Home

Luminex 100 IS User Manual. To be used only by Scott Placke.

1. Figure 5 75 Data Interpretation Report Print Preview Luminex 100 IS User Manual Version 2 3 xMAP Technology View Detailed Test To view detailed test analysis Analysis 1 On the Home tab click Analysis The Open Batch dialog box opens 2 Click on the desired batch to analyze and click Select The Analysis window opens showing the progress as the system opens the batch and analyzes the data See Figure 5 74 Each test displays Analyzing as the system calculates 3 On the Standards tab select the test or analyte you want to view The system displays this analyte in detail Switch between tabs to observe the tests errors under the Errors tab and unknown results under the Samples tab To view the next test in the batch click Next Test F2 To view the previous test click Previous Test F3 You may also click on the test name in the left grid control Standards Tab The Standards tab lists all the batch tests with system comments specific to each test The detailed test information that is displayed on the three tabs of the Analysis window is determined by the test selected under the Standards tab See Figure 5 76 The Standards tab displays the quantitative batch s standard curve It displays qualitative batches as a graph plotting the assay standard Above the graphical information the tab displays the formula that it used to calculate batch data Below the graphical information
2. 12 D2 Plate1 Acquire Patient 1 13 E2 Plate1 Acquire Patient 1 9 Name 14 F2 Plate1 Acquire Patient 1 Help B36 RepQt Assay 15 62 Plate1 Acquire Patient 1 lel Description 11213141516 8 T9 v0 4 12 Replicate Simplex Quant E A O a 6 Q QO Q QO QO Q O QO O00000 QQQ eve Q r Standard Info Iri s9Seeooooooooo Product No 3000 Version No B ome 2 M 9 2 2 M 9 E Md Lot Name SoRepaistd A aam o seeseooooooooo Expiration Date 06 10 2005 M OOOO0O000O Control Info Developing Co seeeooooOoOoooo aeo No 3000 m LMNX E Q Q Q Q Q Q Q Q Q Lot Name 36Repaicon Expiration Date 06 10 2005 Figure 5 51 Luminex Batch Setup Dialog Box 3 Click Load Patient List The Open Patient List File dialog box opens See Figure 5 52 Open Patient List File x Look in a Common 7 58 ck EJ ExportedT emplates IVD ConReport oc E IVDImplements dii EY E BrowseDB ocx amp IVD CPReport ocx E I DInterfaces dll History s cbMsgbox oc ET IVD LVJTRepart oc E IVDInterpGraph o 74 E crviewer dll E IVD_MainReport ocx amp IVDInterpGraphD amp E Datalnterpretation2 ocx E IVD_PSReport ocx E IVDMachineCalib Desktop E GenFormulaDisplayLib ocx E IVDBackup ocx E WOMathdll AN E GraphObiects dll 5 IVDBeadSelect ocx E IVDMathCommon um GraphObjectsInterface dll amp IVDDevice dll amp IVDMathE sp dll Ter eres j IVD CalReport
3. Time 06 06 2002 4 46 45 PM Time 06 06 2002 4 46 07 PM J Time 06 06 2002 4 46 01 PM Old State Idie 14 Device State Change Time 06 06 2002 4 45 43 PM Old State Processing New State idle 13 Command Completed Time 06 06 2002 4 45 43 PM CommendNeme CON1 CommandNo 1 of 1 Plate Location C1 Plat 12 Command Started Time 06 06 2002 4 45 03 PM CommandName CON1 CommandNo 1 of 1 Plate Location C1 Plat 11 Device State Change Time 06 06 2002 4 44 56 PM Old State Idie 10 Device State Change Time 06 06 2002 4 44 04 PM Old State Processing New State Idle Time 06 06 2002 4 44 04 PM CommandName CAL2 CommandNo 1 of 1 Plate Location B1 Plat Tima Diinginnnn A A209 OM Cammandihiama CIO Diam E seh DA i Plate Location D1 Plat Plate Location D1 Plat Figure 5 30 Diagnostics Tab Use these tools to find information about the system and what occurs during sample acquisition and other functions For example you may look on the Message Log to see the last completed command or the one currently in progress The System Monitor provides information about the physical state of the 100 IS instruments lasers and system calibration status The values in the System Monitor are reported directly from the Luminex 100 analyzer and the Luminex XYP instrument The System Monitor shows whether CAL1 CAL2 CON1 and CON2 results completed successfully by displaying green text for successful events and
4. Next Test F2 Invalidate Standard F4 Invalidate Control F6 ee ere ae hans C Alphabetically by Sample ID Previous Test F3 Validate Standard F5 _ Validate Control F7 _ change Change Lot Alt F9 start S Luminex100 15 Software J zx analysis Gi Fulshat 99 b Ed 4 28PM Figure 5 84 Analysis Window Samples Tab The data analysis function supports replicate sampling The function calculates each sample as an individual sample then averaged to obtain a replicate average e Standards tab displays standards and controls average values e Samples tab displays samples average values Replicate averages are displayed with AVG in the Loc location column The AVG entry appears immediately after the wells being averaged or at the end of the list depending on what you select under Sort Sequentially or Alphabetically See Sample Progress Sorting in the following section If the system fails to determine the results for a replicate due to an excessive skew of one of the samples you can invalidate the out of tolerance value Use the Invalidate Standard F4 or Invalidate Control F6 buttons at the bottom of the Analysis window PN 89 00002 00 071 Rev A xMAP Technology Sample Progress Sorting Errors Tab PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software However this only fixes standards control not necessarily patient sample If any of t
5. Figure 5 65 Update Lot Information Dialog Box Click the Exp Date arrow and select the date from the calendar Enter the standard concentration values provided in the kit manufacturer s instructions See Figure 5 65 Enter the control reagent values The controls are divided into 3 separate tabs Low Limit Expected Value or Mean and High Limit All information must be defined to enable the Save button Click Save The system applies the lot you just created to the template To edit information for an existing lot On the Home tab click New Lot The Open Template dialog box opens See Figure 5 66 Luminex 100 IS User Manual Version 2 3 xMAP Technology Open Template ID Template Name Description 3 Template 1 28 02 9 32 bwh vbby h 4 Template 1 28 02 10 22 21h 5 Template 1 29 02 12 2 2 90 B Template 1 29 02 12 25 123 7 Template 2 5 02 16 42 2 2 100 8 Template 2 6 02 10 04 22 101 9 Template 2 6 02 10 55 2 2 101 10 Template 2 6 02 10 58 2 2 101 11 Template 2 6 02 11 00 22 101 12 Template 2 5 02 11 01 2 2 101 13 Template 2 6 02 11 02 22 101 14 Template 2 7 02 13 35 Select Cancel Figure 5 66 Open Template To Update New Lots Highlight the template that you want to edit and click Select The Update Lot Information dialog box opens See Figure 5 67 Change or edit the expiration date and the lot concentration values Click Save The system updates the lot changes
6. Lurririe a 1 Thumb Wheel 2 Height Adjustment Locking Screw Figure B 9 Thumb Wheel and Height Adjustment Locking Screw To adjust the sample probe vertical height 1 Remove the clear plastic shield that covers the sample probe area PN 89 00002 00 071 Rev A xMAP Technology Note Alignment discs can be placed in any well as long as the well is designated in the software Luminex 100 IS System Setup In a 96 well microtiter plate where overall height is no more than 0 75 inches 19 mm place the appropriate alignment tool in the plate For a standard plate with flat bottom wells stack two of the larger 5 08 mm diameter alignment discs together and place them into the selected well For a filter bottom plate stack three of the larger 5 08 mm diameter alignment discs together and place them into the selected well For a half volume plate with flat bottom wells stack two of the smaller 3 35 mm diameter alignment discs together and place them into the selected well For a round bottom U bottom plate stack two of the smaller 3 35 mm diameter alignment discs and place them into well A1 For a plate with conical wells place one alignment sphere into the selected well Select the Maintenance tab then click Eject Retract to eject the plate holder Place the 96 well microtiter plate on the Luminex XYP instrument plate holder with position A1 in the top left corner Click Eject Retract to
7. lees 5 24 Drain Command 0 0 00 eee eee ees 5 25 Soak Command 0 000 eee ees 5 26 Self Diagnostics Command 00 5 27 View Self Diagnostic Details 5 28 Calibration and Verification 000000 0s 5 28 Run System xMAP Calibrators 5 28 Run System xMAP Controls 2000005 5 31 Calibration and System Control Trend Reports 5 32 Print or View Calibration or System Control Trend R portS edere x CCP ded RC eR CTS eps 5 33 Select Existing Lots for Reuse 5 35 Import System Calibration or Control Lots 5 35 Export System Calibration or Control Lots 5 35 Luminex XYP Instrument Commands 5 36 Eject and Retract Luminex XYP Instrument Plate HOoldeE e eee uie EC ERRORES DUET Dune US eer 5 36 Lower and Raise Sample Probe 5 36 PN 89 00002 00 071 Rev A Contents iii Luminex 100 IS User Manual Version 2 3 xMAP Technology Diagnostics Tab 0 0 ec ee eee 5 37 System Monitor ees 5 37 Detailed Sample Progress llle 5 39 Message L g s esr er eee e en 5 40 Clear the Message Log lsleeeeeeeeees 5 40 Error Messages des area eyed eet t gegen 5 41 Acquisition Detail Tab 0 0 0 0 2 eee eee ees 5 41 Acquisition Detail Toolbar scele 5 42 Replay Batch 255 emere Ebo es 5 43 New Advanced Batch
8. Selected Column Select desired rows under column and right click You can select or deselect Events Column Select desired rows under column and right click The values displayed in the Default Events box update the selected rows when you click Apply Default while right clicking Caption Column If names are defined under this column you can right click selected rows and Reset back to normal defaults Entire Column Select an entire column by clicking the column heading Selected Events or Caption PN 89 00002 00 071 Rev A 5 69 Luminex 100 IS User Manual Version 2 3 Note The legend at the left side of the tab No Cmd Name and Symbol columns shows available commands and their colored coded symbols Symbol appears in the well when selected from the Command Menu Table 5 7 Symbol Color Codes Symbol Color A Blue C1 Red C2 Green N1 Teal N2 Purple W Olive D Black S Fuchsia Note Wells are always read in rows letters A to H and columns numbers 1 to 12 starting with A1 If partial columns are selected they are still read in the same order Unselected wells are skipped xMAP Technology Click the Plate Layout tab See Figure 5 58 On this tab you define commands for the desired wells on the plate You can define commands that apply to one or more wells one or more rows of wells or one or more columns of wells You can define on plate or off plate comm
9. 1 Std s 75 75 2 Std m 75 75 3 Std 75 75 A Std xI 75 75 5 Std XxI 75 75 6 Low Control 75 75 7 Patient 1 75 75 8 Patient 2 75 7b PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 xMAP Technology Luminex 100 IS OUTPUT CSV file with all additional features enabled Program Luminex 100 IS Build 2 3 BETA Date 7 28 2004 2 16 30 PM SN LX10001298011BE Session Bead 22 Quant Batch Operator TemplatelD 4 TemplateName Quant Batch TemplateVersion 2 3c TemplateDescription IS 2 3 137 TemplateDevelopingCompany Luminex TemplateAuthor MAC SampleVolume 50 uL DDGate 8000 to 15000 SampleTimeout 50 sec BatchAuthor Name BatchStartTime 7 28 2004 2 06 44 PM BatchStopTime 7 28 2004 2 10 50 PM BatchDescription Software Testing BatchComment Batch Comment for Bead 22 Quant Batch This field should be used for general batch information entered by the end user CALInfo ProductName ProductNo LotName ExpirationDate CalibrationTime BoardTemp DDTemp CL1Temp CL2Temp Pressure DDVolts CL1 Volts CL2Volts RP1 Volts DDRVal CL1RVal CL2RVal Passed MachineSerialNo Classification Calibrator L100 CAL1 A4206 06 07 2006 12 00 00 AM
10. 8 Patient 2 14567 75 Sample Comment for Patient 2 DataType Result Location Sample Test 22 Total Events Notes 1 Std s 2 99 pg mL 75 2 Std m 15 79 pg mL 75 3 Std I 126 71 pg mL 75 A Std xI 61 6 93 pg mL 75 5 Std xxl 31 94 84 pg m L 75 6 Low Control 3 02 pg mL 75 7 Patient 1 15 98 pg mL 75 Sample Comment for Patient 1 8 Patient 2 636 38 pg mL 75 Sample Comment for Patient 2 DataType Count Location Sample Test 22 Total Events Notes 1 Std s 75 75 2 Std m 75 75 3 Std 75 75 A Std xI 75 75 5 Std xxI 75 75 6 Low Control 75 75 7 Patient 1 75 75 Sample Comment for Patient 1 8 Patient 2 75 75 Sample Comment for Patient 2 DataType Mean Location Sample Test 22 Total Events Notes 1 Std s 240 733333333333 75 2 Std m 503 213333333333 75 PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 3 Std l 4450 92 75 xMAP Technology 4 Std xI 13478 6666666667 75 5 Std xxI 24817 8933333333 75 6 Low Control 60 75 7 Patient 1 561 12 75 Sample Comment for Patient 1 8 Patient 2 14402 34666
11. xMAP Technology Using Luminex 100 IS 2 3 Software Table 5 1 Status Bar Color Coding Continued Category Color Indicates Idling waiting for a command Aspirating drawing in sample Collecting Data collecting data Sanitizing sanitizing the instrument Washing washing the instrument Priming priming the instrument Calibrating calibrating the instrument Canceling canceling a command Backflushing backflushing the instrument Draining draining the instrument Warming Up warming up the instrument Verifying verifying calibration Soaking soaking the probe Adjusting sample probe Self Diagnosing performing self diagnostic routine Laser Status Laser temperature and readiness status Green Lasers warmed up Yellow Warmup timer countdown in seconds from 1800 Red Lasers off Total Events Second Number of total bead events detected per second Region Events Second Number of bead events detected per second that are classified in a region The Status Bar displays status information as the software processes commands Errors appear in the Message Log at the bottom of the Diagnostics tab Text on the Diagnostics tab turns red if the system encounters an error The Message Log on the Diagnostics tab indicates where the error occurred PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 Status Communication Messages xMAP Technology Table 5 2 s
12. 4 To print a report from a batch or a specific time frame Luminex 100 IS 2 3 Install the printer before initiating the print command 1 Click Print Report The Report Selection dialog box opens is Report Selection lnl x r Selecta report Analyte Report C Maintenance Report Clinical Patient Report C Batch Summary Report C Patient Summary Report C Calibration Trend Report C Quality Control Report C System Control Trend Report Cancel Figure 5 94 Report Selection Dialog Box 2 Select the type of report that you want to print and click Next For the Analyte Clinical Patient and Batch Summary Reports the Batch Selection dialog box opens Select the batch to print See Figure 5 95 For the Quality Control Maintenance Note The system information Calibration Trend and System Control Trend Reports a dialog may vary depending on the type box related to the specific report opens of report that you select Batch Selection Select the batch that contains the patient information Batch Name Batch Date Figure 5 95 Batch Selection Dialog Box 3 Enter the information in this example a patient report and click Next Another information dialog box opens Enter specific information for the type of report the system is compiling Figure 5 96 shows a Patient Selection example PN 89 00002 00 071 Rev A 5 109 Luminex 100 IS User Manual Version 2 3 Print Using External Program 5 11
13. 6 69E 01 a ILA LI EIL 6 R 2 0 8888 Sample HighiLow Logtis p yes Pics yt EIL 8 R 2 0 8894 Sample HighiL 2s LI sample High Low 22500 m 4 20000 17500 15000 gt S D 1000 2000 3000 sooo sooo 6000 7000 sooo sooo 10000 Loc Standard Expected Conc MFI TestResult CV Unit n c1 10 10 62 1466 oink Di 10 10 68 1511 pain E1 316 anej 212 2770 pain Fi 315 316 208 2730 pain Hext Test F2 Invalidate Standard F4 Invalidate Control F6 f VETERES Previous Test F3 Validate Standard F5 _ Validate Control F7 Change Lot Ait F8 C Alphabetically by Sample ID Figure 5 72 Analysis Window Siandards Tab PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software Enable Automatic Analysis Note You cannot select both Auto Export Batches and Auto Start Analysis The Auto Export Batches checkbox is located on the Data Export tab of the Options dialog box Also note that Analysis and data reduction are synonymous terms Analyze Processed Batch Data You can configure the system to automatically start analysis data reduction immediately following batch acquisition If you disable the Auto start Analysis feature you must select Analysis from the Home tab to analyze a batch Note that the Auto start Analysis feature is automa
14. PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 Log Linear LIH fi Maximize Minimize Dot Plot Note You can change the X axis and Y axis of the dot plot for troubleshooting purposes Luminex recommends using the default settings in all other scenarios Dot Plot Buttons Density Li Decaying xMAP Technology Select to toggle the X axis scale between logarithmic and linear modes Select to toggle between maximum and minimum histogram views Click Maximize up arrow to enlarge the entire histogram and observe in greater details Click Minimize down arrow to reduce the histogram down to original size This section provides an overview of the Dot Plot Details are provided in the Luminex 100 IS Developer Workbench Guide Version 2 3 The Dot Plot or bead map appears in the lower right section of the Acquisition Detail tab See Figure 5 38 The dot plot shows a graphical display of real time data collection as a dot plot You may define the X axis and Y axis scales from within the dot plot Luminex recommends using the default settings to collect data The default axis are Classification 1 on the X axis and Classification 2 on the Y axis To see the dot plot you must use the default axis To display the bead set information hover the mouse pointer over the desired region and click s belo fj 10000 1000 Classification 2 100 10 1 10 100 1000 100
15. Ajuo Buiupee aAjoajoid ui sjenno ojU peb6njd eq pjnoys sp109 eur y BY 82 26 d ZL SL2 14610m ues ejo 64 LLZ AI Sg 9v UMOYs jou 100jj uo xog pini ureeus f By 7997 a 29 891 3u81ew uieisAs douejunoo 30 SS929e YO IMS Jewod ia azes x pel JO eoueJeejo ejqeo pue jsneuxe exeiui pue DBuyooo 40 eoueJeo OO xeuium Ayurejo 10 Buimesp Stu Woy peniuo ueeq eAeu Japeel epoojeq pue Od eu Japeal epoojeq yeus euro Od jjeus eur Jo GS xeutuim dAX xeuiun 004 xeurum Sjueuodujoo jJofeuu c jo sisisuoo uieis S SI 001 xeuium eu L SO ON Installation Drawing xMAP Technology B 27 PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 xMAP Technology PN 89 00002 00 071 Rev A Output cSV Overview Overall Design PN 89 00002 00 071 Rev A This chapter describes the file specification for the Luminex 100 IS 2 3 OUTPUT CSV file Although this document may refer to older versions of Luminex software for historical purposes it is intended only to describe the OUTPUT CSV file for the Luminex 100 IS 2 3 system Although this chapter was prepared to ensure accuracy Luminex assumes no liability for errors or omissions or for damages resulting from the application or use of this information The OUTPUT CSV file was created to provide a simple data report The file displays general batch information and statistical results Note that the term Batch is synonymous wit
16. The following is a list of lots that are available to apply to this batch Please choose the lot that you wish to apply Standard Lots for Product Control Lots for Product B3638 Qt Kit B3638 Qt Kit B3538Con Edited ID 16 fghfgfghf ID 9 B3638Con ID 8 B3638Std ID 7 Note indicates the lot that is set as the current lot for new batches OK Cancel Figure 5 82 Choose Lot Dialog Box Standard and Control PN 89 00002 00 071 Rev A xMAP Technology Samples Tab Note The Comments column cells are editable and the information is displayed in reports PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software Choose Lot The following is a list of lots that are available to apply to this batch Please choose the lot that you wish to apply Standard Lots for Product B21Lum Qual B21LGStd ID 6 Note indicates the lot that is set as the current lot for new batches Cancel New Lot Figure 5 83 Choose Lot Dialog Box Standard Only 3 To create a new lot from this dialog box as an alternate method click New Lot and follow the steps in the Create New Lot procedure on Create a New Lot on page 5 75 To select a lot as the current lot for use with future batches 1 Click New Lot 2 Inthe Update Lot Info dialog box select Standard lot or Control lot then click Save to display the Choose Lot dialog box An asterisk identifies the selected lot See Figure
17. The main window contains five tabs Home Run Batch Maintenance Diagnostics and Acquisition Detail These tabs contain features and commands performed during various stages of the sample acquisition process Each tab is described in the following sections The Home tab is part of the main window It contains a Favorites list and five categories representing different data acquisition phases including daily startup instrument calibration batch setup reports and analysis and daily shutdown See Figure 5 9 Luminex Luminex100 Integrated System 2 3 ENDE E I xlii Instrument Calibration S a Soak d Template 3 12 01 17 Batch Setup Template 3 27 0115 F4 New Now New Lot Reports and Fo m Shutdown 1 Home Tab button 2 Favorites Section Figure 5 9 Home Tab The Favorites list contains a list where you can add frequently used templates and commands for easy access You can tailor the list to your specific needs For instance if you use a template often you may want to include this template in the list Items appear in alphabetical order for easy locating See Figure 5 10 Luminex 100 IS User Manual Version 2 3 xMAP Technology Favorites Add Add mno Template Command i Ed BackFlush Cerebral Palsy Templ CONI CON2 Drain Prime Protein Demo 2 Templ Protein Demonstratio Sanitize Alcohol Flush Self Diagnostic Soak Template 3 12 01 1 7 Template 3
18. 0000 cece eee 5 43 View Batch Data 0 0 0 cee 5 43 Niue 5 43 Cancel sra ar dce eher re PR e Rea 5 43 Cancel Alli ree cena Be eae eR EUR vs 5 43 Eject Retract c raie eee etre paar Re e 5 43 Pause cese x RR PIE ERN YS 5 43 RESUME ees Oh RR eee 5 43 Batch Data Area and Buttons 2000 0000s 5 43 Batch Name and Description 5 43 Batch Data Area 0 0 eee eee 5 43 Copy and Export Menu 0 000000 e eee 5 44 AAULOSIZE es ade esu ee d eb RE eda a EIAS 5 44 STAS UCS ots esse penc CREUSE eere ed E Res 5 44 Histogram and Gates 0 0 eee ee eee 5 45 Histogram Buttons sss 5 45 Show Bead tad darted ddan dae tag eas CERES 5 45 Auto SCal esee ete SER eH SR dues Gaited 5 45 ZOOM za carae aber EE RR UP MES Glee e cx PN 5 45 Log Eineat 2 oreet Stt met ec 5 46 Maximize Minimize 0 0 0 e eee eee 5 46 Dot Plot i taste e ed oo bade bapa ad oeste e dob buts 5 46 Dot Plot Buttons 00 0 eee eee 5 46 Density Decaying 0 0 eee eee eee 5 46 Log Lineatr ernier nias ioa nia meer ede RO s 5 47 ZoouPRPC 5 47 Maximize Minimize 0 0 0 eee eee ee 5 47 Replay Batch File Mode 0 200000 eee 5 47 Reprocess Samples Using Replay Batch 5 48 Analyze Reprocessed Data with Replay Batch 5 49 Batches PCM 5 49 Batch Commands and Procedures 5 50 Create
19. 07 28 2004 09 39 32 AM 26 5625 25 26 25 04 25 26 6 3 74 04 81 33 62 83 1 556 719 450 True LX10001298011BE Reporter Calibrator L100 CAL2 A4071 02 18 2006 12 00 00 AM 07 28 2004 09 43 01 AM 26 7795138888889 1 n 1 td 6 3 1 a nef 590 5 1 o 1 True LX1 0001 298011 BE CONInfo ProductName ProductNo LotName ExpirationDate VerificationTime GatedBeads MachineSerialNo Passed Classification Control L100 CON1 A4153 04 13 2006 12 00 00 AM 07 28 2004 09 45 39 AM 5222 LX10001298011BE True Reporter Control L100 CON2 A4137 04 06 2006 12 00 00 AM 07 28 2004 09 52 49 AM 4345 LX10001298011BE True AssayLotinfo ManufacturerName ProductName ProductNo ProductType LotName ExpirationDate LMNX Quant Kit 200 Assay Standard B22std 08 01 2006 11 59 59 PM LMNX Quant Kit 200 Assay Control B22con 08 02 2006 11 59 59 PM C 8 PN 89 00002 00 071 Rev A xMAP Technology Samples 8 Min Events 0 Results DataType Median Location Sample Test 22 Total Events Notes 1 Std S 57 75 2 Std m 525 75 3 Std I 4344 75 A Std x 1 431 6 75 5 Std xxl 25694 75 6 Low Control 58 75 7 Patient 1 532 75 Sample Comment for Patient 1
20. Do not use dilution factors for qualitative testing You define the dilution factors on a sample by sample or patient by patient basis The list displays each sample s accession number and dilution factor in relation to its well position To assign sample dilution factors Onthe File menu click New Batch The Open Template dialog box opens 2 Select the desired template and click Select The Luminex Batch Setup dialog box opens See Figure 5 55 3 Highlight or select the item that uses the dilution factor that you are setting You cannot change any item that is grayed out or locked into the command list Luminex Batch Setup Please establish the starting location for the batch and enter the appropriate patient information Note indicates a required field Insert Acquire Patient X Apply peur d No Location Command Sample ID Dil Factor Name A 1 A1 Plate1 Acquire Standard Standard Conc 1 1 v Batch 6 3 02 10 36 amp 2 B1 Plate1 Acquire Standard Standard Conc 2 1 af um 5 3 Acquire Standard Standard Conc 3 1 Finish Description 8 4 D1 Plate1 Acquire Standard Standard Conc 4 1 lt None gt 8 5 1 Plate1 Acquire Standard Standard Conc 5 1 amp 6 F1 Plate1 Acquire Control Control Reagent 1 c l H 7 G1 Plate1 Acquire Patient 3 ance 8 H1 Plate1 Acquire Patient 3 Created By 9 A2 Pla
21. Figure 5 34 Clear Message Log Dialog Box If an error occurs during system operation the Diagnostic tab turns red Click on the Diagnostics tab The Message Log displays errors as a row with red text If the row with the red text has a yellow background double click that row An Error message appears with error details The Acquisition Detail tab offers advanced batch sampling monitoring and on the fly data acquisition without using templates The primary function is real time monitoring of batch samples during acquisition through the display of sample bead statistics histogram and dot plot data During batch acquisition certain bead statistics can be useful if batch errors occur For example if samples are constantly failing due to insufficient bead count you can monitor whether the failure is due to low sample bead concentration or if other assay problems are present The Acquisition Detail tab provides access to the Luminex 100 IS Developer Workbench DWB software features Details about these features are provided in the Luminex 100 IS Developer Workbench Guide Version 2 3 documentation You must have the DWB software installed to enable these features Caution End users should not alter kit manufacturer s predefined templates or create alternative templates for off the shelf kits unless instructed by the kit manufacturer Acquisition Detail tab Main features e New Advanced Batch View Batch Data e Replay
22. On the back of the Luminex 100 analyzer in the upper left corner remove the screw at the top of the panel and open the panel door Grasp the tubing and pull the filter 3 to 4 inches from the unit See Figure 6 2 gt Ji e Be No Luminex nex et qai S N LX 100002450 Figure 6 2 Grasping the Tubing Remove the filter with one hand and hold the tubing with the other hand Connect a new filter to the tubing and position the filter inside the panel Reattach the panel door to the unit Plug in and power on the Luminex 100 analyzer PN 89 00002 00 071 Rev A xMAP Technology Maintenance and Cleaning Luminex XYP Instrument To replace the XYP instrument air intake filter Air Intake Filter 1 Disconnect the Luminex XYP instrument from ac power by turning off the power switch on the rear of the Luminex XYP instrument then unplugging the Luminex XYP instrument power cord from the wall source 2 Onthe back of the Luminex XYP instrument to the left side gently remove the screen from the Luminex XYP instrument filter Note Do not remove the screws See Figure 6 3 Figure 6 3 Removing the Screen 3 Replace the filter and replace the screen See Figure 6 4 Figure 6 4 Removing and Replacing the Filter 4 Plug in and turn on Luminex XYP instrument power PN 89 00002 00 071 Rev A 6 7 Luminex 100 IS User Manual Version 2 3 Syringe Seal xMAP Technology To replace the syringe plunger sea
