3 Click the magnifying glass to display a calendar FOR RESEARCH USE ONLY 5 19 LC1115RUO 3 2 15 x Choose the date or range of dates of when f Antibody Batch Reporting IAS Batc A p TET the batch Was gt 20090923PRA C1 d 2106019 imported 022703 LML N
126. tion 4 2 Date Range Selection 4 2 Viewing and Changing the Results of a Batch 4 3 Scrolling through a Batch 4 3 Navigating to a Particular Sample 4 3 Changing the Sort Order 4 4 Displaying BAF Values 4 4 Displaying Phenotypes 4 4 Displaying Bead Counts 4 4 Assignments Displayed Values and Calculations 4 5 Batch Failures 4 5 Overriding an Assignment 4 6 Overriding Default Parameters 4 6 Optional VBAF Analysis 4 7 Approving the Results of the Analysis 4 7 Saving Completing and Approving an Assignment 4 7 Reports 4 8 Printing Standard Report 4 8 Printing an Individual Sample Report or Audit Report 4 8 Batch Reporting 4 8 Exporting Reports 4 9 Exporting Summary Results 4 10 FOR RESEARCH USE ONLY TOC 4 LC1115RUO 3 2 15 Chapter 5 LIFECODES ID Analysis Importing ID Results into MATCH IT 5 1 Importing EDS files 5 1 Manually Importing CSV Files 5 1 Opening a Batch 5 2 Direct Selection 5 2 Date Range Selection 5 2 Viewing a Sample within a Batch 5 3 Navigating to a Particular Sample 5 3 Tabs in the Analysis screen 5 4 Column Customization 5 4 Graphical Display 5 6 Antigen Graph 5 6 Control Graph 5 6 Additional Graphing Features 5 7 Calculations and Displayed Values 5 8 Calculations 5 8 Making a Positive or Negative Assignment 5 9 By Standard Mode 5 9 By MFI Cutoff 5 10 Batch Failures 15 10 Tools for Making an Assignment 5 11 Tail Analysis 5 12 Automatic Tail 5 13 Manual Tail 5 13 Creating a
127. umn 3 which will include them in the batch report 7 If individual reports of the samples moved to the Print right column are preferred choose the LMX DSA tab under Reporting Options per Test and check Single Sample per Report There is then the option to Include Pos Neg Controls 8 Select desired Printing Option Send to Printer Save to PDF Save to Excel or Save to RTF Multiple options may be chosen If Save to PDF Save to Excel or Save to RTF is chosen choose a Save File Path 9 Click the Print icon Either one report containing all chosen samples will be generated or individual reports for each chosen sample will be gener ated 10 If an Audit Report is desired click Audit Report This report is only available in pdf format Exporting Reports PDF HTML MHT RTF Excel CSV txt or Image File FOR RESEARCH USE ONLY 4 9 LC1115RUO 3 2 15 1 Generate a report from the Reports tab in the LifeScreen Analysis tab LMX Analysis o J 2 Batch Name 100414 _EL_DELUXE Assign Cutoff ji Options Reports Sort El Run Date 04 14 10 Assign Adjust 0 0 Sort By i Lot Number 091609 LMx Supplemental Assign Cutoff one O Sample well Location E Expiration Date 05 16 10 Supplemental Assign Adjust 0 0 D gt a Reviewed By Generate LMX Report IE CON Ranges CON 1 50 332 CON 2 16 505 CON 3 23 641 Save Assignments d Complete J Approve 2 Once a report
128. umns The columns will size according to the values in the column and apply it to only that column or to all columns depending on what is chosen Displaying Selected Bead Values 1 Hover over a column A small p n will appear in the upper right corner of the chosen column 2 Left click the column header pin All values or text within that chosen column will be listed 3 Choose any one of the values or text items displayed When chosen only the bead s that includes that value or text within that column will display Note All of the sub windows and columns ma y be resized by placing cursor on the line to be moved and dragging the mouse Antigen Graph FOR RESEARCH USE ONLY 6 13 LC1115RUO 3 2 15 A graph of Raw MFI vs Bead enables the user to visualize the strength of each bead relative to the sample and the assignment for each bead red is a positive assignment green is a negative assignment and gold is a weak assignment There are two views for the graph eThe Standard Mode displays a graph with the positive and negative assignments for beads based on the parameters set BCM BCR AD BCR and Assign Cutoff or BG Adjusted BCR and R Strength See Preferences TER EEEN seeyeieesi page mure Bye eee EURE a eThe MFI Cutoff displays a graph with positive and negative assign ments for beads based on the MFI value the user sets as the cutoff Control Grap