23. o Soak a Clear Selecti ar jon EC gt Add Command Label s H C Clear Command Label s Insert Off Plate Cmd s Clear Off Plate Cmd s Preliminary Off Plate Cmd s Figure 5 59 Plate Layout Tab Command Menu 11 Establish preliminary off plate commands The system performs preliminary off plate commands before the first well command To establish a preliminary off plate command right click anywhere over the plate layout and select Preliminary Off Plate Cmd s from the menu double click the corner marker or right click on the corner marker space The command list dialog box appears similar to Figure 5 60 Notice the prompt sentence over the commands Establish the off plate commands to run before the plate begins Double click the desired commands The commands appear in the list gray area to the right Click OK after you select the desired commands The white corner marker in the top left corner of the plate above the letter A turns green to indicate an off plate command is established The selected commands run before the plate begins PN 89 00002 00 071 Rev A 5 71 Luminex 100 IS User Manual Version 2 3 Note White corner marker turns green to indicate Preliminary Off Plate command in effect Right click on corner marker to display menu See arrow in Figure 5 61 xMAP Technology General Bead Set Plate Layout Right click the grid to display the popup command menu E
24. s name To add samples for processing in addition to the template commands in the batch that you are creating scroll down to the last item in the command list section to the left of the Finish Cancel Load Patient List and Help buttons If you are running a maintenance template go to step 11 to save and finish creating the new batch Luminex 100 IS User Manual Version 2 3 xMAP Technology 6 Click the Sample ID box on the last row for the empty well on the microtiter plate See Figure 5 42 Luminex Batch Setup E Please establish the starting location for the batch and enter the appropriate patient information Note indicates a required field Insert Acquire Patient X f1 Amy pes nie No Location Command Sample ID Dil Factor E Namek A 1 A1 Plate Acquire Standard StdM 1 v Baten 6 3702 16 38 5 2 B1 Plate1 Acquire Standard Std M 1 kem m j 3 C1 Plate1 Acquire Standard StdL 1 Finish Description 4 D1 Plate1 Acquire Standard StdL 1 None E A 5 E1 Plate1 Acquire Standard Std XL 1 8 6 F1 Plate1 Acquire Standard Std XL 1 Gencel 8 7 G1 Plate1 Acquire Control ConL 1 A 8 H1 Plate1 Acquire Control ConL 1 Created By 9 A2 Plate1 Acquire Patient 2 Ld lt Name gt 10 B2 Plate1 Acquire Patient 2 Load Pa List 11 C2 Plate1 Acquire Patient 2 Template Info 4 12 D2 Plate1 Acqui
25. software barcode reader sheath and waste containers and xMAP technology reagents The Luminex software is designed to use xMAP technology with assay kits available through kit manufacturers The Luminex 100 IS 2 3 system performs a wide range of xMAP technology based laboratory tests measuring biomolecular reactions on the surface of xMAP microspheres This system is intended for indoor general laboratory use Luminex 100 IS User Manual Version 2 3 Technical Support Luminex Website xMAP Technology Luminex Technical Support representatives are ready to help you particularly when the system or software cause any questions or problems If the question or problem relates to materials from the assay kit you should contact the kit provider directly Luminex Technical Support is available to users in the U S and Canada by calling 1 877 785 BEAD 2323 between the hours of 7 00 a m and 7 00 p m Central Time Monday through Friday Users outside of the U S Canada Europe can contact us at 1 512 381 4397 between the hours of 7 00 a m to 7 00 p m Central Time Monday through Friday Inquiries may also be sent by email to support luminexcorp com Luminex Technical Support is also available to users in Europe by calling 31 162408333 between the hours of 8 30 and 5 30 Central European Time Monday through Friday Email inquiries in Europe can be sent to supporteurope luminexcorp com Additional information is available o
26. After completing the SD firmware upgrade reattach the serial cable to the back of the XYP Then replace the serial interface cable with the SD interface cable the shorter cable supplied in the upgrade kit If you are upgrading the firmware for more than one component for instance the SD and the XYP you must upgrade the SD system first Luminex 100 analyzer cable Continue to use the existing USB interface cable between the PC and Luminex 100 analyzer Luminex 100 IS User Manual Version 2 3 Luminex 100 Analyzer Firmware Upgrade Connect Cable Note If you are not familiar with connecting the cables refer to Luminex 100 IS System Setup page B 1 Upgrade Firmware xMAP Technology Luminex XYP instrument Continue to use the serial interface cable between the PC and Luminex XYP Follow the steps in this section to update and verify the Luminex 100 analyzer firmware Perform the Luminex 100 IS Version 2 3 software update before installing firmware upgrade tools and firmware files See Luminex 100 IS 2 3 Software Installation page B 14 for the procedure There are two types of interface cable that connect between the Luminex 100 analyzer and the PC one is a serial cable and the other is a USB cable To upgrade from Luminex 100 Version 1 7 use the existing serial interface cable Then replace with USB cable after the upgrade To upgrade from Luminex 100 IS Version 2 1 or 2 2 use the existing USB cable
27. Luminex 100 IS User Manual Version 2 3 xMAP Technology STDS Median Fluorescent Intensity MFI Unknown B Concentration STDS Unknown A Concentration STD 1 Concentration Figure 5 77 Non Competitive Assay Examples of out of range sample labeling for competitive assays are shown in Table 5 10 Figure 5 78 shows what a standard curve for a competitive assay should look like Condition Concentration Label MFI of Standard Referenced Left of Curve min concentration standard Highest Right of Curve max concentration standard Lowest Table 5 10 Competitive Out Of Range Labeling 5 92 PN 89 00002 00 071 Rev A xMAP Technology Function Keys Recalculation PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software Unknown C STD 1 Median Fluorescent Concentration STD 3 Unknown D Intensity STD 1 Concentration MFI gt STOS Concentration Figure 5 78 Competitive Assay Eight function buttons are available on the lower portion of the Analysis window These buttons perform tasks or functions that are relevant to the Standards tab although they appear on all three tabs of the Analysis window The buttons are e Next Test F2 Previous Test F3 e nvalidate Standard F4 see Invalidate or Validate Standards and Controls on page 5 94 e Validate Standard F5 see Invalidate or Validate Standards and Controls on page 5 94 e nvalid
28. Luminex XYP Instrument Air Intake Filter 6 7 Sytinge Seal su eae Gd saledam staan cei a oec E 6 8 Luminex 100 Analyzer Ventilation Filter 6 9 Annually ees ose ced eed der Eee p pre boda trae 6 10 Sheath Filter 0 2 eee ee eee eee 6 10 AS TEQUITCE 3 od ici nU RE eh gr PRA eee ed 6 11 BUSES cic ipa eea vid meer ahs Shee w eke ah Nadas eee 6 11 Maintenance L0g 2 222 ouo e t Race ee obs 6 13 Troubleshooting 7 1 Troubleshooting the Luminex 100 IS System 7 1 Power Supply Problems 0 0 0 c eee eee eee eee 7 2 Communication Ge eee be eee eke kee dn 7 2 Pressurization 0 cece eect eee ene 7 3 Fid Leaks uot pe expe we ae en ee ee 7 4 Sample Probe ssec s Miandad pascere m bats wha s 7 5 Calibration and Control Problems llle esee 7 7 Acquisition Problems 0 0 00 cece cece eee eens 7 9 Bead Detail Irregularities 0 0 0 eee eee eee 7 10 Error States TCR 7 13 System Error Messages leen 7 14 Sample Error Messages lees 7 16 Luminex SD Problems 0 0 0 0 ee eee ee eee 7 19 uic Em 7 19 Maltunction ee tient Pu eh ee oed Wo gd 7 19 Draining the Reservoir 7 19 VeMMCalON senses aterea aa men RR Rae d eee 7 19 Product Numbers 8 1 Hardware eei San dla epa e each ie 8 1 Nine EE 8 3 xMAP Reagents z uel xu abr ER cian dea ep RE Gies 8 3 lraming i e xe tee Da debo dele ea d vea da 8 3 Glossary A 1 PN 89 00
29. Plate Succeeded p A 6 Calibrate CAL1 E11 Plate1 Succeeded 7 Wash Reservoir Platel Succeeded Eje pl use 8 Calibrate CAL F11 Plate1 Succeeded Figure 5 49 Insert Next Plate Prompt 4 Click Eject then remove the acquired plate and load the next plate for processing 5 Click Resume The system resumes the acquisition process Scan In New The barcode reader lets you quickly enter the sample identification Samples with a numbers or accession numbers The barcode reader is particularly Barcode Reader useful when you have many samples to enter into the system Use the Code 128 barcode label type when scanning barcode labels into the system as patient identities Toscan samples into the system using the barcode reader Warning Laser light Do not stare into the beam Class Il laser product 1 Aim the barcode reader s beam to read the middle of the barcode series horizontally See Figure 5 50 Figure 5 50 Barcode Reader Beam Aimed Across Code Note The barcode reader beam must encompass the entire set of bars in the barcode Shaded area of Figure 5 50 5 60 PN 89 00002 00 071 Rev A xMAP Technology Add a Patient List Note You can create a Patient List text file using Windows Notepad or a text editor PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software 2 Squeeze the barcode reader s trigger The beam activates and reads the barcode The barcode
30. Plug in and power on the Luminex 100 analyzer Close the left analyzer door Prime twice PN 89 00002 00 071 Rev A xMAP Technology Maintenance and Cleaning As required Fuses Danger To avoid serious injury or death by electric shock you must turn off the system and unplug it from the wall outlet To replace the fuses in either the Luminex 100 analyzer or the Luminex XYP instrument 1 Turn off the power switch on the rear of the analyzer or instrument then unplug the instrument power cord from the wall source Remove the power cord from the analyzer or instrument 2 With a small flathead screwdriver open the module door on the lower left corner of the back of the analyzer or instrument See Figure 6 8 Figure 6 8 Opening the Module Door 3 Remove the red cartridge use a flathead screwdriver 4 Check both fuses for damage 5 Replace damaged fuses with the type specified on the sticker to the right of the power input module 6 Replace the module door 7 Plugin and power on the analyzer or instrument PN 89 00002 00 071 Rev A 6 11 Luminex 100 IS User Manual Version 2 3 xMAP Technology PN 89 00002 00 071 Rev A Luminex 100 IS Maintenance Log Month s Year Procedure Use this form to record information over a four week period Fill in the month s and year above Fill in the dates in the first line of the table For each item listed at the left enter your initials under eac
31. The Run Batch tab displays a warning when you need to refill or replace the sheath fluid container See Figure 6 1 PN 89 00002 00 071 Rev A xMAP Technology Maintenance and Cleaning ANTT 100 I5 Software 5 xj ELLET FELYN Home Run Batch Maintenance 6 Lisgnuslss Luminex100 integrated System 2 3 lt No Batch Loaded gt 1 2 8 4 5 68 7 8 9 10 11 12 r 00 Teme 5 MOOQQOOOQOO0O00O0 IM BIOOOOO0O00000 5 2 X eC 000000000000 dE TTL IB OO C0 0O0000000 e 3 E EQOOD00000090090 gt D EOOOOOOOOOOOQ0 aC OOOOOOOOOQO0 HK OOOOQOOQOOQOCOQOGO Cmd No Command Plate Loc 7 Wash A1 Plate Cod Pr gt Start Plate p gt i Fa Resume Device Activity Laser Salus Tolaltvente Sec Rogon Evente Soc Sheath Lmpty Standby Iding warmned p o 8 al Cance LAII Pause Figure 6 1 Refill Sheath Fluid Warning Circled in Photo Refill the Sheath 4 To refill the sheath fluid container Fluid Container 1 Release system pressure by removing the lid from the sheath fluid container 2 Replace the sheath fluid box with a new box or refill the sheath fluid container Empty the Waste To empty the waste container Container 1 Disconnect the waste container from the Luminex 100 analyzer Note There is NO warning of 2 Discard the waste from the waste container by appropriate a high waste volume Empty means the waste container each time YOU
32. The system stores data results for instrument calibrators instrument controls assay calibrators and assay controls It records acquisition and maintenance data in real time to minimize data loss in case of system failure Each batch file records the date and time command cancellation if applicable and voltages used for the commands performed during the batch Back up the system database following the schedule set by your laboratory Your laboratory may require you to back the system up weekly daily or after you complete each batch If your laboratory has no schedule for database backups the system does inform you when your database approaches its size limit You should back up the database according to a periodic schedule To back up the database 1 On the Tools menu click Database Backup The Backup Database To dialog box opens Save in Ci Backup x ex E3 History E Deskto a LX100I506112002 bak My Documents 3 i Co jen File name L lt 1001S07032002 bak ec a Save as type Cancel Z My Network P Figure 5 100 Backup Database To Dialog Box 2 Choose the file name and location of the database that you want to back up 3 Click Save The LX100 IS Database Backup dialog box opens informing you the backup is in progress to the specified location See Figure 5 101 PN 89 00002 00 071 Rev A xMAP Technology Erase the Database Data PN 89 00002 00 071
33. VESIN DC B 19 Backup Luminex 100 IS 2 1 or 2 2 Database B 19 Remove Luminex 100 IS 2 1 or 2 2 B 20 Install Luminex 100 IS 2 3 Software B 21 Luminex 100 IS 2 3 Firmware Installation B 21 Firmware Upgrade Cable Configurations B 21 Luminex 100 Analyzer Firmware Upgrade B 22 Connect Cable siate roisia sa E E R B 22 Upgrade Firmware 0 00 cece ee eee B 22 Verify Successful Firmware Upgrade B 23 Update Interface Cable 0000008 B 24 Luminex XYP Instrument Firmware Update B 24 Update Firmware sseeeeeeee eese B 24 Verify Successful Firmware Upgrade B 24 Luminex SD System Firmware Update B 25 Update Firmware llllsleleee ee B 25 Verify Successful Firmware Upgrade B 25 Network Installation Advisory l l B 27 Prepare System for First Use 0 0 0 0 2 eee eee eee B 27 Installation Drawing 2 0 0 eee eee eee B 28 Vili PN 89 00002 00 071 Rev A xMAP Technology Output C SV D 1 OVervVle Wurm e vede a dae bee wend Deui E arene des D 1 Overall D sign eira eae eS d ex RES REL ERE CLSS CRAS D 1 Blank Lin6e5 4 es Aera o Ree Ue Re Uc D 2 Field Definitions 0 00 00 ccc eee D 2 Statistics Definitions llle D 4 Statistics Column Definitions 00055 D 5 Luminex 100 IS OUTPUT CSV
34. Windows XP Professional English language version e CE marked and UL listed e Two button mouse or equivalent e Monitor A minimum of 17 inch diagonal monitor e Keyboard a 104 key keyboard or equivalent e Power cords Power cords specific to the country of use are included in the system as required e Power 115 230 V 6 Amps 50 60 Hz Luminex highly recommends using an uninterruptible power supply UPS to protect your system from power outages Choose one that can provide 1050 Watts for at least 45 minutes The UPS should be UL listed CSA certified and CE marked when used internationally If you do not use a UPS use a surge protector Choose a protector that meets your needs Factors to consider include electrical environment endurance suppressed voltage rating and method of protection It should have six outlets rated at least 1500 Watts and be UL listed CSA certified CE marked for nondomestic use when used internationally Printer HP LaserJet 2300 or available equivalent Use the Code 128 barcode label type when scanning barcode labels into the system as patient identities VWR product number 58816 121 Speed range 0 3200 rpm or equivalent Cole Parmer product number 08849 00 Operating frequency 55 kHz or equivalent Luminex 100 IS User Manual Version 2 3 xMAP Technology System Overview The system consists of three subsystems electronic fluidic and optical The following section describes the user acce
35. Wizard You define unknown replicates during the Batch Setup process When kit manufacturers create templates they choose one of two methodologies to generate standard curves Fit of All Standards default e Mean of Replicates The assay developer defines the curve fit generation method while creating the assay template The system default is to generate the curve fit according to the fit of all standards method When generating a curve fit according to the fit of all standards the system plots all standards to define the curve If the curve is generated from the mean of replicates the system determines the fluorescent value for each of the replicate standards then calculates the mean fluorescence of all replicates The system plots the average mean of the replicate standards on the standard curve Luminex offers this method to reduce the time it takes to calculate the standard curve If the system detects that you validate or invalidate a sample the change affects the final results The system flags the change and enables the Recalculate button so you can recalculate your results after changing data Click Recalc to recalculate data Checking the auto box below Recalc causes the system to automatically recalculate the results after each change Regardless of how the system generates the curve fit the system averages replicate test results for all samples standards controls or unknowns to determine the reported tes
36. after acquisition completes Copy Output csv file to Common Output Dir Select to send a copy of the Output csv file to the My Batches Output folder Prompt for Batch Comment Check this button to initiate a prompt for batch commenting when a batch is finished Write Sample Comments Select to add sample comments to the Notes column in the output csv file Additional Export Stats Select to define which sample statistics to export outside the Luminex 100 IS software to the output csv file Test Sort Order Choose an option to define the sorting order Click the radio button adjacent to the desired test sorting order Additional Batch Information Select one or more options to add additional information to the exported batch file Export Location Label Style Choose one of these options to define the label data style exported to the Output csv file You can select sequential numbering by plate location or both default PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software To configure the data that you export to files 1 On the Tools menu click Options and then click the Data Export tab See Figure 5 6 2 Click the checkboxes and radio buttons next to the desired features for your export data click OK to save your selections Agtx General Company Information Data Export Iv Auto Export Batches Additional Batch Information iv Copy Output csv to Common O
37. and Style Also notice that there are six buttons along the bottom of the dialog box They are the OK Cancel Apply Original Export and Maximize buttons 5 101 Luminex 100 IS User Manual Version 2 3 xMAP Technology Test 36 Customization x General Axis Font Coor Style Main Tithe r Tes A m iu Numenc Precision Sub Title e wv OQ Viewing Style Grid Lines Cole Boh C Y C X C None C Monochrome Grid in front of data Monochrome Symbols Eont Size C Lage Med Small Figure 5 87 Customization Dialog Box General Tab Customization Dialog Box Buttons OK click to update the graph s parameters with the new information and exit the Customization dialog box Cancel click to abort selections and exit Apply Apply is similar to the OK button but does not close the Customization dialog box It updates graph parameter with new information Original click this button to restore the edited information to the previous or original values Export click this button to export data from a Metafile or BMP graphic to a csv output file in the batch folder file or to the clipboard You can also export to a printer and specify the object size Select the desired features and click Export See Figure 5 x r Export MetaFile C BMP C Text Data Only r Export Destination ClipBoard C File C Printer Object Size C No S
38. e Histogram Dot Plot This section provides an overview and basic descriptions of the Acquisition Detail tab Figure 5 35 displays the Acquisition Detail tab and identifies the major features Luminex 100 IS User Manual Version 2 3 xMAP Technology Jefe E Luminex 1 IS toolbar 5 Status bar 2 Batch name and description 6 Histogram 3 Batch data area and buttons 7 Dot Plot 4 Acquisition detail toolbar Figure 5 35 Acquisition Detail Tab Acquisition Detail Toolbar The Acquisition Detail toolbar provides batch and advanced functions to acquire raw data without using templates The toolbar provides a variety of commands to use during a batch including Start Plate Cancel Command Pause and Resume 1 Replay batch 6 Cancel All 2 New advanced batch 7 Eject 3 View batch data 8 Pause 4 Start 9 Resume 5 Cancel Figure 5 36 Acquisition Detail Toolbar 5 42 PN 89 00002 00 071 Rev A xMAP Technology Replay Batch New Advanced Batch View Batch Data Start Cancel Cancel All Eject Retract Pause Resume Batch Data Area and Buttons Batch Name and Description Batch Data Area PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software Click to replay batch sample acquisition All batch commands are replayed allowing for batch acquisition viewing exactly as in real time You cannot replay New Advanced Batches When running a Replay Batch command the original acquisition dat
39. pr sentes prescriptions peuvent entrainer d une exposition un rayonnement dangereux This label appears above the laser apertures located inside the optics enclosure inside the Luminex 100 analyzer Figure 2 8 Avoid Exposure Label This label is attached to the barcode reader PN 89 00002 00 071 Rev A xMAP Technology Safety 4 460 120 4 593 186 4 652 750 e 4 673 805 4 736 095 e 4 816 660 N 4 845 350 e 4 861 972 4 866 257 4 897 456 5 179 270 e 5 810 904 5 237 161 5 247 161 5 247 162 5 258 604 e 5 260 554 e 5 298 728 5 311 000 5 330 370 5 468 949 5 474 206 5 481 098 Other patents pending COVERED BY ONE OR MORE OF THE FOLLOWING PATENTS 4 387297 e 4 409 470 Figure 2 9 Barcode Reader Laser Label Do not stare into the beam or shine it into other people s eyes Mechanical Warning During operation this system contains exposed moving parts Risk of personal injury is present Observe all warnings and cautions Warning During operation this system contains exposed moving parts which could result in puncture hazard Risk of personal injury is present Keep hands and fingers away from the Luminex XYP instrument slot during operation Warning During operation this system contains exposed moving parts which could result in pinch point hazard Risk of personal injury is present Keep hands and fingers away from the Luminex XYP instrument slot during operation Note Ac
40. the tab displays the Standards and Controls values for the selected test 5 90 PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software Open Batch Export Data Close Protein Batch IL 4 Errors F9 Standards F11 Samples F2 Test lame System Comments y 7 1 48E 02 2 85E 04 1 X 4 85E403 1 26E 00 6 69E 01 z 14 Olews R 2 0 9993 Sample High Low LogisticSp yeatb i4pe e Pay Des R 2 0 8994 Sample High Low PE i 20000 nen 15000 an pettiriiftisiifiriifiriitisiifiriifiviifisiitiiiitis o 1000 2000 3000 4000 sooo 6000 7000 5000 9000 10000 pott Loc Standard Expected Conc MFI TestResult CV Unit ct 10 10 62 14 66 po mL Di 10 10 68 1511 pain E1 315 316 212 27 70 paimL FA 316 31 6 208 2730 pgimL Gt 100 100 853 93 05 palin Ht 100 100 833 90 84 paimL A2 316 316 2824 34457 poinL ic Loc Control Expected Cone MFI Low Limit HighLimit TestResut CV Unit n A3 Coni00 100 797 75 125 86 89 paml B3 Con 100 100 815 75 125 88 86 pg mL C3 Con 1000 1000 6390 850 1150 934 46 palm D3 Coni000 1000 6874 850 1150 102827 Avg Con 100 806 87 87 1 587 pg mL Avg Con 1000 6632 981 36 6759 pgimL i Recale IV Auto Next Test F2 Invalidate Standard FA _ invalidat
41. 071 Rev A Contents Luminex 100 IS User Manual Version 2 3 xMAP Technology Analyze Data Outside the IS Software 5 106 Data Output ice tepUee eee mew e E e ES 5 108 Report Types scc saan ex er ner atem ers 5 108 Analyte Report 0 0 cece eee eee 5 108 Clinical Patient Report 2 0000005 5 108 Patient Summary Report 0000 5 108 Quality Control Report lllsleeeeeess 5 108 Maintenance Report 00 00 e eee eee 5 108 Batch Summary Report 0 2000 5 108 Calibration Trend Report 0 0055 5 108 System Control Trend Report 0 5 108 Print Reports esse eR REOR d e Xr s 5 109 Print from within Luminex 100 IS 2 3 5 109 Print Using External Program 5 110 Export Batch Data 0 eee ee 5 111 Database Management 0 0 0c eee eee eee 5 112 Back Up the Database 004 5 112 Erase the Database Data 004 5 113 Restore Database Data 0 0 000000 cea 5 114 Cleanup Utility 0 eee eee 5 115 Disk Cleanup eee ast een area ing mene ees 5 115 Delete MsgLog Directory 0 002 5 117 Delete Batch Directory 0 000 cee eee eee 5 117 Help Menu 0 cece eee eee eee 5 117 Online Help Structure 20 0 0 cee eee eee 5 118 TOPIC eerte AD et rt etg dt e 5 118 hn 5 118 Hyperlimk tp
42. 100 IS 2 3 Software box turns red with an asterisk proceeding it When validating the red returns to the normal color Invalidate Standard Invalidate Control Invalidate Standard All Tests Invalidate Control All Tests Validate Standard Validate Control Validate Standard All Tests Validate Control All Tests Invalidate Standard Invalidate Control Validate Standard Validate Control 1 Menu for multiple tests 2 Menu for single test Figure 5 80 Invalidate and Validate Shortcut Menus Recalculate using Auto or the Recalc button To validate or invalidate a standard or control entry using the Invalidate and Validate Buttons Select the desired standard or control name in the Standards or Controls grid Click one of the appropriate buttons at the bottom of the Analysis window Invalidate Standard F4 Validate Standard F5 Invalidate Control F6 or Validate Control F7 The appropriate Standard or Control dialog box opens Figure 5 81 shows an invalidate example If you want to invalidate or validate all tests click Yes For only the single test click No When invalidating the Name box turns red with an asterisk proceeding it When validating the red returns to the normal color Click Auto or Recalc to recalculate the results Data Analysis xj Do you wish to invalidate Std XL C1 For all tests No Cancel Figure 5 81 Invalidate Data Analysis Example Luminex 100 IS User Ma
43. 2 Toggle button 3 Expand Margin arrows Figure 5 32 Detailed Sample Progress PN 89 00002 00 071 Rev A 5 39 Luminex 100 IS User Manual Version 2 3 xMAP Technology Message Log The Message Log shows a list of completed commands errors and warnings It is located on the lower part of the Diagnostics tab It also displays each operation s progress time and date and results See Figure 5 33 55 Databas ge Time 5 1001 11 10 06 AM CAMy BatchesiDNA Batch DAOU 54 Commands Finishe Time 5 25 2001 11 10 05 AM 53 Device State Change Time 5 25 2001 11 10 05 AM Old State Processing New State Idle 52 Command Completed Time 5 25 2001 11 10 05 AM CommandName Acquire Patient 4 CommandNo 15 of 15 51 Command Started Time 5 25 2001 11 09 50 AM CommandName Acquire Patient 4 CommandNo 15 of 15 50 Command Completed Time 5 25 2001 11 09 50 AM CommandName Acquire Patient 3 CommandNo 14 of 15 49 Command Started Time 5 25 2001 11 09 34 AM CommandName Acquire Patient 3 CommandNo 14 of 15 48 Command Completed Time 5 25 2001 11 09 33 AM CommandName Acquire Patient 2 CommandNo 13 of 15 47 Command Started Time 5 25 2001 11 09 18 AM CommandName Acquire Patient 2 CommandNo 13 of 15 46 Command Completed Time 5 25 2001 11 09 17 AM CommandName Acquire Patient 1 CommandNo 12 of 15 AR Cammanad Ctartad Timea BIQEIINAA 44 09 AN AKA Carmrmandtlarnn Neeuira Datiant 4 Camraandnia 19 af 1R A gt Batch data exported F
44. 38 2 B1 Plate1 Acquire Standard Std M 1 AE B 3 C1 Platel Acquire Standard StdL 1 Finish Description A 4 D1 Plate1 Acquire Standard Std L 1 None z A 5 E1 Plate1 Acquire Standard Std XL 1 amp 6 F1 Plate1 Acquire Standard Std XL 1 Cancel a a 7 G1 Plate1 Acquire Control Con L 1 r 8 8 H1 Plate1 Acquire Control ConL 1 Created By 9 A2 Plate Acquire Patient 2 Ld Names 10 B2 Plate1 Acquire Patient 2 Teed ESSE 11 C2 Plate1 Acquire Patient 2 Template Info 12 D2 Plate1 Acquire Patient 1 13 E2 Plate1 Acquire Patient 1 g Name _ 14 F2 Plate1 Acquire Patient 4 Help B36 RepQt Assay 15 G2 Plate1 Acquire Patient 1 Di 6 escription Peacenitoad Replicate Simplex Quant rc New Lot Save only r Standard Info Ij Product No 3000 Product Name 36 Rep t Kit Version No Lot Name 36Repatstd 2227 Expiration Date 06 10 2005 r Control Info Developing Co oe ee Product No 3000 Vaan Product Name 36 Rep t Kit LMNX OLX ION QQ Q OO 500 Lot Name 36RepatCon Expiration Date 06 10 2005 Figure 5 45 Luminex Batch Setup Dialog Box Use this procedure to open a batch that you created earlier save only To verify that you opened the correct batch the batch name and batch description appear on the Run Batch tab when you load the batch PN 89 00002 00 071 Rev A xMAP Technology Delete a Batch Note Make sure that the batch that you want to delete is the batch that you selected Once you
45. 5 82 The Samples tab lists tests from your batch and displays the results for each sample Figure 5 84 shows a Sample tab example listing three tests Notice that the left column displays Test IL 4 IL 6 and IL 8 with Test IL 4 selected The Sample column on the right side shows the IL 4 sample results Notice that the well G3 location test result is lt 10 and the associated Comments column for the third sample indicates a sample out of range error Sample High Low because this sample has an MFI less than the lowest standard in the standard curve for this non competitive batch The first sample is within the standard curve range and thus displays an unflagged test result Luminex 100 IS User Manual Version 2 3 xMAP Technology Replicate Averaging Note You predefine standard and control replicates in the template You define unknown sample replicates in batch setup indicated by replicate Sample ID The system does not flag results as normal or abnormal according to a defined range Error flags only note samples that fall below or above the standard curve BB Analysis zii xd pen Batch Export Data Close Protein Batch IL 4 Errors F9 Standards F11 System Comments R 2 0 9995 Sample High Low R 2 0 9999 Sample High Low R 2 0 9994 Sample High Low Sys Sample HighLow Sys Sample High Low Sys Sample HighLow Sys Sample HighiLow
46. 94 These reports include e Analyte Report Clinical Patient Report e Patient Summary Report e Quality Control Report e Maintenance Report e Batch Summary Report e Calibration Trend Report e System Control Trend Report This report prints some or all of the samples grouped by the test in a batch This report provides a breakdown of samples according to the test analysis with that sample This report prints all of the test results for a patient It may include all tests or selected tests on the report This report is used to track the trends of assay standards and assay controls over a period of time This report provides a history of all maintenance operations performed during the date range entered by the operator This report prints batch information in a sample versus test grid format A batch summary report is useful for an assay developer to quickly reference a test result for a particular sample This report provides information about all instrument calibration operations that occurred during the date range entered by the operator This report provides information about all verification operations that were performed during the date range entered by the operator PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software Print Reports You can print reports from within the Luminex 100 IS 2 3 software or external using a stand alone program included in the installation Print from within
47. An incomplete batch can be caused by situations such as a power failure software failure marking a batch for deletion or clicking Cancel All Use this procedure to re run or recover an incomplete batch To open an incomplete batch Onthe File menu click Open Incomplete Batch The Open Run dialog box opens Select the batch you wish to recover from the list 2 Click Start to continue where the batch left off Note that a comment is added to the batch to indicate that the batch is being rerun Use this procedure to open a multi batch that you created earlier for acquisition To load a multi batch for acquisition 1 Click Open Multi Batch The Open Multi Batch dialog box opens listing the available multi batches for selection 2 Select any one of the batches having the desired multi batch name 3 Click Select The system loads the multi batch to the Run Batch tab 4 Click Eject Retract to eject the plate holder 5 Load the first microtiter plate onto the plate holder 6 Once you load the plate to the system click Start Plate to retract the plate holder and begin acquiring the multi batch data You can process multiple plates per batch or multi batch After loading a batch or multi batch that spans more than one plate a new PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software plate appears to the immediate right of the existing plate image on the screen A dark blue line sep
48. Definitions Optional The average of any replicate samples final test results based on a qualitative or quantitative analysis The blocks of statistical data are displayed such that the first row of data represents the column headers and the following rows represent the samples that were acquired for the batch Table D 3 Statistic Column Definitions Column Name Description Location The location of the sample in terms of the command list sequence 1 2 3 the well placement A1 B1 C1 or both 1 A1 2 B1 3 C1 Sample The name of the sample as defined in the batch setup Limited to 30 characters Test Test2 TestN The number of test columns following the Sample column will depend on the number of tests defined in the Template used to create the batch Each of the test columns will contain the test name for any given test Therefore if the Template has 3 tests named Protein A Protein B and Protein C then these names will appear in the 3 test column headers in the OUTPUT CSV file Limited to 30 characters PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 xMAP Technology Table D 3 Statistic Column Definitions Column Name Description Total Events one of the defined regions The number of events that fell with in the defined DD gate and into one of the defined regions for a test in the batch For example if a template had 3
49. FOR USE ONLY WITH LUMINEX PRODUCTS TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW LUMINEX AND ITS SUPPLIERS DISCLAIM ALL WARRANTIES EITHER EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT 7 LIMITATION OF LIABILITY IN NO EVENT SHALL LUMINEX OR ITS SUPPLIERS BE LIABLE FOR ANY SPECIAL INCIDENTAL INDIRECT OR CONSEQUENTIAL DAMAGES WHATSOEVER INCLUDING WITHOUT LIMITATION DAMAGES FOR LOSS OF BUSINESS PROFITS BUSINESS INTERRUPTION LOSS OF BUSINESS INFORMATION OR ANY OTHER PECUNIARY LOSS ARISING OUT OF THE USE OF OR INABILITY TO USE THE SOFTWARE PRODUCT EVEN IF LUMINEX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES MISCELLANEOUS This EULA is governed by the laws of the State of Texas U S A without reference to conflicts of laws principles You shall not assign or sublicense or otherwise transfer the rights or license granted hereunder by agreement or by operation of law without the prior written consent of Luminex and all assignments in violation of this prohibition shall be null and void This EULA is the complete and exclusive agreement of Luminex and you and supersedes all other communications oral or written relating to the sub ject matter hereof No change to this EULA shall be valid unless in writing and signed by the party against whom enforcement is sought The waiver or failure of Luminex or you to exercise in any respect any
50. Histogram Dot Plot The system displays the batch name and description in the upper left side of the Acquisition Detail tab This displays sample results The left column shows plate location and well description The remaining columns display selected bead Luminex 100 IS User Manual Version 2 3 xMAP Technology sets for the assay Each row represents the data for each bead set from one well Copy and Export This popup menu is available when you right click in the Batch Data Menu Area Select Copy to copy the currently displayed data to the clipboard Select Export to manually export the currently loaded batch to the appropriate Output csv file Autosize Click to automatically adjust column widths to fit the data and header sizes Statistics Allows you to display the selected statistics for your sample data Select an entry from the scroll list There are eleven statistics This does not change the format of the expected data CV Trimmed CV Count Trimmed Count Mean Trimmed Mean Median Trimmed Peak Peak Trimmed StdDev StdDev Luminex 100 IS 2 3 software and Luminex 100 IS Developer Workbench use only median statistics However you can export the other statistics to reports You define which statistics to export through the Data Export tab on the Options dialog box select Tools Menu then Options CV Coefficient of Variation Standard Deviation Mean x 100 Count Gated events if gates are set e Peak Histog
51. IS data base or allow you to perform data analysis on acquired batches Luminex 100 IS User Manual Version 2 3 Note Use plates with wells that will hold at least 185 uL the extra 25 uL from the sample plus an extra 160 uL that is dispensed back into the well following acquisition Note The Luminex 100 IS software uses only the 100 region bead map However at the Acquisition Detail tab you can view the data for 25 50 and 100 regions and save the data to a csv file xMAP Technology To create a New Advanced Batch 1 Select Acq Detail tab 2 Onthe Acquisition Detail toolbar click New Advanced Batch The Options Dialog Box opens with the General tab displayed See Figure 5 56 General Bead Set Plate Layout Name Description Operator Sample size 5g uL DD Gate Timeout 25 sec 7500 to 15000 Bead Events 1 PerBead Total Beads 1000 OK Cancel Figure 5 56 Options Dialog Box General Tab 100 regions 3 Enter the Name Description and Operator information 4 Edit the following information as desired e Sample Size use values from 20 to 200 uL To avoid air uptake we recommend that your sample well contains at least 25 uL in addition to the sample size DD Gate use values within the range of 0 to 32767 Timeout use values of 0 to 400 where 0 no timeout 5 Click the arrow down next to 100 regions to select the desired bead map The availa
52. Luminex 100 Version 1 7 with Windows 98 you need Upgrade Kit CN U010 01 Follow the procedure on page B 15 e Luminex 100 Version 1 7 with Windows 2000 you need Upgrade Kit CN U010 06 Follow the procedure on page B 17 e Luminex 100 IS Version 2 1 or 2 2 you need Upgrade Kit U010 07 Follow the instructions on page B 19 B 14 PN 89 00002 00 071 Rev A xMAP Technology Luminex 100 Version 1 7 with Windows 98 to Luminex 100 IS Version 2 3 Install New PC Install Luminex 100 IS 2 3 Software PN 89 00002 00 071 Rev A Luminex 100 IS 2 3 Software Installation Overview of upgrade to Luminex IS 2 3 software procedure 1 Install new PC Install Luminex IS 2 3 software Verify successful upgrade To install the new PC Close all applications Perform a complete system shutdown Turn the power off and unplug the Luminex 100 analyzer Luminex XYP and PC Remove all connections from the old PC Remove the old PC and set aside Place the new PC in place Connect the monitor power and Com cables to the new PC Install the keyboard into a USB port Connect the barcode reader to the back of the PC Connect the mouse to the mouse port Continue with the Install Luminex 100 IS 2 3 Software section To install the Luminex 100 IS 2 3 software Turn on power to only the PC and monitor switches are on the front The system starts up Windows Log into Windows as local Administrator a In the Welcome to Windo
53. Luminex SD system 2 Wipe all exterior surfaces with mild detergent then a 10 to 20 bleach solution and finally with plain distilled water 3 Open both doors of the analyzer and clean all accessible surfaces with detergent followed by a 10 to 20 bleach solution and then plain distilled water 4 Dry the sheet metal surfaces to prevent corrosion 5 Plug in and power on the Luminex 100 analyzer the Luminex XYP instrument and the Luminex SD system 6 Calibrate the system as outline in Calibration and Verification on page 5 28 Calibration and System Run calibration and system controls at least once a month during Controls routine use and following installation if the system is moved if a part is replaced if the delta calibration temperature shown on the system monitor located on the Diagnostics tab is more than 3 degrees Each step usually takes less than one minute You must run xMAP controls after each calibration See Run System xMAP Controls on page 5 31 PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 Every Six Months xMAP Technology Luminex 100 Analyzer Air To replace the analyzer air intake filter Intake Filter l Note Hold on to the tubing Do not allow the tubing to fall inside the the analyzer Disconnect the Luminex 100 analyzer from ac power by turning off the power switch on the rear of the analyzer then unplugging the power cord from the wall source
54. Rev A Using Luminex 100 IS 2 3 Software xi Backing up LX100 IS Database Figure 5 101 Database Backup Dialog Box You can erase sample information from the database at any time You will see a warning when the database is 80 full approximately 200 MB free of a two GB hard drive limit This provides advanced warning to erase database information When the database is 98 full sample acquisition is prevented System calibration and control information is not affected when you erase sample information The system also does not affect standard and control information while erasing data from the database To erase information from the database 1 3 On the Tools menu click Erase Database The Choose Date calendar opens See Figure 5 102 Choose the day after the last day of the database entries that you want to erase For example all data prior to January 16 are erased January 16 is kept ii xi Delete database entries prior to the selected date E January gt 2002 1 Cancel Figure 5 102 Choose Date Calendar Click OK The Delete Database Entries dialog box opens and warns that you are about to delete database records 5 113 Luminex 100 IS User Manual Version 2 3 xMAP Technology Delete Database Entries EI 9 You are about to delete database records prior to 01 16 2002 Are you sure Figure 5 103 Delete Database Entries Dialog Box 4 If you are sure you want to delete t
55. The Confirmation dialog box opens Click OK to begin priming Wait until the Prime is completed Click Eject Retract to eject the Luminex XYP instrument tray Place 70 isopropanol or 70 ethanol in the reservoir Click Alcohol Flush The Confirmation dialog box opens Click OK to begin the Alcohol Flush Click OK and wait until the alcohol flush completes The Device Status section on the Status Bar changes from yellow to green and indicates Standby This takes about five minutes Select the well where CONI is located from Step 2 using the drop down arrow located to the right of the CONI button Verify the location Click CONI The Confirmation Screen dialog box opens Click OK Wait until CONI completes Select the well where CON2 is located from Step 2 using the drop down arrow located to the right of the CON2 button Verify the location Click CON2 The Confirmation Screen dialog box opens Click OK Wait until CON2 completes Verify that the system controls completed successfully from the Diagnostics tab System Monitor If controls are successful the date and time appear as green text If controls fail the date and time are appear as red text On the Maintenance tab click the well where you placed the sheath fluid Click Wash A confirmation dialog box opens Luminex 100 IS User Manual Version 2 3 xMAP Technology 15 Click OK and wait until the Wash completes The Device Status section on the Status Bar changes to standby
56. Varying amounts of fluorochromes embedded within each xMAP microsphere give each xMAP microsphere set an unique fluorescent signal To ensure the stability of this signal it is essential to protect the microspheres from light Follow the product information sheet instructions for storage procedures for xMAP microspheres and assay kits Calibrator xMAP microspheres are used to normalize the settings for the reporter channel both classification channels and the doublet discriminator channel for the Luminex 100 analyzer The control x MAP microspheres are used to verify the calibration and optical integrity of the system This section provides a brief overview for using the Luminex 100 IS 2 3 software With the Luminex 100 IS 2 3 software you work with assay kits provided by a kit manufacturer A template may be included with each kit that is imported into the software The template includes a sequence of commands required for the assay Once you select the template you enter sample data into a batch Sample input can be done quickly with either the keyboard or a barcode scanner A batch can include as many samples as you have for the assay and can include multiple microtiter plates You can even group multiple batches together into a multi batch for efficient processing You can process a batch immediately or choose to archive the batch for testing later As testing proceeds through the plate you will see the display update to show
57. a 6 F1 Platei Acquire Standard Std XL 1 Concel 8 7 G1 Plete1 Acquire Control__ ConL 1 3 B 8 H1 Platel Acquire Control Cont 1 Created By 9 A2 Plate Acquire Patient 2 J Name 10 62 Plate1 Acquire Patient 2 Load Pa List 11 C2 Plate1 Acquire Patient 2 Template Info 12 D2 Plate1 Acquire Patient 1 13 E2 Plate1 Acquire Patient 1 Lr Name 14 F2 Plate1 Acquire Petent 1 Help B3 Repat Assay 15 G2 Plate Acquire Patient m Description 1 2723 s e 7 u 9 200 12 Save and Loa Replicate Simplexduant 996 00000000 Seka cl New Lot e 000000000 i Y Y Standard Info ud GOLDI JLL Product No 3000 O Product Name 38 Repot Kit Version No Re O ded Sd ddad Lot Name J6R epototd ea 9000000000 Expiration Date 06 10 2005 reeeooo0O0O0O0O0OO Control info Developing Co o Product No 3000 png 009 lt 4 2 x z Product Name 36 RepOt Ki MNX eeooOoOOOOOO Lot Name 36Repatcon Expiration Date 08 10 2005 Figure 5 47 Luminex Batch Setup Enter the Patient Sample IDs and dilution factors in the appropriate rows You can manually enter the Sample ID or scan in using the system barcode scanner If the Sample ID row is blue the software will not apply the sample IDs until it is white If you want to add a patient list to this batch click Load Patient List Select a patient list text file to append to the batch and click Open The patients from that text file append to the latest
58. a New Batch 0 0 0 0 cee eee eee 5 50 Insert Menu 2 aan a i aa ik eee 5 53 Open a Baths 5 oe ee tee eom nomad angers 5 54 Delete a Batch 0 eee ee eee 5 55 Create a Multi Batch 0 0 00 ee eee eee 5 55 Re run or Recover Incomplete Batch 5 58 Open a Multi Batch 0 0 00 0 eee eee 5 58 iv PN 89 00002 00 071 Rev A xMAP Technology Process Multiple Plates 0000 5 58 Scan In New Samples with a Barcode Reader 5 60 Adda Patient List 0 0 eee ee eee eee 5 61 Edit a Patient List 0 0 ee eee eee eee 5 63 Change Start Acquiring Data Location 5 64 Change Start Acquiring Data Location in Multi Batches 5 64 Assign Sample Dilution Factors 4 5 65 Copy Batch Information to Clipboard 5 67 Paste Batch Information to a Document 5 67 Clear a Batch From the System 4 5 67 Create a New Advanced Batch 5 67 Background Samples 0 0 cece eee eee 5 73 Templates 222 oeil hr eae bee eee be oe ba 5 73 Import a Template 0 0 0 0 0 eee eee eee 5 74 Assay Lot Management 0 0 00 c eee eee eee 5 74 Create a New Loto cess 0 eee eee eee 5 75 Edit Lot Information on an Unused Template 5 77 Edit Lot Information on a Used Template 5 79 Import a Lot to an Existing Template 5 80 Export a Lot from
59. an Existing Template 5 80 R plicates ser ees dciss Een eia ius 5 81 Generate a Standard Curve 000 eee eee eee 5 82 Plate Commands cerva eR eR ETE 5 82 Start Plat sia bbe ERIDATER E RES 5 83 hour E arate nasa avcaasdoavace E E E widbalene 5 84 RESUME EE 5 84 Cancel Command 0 00 e cece eee eee 5 84 Cancel All occ eens 5 84 Bbject R tract sese ha chat te phen wae eA ae 5 85 Analyze Batches and Multi Batches 5 85 Enable Automatic Analysis 000 5 5 87 Analyze Processed Batch Data 5 87 Print Data Analysis Report 00005 5 88 View Detailed Test Analysis 04 5 90 Standards Tab susce heed eel DA wr Er UR EE EES 5 90 Function Keys 0 cece eee 5 93 Recalculation eee erario bea an re ete 5 93 Invalidate or Validate Standards and Controls 5 94 Expected Concentrations 0 00 eee 5 96 Change Lots peres eiea erea cc cece eee eee 5 96 samples Tab dss hed tea wala De et ag ard ada RU eR aun 5 97 Replicate Averaging 0 0 e eee eee eee 5 98 Sample Progress Sorting 0 0 0 0 cece eee eee 5 99 Errors T b scere eee Saga ete oh 5 99 View Detailed Error Information 5 100 Customize Data Analysis Settings 5 101 Customization Dialog Box 0 005 5 101 Graph Menu oe eee ea ERE EE ERE rd 5 106 PN 89 00002 00
60. and 5 30 Central European Time Monday through Friday Email inquiries in Europe can be sent to supporteurope luminexcorp com Power supply problems often involve a blown fuse faulty electronic P roblems component or even something as simple as a disconnected cable Use extreme care when you replace a fuse Symptom Possible problem Solution Analyzer will not turn on or XYP will not turn on Fuses continue to open blow Communication The power cord is disconnected Verify that the power cord is Plugged in No voltage is coming from the Verify that the electrical outlet is electrical outlet operational The power supply is faulty Contact Technical Support A fuse has burned out See page 6 11 for instructions on changing fuses A component has a short circuit Contact Technical Support The communication problems described in this section involve the links between the data system PC and Luminex Data Collector software and the Luminex 100 analyzer and XYP instrument This section does not address communication issues with other peripheral devices The term Communication refers to The transfer of data between the PC and the analyzer The current status of the analyzer and XYP instrument e Instrument readbacks e Instrument control sample acquisition session uploading and start stop and pause features Symptom Possible problem Solution PC cannot initialize communication with a
61. and applies them to the template The Update Lot Information dialog box closes Update Lot Information Import Export cD uc x Lai e Revert Save Cancel Change the current lot by saving selected lot r Test Standards 2000 Current Lot B3654QtStd Current Lot _NewLot Delete Lot Exp Date 06 05 2008 gt Test 54 mg dL r Test Controls 2000 Current Lot B3654QtCon Current Lot e3664c1Con NewLot DeleteLot Exp Datefo3 07 2003 gt Low Limit Expected Values High Limit Figure 5 67 Update Lot Information Dialog Box PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software Edit Lot 4 To edit lots on a used template may have new lot number of Information on a reagents but are using same template Used Template 1 On the Home tab click New Lot The Open Template dialog box opens See Figure 5 68 ID Template Name Version Description 3 Template 1 28 02 9 32 bwh vbby h 4 Template 1 28 02 10 22 21h 5 Template 1 29 0212 2 2 90 B Template 1 29 02 12 25 123 7 Template 2 5 02 16 42 2 2 100 8 Template 2 6 02 10 04 2 2101 9 Template 2 5 02 10 55 2 2 101 10 Template 2 6 02 10 58 2 2 101 11 Template 2 6 02 11 00 2 2 101 12 Template 2 6 02 11 01 13 Template 2 5 02 11 02 Select Cancel Figure 5 68 Open Template To Update New Lots 2 Double click the template that you want to edit An Update Lot Infor
62. correct calibration lot number in the Update CAL Targets dialog box Enter the correct target values in the Update CAL Targets dialog box Ensure that the correct wells are selected in the Run Batch tab Slow or unsuccessful sample acquisition The air pressure is out of range The sample probe is clogged The sample probe is not vertically aligned Air is present in the system The acquisition volume is set too high The xMAP microspheres are not fully suspended You are using photobleached microspheres See Pressurization on page 7 3 Clean the sample probe See page 6 4 Adjust the sample probe height See page B 8 Run three Prime commands then resume sample acquisition Set the acquisition volume to at least 25 uL less than the actual volume in your wells This setting lets the analyzer acquire sample more efficiently with less chance of acquiring air Vortex or pipette your samples up and down to ensure that the beads are present in the solution Replace photobleached microspheres with a fresh lot of microspheres There is an insufficient number of beads in the sample Ensure that there are 2000 5000 beads per set per well Bead Detail Irregularities Use these tools to assist in diagnosing system and kit related problems system calibrators system controls assay standards assay controls PN 89 00002 00 071 Rev A xMAP Technology Troubleshooting err
63. dialog box select the batch you want to analyze then click Select The most recent Replay Batch is the last or has the highest ID number See Figure 5 39 Open Batch ID Batch Name Description Multi Batch ID Name 2 B3654 Quant Testing Mean SD Tammed Mean 4 3654 Rep Quant Batch Mean SD Trimmed Mean 5 Batch 6 1 02 16 10_FILEMODE None 6 Batch B 1 11 FILEMODE None 7 Batch 6 3 349 FILEMODE None B Batch 5 3 02 FILEMODE None 9 Batch 5 3 FILEMODE None 10 Batch 5 342 FILEMODE None 454 FILEMODE None 11 Batch 5 3 02 12 Batch 5 34012 14 13 FILEMODE None 13 Batch 6 3412 14 17 FILEMODE None 14 Batch 6 302 14 17_FILEMODE None 15 Ratch RAMI 14 19 Ell EMODE e None x Cancel Figure 5 39 Analyze Open Batch 3 The Analysis window opens showing the Batch info in the Standards tab To close the Analysis window click Close See Analyze Batches and Multi Batches on page 5 85 A batch consists of a group of samples processed under control of a template Batches are set up using templates defined by assay kit manufacturers Batches consist of templates and samples for acquisition and can span more than one plate Templates contain predefined commands that must be included in every batch acquisition Commands may consist of Acquire Standard Acquire Control Acquire Background Wash from Well or Prime You can group batches together as a multi batc
64. ethanol Mild detergent Luminex 100 IS 2 3 software provides complete control of the system and performs data analysis Your Luminex 100 IS 2 3 system is preloaded with the Luminex software However we supply a software CD should you need to reinstall the software This software requires a dedicated system Unauthorized additional software is prohibited and may result in improper operation of the system e Speed greater than or equal to1 7 GHz Intel Pentium IV processor with 256 MB RAM USB communications link for fast data transfer e Automatic transfer of assay templates and new reagent information into the system via a 3 2 diskette or large capacity read write CD e Installation lt 4 hours e System calibration lt 10 minutes e System controls lt 10 minutes e Barcode reader entry of sample IDs e Automatic post analysis e Analyze one 96 well plate hour depending on manufacturer s kit e Up to 100 x MAP microsphere sets per sample e Sheath flowrate 90 uL sec 5 uL Luminex 100 IS User Manual Version 2 3 Accuracy and Precision Sensitivity Capacity xMAP Technology Sample injection rate into detector area 1 uL sec 0 05 uL System warmup 30 minutes Systems that remain inactive for at least four hours will require a warm up to restart the lasers After acquiring sample running system calibrators running system controls and warming up the instrument the system resets the four hour internal c