129. w to customize the layout 3 To change the width of a column right click the column and choose Best Fit or Best Fit all columns The columns will size according to the values in the column and apply it to only that column or to all columns depending on what is chosen Displaying Selected Bead Values Specific beads containing particular information can be viewed 1 Hover over a column A small p n will appear in the E custom ae upper right corner of the chosen column Blanks A E 5 Pas Mon blanks i hae 2 Left click the pin All values or text within that chosen ema 2 gt column will be listed Og 1 0 2 62 54 253 3 Choose any one of the values or text items displayed 2 82 43 When chosen only the bead s that includes that value or 1 7 A ry ee text within that column will display 1 5 2 35 T oe Note All of the sub windows and columns may be resized by placing ze aes cursor on the line to be moved and dragging the mouse Sl 1 1 FOR RESEARCH USE ONLY 5 5 LC1115RUO 3 2 15 Graphical Display Antigen Graph A graph of Raw MFI vs Bead Antigens is displayed by default on the main page in a separate tab The graph enables the user to visualize the strength of each bead relative to the sample and the assignment for each bead red is a positive assignment while green is a negative assignment There are two views for the graph eThe Standard Mode displays a graph with
130. will be added to the Excluded Antigen s list Positive Haga tive Exdudad Antigan s ig ih EMEA OC A205 ARO AM a i ror A ADEI AMOUOS ACOROL A DROZ ATINIZ AINO A 25 01 gg a 2301 Antigens that are known or predictive Positives can be selected from the Positive drop down list When an Antigen is assigned as Positive it will change to bold text and the associated Eplet will be highlighted in the grid Le Exclude antigens with H7 hd lt 1000 Positive legati 1 B C g EC 4 02 02 A0205 A 23 01 A 24 03 ie man 9 AT Z01 A O2 03 A O3 01 A 24 02 A 29 02 A 31 EE lu JA 26 01 aranan io 7 o 07 00 1008 151AHA LE3RW 8 27 05 esse ll D 25 01 5308 M ar25 01 4353 5 M am43 01 3547 area 5442 D 5 07 02 1345 B 27 05 1767 52708 1469 5 FIKA HER e 1253 The user can use the Undo and Reset buttons at any time during analy SIS Export to Excel When Analysis is complete the results can be exported to an Excel worksheet using the Export to Excel button FOR RESEARCH USE ONLY 6 10 LC1115RUO 3 2 15 Creating a History LSA and C3d In the History tab a user has the ability to load antigens to create a reac tivity group specific to the sample This will enable a user to create a snap shot for a particular sample and monitor changes in antibody sta tus for a patient across kits and over time 1 Go to the History tab Sample Info Reactiity Adustments Groupings Hstory Pr
131. xport Results Batch Reports Export IgG C3d Paired Results Export Design Wizard The wizard will help the user to create a user defined export for all tests 1 Choose a test to create an export Back Choose Test Type Please deore a test to este si eoh F CEA LATE ne Il 2 Customize the export columns to include in the final export P Export Creation gt O as Back Select Export Columns HaType a a Batch Mame drewOt sample donorCenterhiumber gt Blank Cour A pra ConpletadBy lt lt Approved y CONIL cong Add Blank Column FOR RESEARCH USE ONLY 212 LC1115RUO 3 2 15 3 Columns can be moved once selected 4 Choose a field delimiter for your final export Q Export Creation kabak Par de Back Ma Choose Delimiter el O O Tab O Other ext gt Cancel 5 Name the final export Export Creation js 4 Back Enter Export Name Peace gie thie export a mame ID Export Note LSA C3d js not available in Export Design Wizard Export Results To export results FOR RESEARCH USE ONLY 213 LC1115RUO 3 2 15 x 1 Select a Search Option SR o Sample ID or Batch Name 2 Type the full or partial Sam 17 07 08 LSA1 BF ro a ple ID or Batch Name into the cell Click the magnifying glass The search results will Export Preview appear Save Options iv Select Search Option J Patient Sample ID 2 Batch Name 3 Se
132. ying or adapting the Software does not affect your rights under any legislation implementing the E C Council Directive on the Legal Protection of Computer Programs If you seek interface information within the meaning of Article 6 1 b of that Directive you should initially inquire with Immucor Transplant Diagnostics Inc 550 West Avenue Stamford CT 06902 USA 3 INTELLECTUAL PROPERTY RIGHTS All intellectual property rights in the Software and user documentation are owned by Immucor Transplant Diagnostics Inc and are protected by applicable intellectual property laws including patent trademark and copyright laws and international treaty provisions Immucor Transplant Diagnostics Inc retains all rights not expressly granted FOR RESEARCH USE ONLY SA 1 LC1115RUO 3 2 15 4 LIMITED WARRANTY For ninety 90 days from your date of purchase Immucor Transplant Diagnostics Inc warrants that i The Software will substantially conform to the applicable user documentation and ii that the magnetic media on which the Software is distributed and the user documentation if any are free from defects in materials and workmanship If the media is defective Immucor Transplant Diagnostics Inc will replace the Software or provide you with corrected items at no charge provided that the defective item s is returned to Immucor Transplant Diagnostics Inc within ninety 90 days from the date of purchase Any misuse or unauthorized modification

LC1115RUO.3 MATCH IT! Antibody v1.2.1 User`s Manual.book

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