65. folder directory Current User Enter the name of the current user or operator Luminex 100 IS User Manual Version 2 3 xMAP Technology Analysis Display Digits Use this feature to customize the number of digits shown on the Data Analysis dialog box and printed reports The data is stored with its full precision that is including all digits but the data appears as requested The default analysis digit display is for two digits to show in the analysis Display Confirmation Screens Select this feature to allow confirmation dialog boxes to display when you initiate many maintenance commands You can disable the confirmation screen display option so that commands initiated from the Maintenance tab do not display confirmation screens before performing the command The confirmation screens remain for commands initiated from the Home tab Enable Raw Data Storage Select this feature to save bead event data that is acquired while processing batches in the database The system defaults to Enable Raw Data Storage Raw data storage is necessary particularly when you use file mode Report Raw Fluorescence Select this feature to enable the median fluorescence intensity MFI display to appear on the Analyte Report This feature was previously used to display MFI values on all reports In the Luminex 100 IS software Version 2 3 the only report affected by this selection is the Analyte Report AII others are hard coded by the system Auto
66. in whole or in part is strictly prohibited End User License Agreement EULA for Luminex Software This Luminex End User License Agreement EULA is a legal agreement between you either an individual or a single entity also referred herein as you the end user and Luminex Corporation Luminex regarding the use of the Luminex software product identified above which includes computer software and online or electronic documentation and may include associated media and printed materials if any SOFTWARE PRODUCT or SOFTWARE The SOFTWARE PRODUCT is protected by copyright laws and international copyright treaties as well as other intellectual property laws and treaties The SOFTWARE PRODUCT is licensed not sold 1 GRANT OF LICENSE Subject to the terms and conditions of this EULA Luminex hereby grants to you a nonexclusive nontransferable nonassignable license without right to sublicense under Luminex s copyrights and trade secrets to use the SOFTWARE PRODUCT on a hardware platform purchased from Luminex pursuant to Luminex s terms and conditions of sale You may make one 1 copy of the SOFTWARE PRODUCT for backup or archival purposes only Although no rights or licenses under any of Luminex s patents are granted by or shall be implied from the license of the SOFTWARE or the sale of Luminex instrumentation to you the purchaser you may obtain a license under Luminex s patents if any to use this unit of Luminex instrume
67. list You may double click a batch for detailed information Note indicates a required field a x X New Batch Finish Cancel r Multi Batch Name Created By 34 00000 OOOCOO 2 2960000000000 3860000000000 3 ee 0000000000 ID Batch Name Batch Description No Cmds 5 Batch 5 23 02 9 53 None 8 Batch 5 28 02 9 43 None 1 First batch 2 Separator Line 3 Second batch Figure 5 54 Selecting Multi Batch Starting Data 3 Drag the highlighted well to the location on the microtiter plate where you want to begin acquiring data For a multi batch ensure each additional batch is in its desired location The display updates to show the wells for acquisition in its new location The empty wells in front of the new starting well now appear red in the Batch Setup box or white in the Multi batch Setup box When you process this batch the system begins acquiring data from the well indicated You do not need to run batches in consecutive wells within a multi batch There can be empty wells between batches Assign Sample You must indicate the sample dilution factor so the sample analysis Dilution Factors in quantitative tests is accurate The system multiplies the result by PN 89 00002 00 071 Rev A 5 65 Luminex 100 IS User Manual Version 2 3 xMAP Technology the dilution factor for reporting You must assign dilution factors as you create a batch
68. on If you replay a batch containing replicates replicate averaging will not be calculated in data analysis A number of variables can affect the final test results You may also change the standards or controls processed with the batch or multi batch These variables may effect your test results minimum number of events for acquisition formula used to analyze the MFI values e standards or controls validation or invalidation e type of analysis qualitative quantitative acquisition only or maintenance Reprocess samples using Replay Batch To reprocess samples using Replay Batch 1 On the Acq Detail tab click Replay Batch The Browse for Folder dialog box opens displaying the My Batches folder 2 Select the desired batch under the My Batches folder and click OK 3 The Open Template dialog box opens Click on the desired template and click Select 4 The Run Batch tab becomes the active tab You can monitor the commands as they process Click on the Acq Detail tab and monitor the data histogram and dot plot PN 89 00002 00 071 Rev A xMAP Technology Analyze Reprocessed Data with Replay Batch Note The Open Batch dialog box does not list or show the templates associated to the batches Batches PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software After replaying a batch you can analyze the data To analyze Replay Batch data 1 Click Start Analysis 2 Inthe Open Batch
69. on another batch xMAP Technology Replicates in quantitative batches are based on a standard curve that is generated by either the Fit of all standards or Mean of replicates The chosen curve fit is defined by the assay developer when defining an assay template The default is Fit of all standards Unknown samples are calculated from the standard curve Replicate samples are averaged to determine the reported quantitative result denoted as AVG The system can analyze only batches that it acquires using qualitative or quantitative templates It does not analyze acquisitions using Data Collection Only or Maintenance templates When the system analyzes batches it displays the data in a three tab format within the Analysis window See Figure 5 72 The following three tabs present the batch information in greater detail e Standards tab lists all tests in the batch a regression chart for each test and the standards or controls associated with the batch e Samples tab lists background samples and all samples or unknowns acquired in the batch with either a qualitative or quantitative result e Errors tab lists errors that occur during batch acquisition and data pertaining to the analyzed data such as controls that failed Open Batch Export Data Close Protein Batch IL 4 Errors F3 Standards F11 Samples F12 Test lame System Comments y TABE O2 2 85E 04 1 x 4 85E 03 1 26E 00
70. retract the plate Use the 3 32 inch hex wrench to loosen the height adjustment locking screw See Figure B 9 Verify that the correct location is selected with the appropriate number of discs The location must be the same as indicated in the software or the location you choose Click Sample Probe Down to lower the sample probe Using the thumb wheel lower the probe until it just touches the top of the alignment discs or sphere Use a 3 32 inch hex wrench to tighten the height adjustment locking screw Click Sample Probe Up to raise the sample probe Replace the plastic shield that covers the sample probe area Install the Luminex XYP Use the Luminex XYP instrument reservoir for the Luminex 100 Instrument Reservoir analyzer maintenance functions PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 xMAP Technology To install the Luminex XYP instrument reservoir 1 On the Maintenance tab click Eject Retract to eject the plate holder 2 Insert the reservoir in the upper right corner of the plate holder See Figure B 10 Figure B 10 The XYP Instrument Reservoir 3 Click Eject Retract to retract the plate holder Calibrate and Verify the Run system calibration See Calibration and Verification page 5 28 System to complete the installation process by running the system calibrators and controls Install the SD System To install the Luminex SD system 1 After performing system calibration a
71. right or rights provided for herein shall not be deemed a waiver of any further right hereunder If any provision of this EULA is held unenforceable the remainder of this EULA will continue in full force and effect EULA PN 89 30000 00 070 Contents Introduction 1 1 About This Manual 0 0 0 0 eee eee eee eee 1 1 The Luminex 100 IS 2 3 System 0 0 0 0 00 00 0000 1 1 Intended Use uela e bee ida ahaa yee aaa 1 1 Technical Support 0 0 0 cece eee 1 2 Luminex Website 0 0 0 0 eiee i Aea eens 1 2 Safety 2 1 Symbols 22s li ead head eR BERNER BERI RT UE et 2 1 Warnings and Notes 20 cece eee 2 2 Safety Precautions llle 2 2 ECC Label eder duode eut e d tud the 2 4 Igitur EP eho aven wi sataetd andes tages 2 4 Luminex 100 Analyzer Laser 00000004 2 5 Barcode Reader Laser 00 0 eee eee 2 6 Mechanical 2 24 este hese cee ee a ede ne ds 2 7 Biological 45 hid daa one ORR Oh ee easels 2 7 Heat rm 2 8 Blue Indicator Light 0 0 0 0c eee eee 2 8 Decontaminating the Luminex 100 Analyzer for Return Shipment liisizaldn cese rer edet bee EG bee Hee ee 2 9 The System 3 1 Theory of Operation ssssleeeeee ee eee 3 1 Hardware lac sis ciao needed ea E iac La eats 3 2 xMAP Technology Reagents l leeeeeeees 3 3 Required Laboratory Reagents 0 0 0 ce eee eee 3 3 Luminex 100 IS 2 3 Software 0 0 0 cece eee eee 3 3 Lumin
72. roll smoothly replace it with a new sample probe Calibration and Control Problems Symptom Possible problem Solution Calibration is slow or fails PN 89 00002 00 071 Rev A The calibration microspheres are not fully suspended Wrong calibration lot number or target values are entered in Update CAL Targets dialog box The system calibrators are in the wrong well on the plate Not enough calibrator microspheres added to the well Calibrator lot is expired The sample probe height is incorrect The sample probe is clogged Vortex the calibration vials to resuspend the microspheres Verify that the correct lot number and target values are used See page 5 28 for further information Verify that you placed the calibrator into the correct well See page 5 28 Make sure that you use four or five drops of calibrator microspheres to the well Use a new bottle of calibrator beads Adjust the sample probe height See page B 8 Clean the sample probe See page 6 4 Luminex 100 IS User Manual Version 2 3 There is a partial clog in the system There is air in the system Possible problem with the laser xMAP Technology Clean the sample probe See page 6 4 Run 3 backflushes 3 drains 2 alcohol flushes and 3 washes with distilled water Run a prime and alcohol flush View the calibration trend report Check for dramatic changes in temperature sheath pressure or volta
73. sample beginning with A to Z then one through nine The AVG results are listed above the individual sample results The Errors tab displays a list of errors that occurred during acquisition See Figure 5 86 It organizes the errors in two categories e System and assay errors top section of tab e Sample errors bottom section of tab Luminex 100 IS User Manual Version 2 3 xMAP Technology Table 5 11 lists the errors in each category Table 5 11 Error Categories System and Assay Errors Sample Errors Instrument Not Calibrated Insufficient Bead Count Failed Verification system Sample High Low lists each failed control e Analyzer Error Failed Control verifier e High Sheath Pressure failed e Low Sheath Pressure Temperature Divergence Sample Timeout from Calibration Sample Empty Temperature e Cannot Calculate Inverse Failed Curve Fit Function Analysis Error Different Qualitative Results APD Temp Range Exceeded XYP Temp Unstable Low Voltage High Sheath Pressure Low Sheath Pressure Command Timeout Low Laser Power Cannot Calculate Inverse Function Failed Std in Batch View Detailed 4 To view error details during acquisition Error Information 1 2 5 100 In the Analysis window click the Errors tab The top half of the screen displays system and assay related error The name of the error and a detailed description is displayed See Figure 5 86 and Table 5 11 The b
74. t sufficiently warmed up Possible Laser Failure Warm up the system This takes approximately 30 minutes Calibrate and verify the system Open the calibration trend report for LIOOCAL2 and record the last three reporter voltages Contact Luminex Technical Support with this information PN 89 00002 00 071 Rev A xMAP Technology Command Encountered Time Out Error The current command failed Troubleshooting Check the system to verify that it is warmed up and that there are no pressurization problems Repeat the command If the command continues to time out contact Technical Support Instrument Not Calibrated The instrument is out of calibration Calibrate the instrument Sample Error Sample error messages occur when there is a problem with sample Mess ag es acquisition These errors can display on the Diagnostics tab in the Message Log in Reports or on the Errors tab in a batch analysis Message Possible problem Solution Insufficient Bead Count There are not enough beads seen to meet the minimum requested Ensure there are 2000 5000 beads per set per well Ensure proper beads are selected Adjust sample probe height Resuspend beads in the wells Check for clogs Temperature Divergence from Calibration Temperature You are running the system at an ambient temperature that is out of range of the temperature at which the system was initially calibrated Calibrate and
75. tab you perform maintenance commands X YP commands and calibration and verification commands during system use See Figure 5 18 Luminex100 Integrated System 2 3 Figure 5 18 Maintenance Tab Perform these commands to maintain your system and to keep it in optimal working condition Follow the step by step instructions for each command found after this section when using as needed maintenance operations Some of the commands are also available on the Home tab The available commands are e Warmup e Prime e Backflush e Alcohol Flush must use the Luminex XYP reservoir due to volume requirement e Sanitize must use the Luminex XYP reservoir due to volume requirement e Wash e Drain e Soak e Self Diagnostics When the system processes a command that you select from the Maintenance tab an animated gear graphic appears for a short time in the upper right corner of the Maintenance tab The system labels Luminex 100 IS User Manual Version 2 3 xMAP Technology the command process in yellow text below the graphic For example Figure 5 19 shows the Warmup command graphic ie Figure 5 19 Processing Device Activity Commands Table 5 3 shows a recommended schedule for maintenance operations Table 5 3 Maintenance Operations Recommended Use Schedule Operation Recommended Use Schedule Warmup Daily After four hours of system inactivity Prime Daily e To remove air from sheath fluid tubing After p
76. takes approximately two minutes and should be followed by an alcohol flush using 7096 isopropanol or 70 ethanol Soak Daily at the end of the day for shutdown To prevent salt crystals from forming in the probe due to exposure to air Soaking the probe replaces sheath fluid in the probe with water The system uses at least 250 uL of distilled water Self To see if the device and all system operations Diagnostics are running correctly If an error occurs the Diagnostics tab appears in red and the command row containing the error is highlighted You can double click that row to see a detailed description of the error Warm up the system to prepare the optics prior to sample acquisition The system automatically begins warming up when you turn power on This process takes approximately thirty minutes seconds left appear in status bar Wait until warmup completes before processing samples Caution Failure to properly warm up the system will effect assay results and system performance After four hours of inactivity the status bar appears red and indicates that the lasers are off You need to warm up the system again by manually initiating warmup procedures Luminex 100 IS User Manual Version 2 3 Prime Command Backflush Command xMAP Technology To warm up the system Click Warmup then click OK The command list on the Run Batch tab indicates that the system lasers are running The Device A
77. that you enter the correct target values for each parameter before clicking OK You can re enter any incorrect information Note The Diagnostics tab turns red if all substances CAL or CON have not been run and under the following conditions e the first time the software is opened the first time a system is calibrated anew database is installed an old database is restored a CAL or CON fails S Update CAL Targets F CAL 1 Product Information r Lot Information Number Title Value L100 CAL1 Lot Number A2501 Name Expiration Date 05 02 2002 Classification Calibrator Manufacturer Larget Information Luminex Target Channel DD Target CL 1 Target 3759 CL 2 Target Current CAL1 Lot A2501 A2501 Import CAL 1 Export CAL 1 New Lot r Product Information r Lot Information Number Title Value L100 CAL2 Lot Number A3735 Name Expiration Date 05 19 2002 bd Reporter Calibrator Mantels Target Information Target Channel RP1 Target Luminex Current CAL2 Lot A3735 A3735 Import CAL 2 Export CAL 2 Newlot Lot Change the current lot by saving selected lot Figure 5 23 Update CAL Targets Dialog Box 11 Enter the values listed on the Certificates of Quality COQ included with your calibrators into the CAL1 boxes You can also find the target value information on the Lumine
78. the sample is noted as Low vortex the sample to ensure homogeneity Sample Timed Out The samples are concentrated Not enough sample loaded into the well Sample probe is clogged Verify that the samples are properly mixed Verify that you loaded the correct sample volume to the well Remove and sonicate or flush the sample probe to remove any clogs PN 89 00002 00 071 Rev A xMAP Technology Sample probe height is set incorrectly There is a clog in the sample line Troubleshooting Adjust the sample probe height Run the following commands Backflush Drain Alcohol Flush and Wash Verify that the delta cal temperature is within 3 0 If the system is not within these limits recalibrate then retry Sample Empty Detected The system completely acquired the entire sample volume There is no sample in the designated well The probe is clogged The sample probe is not properly aligned There is a clog in the fluid line Delta Cal temp out of range There is a problem with the kit Verify that you properly mixed the samples before dispensing into the wells Verify that you loaded the sample to the correct well on the plate Verify that the sample volume added to the well is correct Clean the sample probe See Clean the Sample Probe on page 6 4 Align the sample probe See page B 8 Run the following commands Backflush Drain Alcohol Flush Wash Ver
79. the system at least once a month and following installation ifthe system is moved ifa part is replaced ifthe delta calibration temperature shown on the system monitor on the Diagnostics tab is more than 3 degrees Each step in the calibration procedure usually takes less than one minute You must run xMAP controls after each calibration Once calibrated the calibration values remain until you calibrate again You can track system calibration and verification results through the Calibration Trend Report and the System Control Trend report You can run calibration and verification commands from the Maintenance tab To calibrate your system with xMAP calibrators 1 Vortex the x MAP calibrators and controls containers to ensure homogeneity PN 89 00002 00 071 Rev A xMAP Technology PN 89 00002 00 071 Rev A 10 Using Luminex 100 IS 2 3 Software Load a microtiter plate with four to five drops of each CAL1 in well Al CAL2 in well B1 CONI in well C1 CON2 in well D1 and distilled water or sheath fluid in well E1 through H1 to wash a total of four times Use different wells as necessary To select different well locations in the software click on the drop down arrow next to the entry cell for the calibrator or control then click in the well location on the microtiter plate image Click Eject Retract then place the plate on the plate holder Fill the Luminex XYP reservoir with a solution of 7096 isopr
80. the wells that have been processed Progress is shown in both graphic and tabular form PN 89 00002 00 071 Rev A xMAP Technology PN 89 00002 00 071 Rev A Basic Concepts System calibrators and controls are provided as part of the system Calibrate at least once monthly when the delta calibration ACAL temperature changes by 3 degrees or if the system is powered off or moved You must run system controls following calibration and as often as you like to ensure that your system continues to operate optimally The software provides you with a variety of reports e Analyte Reports provide batch results grouped by the test in a batch e Patient Summary reports provide batch results grouped by each patient or unknown in a batch Clinical Patient reports provide a breakdown of samples according to the test analysis with that sample Maintenance Reports provide a history of all maintenance operations performed during a specified period of time e Calibration Trend reports provide results of calibration commands performed over a specified time period e System Control Trend Reports provide results of system controls performed over a specified time period e Batch Summary Reports provide batch information in a sample versus test grid format Quality Control Reports track the trends of assay controls over a period of time These reports let you look at specific details regarding the samples you process through the Luminex 1
81. through which the sample is read The analysis of acquired batch data The difference between the current temperature of the Doublet Discriminator APD and its temperature at your last calibration The system displays this value on the Diagnostics tab within the software The current temperature of the doublet discriminator avalanche photo diode Wavelength range that an excited fluorochrome emits when its electrons fall from a higher to a lower energy state Expressed in nanometers nm Occurs when the signal processor determines that a particle is being observed Referred to as one bead as it passes through the laser Wavelength range that excites a molecule s electrons to a higher energy state Expressed in nanometers nm Light emission that occurs when the electrons of a fluorochrome drop to a lower energy state A fluorescent molecule See fluorochrome A technique which uses a covalently linked fluorochrome antibody complex to detect or quantify a particular antigen PN 89 00002 00 071 Rev A xMAP Technology Luminex xMAP microsphere set laser microparticle microspheres multi analyte multi batch photobleaching PMT qualitative quantitative reporter reporter channel RP or RP1 RP1 RP PN 89 00002 00 071 Rev A Luminex xMAP microsphere set Luminex multi analyte microspheres containing a unique mixture of two distinctly colored fluorochromes to distinguish them from other mu
82. to retract the plate holder Click OK to continue Wait until the Sanitize command completes before initiating another command Perform two Washes with distilled water Click Soak to fill the sample probe with distilled water to prevent sheath fluid crystals from forming in the sample probe A confirmation dialog box opens See Figure 5 116 Place the Soak solution in well D1 and click OK to continue Click Cancel to abort this command p OK EL i j a Figure 5 116 Confirmation Screen Dialog Box Click the drop down arrow to the right of the Eject Retract button An image of the microtiter plate and reservoir appears in the plate holder See Figure 5 117 PN 89 00002 00 071 Rev A xMAP Technology Note The system may show a default location from which to draw fluid In this case the microtiter plate shows that well with a yellow line outlining the well Exit Luminex 100 IS 2 3 Software PN 89 00002 00 071 Rev A 10 Using Luminex 100 IS 2 3 Software d amp 11 59 amp r Br 613 Ci en pid bri E10 En F10 F11 69 6 69 63 H10 H11 Figure 5 117 Microtiter Plate Image For Location Selection Select a well location to draw fluid from using the image of the microtiter plate and reservoir then click Eject Retract The plate holder ejects Place 200uL of distilled water into selected well location Click OK to continue The Message Log on the Diagnostics tab indicates that the
83. to the Luminex 100 analyzer Blue sheath green air orange waste Fill the sheath bottle with sheath fluid to just below the air intake fitting Place the sheath and waste containers to the left side of the analyzer Connect the blue connector to the sheath fitting bottom fitting on the sheath bottle Connect the green connector to the air fitting top fitting on the sheath bottle Connect the orange connector to the waste fitting on the waste bottle Plug the Luminex XYP instrument Luminex 100 analyzer PC and monitor power cords into approved outlets We strongly recommend using an uninterruptible power supply to protect the system from power variations Refer to Recommended Additional Equipment page 3 7 for additional information To install the Luminex XYP instrument sample probe Verify that the Luminex 100 analyzer and Luminex XYP instrument power switches are off Unplug them from the electrical outlet Remove the light housing directly above the sample arm by grasping and firmly pulling out It remains attached by a wire harness Place it on top of the analyzer See Figure B 6 1 Light Housing 2 Cheminert fitting with cap Figure B 6 Light Housing Hemoved PN 89 00002 00 071 Rev A xMAP Technology Luminex 100 IS System Setup 3 Unscrew the cap from the Cheminert fitting 4 Insert the sample probe into the sample probe holder Insert the Cheminert fitting into the sample probe holder turning it c
84. use or it loads it for immediate use according to the decision you made when creating it Use this procedure to open a previously processed batch and correct the batch s sample names and dilution factors You can delete a sample from a batch If you change the patient information in a batch including those imported from a patient list the system automatically notes the change in the comments box of the sample table within the database While editing the database the system marks the changes you make in red text This distinguishes the change from the patient information entered into the original batch Figure 5 53 shows an edited patient list To edit a patient list 1 On the File menu select Edit Patient List The Open Batch dialog box opens 2 Select the desired batch containing the patient list that you want to edit and click Select The Edit Patient List dialog box opens similar to Figure 5 53 3 Editthe desired patient and associated dilution factor information Click Finish to accept your edits and close the dialog box Luminex 100 IS User Manual Version 2 3 xMAP Technology BF Edit Patient List Batch 4 5 02 12 09 ID 6 Location Sample ID Dil Factor 7 Finish 1 Cancel LJ Load Pa List Figure 5 53 Edit Patient List Dialog Box Change Start While creating a batch you can define where to begin acquiring Acquiring Data samples that is in a location other than the first a
85. you run samples 1 Turn the Luminex 100 analyzer on The system begins warming automatically 2 Verify the levels of sheath fluid and waste fluid 3 When the system is warmed up click Prime to prime the analyzer then click OK 4 Click Alcohol Flush A confirmation dialog box opens Click Eject Retract to eject the Luminex XYP instrument tray Place at least 1 2 mL of 70 isopropanol or 70 ethanol in the reservoir Click OK Luminex 100 IS User Manual Version 2 3 After Running Samples Routine Tasks Sheath and Waste Fluids 5 xMAP Technology Click Wash In the confirmation dialog box click on the drop down arrow located to the right of the Eject Retract button to choose the desired location Click Eject Retract The Luminex XYP instrument tray ejects Place sheath fluid in the selected well or reservoir on the plate Click OK Perform this step twice Check that the Luminex XYP instrument sample probe has been vertically aligned for the plate used in the kit After running samples Refer to Maintenance Commands on page 5 19 for detailed Sanitize and Soak command operation 1 2 Sanitize with a 10 to 20 household bleach solution Run two Wash cycles with distilled water Soak with distilled water Wait until the soak completes If desired turn off the Luminex 100 analyzer Replace the sheath fluid and empty the waste container as required You must manually monitor waste container levels
86. 0 xMAP Technology iw Patient Selection Select available Patients from the list on the left Patient 2 Patient 3 Patient 4 Ea Previous Einish Cancel Figure 5 96 Patient Selection Dialog Box 4 Select the desired entry or click the double arrow gt gt to select all the entries Click Finish A report print preview appears using the information you entered See Figure 5 97 You may have more than one dialog box in which to enter information Analyte Report 1 25 2002 12 17 56 Pi A quired by Acquired on 1 25 2002 1155 05 AM Aura Name CNA Ania Dev Comp LMNX Corp Test Name IL 4 Tort Gore nution A quired by Acquired on 1 25 2002 1135505 AM Dev Comp LMNs Corp Te it Dec accession No tams lution Ac quired by Acquired on 172572002 1155 05 AM Oey Comp LMN Corp Test Name IL 3 Toit Gore Diution Figure 5 97 Report Print Preview Dialog Box 6 Click Print Report to print the report 7 The Print dialog box opens Select the desired parameters and click Print There are two ways to print reports from outside of the Luminex 100 IS 2 3 software To print a report using the desktop Start menu or Explore Click Start at the bottom left corner of the desktop PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software 2 From the desktop Start menu select Programs Luminex Luminex 100 IS Report Application The Report Selecti
87. 00 Classification 1 Figure 5 38 Dot Plot Display Example Four buttons appear at the top of the frame to control the display Select to toggle between the default density dot plot and the decaying dot plot views PN 89 00002 00 071 Rev A xMAP Technology Log Linear LIH fa Zoom Maximize fl Minimize Replay Batch File Mode PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software The Decaying Dot Plot plots only the 100 most recent acquired events The Density Dot Plot displays a constant accumulation of events Increasing density is indicated by contrasting colors See Table 5 5 for the density dot plot color legend Table 5 5 Dot Plot Color Legend Layer Color none dark blue pink dark green cyan light blue light green orange dark red ONoOaRWNM O The density dot plot allows visual elimination of data values determined to be insignificant to the display Luminex recommends you collect your data in density dot plot mode to observe all collected events Post acquisition does not display decaying dot plot it s only a real time function Click to toggle the X axis and Y axis scale between logarithmic and linear modes This button is only active when viewing a dot plot Click to zoom or enlarge a specific area on the display to focus in on any specific area that you want to see in detail Use the scroll bar to move across the bar graph Click and drag right to left in th
88. 00 analyzer then attach the USB cable PN 85 10011 00 046 to P1 on the analyzer Do not plug the power cord into the power outlet See Figure B 4 Connect the Luminex 100 analyzer USB cable and the Luminex XYP instrument serial cable to the PC See items 12 and 14 in Figure B 4 PN 89 00002 00 071 Rev A xMAP Technology Luminex 100 IS System Setup 4 1 USB Communication Cable P1 9 Y Cable Port 2 Luminex XYP Instrument 10 Mouse Cable port 3 Luminex XYP Instrument to PC Serial Cable 11 PC Power Cable 4 Power Cords 12 Luminex 100 port USB 5 Luminex XYP Instrument Power Switch 13 Monitor cable port 6 Luminex 100 Analyzer Power Switch 14 Luminex XYP port 7 Luminex 100 analyzer 15 Printer cable port 8 SD Cable P2 Figure B 4 Luminex 100 IS Connections Luminex 100 analyzer Luminex XYP Instrument and PC 11 Connect the Y cable to the barcode reader and keyboard then connect the Y cable to the PC See Figure B 5 1 Keyboard 3 Y Cable 2 Barcode Reader 4 Mouse Figure B 5 Connecting the PC Mouse Barcode Reader and Keyboard PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 Note The sheath and waste containers must be placed on the same surface as the Luminex XYP instrument Do not place the containers on top of the Luminex 100 analyzer Install the Luminex XYP Instrument Sample Probe 12 13 14 xMAP Technology Connect the color coded tubing connectors
89. 00 IS 2 3 software and system operation System tools help you monitor the system including a display showing real time system property values and a message log Errors are shown in the message log and also on your reports You can even add comments to specific results in some of these reports To keep track of your reagents the Luminex 100 IS 2 3 software stores lot numbers expected values and expiration information A comprehensive set of self diagnostic tests ensure that your system is working correctly These tests are performed at startup and can be performed at any time If any problem is detected an error message appears in the message log to inform you Luminex 100 IS User Manual Version 2 3 xMAP Technology PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software Luminex 100 IS 2 3 The Luminex 100 IS 2 3 software starts automatically when you log Software into Windows When the Luminex 100 IS 2 3 software starts a splash screen displays for about ten seconds See Figure 5 1 Luminex 100 IS 2 3 1996 2004 Luminex Corporation 4ll rights reserved Figure 5 1 IS 2 3 Software Splash Screen PN 89 00002 00 071 Rev A 5 Luminex 100 IS User Manual Version 2 3 xMAP Technology L u minex 100 IS The Luminex 100 IS Main window is shown in Figure 5 2 Main Window pecie nai Self Diagnostic Soak e Template 3 12 01 17 Template 3 27 01 15 1 Title bar 4 Tabs 2 Menu bar 5
90. 002 00 071 Rev A vii Luminex 100 IS User Manual Version 2 3 xMAP Technology Luminex 100 IS System Installation B 1 OVerVIE W xo dit a debe ae ede qoe E IP NUR dada days ea daa B 1 Luminex 100 IS System Setup 0 0 0 0 000005 B 1 Connect the Luminex 100 analyzer and Luminex XYP to the PC ideam e Cons pcs eee Cere aaa eae B 3 Install the Luminex XYP Instrument Sample Probe B 6 Power On System Components B 8 Accept the Luminex 100 IS 2 3 Software License Agreement B 8 Adjust the Sample Probe Vertical Height B 8 Install the Luminex XYP Instrument Reservoir B 9 Calibrate and Verify the System B 10 Install the SD System eese B 10 Install the Luminex XYP Instrument Heater Block B 13 Luminex 100 IS 2 3 Software Installation B 14 Luminex 100 Version 1 7 with Windows 98 to Luminex 100 IS Version 2 3 0 0 0 0 eee ee eee B 15 Install New PC 2 ee eee B 15 Install Luminex 100 IS 2 3 Software B 15 Verify Successful Upgrade 200005 B 16 Luminex 100 Version 1 7 with Windows 2000 to Luminex 100 IS Version 2 3 0 00 00 eee ee eee B 17 Archive My Sessions folder 4 B 18 Remove Luminex LMAT Software B 18 Remove Luminex 100 Version 1 7 Software B 19 Install Luminex 100 IS 2 3 Software B 19 Luminex 100 IS Version 2 1 2 2 to Luminex 100 IS
91. 02 0 6 c917 4 cee4gf 1 Luminex 100 IS User Manual Version 2 3 xMAP Technology To add a Patient List text file while creating a batch or multi batch 1 On the toolbar click Create New Batch or Create New Multi Batch The Open Template dialog box opens 2 Select a template to create a new batch and click Select The Luminex Batch Setup dialog box opens showing the template commands and the microtiter plate representation For multi batches the Luminex Multi Batch Setup dialog box opens See Figure 5 51 Luminex Batch Setup Please establish the starting location for the batch and enter the appropriate patient information Note indicates a required field Insert Acquire Patient X 1 Apply penie No Location Command Sample ID Dil Factor 5 Name B 1 A1 Plate1 Acquire Standard StdM 1 vi Batch 5 3 02 16 38 amp 2 B1 Plate1 Acquire Standard StdM 1 M ux 5j 3 C1 Plate1 Acquire Standard StdL 1 Finish Description 8 4 D1 Plate1 Acquire Standard StdL 1 None E 5 E1 Plate1 Acquire Standard Std XL 1 5j 6 F1 Plate1 Acquire Standard Std XL 1 Cancel B 5 7 G1 Plate1 Acquire Control ConL 1 5 8H1 Plate1 Acquire Control ConL d Created By 9 A2 Plate1 Acquire Patient 2 gl Name 10 B2 Plate1 Acquire Patient 2 loadea List 11 C2 Plate1 Acquire Patient 2 Template Info
92. 1 3 10 C14 9 Did b11 10 1 Fio Fr 61d 611 61 Aid fi Figure 5 12 Microtiter Plate Image To remove items from the Favorites list Select the item you want to remove from the Favorites list then click Remove The item disappears from the Favorites list The Home tab contains categories representing different phases of data acquisition Each category consists of a group of command buttons associated with typical phases of data acquisition At the click of a button the system performs or initiates the process to perform the function for the button you click See Figure 5 9 At the Daily Startup section you perform the recommended daily startup procedure by selecting the buttons in the order they appear These buttons include Warmup Prime Alcohol Flush and Wash See Maintenance Commands on page 5 19 for more detailed information regarding startup functions At the Instrument Calibration section you perform system calibration and control functions This section contains CALI CAL2 CONI and CON2 buttons At the Batch Setup section you create a new batch create a new multi batch and create new lots for an assay s standards and controls Luminex 100 IS User Manual Version 2 3 xMAP Technology Run Batch Tab Run Batch Tab Buttons Start Plate Cancel Command Cancel All At the Reports and Analysis section analyze acquired batch data compile the data into reports and print reports fro
93. 1 Luminex XYP specifications 3 6 M main screen 5 3 illustration 5 2 main window 5 11 maintenance commands 5 19 reports 4 3 5 108 tab 5 19 B 9 maintenance schedule annual 6 10 as required 6 11 daily 6 1 monthly 6 4 routine tasks 6 2 PN 89 00002 00 071 Rev A xMAP Technology semi annual 6 6 weekly 6 4 manual adjustment 3 12 Manual recalculate 5 94 marketing 2 3 Maximize Minimize 5 46 Mean of Replicates 5 82 mechanical 2 2 2 7 menu analyze 5 3 edit 5 3 file 5 3 help 5 3 tools 5 3 view 5 3 message log 4 2 5 2 5 40 Microsoft 5 67 microsphere 4 1 4 2 microtiter plate 4 1 5 49 microtiter well 5 24 monitor the system 4 2 monitor waste fluid refill sheath container 6 2 multi analyte 4 1 multi batch analyze 5 85 load 5 58 multiple batches start location 5 64 multiple plates 5 58 multiple sessions sequence 5 58 N needle 4 1 New Advanced Batch 5 43 New Batch command 5 50 0 off plate commands 5 71 opening system help 5 118 operation of instrument 2 1 optical 3 12 optical assembly 3 12 optical integrity 4 2 optics 3 5 specifications 3 5 PN 89 00002 00 071 Rev A Index options 4 2 P pass or fail 5 28 paste information from batch 5 67 paths 4 1 pathway 4 1 patient summary reports 4 3 5 108 Pause 5 15 5 43 paused 5 10 pausing 5 10 pausing a session temporary 5 84 PC specifications 3 6 performance specifications 3 3 photodiode 4 1 photomultiplier 4 1 plate 4 1 5 4
94. 27 01 15 Warmup Wash Figure 5 10 Favorites List Add Templates to 4 To add templates to the Favorites list Favorites 1 On the Favorites list click Add Template 2 Inthe Open Template dialog box double click the template to add to your Favorites list Add Commands to To add commands to the Favorites list Favorites 1 Click Add Command from the Favorites list The Command List dialog box opens See Figure 5 11 i Command List i ol x Location Reservoir gt CON2 zi p ok F E d Figure 5 11 Command List Dialog Box 2 Select the command that you want to add to your Favorites list 5 12 PN 89 00002 00 071 Rev A xMAP Technology Note Ensure that the location you select is compatible with the volume intended for that location The location s capacity may vary depending on the microtiter plate sizes used Refer to the specifications in Chapter 3 for additional information Remove Items From Favorites Data Acquisition Categories PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software 3 Forcertain commands select the location where you want to draw or expel fluid You do this using the location drop down arrow and clicking over the microtiter plate location on the image See Figure 5 12 The rectangular box in the upper right corner represents the reservoir 4 Click OK to add the command The command is displayed in the Favorites List aid i1 B8 Bid B1
95. 66667 75 Sample Comment for Patient 2 DataType CV Location Sample Test 22 Total Events Notes 1 Std s 662 071761559013 75 2 Std m 42 0677216044823 75 3 Std I 28 540875012004 75 4 Std xl 30 4524100927965 75 5 Std xxl 17 3369506373774 75 6 Low Control 34 9506301308939 75 7 Patient 1 27 7364540209588 75 Sample Comment for Patient 1 8 Patient 2 28 9726898443063 75 Sample Comment for Patient 2 DataType Peak Location Sample Test 22 Total Events Notes 1 Std S 45 75 2 Std m 447 75 3 Std l 3985 75 A Std xI 31 76 75 5 Std xxI 1 2044 75 6 Low Control 58 75 7 Patient 1 430 75 Sample Comment for Patient 1 8 Patient 2 371 75 Sample Comment for Patient 2 DataType StdDev Location Sample Test 22 Total Events Notes 1 Std s 1593 82742065973 75 2 Std m 211 690384143302 75 3 Std I 1270 33151408429 75 4 Std xI 4104 5788483744 75 5 Std xxl 4302 66591643698 75 6 Low Control 20 9703780785363 75 7 Patient 1 155 634790802404 75 Sample Comment for Patient 1 8 Patient 2 4172 74723003512 75 Sample Comment for P
96. 9 plate holder ejecting tray B 10 polystyrene 4 2 power down 6 5 Practical Flow Cytometry 3rd edition by Howard M Shapiro M D New York Wiley Liss Inc 1995 4 1 Preliminary Off plate commands clear 5 72 pressure gauge 5 15 preventing corrosion 6 5 prime remove air in waste line 6 2 priming the system 5 22 printer 3 7 printing 4 3 probe 4 1 B 8 probe removal B 7 process multiple plates 5 58 processed batches analyze 5 87 processing 5 10 processing multiple sessions 5 55 product numbers 8 1 product selection 5 32 product selection dialog box 5 33 protect 4 2 protection provided 2 2 protective housing 2 6 Index 5 Luminex 100 IS User Manual Version 2 3 Q Qualitative analysis 5 85 Quality Control Report 5 108 Quantitative analysis 5 85 R radiation exposure 2 6 rate 4 1 raw fluorescence 5 4 reaction 4 1 reagent specifications 3 3 reagents 3 3 8 3 specifications 3 3 recalculation 5 93 auto select 5 94 manual 5 94 recover incomplete batch 5 58 refill sheath warning 6 2 release system pressure 6 2 remove controls 5 94 probe B 7 shield B 8 standards 5 94 replace fuses 6 11 replace syringe plunger 6 8 replay batch 5 43 Replicate averaging 5 98 Replicates 5 81 report raw fluorescnce 5 4 report create and print 5 109 reporter 4 1 reporter channel 3 6 reporter laser 4 1 specifications 3 5 reports 4 3 5 108 reports and analysis 5 14 reprocess batches 5 47 reprocess samples in File Mode 5 48 r
97. 9 00002 00 071 Rev A xMAP Technology Alcohol Flush Command Note You need to remove air bubbles from the system because air bubbles can interrupt the sample flow and can distort your bead results Sanitize Command PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software During a backflush the system draws sheath fluid from the sheath fluid container You do not need to supply solution in a plate A backflush takes about seven seconds To backflush obstructions from the cuvette Click Backflush then click OK to verify that you want to backflush the system The command list indicates that the system is running The Device Activity box on the Status Bar indicates that the system is backflushing Upon completion the command list indicates whether the command succeeded with green text or the command failed with red text Alcohol flush the system to remove air bubbles from the sample tubing and the cuvette using 70 isopropanol or 70 ethanol The cuvette is the principal fluid pathway within the optics component of the system where the system reads the sample The alcohol flush takes about five minutes To remove air bubbles from the sample tubing and cuvette 1 Click Alcohol Flush 2 Click Eject Retract The plate holder ejects 3 Place the solution in the reservoir and click Eject Retract to retract the plate holder 4 Click OK The command list on the Run Batch tab indicates that the system is ru
98. B 10 electronics 3 6 3 8 specifications 3 6 Enable Automatic Analysis 5 87 enable raw data storage 5 4 entering sample data 4 2 erasing data from database 5 113 error information view 5 100 error messages 5 8 5 41 errors tab 5 86 5 99 establish insert off plate commands 5 72 European Union EU safety requirements 2 3 excitation 4 1 excitation wavelength 4 1 exit the Luminex 100 IS software 5 121 Expected Concentrations column 5 96 export batch data 5 111 batches 5 6 PN 89 00002 00 071 Rev A Index F Favorites list 5 11 add commands 5 12 add templates 5 12 remove items 5 13 file menu 5 3 File Mode analyze data 5 49 filter 3 8 air intake 3 10 replacing air intake 6 7 sheath 3 10 3 11 Fit of All Standards 5 82 flow cytometry 4 1 flow rate 3 5 fluidics 2 3 3 5 4 1 components 3 8 illustration 3 8 leak 2 4 path 4 1 specifications 3 5 warning 3 8 fluorescence 3 4 4 2 5 4 fluorescent signal 4 2 Function Keys 5 93 fuses product number 8 1 replacing 6 11 G gate settings 5 45 gauge pressure 5 15 temperature 5 15 general Luminex 100 analyzer specifications 3 5 graph menu items 5 106 H hardware specifications 3 2 testing 3 2 heat 2 2 2 8 heat warning labels 2 8 heater block 5 17 8 1 height adjustment locking screw B 8 Index 3 Luminex 100 IS User Manual Version 2 3 help menu 5 3 5 119 learning about the device 5 117 learning about the IS software 5 117 opening system help 5 117 table
99. CD CN SW08 01 Product Description Customer Number Microspheres LX100 CL1 CL2 Calibration L100 CAL1 xMAP Classification Calibrator Microspheres LX100 RP1 Calibration L100 CAL2 xMAP Reporter Calibrator Microspheres LX100 CL1 CL2 Control L100 CON1 xMAP Classification Control Microspheres LX100 RP1 Control xMAP L100 CON2 Reporter Control Sheath Fluid LX100 40 50000 Product Description Customer Number Basic Training Course CN 0070 01 Luminex 100 IS User Manual Version 2 3 xMAP Technology 8 4 PN 89 00002 00 071 Rev A Glossary agglutination ambient temperature analyte analyzer APD background noise batch bead calibration calibrators PN 89 00002 00 071 Rev A The coalescing of small particles that are suspended in solution these larger masses are then usually precipitated The temperature of the surrounding environment A substance that is detected through assay analysis Each test or bead set will test for a specific analyte This term is used to refer to the Luminex 100 analyzer Avalanche Photo Diode Measures the excitation emission intensity of the color coding classification dye mixtures inside the microsphere and the amount of light scattered as particles pass by the lasers That portion of a bead set result that can be attributed to excess reporter molecules in the solution nonspecific binding or fluorescent spillover from another fluorochrome A group of sample
100. Change Remove The InstallShield Wizard dialog box opens similar to Figure B 17 Select Remove and click Next The Confirmation File Deletion dialog box opens Click OK If a Shared File Detected dialog box opens select the Don t display this message again checkbox then click Yes If a Self registration error dialog box opens Click OK When the InstallShield Wizard Maintenance Complete dialog box opens click Finish In the Add Remove Programs dialog box click Close Click the X on the Control Panel to close it If the Luminex 100 IS icon is still present on the desktop select the icon and drag it to the Recycle Bin To install the Luminex 100 IS 2 3 software continue with Install Luminex 100 IS 2 3 Software page B 15 PN 89 00002 00 071 Rev A xMAP Technology Luminex 100 IS 2 3 Firmware Installation Firmware Upgrade Cable Configurations PN 89 00002 00 071 Rev A Luminex 100 IS 2 3 Firmware Installation The Luminex 100 analyzer the Luminex XYP instrument and the Luminex SD system use firmware to perform internal control functions Although seldom required firmware updates may become available to enhance functionality If you are directed to update the firmware due to an upgrade kit or other enhancement follow the appropriate procedure in this section There is a separate section for the Luminex 100 analyzer Luminex XYP instrument and the Luminex SD system Review the following Firmware Upgrade Ca
101. Comments PN 89 00002 00 071 Rev A Troubleshooting Troubleshooting the Luminex 100 IS System PN 89 00002 00 071 Rev A Troubleshooting procedures help users isolate identify and remedy problems with the Luminex 100 analyzer and Luminex XYP This chapter does not troubleshoot problems with the PC For help with PC problems please call Dell Technical Support at 800 624 9896 To troubleshoot a problem select a general symptom Next identify the possible problem and remedy it with one of the solutions listed This troubleshooting chapter supplies information for the following topics Power Supply Problems Communication Pressurization Fluid Leaks e Sample Probe Calibration Problems Acquisition Problems Bead Detail Irregularities Error Messages Printing Errors Verification You can find answers to frequently asked questions FAQs on our website http luminexcorp custhelp com Luminex Technical Support is available to users in the U S and Canada by calling 1 877 785 BEAD 2323 between 7 00 a m and 7 00 p m Central Time Monday through Friday Users outside of the U S Canada and Europe can call us at 1 512 381 4397 between Luminex 100 IS User Manual Version 2 3 Power Supply xMAP Technology 7 00 a m and 7 00 p m Central Time Monday through Friday Inquiries may also be sent by email to support luminexcorp com Users in Europe can call us at 31 162408333 between 8 30
102. I and CON reagents are correct See Figure 5 106 Database Restored A The Luminex100 IS Software database has been restored Please verify that the lot information for CAL1 CAL2 CON1 and CON2 reagents is accurate Performing instrument Calibration and Verification is recommended Figure 5 106 Database Restored Dialog Box 4 Click OK to verify that the lot information is accurate C lean u p Utility Use the Cleanup Utility to e Perform a disk cleanup e Delete the Message Log Directory e Delete the Batch Directory To display the Cleanup Utility dialog box 1 On the Tools menu click Cleanup The Cleanup Utility dialog box opens 2 Continue with the desired following section Disk Cleanup Delete MsgLog or Delete Batch Directory amp Luminex100 IS Software Cleanup Utilit lol xl 9 Fisk l Delete Delete Clean MsgLog Batch up Directo Directo Figure 5 107 Cleanup Utility Dialog Box Disk C leanup This is a shortcut to the Windows Disk Cleanup feature To perform a disk cleanup 1 In the Cleanup Utility dialog box click Disk Cleanup See Figure 5 107 PN 89 00002 00 071 Rev A 5 115 Luminex 100 IS User Manual Version 2 3 5 116 2 xMAP Technology In the Select Drive dialog box select the desired drive and click OK See Figure 5 108 The Disk Cleanup dialog box opens showing it is calculating progress This can take several minutes See Figure 5 109 Select the dr
103. Instrument Sample Probe 3 9 Cheminert Fitting 0 0 0 0 eee ee eee 3 9 ACCESS DOOIS s ta ebeeb d eb iaaetaa Bes Shares 3 10 Air Intake Filt r Mereste eee ert eR 3 10 SYMNGSC icc ta daw eerie pera pu e atia doe ace 3 10 sheath Filter dec eee er eR e ERR s 3 11 Air Waste and Sheath Fluid Connectors 3 11 Luminex Sheath Delivery System 3 12 Waste Fluid Container 0 0 20 ee ee eee 3 12 Optical nation eae So Foe cola N dard ack 3 12 xMAP Technology Reagents 0 000008 3 12 Basic Concepts 4 1 Background Information lllslleeeeeeeeeeeA 4 1 a e uice re e ob eR ERST ef CERT a ERST 4 Excitation ea eaa loli e RA ERR IRE sab bene ERE RE E 4 1 xMAP Microspheres 0 0000 cece eee 4 2 Software Overview 0 6 ccc een ens 4 2 Using Luminex 100 IS 2 3 Software 5 1 Luminex 100 IS 2 3 Software 0 0 0 ce eee eee eee 5 1 Luminex 100 IS Main Window 0 020 eee eens 5 2 Menu Bar sse shoe wi 4 branes dae Obed aeu 5 3 Options Setup scis biases diane dasa den RR D aes ane 5 3 General Tab in cae emirii e ea ee AR e ee 5 3 Company Information Tab 0000 5 5 Data Export Tab 0 0 0 0 5 6 TOolb E 4 oP eka tak ord tee ae eee MR eck Dh ase ees 5 7 Single Step icis ue See ee eee eo dy dd 5 8 ii PN 89 00002 00 071 Rev A xMAP Technology Status Bar i cuoi od ORS GS a A due edem E RE GE 5 8 Status Co
104. K 10 Turn off the power for 5 seconds then turn it back on 1 On the PC desktop click Start gt Programs gt Luminex gt LXR gt LX Firmware The LX Firmware Update Tool dialog box opens See Figure B 19 2 Anentry in the Movement Device text box should read Firmware up to date Luminex 100 IS User Manual Version 2 3 xMAP Technology Turn the power off to the SD XYP and LX100 Reconnect the serial cable to the X YP Connect the SD interface cable to the SD and LX100 Turn on the power to the SD The XYP and the LX100 Netwo rk Installation This section is intended for your network IT representative regarding Advisory computer name changes Luminex does not support network installations However if your installation requires that you change the computer name perform these steps Note The Windows XP security settings Virus Protection and e Automatic Updates alerts have been turned off by default Please 1 refer to your IT department when connecting to the network If you 2 have questions please call Luminex Technical Support To change the computer name on Luminex 100 IS 2 3 systems Change the computer name following the Windows process When you reboot the system an error message appears warning about database errors Reinstall Luminex 100 IS 2 3 software using the Repair option After the reinstall the database is available you do not need to reboot P repa re System for After you install the h
105. Luminex Luminex 100 IS User Manual Version 2 3 LUMINEX CORPORATION 2001 2004 All rights reserved No part of this publication may be reproduced transmitted transcribed or translated into any language or computer language in any form or by any means without prior express written consent of 12212 Technology Boulevard Austin Texas 78727 6115 U S A Voice 512 219 8020 Fax 512 219 5195 LUMINEX CORPORATION Luminex 100 IS User Manual Version 2 3 CN MO017 01 PN 89 00002 00 071 Rev A November 2004 Luminex Corporation Luminex reserves the right to modify its products and services at any time This guide is subject to change without notice Although prepared to ensure accuracy Luminex assumes no liability for errors or omissions or for any damages resulting from the application or use of this information The following are trademarks of Luminex Luminex Luminex 100 Luminex 100 IS LabMAP xMAP LumAvidin Luminex XYP Luminex FlexMAP and Luminex SD All other trademarks including Windows Cheminert Pentium and Dell are trademarks of their respective companies The Luminex 100 IS software uses the VideoSoft VsFlexGrid Pro 7 0 VsPrinter 7 0 and VsView 3 0 ActiveX controls which are copyrighted by VideoSoft 2001 The contents of this manual and the associated Luminex software are the property of Luminex and are copyrighted Except as specified in the End User License Agreement any reproduction
106. Me sheath container 3 Reconnect the waste container to the Luminex 100 analyzer and replace the cap Any time the sheath container is disconnected from the Luminex 100 analyzer you must remove air from the sample lines by priming If the sheath container ever runs dry prime the system at least twice until the air is removed from the system PN 89 00002 00 071 Rev A 6 3 Luminex 100 IS User Manual Version 2 3 Weekly Visual Inspection Run Self Diagnostics Clean Sample Probe Flush the System Monthly Clean the Sample Probe xMAP Technology Open all of the Luminex 100 analyzer doors and visually inspect for leaks corrosion and other signs of improper function Check all visible tubing connections Check the Luminex XYP instrument air intake filter for buildup of dust Check the SD system and its connection for leaks If you see a leak turn off the power to the Luminex SD system and contact Luminex Corporation Run Self Diagnostics on a weekly basis to check system integrity On the Maintenance tab click Self Diag The system performs self diagnostic tests The results display on the Diagnostics tab Clean the sample probe Remove the sample probe and sonicate the narrow end for 2 3 minutes Use a syringe to flush the sample probe with distilled water from the narrow end out through the larger end Replace the sample probe and readjust the sample probe height for the plates you are using with the Luminex XYP instr
107. New CAL Targets or New CON Targets An Update CAL Targets or Update CON Targets dialog box opens Ensure you have the desired lot to export displayed or selected Click Export CAL or Export CON as appropriate In the Save As dialog box select the folder directory where you want to export the lot as the Save in location The default is the Backup folder directory found in C Program Files Luminex Luminex 100 IS Backup Luminex 100 IS User Manual Version 2 3 Luminex XYP Instrument Commands Eject and Retract Luminex XYP Instrument Plate Holder Lower and Raise Sample Probe xMAP Technology 4 Enter the lot name for the exported lot into the File Name box 5 Click Save then click OK The dialog box closes After you click OK you can use the lot target values with the next calibration or verification The system saves the lot to the existing software as a lot accessible for the next calibration and or verification Once you export the desired calibration or control lot you can save it to disk to import to another computer The Luminex XYP instrument commands are those commands primarily involving the Luminex XYP instrument portion of the system The Luminex XYP instrument commands let you eject or retract the plate holder on the Luminex XYP instrument and command the sample probe up or down To eject and retract the Luminex XYP instrument plate holder 1 On the Maintenance tab click Eject Retract The Lumine
108. Patient 2 636 38 pg mL 75 Sample Comment for Patient 2 CRG CRC32 A398CCAD PN 89 00002 00 071 Rev A Index A access doors 2 7 3 10 accessories see accessory instructions 6 11 accuracy precision specifications 3 4 acquisition area 5 2 Acquisition Detail New Advanced Batch 5 43 Replay Batch 5 43 Acquisition Detail tab 5 41 Acquisition Detail toolbar 5 42 add sheath fluid 6 2 additional equipment barcode labels 3 7 bath sonicator 3 7 printer 3 7 surge protector 3 7 vortex 3 7 additional software 3 3 adjust sample probe vertical height B 8 adjust sample probe B 8 adjust sample probe height B 8 after running samples releasing pressure 6 2 sanitize 6 2 wash twice 6 2 air bubbles remove 5 23 air connector 3 11 air intake 3 8 air intake filter 3 8 6 6 replacing 6 7 XYP 3 8 6 7 alcohol flush 5 23 alignment discs B 8 analysis 5 4 auto start 5 87 PN 89 00002 00 071 Rev A customize settings 5 101 qualitative 5 85 replicate averaging 5 98 view 5 90 Analysis window function keys 5 93 Analyte Report 5 108 analyze acquired batch data 5 85 batches and multi batches 5 85 data outside the IS software 5 106 File Mode data 5 49 Analyzed Data print analyzed data 5 88 analyzer 2 3 3 8 4 1 connections 3 8 maintenance functions B 9 ventilation filter 6 9 analyzing results 4 2 assay errors 5 100 assay kit 5 85 assay kits 1 1 1 2 4 2 assembling and powering system B 1 assigning dilution fa
109. Setup dialog box enter the batch name creator name and batch description See Figure 5 47 PN 89 00002 00 071 Rev A xMAP Technology Note Batches may span more than one plate When the first plate is full a blue line appears to separate the columns of the first plate and those of the second plate Note If any of the acquire sample commands within the template of the batch has an unassigned Sample ID the system applies the first patient ID in the list to the unassigned sample acquisition command The system appends any remaining patient IDs to the end of the command list in order as they appear in the patient list Note Multi batches may span more than one plate A blue line separates the first plate and the second plate A scroll bar appears along the bottom of the microtiter plate image so you can view additional plates PN 89 00002 00 071 Rev A 10 11 Lumines Watch Setup Using Luminex 100 IS 2 3 Software Please establish the starting location for the batch and enter the appropriate patient information Note indicates a required field insert Acquire Patent 9 X fi Amy Boch dn No Location Command Sample ID Dil Factor l Name 3 1 A1 Plate Acquire Standard Std M 1 v Batch 6 202 16 38 2B1 Plate1 Acquire Standard Std M 1 3 C1 Plate1 Acquire Standard StdL 1 Finish Description 5 4 D1 Plate1 Acquire Standard StdL 1j None 8 5 E1 Plate1 Acquire Standard Std Xl 1 X
110. Start Analysis Select this feature to enable or disable the software to begin analyzing data immediately after processing batches The automatic analysis feature takes place after the system finishes acquiring data while processing batches To configure General tab information 1 On the Tools menu click Options then click the General tab 2 Select the browse button amp and navigate to a different folder directory if you want the batch files written to a folder other than CAMy Batches the default location 3 Ifdesired enter the name of the current user or operator in the Current User box 4 Enter the number of digits that you want to appear in your sample data in the Analysis Display Digits box PN 89 00002 00 071 Rev A xMAP Technology Note You cannot select both Auto start Analysis and Auto Export Batches Data Export tab Company Information Tab Note For Luminex 100 IS 2 3 software the logo will not alter any Luminex 100 IS report or screen PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software Luminex100 15 Software Options Aat xi General Company Information Data Export Default Batch Directory CAMy Batches E Current User C Analysis Display Digits 2 iv Display Confirmation Screens I Enable Raw Data Storage F Report Raw Fluorescence Auto start Analysis F OK E a a Figure 5 4 Options Dialog Box General Tab Select the desired checkboxes to en
111. Status bar 3 Tool bar Figure 5 2 Luminex 100 IS Main Window The Luminex 100 IS Main window includes menus and tools to use the software and monitor acquisition and diagnostic processes These tools include menus a status bar tabs providing access to specific types of information commands and features The Luminex 100 IS Main window displays five tabs across the top Home Tab This is the default tab It is organized by the natural order of system use That is Daily Startup Instrument Calibration Batch Setup Reports and Analysis and Daily Shutdown Run Batch Tab This tab contains a command list displaying batch commands and their status a microtiter plate image plate command buttons and Luminex XYP instrument commands and settings Maintenance Tab The Maintenance tab contains maintenance commands XYP commands and calibration and verification commands for use during system operation 5 2 PN 89 00002 00 071 Rev A xMAP Technology Menu Bar Options Setup General Tab PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software Diagnostic Tab The Diagnostics tab displays the progress of commands initiated in the system The tab also shows specific details regarding each sample analysis and the state of system components The tab displays the System Monitor Message Log detailed sample progress chart and the status bar Acquisition Tab The Acquisition Detail tab displays the progress of sample acq
112. The XYP heater temperature measures the internal Luminex XYP instrument plate temperature The DD temperature measures the doublet discriminator temperature DD temperature shifting usually indicates a need for system recalibration If you see that your DD temperature is out of range Luminex 100 IS User Manual Version 2 3 Note If you have not calibrated the arrows showing the temperature range for the DD Temperature thermometer both appear at the bottom of the thermometer and the thermometer appears in red Note While warming the Luminex XYP instrument heater block the temperature can fluctuate prior to reaching the target temperature Wait for the temperature to stabilize before acquiring sample Set Luminex XYP Instrument Heater Temperature Note Do not use standard 96 well microtiter plates if you are using the heater block xMAP Technology indicated when the DD Temperature thermometer representation turns red recalibrate the instrument An out of range temperature logs an error but does not halt the acquisition Refer to Figure 5 13 and Figure 5 15 to identify the temperature and sheath pressure gauges XYP Htr Temp DD Temp 35 W a a a a N ononon Turn OH rrrrqurrrprrrrp rrr 1 XYP Target Temperature 2 XYP Current Temperature 3 DD Current Temperature 4 Current Sheath Pressure Figure 5 15 Temperature and Pressure Gauges Refer to your assay kit instructions to see if the
113. The number of events to collect for each test in a sample is defined in the template from which the batch was created In any equations listed below N indicates the number of events that were collected for an individual test in a single sample The trimmed distribution represents the events that were collected for an individual test in a single sample with the lowest 5 and highest 5 of the data points removed to help eliminate outliers Table D 2 Statistics Definitions Statistic Description Median The middle value in the distribution of data Result The final test result based on a qualitative or quantitative analysis This value could have units associated with it as defined in the template It may also indicate some error condition in the analysis such as the sample was beyond the range of the curve fit a divide by zero error occurred etc Some example include Invalid the user invalidated this sample or a single test within a sample lt 10 pg mL the result could not be calculated because it fell outside the valid range of the curve fit 210000 pg mL the result could not be calculated because it fell outside the valid range of the curve fit ERROR some mathematical error occurred such as an MFI value that does not intersect the concentration curve N A a result is not applicable for this sample i e a background sample Count The number of data points in the distribution N T
114. To upgrade the Luminex 100 analyzer firmware 1 2 Close any open applications On the PC desktop click Start Programs Luminex LXR LX Firmware The LX Firmware Update Tool dialog box opens See Figure B 19 Notice in the Detector Device text box item 2 in Figure B 19 that the top line displays the current firmware version and the second line displays the firmware status That is either an update is available or the firmware is up to date See note If the second line indicates that the firmware is up to date then click Close No further action is required If an update version is available then continue with step 4 PN 89 00002 00 071 Rev A xMAP Technology Luminex 100 IS 2 3 Firmware Installation Note If you are directed by LxFirmware Update Tool x Technical Support or by Welcome to the LxFirmware update tool upg rade kit instr uctions to If any upgrades are available the appropriate Upgrade buttons will be upgra de toa speci fic 1 enabled To load an older firmware version select the Browse button z r Lar Version 2 0 582 firmware version then click iac the Browse button and select PEELE i No device detected Detecting the desired firmware version 2 POSSEM from the Open dialog box BEES Movement Device To enable a connection to the SD device connect the SD device to G the host PC using the serial cable from the XYP and select the SD f Movement 5 device radio butto
115. Trend Reports Performing Maintenance Command CON2 Cmd No Command PlateLoc Cmd Status xMAP Technology In the Maintenance tab click CON1 then click OK Wait until CONI completes The Device Status section in the status bar changes from Running to Standby Click CON2 then click OK Wait until CON2 completes The Device Status section in the status bar changes from Running to Standby The System Monitor on the Diagnostics tab displays date and time in green if both CONI and CON2 are successful Ensure the analyzer is set to the draw distilled water or sheath fluid from the well you loaded it in step 2 of Run System xMAP Calibrators on page 5 28 Click Wash to wash the system after running the system calibrators Wash a total of four times You will need to change the well location Click on the down arrow located to the right of the Wash button Click OK and wait until the wash completes The device status section in the status bar changes from Running to Standby Luminex100 Integrated System 2 3 1123 4 6 6 7 8 9 10 11 12 6 s E 45 40 E E 1CON2 Di Platel FAILED 222 sec p Start Plate Fa gt Tideri Standby tating Mane p28 3 Figure 5 25 Command List and Diagnostics Tab Error Warnings You can track the results of calibrations and system controls by accessing the Calibration Trend Report or the System Control Trend Report You can v
116. Version 2 3 CN M020 01 German Luminex 100 IS User Manual Version 2 3 CN M030 01 Greek Luminex 100 IS User Manual Version 2 3 CN M022 01 Italian Luminex 100 IS User Manual Version 2 3 CN M021 01 Spanish Luminex 100 IS Developer Guide to xMAP CN M029 01 Technology Version 2 3 Power Cord USA CN P001 01 Power Cord Australia CN P002 01 Power Cord Brazil CN P003 01 Power Cord Denmark CN P004 01 Power Cord Germany Sweden France CN P005 01 Belgium and Spain Power Cord Switzerland CN P006 01 Power Cord Israel CN P007 01 Power Cord UK CN P008 01 Power Cord Italy CN P009 01 Power Cord Japan CN P010 01 Power Cord China CN P012 01 Reservoir XYP CN 0022 01 Sample Needle Height Alignment Kit CN 0015 01 Sample Probe Alignment Kit Short Sample Needle CN 0006 01 Long Sample Needle CN 0007 01 Sample Holder Large 1 5 mL CN 0008 01 Sample Holder Small 1 2 mL CN 0009 01 Sheath Filter with Quick Disconnect CN 001 0 01 Sheath Bottle CN 0011 01 Syringe Cylinder with Seal CN 0013 01 PN 89 00002 00 071 Rev A xMAP Technology Software XMAP Reagents Training PN 89 00002 00 071 Rev A Product Numbers Syringe Seal Qty 4 CN 0014 01 Cable USB CN 0018 01 Waste Bottle CN 0012 01 Luminex SD Luminex Sheath CN S001 01 Delivery System Product Description Customer Number Luminex 100 IS Version 2 3 Software
117. a is not altered A new file is created the most common use is for system demonstration and training Assay developers use New Advanced Batch to acquire data without having to build templates This provides the developer with a faster and convenient tool to develop assays It does not store the results in the Luminex 100 IS database It writes raw data to the output csv file if Auto Export is selected and writes run files if Enable Raw Storage is selected This feature is the primary use of the Acquisition Detail tab When you click on the New Advanced Batch button the Options tab displays with the following tabs General use this tab to enter general information about the batch Bead Set use this tab to define the bead events for the session Plate Layout use this tab to define commands for desired wells on the plate Click to open a previously acquired batch that is stored in the database You cannot view New Advanced Batches Click to start data acquisition on the new advanced or selected batch Click to cancel the process for the last command initiated in the system The system then processes the next command Click to cancel all the commands in process Click to eject or retract the microtiter plate on the Luminex XYP Click to pause the command that the system is currently processing Click to resume or continue the process that was paused This refers to the screen area from the bottom of the toolbars to the top of the
118. able Display Confirmation Screens Enable Raw Data Storage Report Raw Fluorescence Auto start Analysis When satisfied with your selections click OK to save your selections You can enter information about your company into the Company Information tab This information is stored in the Registry for reference Toenter your company information into the system T On the Tools menu click Options and then click the Company Information tab See Figure 5 5 Enter your company s name address phone and fax numbers Enter the location of the company s logo file to use Click OK The system saves the company information in the database Luminex 100 IS User Manual Version 2 3 Data Export Tab xMAP Technology Luminex100 IS Software Options General Company Information Data Export Name uminex Corporation 0g Address 12212 Technology Boulevard Austin TX 78727 6115 gi Phone 512 219 8020 FAX 512 219 5195 E Logo E l Figure 5 5 Options Dialog Box Company Information Tab Use this tab to configure your export data See Figure 5 6 The following checkboxes and radio buttons are available Auto Export Batches Select this feature to automatically export the csv file formats when the system finishes analyzing the batch This allows you to run your own programs on exported data without having to manually start the export This feature also takes place
119. age 5 26 PN 89 00002 00 071 Rev A xMAP Technology Note The system may show a default location In this case the microtiter plate shows a well with a yellow line inside the well Self Diagnostics Command Note Running the self diagnostics test resets the laser and begins a 30 minute warmup process PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software Click OK The command list on the Run Batch tab shows that it is running The Device Activity box on the Status Bar indicates that the system is soaking Wait until the soak command completes before initiating another command Upon completion the command list indicates whether the command succeeded with green text or the command failed with red text Run self diagnostics to see if the Luminex 100 analyzer and all system operations are running correctly The system tests these functions when running self diagnostics Flash memory test Microcontroller RAM test Nonvolatile memory test DSP program CRC test DSP capture test High voltage module Channel backgrounds test Pressurization test Actuator test Syringe pump test Backflush valve test Debubbler Valve test To run self diagnostics On the Maintenance tab click Self Diag Click OK The system processes the various self diagnostic tests When tests are complete the Status Bar changes from a Processing command state to an Idle command state The self diagnostic tests should take less than one min
120. ands Right click the grid to display the popup command menu 1 2 3 4 5 6 7 8 9 10 11 12 000000000000 COOOOOOQ0QCOO0O000 COOOOOOQO0O0O000 C OOOOOQOQ0QO0O0O000 OOOOQOOQOO0O000 COOOOO0O0QO0O000 0 COOOOOOQO0O0000 OOOOOOO0O0O0O0O00 z o 7 9 0o 95 9 10 OK Cancel Figure 5 58 Plate Layout Tab Select wells To select a single well click the well To select multiple wells in a group click and hold the mouse button with the cursor over the first well then drag the cursor around the desired wells To select a row or column click the letter or number of the row or column Select plate commands Right click over the selected wells to display the Command menu See Figure 5 59 Select the desired command The associated command symbol appears in the designated plate well To make a correction select the wells selected wells are blue right click over the selected wells to display the Command menu and then click Clear Selection from the list Table 5 8 following lists Plate Layout selection shortcuts PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software Options General Bead Set Right click the grid to display the popup command menu Cmd Name 3 2 3 4 5 6 7 8 9 10 11 12 Acquire Data A C MC MC NNN c mm G Key OOOO0Q0 CAL2 C2 B CALI cont N1 m oo CON2 N2 eC cont Wash wW D CON2 Drain D 7 Wash Soak S EC Drain
121. arates the adjacent columns of the two plates See Figure 5 48 ih Luminox 100 FS Softwar none Plato t none Platet none Platet Reservoir Piato1 6 Calibrate CAL 1 E11 Piate 7 Wash Reservoir Ptate1 8 Calibrate CAL2 F11 Plate1 ANKE Figure 5 48 Processing Multiple Plates Note You may need to scroll to the right of the screen to see additional plates During acquisition for multiple plate batches after the first microtiter plate has been acquired the system pauses and prompts you to insert the next plate To process multiple plates during a batch or multi batch 1 Create the batch or multi batch See Create a New Batch on page 5 50 or Create a Multi Batch on page 5 55 for more information 2 Load the batch or multi batch See Open a Batch on page 5 54 or Open a Multi Batch on page 5 58 for more information 3 Onthe Run Batch tab click Start Plate to begin processing the batch When the initial plate is through the system pauses and displays the Insert Next Plate message in red See Figure 5 49 PN 89 00002 00 071 Rev A 5 59 Luminex 100 IS User Manual Version 2 3 xMAP Technology 5 4 B 3 7 2 o Sheath Ai Cmd No Command Plate Loc 1 Warmup none Plate1 Lasers Warm 2 Pnme lt none gt Plata Succeeded 3 Prime nones Plate1 Succeeded Start Plate Cancel cmd Cancel All 4 Pnme none Plate Succeeded 5 Wash Reservoir
122. ardware and software run the following F irst U se commands to prepare the system for first time use Also consider running these commands when the system has been idle for extended periods of time Refer to Maintenance Commands page 5 19 for command operation Run the following commands in order 2 Backflushes 2 Drains 2 Alcohol flushes 3 Washes with water PN 89 00002 00 071 Rev A c wwz 92 ysne e 7 uxd MOIA yor ea MBIA PIS 1uBIu 4 uuug 101 JosoJev 1A 02g oE 9 dissoqd Nw S exeiu aiv Duro isneux3 suut 9 AV amp ujoo5 Buljoo fS wn lt i D ME Fra LI eoueJee o i t UL MH er gji 4 l T lt 9 um err E u Ley 8 eao eoueJeo 2 fc l f wwop zsi Keil dAX xeuiun e z 7009 i uuug og aii N o z UlulQG gt on jsneuxa julog jsneux3 joso4ey ejqeqoud JosoJoy sonsouBeiq pue uomel eisu 104 yY e qissog 6 85 01 al S0c aqoid HOUS Duis ueuw snes dAX xeuiun Bildes eoeung P eoeuns Bunoddng Bumoddns x SNU W9 eui ejsew Jo 19 deo epoq 9 S uJ0JJ jsneuxe osoJoe ejqeqoud 6 B 20 o sneuxe Josojoe o oS te ejqgeqoud eougjee o uorsueixe Aes lt 8 pu eoueJe9p ejqeo lt 2 Sse29e eoueuejureui SNY uoyMs Jewog lt 9 HI yl 0 ejdoed z sesinbes 00X7 enuew Jasn perjddns jo suononuisul 3 uonej eisui pue Bui amp exoed uo suononujsui Buipueu pue Burddius wojoJ G X RO fenueui Jasn 39U 19491
123. ardware installation Upgrades become available for enhancements or to repair a corrupted file Upgrade instructions or Luminex Technical Support may direct you to sections in this appendix to perform a software or firmware procedure If this is a new Luminex 100 IS 2 3 system installation then only perform the procedure in the following Luminex 100 IS System Setup section Otherwise perform any of the following procedures as required Q Luminex 100 IS System Hardware Setup lIf you are install ing the Luminex 100 IS 2 3 system hardware continue with Luminex 100 IS System Setup page B 1 Q Luminex 100 IS Software Installation If you need to upgrade or reinstall your Luminex 100 IS 2 3 system software refer to Luminex 100 IS 2 3 Software Installation page B 14 Q Luminex Firmware Installation If you need to perform a firmware upgrade in your Luminex 100 analyzer Luminex XYP instrument or Luminex SD system refer to Luminex 100 IS 2 3 Firmware Installation page B 21 Before connecting the system components ensure that the facility complies with all system and safety requirements Read the safety information that begins in Warnings and Notes page 2 2 Position the instrument to minimize temperature fluctuations Luminex 100 IS User Manual Version 2 3 xMAP Technology The following sections describe how to connect the Luminex 100 IS system components An Installation Drawing page B 27 provides clearances and other re
124. assay needs to be analyzed at a particular temperature If the instructions indicate that the Luminex XYP instrument heater is needed you may manually set the heater to the specified heat setting The user definable heater range is 35 C to 60 C Use the heater only with the Luminex XYP instrument heater block in place Luminex recommends using a Costar Thermowell thin wall polycarbonate 96 well plate nonskirted model P over the heater block sent with the 100 IS Any temperature that you set remains in effect until you set another temperature or turn off the Luminex X YP instrument plate heater The system displays the target temperature in the box below the Turn ON button Before the heater block temperature reaches the new temperature setting the XYP Heater Temperature thermometer appears red Upon reaching the target temperature the thermometer turns green See System Monitor on page 5 37 for more information about the system monitor PN 89 00002 00 071 Rev A xMAP Technology Note Do not insert a cold heater block into the XYP if the XYP is already warmed up Command List PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software Prior to being turned on or set the Turn ON button appears gray and disabled To set the Luminex XYP instrument heater temperature Warning The heater plate of the Luminex XYP instrument is hot when in use and may cause personal injury Do not touch the heater plat
125. atabase Backup The Backup Database To dialog box opens See Figure B 18 Backup Database To Database To 2 x Save in ja Backup FEM Ex E3 mp Luminex 100 IS E1 in LX1001504232002 bak History is LX100I506112002 bak E Desktop My Documents My Computer ao L lt 1 001507032002 bak BZ Save as type Y Cancel My Network P File name Figure B 18 Backup Database To Dialog Box PN 89 00002 00 071 Rev A B 19 Luminex 100 IS User Manual Version 2 3 Remove Luminex 100 IS 2 1 or 2 2 Note During the Luminex 100 IS Version 2 1 or 2 2 software removal error dialog boxes may appear They are of no consequence to the uninstall Just click OK or Yes in response and continue with the uninstall Install Luminex 100 IS 2 3 Software 2 xMAP Technology Choose the file name and location of the database that you want to back up and click Save The database is backed up and the Backup Database To dialog box closes Close the IS Sofware You remove the Luminex 100 IS Version 2 1 or 2 2 software through the Windows Control Panel 1 On the PC desktop select Start gt Settings gt Control Panel The Control Panel dialog box opens on the desktop Double click the Add Remove Programs icon The Add Remove Programs dialog box opens Under the Currently installed programs list select the Luminex 100 IS entry The entry expands to include the Change Remove button Click
126. ate Control F6 see Invalidate or Validate Standards and Controls on page 5 94 e Validate Control F7 see Invalidate or Validate Standards and Controls on page 5 94 e Change Lot Alt F8 see Change Lots on page 5 96 e Recalc Standards tab only see Recalculation on page 5 93 Edit lots Click Change Lot Alt F8 to edit lots Restrict the use of this button to correct only entry errors for standard and control lot values To create new lots refer to Create a New Lot on page 5 75 When you make a change such as invalidating a standard or editing lot information you must recalculate the affected test The system provides two options Automatic recalculate and manual recalculate Luminex 100 IS User Manual Version 2 3 Note The Recalc button is greyed out unless you make changes that require recalculation Invalidate or Validate Standards and Controls xMAP Technology The Auto checkbox under Recalc button at the bottom right of the Standards tab determines the option v Auto Figure 5 79 Recalc Button Auto selection In the Auto selection mode changes automatically trigger the system to reanalyze the affected test This is the default mode unless you uncheck the Auto checkbox Uncheck Auto to use the Recalc button in the Manual recalculate mode Manual recalculate After making changes that require a recalculation the system enables the Recalc button In this mode you press th
127. atient 2 DataType Trimmed Count Location Sample Test 22 Total Events Notes PN 89 00002 00 071 Rev A xMAP Technology 1 Std s 69 75 2 Std m 69 75 3 Std I 69 75 A Std xl 69 75 5 Std xxl 69 75 6 Low Control 69 75 7 Patient 1 69 75 Sample Comment for Patient 1 8 Patient 2 69 75 Sample Comment for Patient 2 DataType Trimmed Mean Location Sample Test 22 Total Events Notes 1 Std s 56 9855072463768 75 2 Std m 494 463768115942 75 3 Std 4466 08695652174 75 4 Std xI 13634 5217391304 75 5 Std xxl 25095 75 6 Low Control 58 8695652173913 75 7 Patient 1 551 36231884058 75 Sample Comment for Patient 1 8 Patient 2 14594 7391304348 75 Sample Comment for Patient 2 DataType Trimmed CV Location Sample Test 22 Total Events Notes 1 Std s 23 9771317653444 75 2 Std m 26 4392256987905 75 3 Std I 20 718201051022 75 4 Std xl 25 4309644452528 75 5 Std xxl 14 0816389192424 75 6 Low Control 22 0787072692933 75 7 Patient 1 21 231629005304 75 Sample Comment for Patient 1 8 Patient 2 20 5061473536575 75 Sample Co
128. batch added to the multi batch The patient list appends to the first well occupied without a command If you have defined patients in batch setup and have added a patient list the patient list is placed in the first available empty well location following the defined patient commands Click Save and Load then click Finish The batch is added to the multi batch To reassign the positions of the batches within the multi batch see Change Start Acquiring Data Location in Multi Batches on page 5 64 for more information Different batches within the multi batch are separated by thick red lines above the first well and below the last well of each batch After all batches are added enter the multi batch name and creator name then click Finish The Run Batch tab opens Luminex 100 IS User Manual Version 2 3 Re run or Recover Incomplete Batch Open a Multi Batch Note Each batch within a multi batch appears on the list of available multi batches The software differentiates them according to the batch ID name and description However the software gives all batches comprising a multi batch the same multi batch ID number and name Process Multiple Plates xMAP Technology representing the batches you selected or created on the microtiter plate 12 Click Eject and load the first plate of the multi batch 13 Click Start Plate to begin acquiring data from the multiple batches in the sequence that you set up
129. ble Configurations section then continue with the desired firmware upgrade section e Upgrading a Luminex 100 Version 1 7 system lIf you are upgrading your firmware from a system previously using the Luminex 100 Version 1 7 software with Windows 98 or 2000 e Luminex SD system lIf you have the optional Luminex SD system remove the serial interface cable between the Luminex XYP and the Luminex 100 analyzer then attach it to the Luminex SD system to perform the firmware upgrade After completing the SD firmware upgrade reattach the serial cable to the back of the XYP Then replace the serial interface cable with the SD interface cable supplied in the upgrade kit If you are upgrading the firmware for more than one component for instance the SD and the XYP you must upgrade the SD system first Luminex 100 analyzer cable Use the existing serial interface cable between the PC and Luminex 100 analyzer to perform the firmware upgrade Then replace the serial interface cable with the USB interface cable supplied in the upgrade kit e Luminex XYP instrument Continue to use the serial interface cable between the PC and Luminex XYP e Upgrading a Luminex 100 IS Version 2 1 2 2 system If you are upgrading a Luminex 100 IS Version 2 1 or 2 2 system Luminex SD system Remove the serial interface cable between the Luminex XYP and the Luminex 100 analyzer then attach it to the Luminex SD system to perform the firmware upgrade
130. ble bead maps are 25 50 64 and 100 default regions Select whether you want the Bead Events results to be displayed as Per Bead or Total Beads If you select Total Beads enter the number of total beads in the text box Select Per Bead to continue analyzing until each bead set has met the minimum events as determined on the Bead Set tab Select Total Beads to continue analyzing until the selected beads meet total beads value Use Total Beads when you are not using all of your selected bead sets in each well Set the total to desired high value PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software 6 Click the Bead Set tab Select the checkboxes next to each desired bead set for this batch Click Select All to select all the listed bead sets or Deselect All to deselect all selected bead sets General Plate Layout Selected Events Caption Select All Oo 100 001 m 100 002 Deselect AIl oO 100 003 L1 100 D04 Default Events cr D TE oO 100 006 100 m 100 007 Oo 100 008 Apply to All O 100 D09 o 100 010 1 100 011 O 00 D12 zi 100 regions Y OK Cancel Figure 5 57 Options Dialog Box Bead Set Tab 7 Editthe Events and Caption information for each bead set Edit the Default Events box to change the default value Click Apply to All to apply the default value to all bead sets Table 5 6 lists selection shortcuts Table 5 6 Bead Set Tab Selection Shortcuts
131. bound to the surface of the xMAP microspheres High speed digital signal processors and advanced computer algorithms provide analysis of the xMAP microspheres as they are processed through the Luminex 100 analyzer Results of the analyses are processed and provided in a report format The Luminex 100 IS system includes the following hardware e Luminex 100 analyzer e Computer PC monitor and accessories e Luminex XYP instrument e Luminex Sheath Delivery System Luminex SD Power cables e Alignment guide e Two long sample probes e Luminex XYP instrument sample probe e Reservoir Shield e Heater block e Sheath fluid container e Waste container e Sheath fluid line e Air line e Sheath fluid intake line e Communications 1 serial communication cable Communications 1 USB communication cable e Communications CANBUS communication cable short cable e Barcode reader e Sample probe height alignment kit e 3 32 Hexdrive Balldriver wrench PN 89 00002 00 071 Rev A xMAP Technology xMAP Technology Reagents Required Laboratory Reagents Luminex 100 IS 2 3 Software Luminex 100 IS Performance Specification Speed PN 89 00002 00 071 Rev A The System e Classification calibration microspheres CAL1 e Reporter calibration microspheres CAL2 e Classification control microspheres CON1 e Reporter control microspheres CON2 e Sheath fluid e Household bleach e 70 isopropanol or 70
132. by a non US operating system the country code in hex is appended Build value The version of the Luminex application that created the OUTPUT CSV file Date date time The date amp time that the OUTPUT CSV file was created This field is not related to batch execution time Note that the date and time values are separated into distinct adjacent fields Date 04 14 2003 02 46 45 PM to maintain compatibility with previous versions of software SN value The serial number of the Luminex 100 device with which the batch was executed Session value The name of the batch The term Session was used here to maintain compatibility with previous versions of software Limited to 30 characters Operator value The name contained in the Current User field on the General tab of the Options dialog in the Luminex 100 IS software TemplatelD value Optional The database ID that is unique to the template used to create the batch PN 89 00002 00 071 Rev A xMAP Technology Table D 1 Field Definitions Continued Field Name Field Value Description TemplateName value Optional The name of the template used to create the batch Limited to 30 characters TemplateVersion value Optional The version of the template used to create the batch Limited to 10 characters TemplateDescription value Optional The description o
133. cess doors must be closed while operating the Luminex 100 analyzer the operator must be present during operation Biological Warning Human and animal samples may contain biohazardous infectious agents Where exposure including aerosol to potentially biohazardous material exists follow appropriate biosafety procedures and use personal protective equipment such as gloves gowns laboratory coats face shields or mask and eye protection and ventilation devices Observe all local state and federal biohazard handling regulations when disposing of biohazardous waste material PN 89 00002 00 071 Rev A 2 7 Luminex 100 IS User Manual Version 2 3 xMAP Technology Heat Warning The heater plate of the Luminex XYP instrument may be hot and could cause personal injury if touched Do not touch the heater plate A Blue Indicator Light The blue light above the Luminex 100 analyzer sample arm indicates the on off status of the Luminex 100 analyzer and is harmless The blue light emitting diode LED does not emit light in the UV spectrum 2 8 PN 89 00002 00 071 Rev A xMAP Technology Decontaminating the Luminex 100 Analyzer for Return Shipment Note It is the user s responsibility to decontaminate the analyzer before shipment PN 89 00002 00 071 Rev A Safety Luminex Technical Support will give you a Return Material Authori
134. command started The Device Activity box on the Status Bar indicates that the system is soaking Wait until the soak command completes before initiating another command Upon completion the microtiter plate representation shows a green well with a check mark to indicate the command s success or a red well with an X mark to indicate the command s failure When you exit the system a confirmation dialog box prompts you to verify that you really want to exit the system To exit the system On the File menu click Exit then click Yes 5 121 Luminex 100 IS User Manual Version 2 3 xMAP Technology 5 122 PN 89 00002 00 071 Rev A Maintenance and Cleaning Daily Maintenance Before Running Samples PN 89 00002 00 071 Rev A To ensure accurate test results properly clean and maintain the Luminex 100 IS system Read and follow all instructions in this section For your convenience a maintenance log form is included at the end of this chapter Warning When analyzing potentially infectious biological samples on the Luminex 100 analyzer follow standard laboratory safety practices These safety precautions should also be taken when cleaning or maintaining the analyzer Do not remove the analyzer cover under any circumstances If the system is powered on but idle for more than four hours click the Maintenance tab Click Warmup Wait 30 minutes for the Luminex 100 analyzer and the optics system to warm up Before
135. cquisition until you disable or deselect the single step option The status bar appears along the bottom of the 100 IS Main window and displays the system status Check the status bar periodically while running a batch to ensure that the system is performing accurately See Figure 5 8 Command State Device Status Device Activity Laser Status TotaltventsSec Region vents Sec Me Sy Ming Wermed p 0 m Figure 5 8 System Status Bar The system displays information about the Command State Device Status Device Activity Laser Status Total Events per Second and Region Events per Second Color coding indicates the urgency of each item s status Device Activity uses no color coding Table 5 1 describes the types of status bar messages in relation to the message color coding Table 5 1 Status Bar Color Coding Indicates Indicates communication with the Luminex 100 analyzer or operations being processed Green Idle or processing Yellow Connecting pausing or paused Red Disconnected or locked out Device Status Indicates the current process of or warning about the Luminex 100 analyzer Green Running or standby Yellow Busy pressurizing sheath is empty or warming up Red Not ready or disconnected Device Activity Indicates the activity that the Luminex 100 analyzer is performing Note The device activity has no color code PN 89 00002 00 071 Rev A
136. ctivity box on the Status Bar indicates that the system is warming The Laser Status section on the Status Bar is yellow as it counts down from 1800 seconds Upon completion the Laser Status bar turns green and displays Warmed Up An animated gear appears in the upper right corner of the Maintenance tab screen Prime the system as necessary to remove air from the system s fluidic pathways after e refilling the sheath container removing and replacing the sheath container changing the sheath fluid filter changing the syringe seal You should also Prime your system as part of the daily startup routine When priming the system draws sheath fluid from the sheath fluid container You do not need to supply solution in a plate Priming takes approximately one minute To prime the system Click Prime then click OK to confirm that you want to prime the system The command list on the Run Batch tab indicates that the system is running The Device Activity box on the Status Bar indicates that the system is priming Upon completion the command list indicates whether the command succeeded with green text or the command failed with red text Backflush the system to perform these tasks to remove obstructions from the cuvette e if fluid does not flow through the waste tubing during prime cycles or during sample acquisition e if fluid drips from the sample probe during priming and forms puddles of fluid on the plate PN 8
137. ctors to samples 5 65 Auto Scale 5 45 Auto selection recalculation 5 94 automatic analysis 5 83 autosize 5 44 auto start analysis 5 4 avoid beam exposure 2 6 shining beam into people s eyes 2 6 staring into beam 2 6 B back up the database 5 112 backflushing 5 22 background information 4 1 analytes 4 1 flow cytometry 4 1 Index 1 Luminex 100 IS User Manual Version 2 3 measure 4 1 soluble analytes 4 1 background samples 5 73 barcode label 3 7 5 60 barcode reader 4 2 5 60 batch analyze 5 85 analyze processed batch 5 87 clear from system 5 67 commands 5 50 copying 5 67 data export 5 111 definition 5 49 group of samples 5 49 new advanced 5 43 open 5 54 pasting from 5 67 processing 5 49 replay 5 43 reprocess 5 47 rerun 5 58 setup 5 13 template 5 49 Batch Data and Buttons 5 43 Batch Name and Description 5 43 Batch Summary Report 5 108 bead map 5 46 biohazard 2 2 biological 2 2 warning 2 7 blue indicator light 2 2 2 8 button bar 5 3 C calibration 6 5 command 5 28 definition A 1 schedule 4 2 setting well location 5 28 trend report 4 3 5 33 5 108 trend report printing 5 32 updating lots 5 28 verification 5 28 cancel 5 14 5 43 5 84 Cancel All 5 14 5 43 5 84 capacity specifications 3 4 caution 2 1 2 5 2 6 Index 2 xMAP Technology CD supplied 3 3 CE mark 2 3 change lot 5 93 5 96 changing data location 5 64 cheminert fitting 3 9 B 7 classification laser 3 5 4 1 cl
138. cy precision 3 4 capacity 3 4 classification laser 3 5 electronics 3 6 fluidics 3 5 hardware 3 2 Luminex 100 analyzer 3 5 Luminex 100 IS 3 3 3 5 3 7 Luminex XYP 3 6 PC 3 6 reporter laser 3 5 sensitivity 3 4 speed 3 3 vortex 3 7 specified volume 5 83 speed specifications 3 3 stability 4 2 Standards and Controls 5 94 standards tab 5 86 5 90 standby 5 10 start 5 14 5 43 starting a plate begins acquisition 5 83 start up procedure 6 1 Statistics 5 44 status bar 5 2 5 10 main screen 5 8 status communication 5 10 status of instrument 2 8 storage PN 89 00002 00 071 Rev A Index raw data 5 4 subsystems 3 8 successful acquisition 5 83 surge protector 3 7 surge protector specifications 3 7 symbols 2 1 syringe 3 10 4 1 syringe seal 6 8 8 2 system backflushing cuvette obstructions 5 22 drain 5 25 errors 5 100 information 5 119 integrity 4 2 monitor 5 37 overview 3 8 performance 5 8 prime 5 22 soak 5 26 status 5 8 trend report 5 108 warmup 5 21 system setup communication cables B 4 PC B 4 XYP B 4 T tabs 5 11 acquisition detail 5 41 diagnostics 5 37 home 5 11 maintenance 5 19 run batch 5 14 5 15 samples 5 86 5 97 standards 5 86 technical support 1 2 7 1 Canada 1 2 email address 1 2 7 1 hours 1 2 7 1 outside U S 1 2 phone numbers 7 1 U S A 1 2 temperature gauge 5 15 templates 4 2 5 50 5 73 5 74 5 85 test analysis view 5 90 Index 7 Luminex 100 IS User Manual Version 2 3 test rat
139. d bag place it in the corrugated box then insert it in its original packaging or an approved shipping container Attach this checklist to the top of the corrugated box prior to packaging in the crate Was there an internal leak in the system Yes No Print Name Signature Date Instrument Serial No Luminex 100 IS User Manual Version 2 3 xMAP Technology PN 89 00002 00 071 Rev A The System Theory of Operation PN 89 00002 00 071 Rev A Luminex 100 IS technology is based on flow cell fluorometry with Luminex developed innovations The fluidics optics robotics temperature control software and xMAP microspheres work together to enable simultaneous analysis of up to 100 analytes in a single test sample Assay analysis requiring temperature control is provided through the Luminex XYP instrument heater block There are two fluidics paths in the Luminex 100 analyzer The first path involves a syringe driven mechanism that controls the sample uptake This mechanism permits small sample uptake volumes from small reaction volumes The syringe driven system transports a specified volume of sample from a sample container to the cuvette The sample is injected into the cuvette at a steady rate for analysis Following analysis the sample path is automatically purged with sheath buffer by the second fluidics path This process removes residual sample within the tubing valves and probe The second flui
140. d in cases where the hazard is minor or only potential hazard is present Failure to comply with the caution may result in potentially hazardous conditions Warning This message is used in cases where danger to the operator or to the performance of the instrument is present Failure to comply with the warning may result in incorrect performance instrument failure invalid results or hazard to the operator Danger This message is used in cases where significant risk of serious injury or death is present Read the following safety information before setting up or using the Luminex 100 IS 2 3 system A user should be present during operation This system contains electrical mechanical and laser components which if handled improperly are potentially harmful In addition biological hazards may be present during system operation Therefore we recommend that all system users become familiar with the specific safety advisories below in addition to adhering to standard laboratory safety practices The protection provided by the equipment may be impaired or the warranty voided if the system is used in a manner not specified by the instructions or by Luminex Corporation This caution label appears on the back of the Luminex 100 analyzer and on the Luminex XYP instrument Caution Double Pole Neutral Fusing Disconnect power before changing fuse Attention Double pole fusible sur le neutre Couper le courant avant de remplacer le fusible F
141. delete a batch you cannot recover it Create a Multi Batch PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software To open a saved batch to the system for acquisition Click Open Batch The Open Batch dialog box opens listing available batches for selection Select the desired batch to load then click Select The system loads the batch as you created it to the Run Batch tab Click Eject Retract then click Start Plate to initiate batch acquisition You can delete unprocessed batches Save Only To delete an unprocessed batch 1 On the File menu click Delete Batch A dialog box opens listing only the unprocessed batches in the database Select the unprocessed batch that you want to delete Click Select The system deletes the batch that you selected A multi batch is a set of batches that you want to process consecutively You can add batches to the multi batch from existing batches in your database or you can create new batches to add to the multi batch You can include as many batches as you need in your multi batch The software does not limit you to a certain number of batches per multi batch To create a new multi batch 1 2 Click Create New Multi Batch In the Luminex Multi Batch dialog box click Add Batch to add an existing batch to the multi batch See Figure 5 46 Luminex 100 IS User Manual Version 2 3 xMAP Technology u Luminex Multi Batch Setup Please ente
142. dialog box opens See Figure 5 28 Luminex 100 IS User Manual Version 2 3 xMAP Technology w Lot and Date Selection nix m Reagent Lot Selection 3 r Date Selection Select one reagent to include in the Select the date range for the report Calibration Trend Report Starting Date joer 6 2002 Ending Date o2 6 2002 Figure 5 28 Lot and Date Selection Dialog Box 4 Select the desired reagent lot and expiration date and the date range starting and ending date and click Finish The Print Report Calibration Trend Report window opens with the information you entered See Figure 5 29 ia Print Preview Calibration Trend Report BEE wal 1 olx Q si 06 15 2001 02 22 05 PM Product Number L100 CAL2 Report amp art Date 06062001 2 Product Name L100 CAL2 Report End Date 06062001 Lot Number A1962 Expiration Date 01 22 2002 RP1 Target 3735 Time Board Temp Sheath Pressure RP1 Volt Pass 40A 3 00 11 06 02 AM 128 95 6 94 586 5 Yes 40300 11 31 02 AM 28 73 7 07 586 4 Yes 1 Click X to close screen 2 Print Button Figure 5 29 Report Print Preview 5 Click Print The Print Document dialog box opens Select the desired options and click Print 6 To close the Print Preview window click the X in the upper right corner of the screen To close the Report Selection dialog box click the X in the upper righ
143. dics path is driven by positive air pressure and supplies sheath fluid to the cuvette and sample path Sheath fluid is the delivery medium of the sample to the optics component The analysis sample is acquired using a sample probe from a 96 well microtiter plate via the Luminex X YP instrument and injected into the base of the cuvette The sample then passes through with sheath fluid at a reduced rate resulting in a narrow sample core to ensure that each microsphere is illuminated individually The sample injection rate is such that the xMAP microspheres are introduced to the optics path as a series of single events The Luminex SD system lets you run samples continuously without refilling sheath bottles It automatically draws sheath from a non pressurized bulk sheath container to constantly maintain a reservoir Luminex 100 IS User Manual Version 2 3 Hardware xMAP Technology of pressurized sheath fluid A single 20 liter sheath container provides enough fluid for 48 hours or more of normal operation The optics assembly consists of two lasers One laser excites the dye mixture inside the xMAP microspheres and the second laser excites the fluorosphere bound to the surface of the xMAP microspheres Avalanche photo diode detectors measure the excitation emission intensities of the color coding classification dye mixtures inside the xMAP microspheres and a photomultiplier tube detects the excitation emission intensity of the reporter molecule
144. dit the lot value If you have entered lot information and you have used the template to setup a batch even if it has not yet been acquired then you can edit the lot values However you must rename the lot Lot procedures include Create a New Lot 9 PN 89 00002 00 071 Rev A Create New Lots Edit Lot Information on an Unused Template Edit Lot Information on a Used Template Import a Lot to Existing Template Export Lot from Existing Template To create a new lot On the Home tab click New Lot The Open Template dialog box opens See Figure 5 63 Open Template ID Template Name Version Description 3 Template 1 28 02 9 32 bwh vbby h 4 Template 1 28 02 10 22 21h 5 Template 1 29 02 12 2 2 90 B Template 1 29 02 12 25 123 7 Template 2 5 02 16 42 2 2 100 8 Template 2 6 02 10 04 2 2 101 9 Template 2 5 02 10 55 2 2 101 10 Template 2 6 02 10 58 2 2 101 11 Template 2 5 02 11 00 2 2 101 12 Template 2 5 02 11 01 2 2 101 13 Template 2 6 02 1 2 2 101 Luminex 100 IS User Manual Version 2 3 Note Depending on the types of products associated with the template that you select the screen may vary from the example in Figure 5 65 That is if you are creating only standard lots then only the upper part of the screen displays xMAP Technology Highlight the template that will use the new lot information and click Select Then continue with substep a or b a If this is a new template with n
145. djacent to the Movement Device text box The Confirm XYP Firmware Download dialog box opens Click Yes to continue with the upgrade Click No to return to the previous dialog box The Download In Progress dialog box opens displaying the progress Read the information presented on the dialog box When the download is finished the Status text box displays Download Complete Turn the power off for 5 seconds then turn the power to the XYP back on Click OK Next verify the upgrade Start up the Luminex 100 IS software On the Help menu click About the Device The About the Luminex100 amp Luminex XYP Devices dialog box opens Verify that the Controller Version entry for the Luminex 100 Device Information section on the dialog box displays the version listed in the upgrade document Your upgrade kit instructions list the correct version number PN 89 00002 00 071 Rev A xMAP Technology Luminex SD System Firmware Update Update Firmware Note If you are directed by Technical Support or by upgrade kit instructions to upgrade to a specific firmware version then click the Browse button and select the desired firmware version from the Open dialog box Note If you are upgrading the Luminex XYP instrument firmware consider doing it at this time then verify the Luminex 100 analyzer and the Luminex XYP instrument at the same time Verify Successful Firmware Upgrade PN 89 00002 00 071 Rev A Luminex 100 IS 2 3 Firmwar
146. e 1 Click Eject Retract to eject the plate holder 2 Insert the Luminex XYP instrument heater block into the plate holder 3 Click Eject Retract to retract the plate holder 4 Inthe Temperature and Gauges area click Turn ON The light on the button turns green and the thermometer fluid turns red as it raises to reach the target temperature 5 Usethe up and down arrows beneath the target temperature box or click and drag the blue arrow on the XYP Heater Temperature thermometer to the temperature you want the Luminex XYP instrument heater block to maintain The user definable heater range is 35 C to 60 C 6 Wait for the heater to reach your selected temperature and stabilize about 30 minutes before processing samples The thermometer turns green when the temperature is stabilized The Command List displays commands that are associated with batches or multi batches that you have loaded for processing on the system The Command List provides the status of each command as the system begins processing it For example the command list will show Wash under Command and under Cmd Status that the system is processing the command by displaying Running The command list indicates whether the command completes successfully or fails Figure 5 16 shows that all the commands are pending Luminex 100 IS User Manual Version 2 3 xMAP Technology Cmd No Command Plate Loc Cmd Status 2 1 Warmup nones Plate1 Pending 2 Prim
147. e command failed with red text Soak Command _ Use the Soak command to prevent salt crystals from forming in the probe due to air exposure Soaking the probe replaces sheath fluid in the probe with water You should perform the soak function at the end of each day The system uses at least 250 uL of distilled water To soak the probe 1 Onthe Maintenance tab click Eject Retract 2 Put water in the reservoir or into a well on a microtiter plate Click Soak A confirmation dialog box opens See Figure 5 21 Q Confirmation Screen x Place the Soak solution in well D1 and click OK to continue Click Cancel to abort this command d OK Eu a E j j a Figure 5 21 Confirmation Screen Dialog Box 3 If you put the water somewhere other than the default location shown in the dialog box click the drop down arrow to the right of the Eject Retract button An image of the microtiter plate and Luminex XYP reservoir appears shown in Figure 5 22 Click on the location in the image A2 a3 aa A5 a6 A7 a8 a9 amp t amp t1 A B3 B4 B5 B6 B7 Be B9 610 B11 Br c3 c4 cs ce c7 ce ca E10 E19 V D3 ba ps D8 D7 ba D9 b t1 E3 E4 ES E6 Er EB E9 E10 E11 2 F3 F4 F5 Fe F7 Fe F9 F10 11 G3 G4 G5 G6 G7 G8 G9 610 611 H2 H3 H4 Hs H6 H7 HB HO H1 H1 812 Figure 5 22 Microtiter Plate and XYP Reservoir Im
148. e lt none gt Plate1 Pending 3 Prime lt none gt Plate Pending 4 Prime snone gt Plate1 Pending 5 Wash Reservoir Plate1 Pending 6 Calibrate CAL1 E11 Plate Pending 7 Wash Reservoir Plate1 Pending 8 Calibrate CAL2 F11 Plate Pending E Figure 5 16 Command List Section on the Run Batch Tab Figure 5 17 shows an example of a failed command in the command list on the Run Batch tab 1 CON1 C1 Plate1 FAILED 45 sec Figure 5 17 Command Failure Notation In Command List If an error occurs during the batch it is recorded in the Message Log See Error Messages on page 5 41 for details Double click the failure row for additional information if it is highlighted in yellow Right click the highlighted row to copy data to the clipboard or to clear the batch from the screen Click the Print Batch Worklist option above the upper right corner to print the list of commands from the command list This applies to the current loaded batch Print Batch Worklist Click this button to print out the status of each command Button 5 18 PN 89 00002 00 071 Rev A xMAP Technology Maintenance Tab Maintenance Commands Note The Sanitize command performs a similar function as the alcohol flush command However the sanitize command uses 10 to 20 household bleach to decontaminate sample lines and the cuvette after biohazard contact PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software In the Maintenance
149. e 4 1 testing 5 83 testing clinical samples 3 2 tests 4 1 thumb wheel B 8 toolbar 5 3 tools menu 5 3 tracking calibration results 5 32 trend report entering a date range 5 33 troubleshooting 7 1 types B 8 microspheres 4 2 types of messages 5 41 types of microtiter plate B 8 typical messages 5 10 U UL mark 2 3 unauthorized additional software 3 3 Underwriter Laboratories Incorporated 2 3 uptake 4 1 user manual conventions 1 1 user accessible components 3 8 V validate Standards and Controls 5 94 ventilation filter XYP 3 8 verification command 5 28 setting well location 5 28 trend report 4 3 updating lots 5 28 View Batch Data 5 43 View Detailed Error Information 5 100 View detailed test analysis 5 90 view menu 5 3 view self diagnostic details 5 28 visual inspection 6 4 volume 4 1 vortex 3 7 W warmup 5 21 6 1 warnings 2 1 2 7 2 8 5 17 6 8 biological 2 7 Index 8 xMAP Technology laser 2 5 warranty 2 2 washing the system 5 24 distilled water 5 24 reservoir 5 24 sheath fluid 5 24 waste connector 3 11 container 3 12 6 2 high volume 6 3 well 5 24 wipe exterior surfaces 6 5 X xMAP 3 4 reagents 3 3 4 1 technology 1 1 XYP 2 3 air intake filter 6 7 commands 5 36 heater block B 13 heater temperature 5 16 5 17 reservoir 5 15 ventilation filter 3 8 Z Zoom 5 45 PN 89 00002 00 071 Rev A
150. e Certificate of Quality then click OK Update CON Targets CON 1 Product Information 4 r Lot Information Number Value L100 CON1 Lot Number jA1682 Name Expiration Date 12 06 2002 a pieni Control Target Information ms pius Reference TargetAl Target Bl Target C1 uber 1 9861 769 218 Current CON Lot A1682 2 9835 763 664 3 10675 23422 5607 eade ae A1682 4 8946 2573 17803 rt ort DM ae ay Nes LE 9386 233 5795 CON 2 Product Information Lot Information Number Value L100 CON2 Lot Number A1440 Name Expiration Date 09 21 2002 zl Reporter Control Manufacturer r Target Information Luminex Reference Target A1 1 Current CON2 Lot A1440 2 A1440 B Import CON 2 Export CON 2 4 Newbot Lot Change the current lot by saving selected lot OK Cancel Figure 5 24 Update CON Targets Dialog Box 4 Ensure that the analyzer is set to draw CONI and CON2 beads from the wells you loaded in step 2 of Run System xMAP Calibrators on page 5 28 Luminex 100 IS User Manual Version 2 3 Note If an error occurs during System calibration or verification an X appears in front of the Diagnostics tab title and the text turns red The command list on the Run Batch tab also reports that the command failed Figure 5 25 shows the error warnings Calibration and System Control
151. e Control F6 om ST Previous Test F3 _ _ Validate Standard F5 _ Validate Control F7 __ Change Lot AltFs C Alphabetically by Sample ID Figure 5 76 Non Competitive Quant Analysis Window Standards Tab When an unknown sample or control that lies outside the standard curve MFI range is measured the concentration cannot be determined from the MFI and the sample s left right position in relation to the curve is reported in the test result using a less than or greater than gt symbol next to the concentration of the limiting standard These out of range samples and controls will also have a Sample High Low statement in the comment column If a sample lies within the standard curve MFI range but the sample s MFI value does not intersect the curve the result will be reported as Error A cannot calculate inverse function statement is added to the comments column Note this error condition usually occurs when a standard curve flattens out at the high or low end Examples of out of range sample labeling for non competitive assays are shown in Table 5 9 Figure 5 77 shows what a standard curve for a non competitive assay should look like Condition Concentration Label MFI of Standard Referenced Left of Curve min concentration standard Lowest Right of Curve max concentration standard Highest Table 5 9 Non Competitive Out Of Range Labeling PN 89 00002 00 071 Rev A 5 91
152. e Installation If you are upgrading the firmware for more than one component for instance the SD and the XYP you must upgrade the SD system first Follow the steps in this section to update and verify the Luminex SD system firmware To update the Luminex SD system firmware 1 Close any open applications 2 Turn off the power to the SD XYP and LX100 3 Remove the serial cable from the Luminex X YP instrument and plug it into P2 on the back of the SD system 4 Turn power back on to the SD system 5 On the PC desktop click Start Programs Luminex LXR LX Firmware The LX Firmware Update Tool dialog box opens See Figure B 19 6 Select the SD Device option button Notice in the Movement Device text box item 3 in Figure B 19 that the top line displays the current version of the Luminex SD system firmware and that the second line displays its status 7 If the second line indicates that the firmware is up to date then click Close No further action is required If an update version is available then continue with step 8 8 Click Upgrade adjacent to the Movement Device text box The Confirm SD Firmware Download dialog box opens Click Yes to continue with the upgrade Click No to return to the previous dialog box 9 The Download In Progress dialog box opens displaying the progress Read the information presented on the dialog box When the download is finished the Status text box displays Download Complete Click O
153. e Recalc button to initiate the recalculation Examples of Recalc scenarios include change formula change lot validate invalidate a standard control in line lot changes changing Expected Conc from the Standards grid You can invalidate or validate a standard or control in either of two ways Use the associated button on the bottom of the Analysis window or right click in the desired Expected Conc cell Invalidating standards You can invalidate or remove a standard if doing so improves the curve fit Invalidating standards greatly affects the curve fit and subsequently the sample results However observe caution when doing so For further instruction on assay standard curves and the appropriateness of invalidating or removing standards contact the assay kit manufacturer Invalidating controls You can invalidate or remove a control in data analysis However Luminex does not recommend invalidating controls For further instruction on assay controls and guidelines regarding accepting or rejecting control values contact the assay kit manufacturer To validate or invalidate a standard or control entry using the shortcut procedure 1 Select the desired standard or control name in the Standards or Controls grid 2 Right click to display the related menu See Figure 5 80 Select the desired menu item to apply When invalidating the Name PN 89 00002 00 071 Rev A xMAP Technology PN 89 00002 00 071 Rev A Using Luminex
154. e dot plot to navigate around the dot plot Click to toggle between expanding the entire dot plot and returning the dot plot to original size You can reprocess batches through the system multiple times using Replay Batch Replay Batch uses the data stored in the run files from the initial acquisition to reprocess a batch creating a new batch output file Luminex 100 IS User Manual Version 2 3 Note The initial batch data and output file always remain intact and unchanged Note The number of beads for collection must be less than or equal to the number previously collected in the original sample Reprocess Samples Using Replay Batch xMAP Technology Each time you reprocess a batch using Replay Batch the system handles it as if it is a new batch thus creating a separate processed batch entry and output file You reprocess a batch using Replay Batch to e Run as demonstrations to see how the system processes samples and analyzes the results e Test a batch using different parameters such as setting a different number of events to be collected or using a different bead map or new formula for analysis also using a different template If you reprocess a batch with the same template parameters the system obtains results similar to the original batch If you reprocess a batch using changed parameters the system may obtain different results When you replay a batch it labels unknown samples as Pal Pa2 Pa3 and so
155. e eee RR RR 5 118 Use Online Help 5 118 Open System Help 0 0 0 0 02 ee eee eee 5 118 About the Device 5 118 About the Luminex 100 IS 2 3 Software 5 119 System Information 00 000 e cece eee 5 119 Shut Down the Analyzer 0 0 0 0 ce eee eee eee 5 120 Exit Luminex 100 IS 2 3 Software 05 5 121 Maintenance and Cleaning 6 1 Daily Maintenance 1 aeaee anres eyr e 6 1 Before Running Samples 0 0 0 0 eee eee 6 1 After Running Samples 0 0 0 0 cee eee eee 6 2 Rovitine Fasks usd eee Iob io Cd enh ata ac neh ath e ced s 6 2 Sheath and Waste Fluids 0 00 cc eee 6 2 Refill the Sheath Fluid Container 6 3 Empty the Waste Container 2 0005 6 3 Weekly ages eder or ee atl ely ow adel teen iet Rada ae odes 6 4 Visual Inspection 0 0 eee eee eee 6 4 Run Self Diagnostics 0 0 0 cece eee eee 6 4 vi PN 89 00002 00 071 Rev A xMAP Technology Contents Clean Sample Probe 0 0 0 cece ee eee eee 6 4 Flushithe System eese deep eher 6 4 Monthly nearne etahaina sida que bag grace E e nca a oe es 6 4 Clean the Sample Probe 0 0 00 020 eee 6 4 Clean Exterior Surfaces 2 0 0 0c eee ee ee eee 6 5 Calibration and System Controls 000 6 5 Every SIX Months curae dad e ra epe s Eg 6 6 Luminex 100 Analyzer Air Intake Filter uus 6 6
156. e system The waste Container container should not be placed on top of the instrument Caution Waste levels must be manually monitored Do not allow the waste container to overflow Optic al The optical system consists of the optical assembly and the excitation lasers The optical assemblies do not require manual adjustment by the user xMAP Technology The xMAP technology reagent system consists of classification Reagents calibration microspheres reporter calibration microspheres classification control microspheres and reporter control microspheres 3 12 PN 89 00002 00 071 Rev A Background Information Fluidics Excitation PN 89 00002 00 071 Rev A Basic Concepts xMAP technology is a versatile system that measures soluble analytes The Luminex 100 IS system performs simultaneous discrete measurements of multiple microsphere based reactions from a single specimen aliquot For more conceptual information refer to Practical Flow Cytometry 3rd edition by Howard M Shapiro M D New York Wiley Liss Inc 1995 There are two fluidic paths in the Luminex 100 analyzer The first path involves a syringe driven mechanism that controls the sample uptake This mechanism permits small sample uptake volumes from small reaction volumes The syringe driven system transports a specified volume of sample from a sample container to the cuvette The sample is injected into the cuvette at a steady rate for analysis Following ana
157. e tube to the top of the sample arm The system monitor changes from Busy to Running and sample acquisition continues Click Cancel to make adjustments before continuing with the rest of the samples 3 Ifthe sample arm still does not raise save all the data that has been collected to this point Turn off the analyzer but keep the XYP instrument on 4 Exit the Luminex IS Software 5 Turn the analyzer back on and restart the software 6 Replace the sample tubing and blue light Adjust the sample arm 7 Runacalibration with DI water to reset the sample probe optical switch Sample arm does not go down smoothly The 96 well plate is incorrectly seated in the XYP instrument The 96 well plate is warped The sample arm is misaligned Adjust the 96 well plate Inspect the 96 well plate Replace it if it is warped Readjust the sample arm horizontal alignment PN 89 00002 00 071 Rev A xMAP Technology The analyzer is misaligned with the XYP instrument The sample probe is bent Troubleshooting Reposition the Luminex 100 analyzer on top of the Luminex XYP instrument so that the holes match up correctly The alignment guide should tighten and loosen fairly easily if the instruments are aligned correctly Continue to square the instruments until the guide loosens and tightens easily Remove the sample probe from the Luminex 100 analyzer Roll it on a flat surface If it does not
158. ean accessible surfaces 6 5 clear batch from system 5 67 clear message log 5 40 Clear Preliminary Off plate commands 5 72 Clinical Assay Report 5 108 clinical samples 3 2 color coding 5 83 command list display 5 17 commands off plate 5 71 company information entering 5 5 component of Luminex 100 IS 2 7 components 2 2 3 2 xMAP reagents 1 1 conceptual information 4 1 confirmation screen 5 4 connect barcode reader B 5 keyboard B 5 Luminex 100 IS analyzer B 3 mouse B 5 PC B 5 XYP B 3 connectors air waste and sheath fluid 3 11 continue interrupted acquisition 5 84 copy information from batch 5 67 create calibration trend report 5 32 new batch 5 49 new session 5 50 report 5 109 Customize Data Analysis Settings 5 101 D daily activities 6 1 shutdown 5 14 startup 5 13 data acquisition categories 5 13 data output 5 108 PN 89 00002 00 071 Rev A xMAP Technology reports 5 108 database backup 5 112 compressed patient reports 4 3 management 5 112 5 113 restore 5 114 DD temperature 5 15 decaying dot plot 5 46 decontamination 2 2 2 9 5 24 density dot plot 5 46 detailed sample progress 5 39 Diagnostics tab 5 37 5 41 digital signal processor 4 1 dilution factor 5 65 discard waste 6 2 disconnect from AC power 6 5 disconnected status 5 10 dot plot 5 46 decaying 5 46 density 5 46 draining the system 5 25 during operation 2 2 edit menu 5 3 efficiency 4 1 eject retract 5 2 5 15 5 43 5 85 XYP plate holder 5 36
159. eath pressure from the sheath container through the system Delta Cal Temperature C temperature deviation from the last calibration Board Temperature C temperature of the analog board DD Temperature C DD temperature at the U block inside the optics platform CL1 Temperature C CL1 temperature at the U block inside the optics platform 5 38 PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software Table 5 4 System Monitor Values Continued Property Value Units of Measure CL2 Temperature C CL2 temperature at the U block inside the optics platform XYP Board Temperature C temperature of the XYP board inside the Luminex XYP instrument XYP Heater Temperature C temperature of the XYP heaters inside the Luminex XYP instrument XYP Heater Temperature In Indicates if the XYP heater is in Range the set range Detailed Sam ple Progress The Detailed Sample Progress window displays the percentage of completion for each bead ID or test The graph shows real time progress so that as each sample is analyzed the graph adjusts to show progress Use the zoom button to view up to 20 tests at a time Use the toggle button to view the bead ID or test name Use the up down and left right arrows to expand the chart margins and view longer test names See Figure 5 32 Detailed Sample Progress 1 23 Complete 34 73 7T Tests Bead ID 1 Zoom button
160. eation Qualitative analysis determines the results as either positive or negative reactive or non reactive and so on The system is also flexible in defining custom result ranges such as negative low positive high positive and so on Refer to the Creating Templates section of the Luminex 100 IS Developer Workbench Guide Version 2 3 for additional information All determinations are based on a single standard Quantitative analysis determines the sample concentrations from standard curves using regression methods such as 4P or 5P logistic curve fitting There are two main assay types non competitive such as capture sandwich and competitive In a non competitive assay the slope of a concentration versus Mean Fluorescent Intensity MFI standard curve is a positive number That is low concentrations result in low MFIs and high concentrations result in high MFIs Conversely competitive assays generate a standard curve with a negative slope the endpoints of which are high MFI low concentration on the left and low MFI high concentrations on the right You may direct the system to acquire samples in replicate regardless of batch type For qualitative batches replicate values are averaged and the reported interpretation determined from this replicate average Luminex 100 IS User Manual Version 2 3 Note Luminex does not recommend performing Data Analysis while the Luminex 100 IS 2 3 system is performing data acquisition
161. ed in Step 4 Follow up with installing the heater block below if necessary Use the Luminex X YP instrument heater block as required by your assay kit instructions This is an optional step When not in use store the heater block in the bracket inside the left access door of the Luminex 100 analyzer Luminex 100 IS User Manual Version 2 3 xMAP Technology To install the Luminex XYP instrument heater block 1 On the Maintenance tab click Eject Retract to eject the plate holder 2 Insert the Luminex XYP instrument heater block on the plate holder See Figure B 14 Figure B 14 The Luminex XYP Instrument Heater Block 3 Click Eject Retract to retract the plate holder 4 Turn the heater on and set the temperature Refer to Set Luminex XYP Instrument Heater Temperature page 5 16 For new system installations perform the preliminary commands listed in the Prepare System for First Use page B 26 before running samples Luminex 100 IS 2 3 New Luminex 100 IS 2 3 systems arrive with the Luminex 100 IS Softwa re 2 3 software installed Upgrading existing systems to Luminex 100 IS Version 2 3 requires that you upgrade your software through an Installation upgrade kit The upgrade kits include necessary components such as software CDs manuals cables and instructions Select the upgrade kit that applies to your current version or is called out in your upgrade kit procedure If your current software version is e
162. elect Clear Selection from the menu 13 After you define the information on the General Bead Set and Plate Layout tabs click OK Click Cancel to abort PN 89 00002 00 071 Rev A xMAP Technology Background Samples Templates PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software Table 5 8 Plate Layout Tab Selection Shortcuts Click column heading to select entire column Click row heading to select entire row Click the top left corner of the plate to select entire plate Each well can have a series of off plate commands that run before the next well is read You can insert preliminary off plate commands that run before the first well Background samples are commonly used in the assay process in the Luminex 100 IS 2 3 system Although recommended the discretion on whether to use or not is left to the assay or kit developer If the background samples are to be included they have been defined in the assay template Background samples are samples with no active test substance The system uses background samples to remove assay background noise from the sample results Typical background samples contain coupled beads assay buffer detection reagents and reporter fluorophore Background samples do not contain target analytes If the background sample is designated accordingly the system subtracts the background sample s reported fluorescence from all other samples in a batch to rep
163. enter the appropriate patient information Note indicates a required field Batch 5 3402 16 38 Descnption lt None gt a Created By Template info Name RepQt Assay Description Replicate Simplex Quant E E Version No pus Developing Co MNX Insert Acquire Paten z Xf Amy Sample ID Dil Factor 1 AT Platel Acquire Standard Std M 2 51 Plate1 Acquire Standard B 3 C1 Plate1 Acquire Standard Std M StdL 4 D1 Plate1 Acquire Standard Std L 8 5 E1 Plate Acquire Standard Std XL fa E Acquire Standard Std XL a7 G1 Plate1 Acquire Control Cont xps j 8 Ht Plate Acquire Control ConL 1 T 9 A2 Platel AcquirePetient 10 52 Plate1 Acquire Patient 11 C2 Plate1 Acquire Patient 12 D2 Plate1 Acquire Patient 13 E2 Plate Acquire Patient 14 F2 Plate1 Acquire Patient 15 G2 Plate1 Acquire Patient ARUN mwina Pa amine Naas 2 2 1 1 1 1 wd Save andLoad C Save only r Standard Info Product No 3000 Product Name 36 RepOt Kit Lot Name 36Repotsed Expiration Oste 06 10 2005 lo Control Info Product No 3000 Product Name 36 Rept Kit Lot Namik 36Repatcon Expiration Date 08 10 2005 Figure 5 41 Luminex Batch Setup Dialog Box Enter the batch name if different from the system default name provided a description optional and the creator
164. er law E nfo Figure B 16 Software Information Window 3 Run system calibration See Calibration and Verification page 5 28 to complete the verification process by running the system calibrators and controls To upgrade to Luminex IS 2 3 software you perform these procedures in the following order Optionally archive your My Sessions folder Remove LMAT software Remove Luminex 100 Version 1 7 software Install Luminex IS 2 3 software Verify successful upgrade To preserve your Luminex 100 Version 1 7 session data archive your C My Sessions folder Copy the files to another folder or save them to a diskette or CD Luminex 100 IS Version 2 3 software maintains session data in a database not in the My Sessions folder Remove the Luminex LMAT software using the Windows Control Panel 1 On the PC desktop select Start gt Settings gt Control Panel The Control Panel opens on the desktop 2 Double click the Add Remove Programs icon The Add Remove Programs dialog box opens 3 Inthe Currently installed programs list select LMAT entry The entry expands to include the Change Remove button Click Change Remove Luminex 100 IS User Manual Version 2 3 Remove Luminex 100 Version 1 7 Software Note During the Luminex 100 Version 1 7 software removal error dialog boxes may open They are of no consequence to the uninstall Just click OK or Yes in response and continue with the uninstall xMAP Techn
165. erforming these actions refilling the sheath container removing and replacing sheath container changing the sheath fluid filter changing the syringe seal Backflush Troubleshooting purposes only to remove obstructions from the cuvette if fluid does not flow through the waste tubing during prime cycles or during sample acquisition if fluid drips from the sample probe during priming and forms puddles of fluid on the plate Alcohol Flush Daily e After changing the sample probe Toremove air bubbles from the cuvette using 7096 isopropanol or 7096 ethanol Sanitize To decontaminate sample lines and cuvette after biohazard contact using 1096 to 2096 household bleach daily if working with biohazards monthly if not working with biohazards 5 20 PN 89 00002 00 071 Rev A xMAP Technology Warmup Command PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software Table 5 3 Maintenance Operations Recommended Use Schedule Continued Operation Recommended Use Schedule Wash As needed using distilled water or sheath fluid Four times after system calibration Twice after sanitize Drain Fortroubleshooting only the cuvette in the system can be drained temporarily and refilled in preparation for running Draining the system helps to remove debris from the bottom of the cuvette when draining you do not need to supply solution Draining
166. eservoir 5 2 5 15 B 9 responsibility 2 9 restoring the database reload database previously saved 5 114 results reports 4 2 Resume 5 15 5 43 resuming acquisition 5 84 Index 6 xMAP Technology return shipment 2 9 Run Batch tab 5 14 command list 5 17 microtiter plate 5 15 running samples after 6 1 before 6 1 once a day 6 1 sheath container cap 6 1 verify 6 1 S safety advisories 2 2 safety information B 1 safety precautions 2 1 2 2 sample arm 3 9 adjusting vertical height 6 11 sample data entering 4 2 sample details 4 3 Sample Errors 5 100 sample probe 5 36 B 7 adjust B 8 clean 6 4 sample progress 5 39 samples tab 5 86 5 97 sanitize 5 23 5 24 6 1 remove air bubbles 5 23 with 7096 isopropanol 5 23 SD Formula 5 44 select product 5 32 self diagnostics 5 27 sensitivity 3 4 4 1 session pasting to 5 67 pause 5 84 resume 5 84 set XYP heater temperature 5 16 setting 5 17 setting gates 5 45 setting up multiple session run 5 55 sheath filter 3 11 8 2 sheath flow rate 3 5 sheath fluid 5 83 connector 3 11 container 3 12 filling 6 2 PN 89 00002 00 071 Rev A xMAP Technology filter 6 10 levels 6 1 product number 8 3 sheath fluid container 3 12 show bead 5 45 Shut Down the Instrument 5 120 single step 5 8 soak 5 26 software 3 3 8 3 software overview Luminex 100 IS software 4 2 software specifications 3 3 dedicated system 3 3 soluble analytes 4 1 sorting methods 5 99 specifications 3 5 accura
167. ex 100 IS Performance Specification 3 3 Noc PM 3 3 Accuracy and Precision lslee eee ee eee eee 3 4 Se sl vity ro rrer du dddowsd ta d ueexe D e ee R DIE ee dede 3 4 Capacity eos tae e Read su dede i ex gra 3 4 Luminex 100 Analyzer General 0 000000 3 5 OPUS soon eneilkks peed AER beads ad Edu Eder iad uds 3 5 PIUIAICS M 3 5 PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 xMAP Technology Blectr ties i ci ies lA Re Re Res LEER RISE 3 6 Luminex XYP Instrument General 2 0 00505 3 6 Luminex SD System General 0 000002 eee eee 3 6 PC Specifications iua aa eoe wc P el eae eed 3 6 Recommended Additional Equipment 3 7 Uninterruptible Power Supply UPS 3 7 Surge Protector n d cia hanes ei AG 3 7 Printer occ os ead ne eae bad ee ERR os 3 7 Barcode Labels esee Ron eae wars ae 3 7 hiosoJq PP a cieie s tiri thr oiri eNe eeii 3 7 Bath Sonicator crase eeneioe eee ta eee ew eae ees 3 7 System Overview 0 0 0 cece eee ene 3 8 EleCtFODIOS 2 iue oret ee eoe mode o Re UR Roe 3 8 Power Input Module 0 0 0 0 eee 3 8 Communications Ports SB9 PIN usus 3 8 Luminex 100 Analyzer Ventilation Filter 3 8 Luminex XYP Instrument Ventilation Filter 3 8 FluidiCS i ser RR Leber ee pir eee E a es us 3 9 sample Arm ide oe oe be ee Sy es oo 4 ais 3 9 Luminex XYP
168. f the template used to create the batch Limited to 200 characters TemplateDevelopingCompany value Optional The name of the company that developed the template used to create the batch Limited to 30 characters TemplateAuthor value Optional The name of the person who created the template used to create the batch Limited to 30 characters SampleVolume value Optional The sample volume defined in the template for sample acquisitions Units microliters DDGate value Optional The DD gate defined in the template for sample acquisitions SampleTimeout value Optional The sample timeout defined in the template for sample acquisitions Units seconds BatchAuthor value Optional The name of the person who created the batch Limited to 30 characters BatchStartTime date time Optional The date amp time that the batch was started BatchStopTime date time Optional The date amp time that the batch was finished BatchDescription value Optional The batch description Limited to 200 characters BatchComment value Optional Comment entered after the batch has run CALInfo Optional Indicates the start of the CAL1 amp CAL2 machine calibration information logged just prior to and anytime during batch acquisition CONInfo Optional Indicates the start of the CON1 amp CON2 machine verification informatio
169. file with no additional features enabled uu eda vad Bald RE Se eos din ed Bhi wal Bhai D 7 Luminex 100 IS OUTPUT CSV file with all additional features enabled p E AARAU aet ut dea ede RD de usa D 8 Index Index 1 PN 89 00002 00 071 Rev A Contents Luminex 100 IS User Manual Version 2 3 xMAP Technology X PN 89 00002 00 071 Rev A Introduction About This Manual The Luminex 100 IS 2 3 System Intended Use PN 89 00002 00 071 Rev A This manual provides you with information to understand and use the Luminex 100 IS system It consists of multiple chapters and appendices that take you from this introduction to complete system operation The manual s text and figures offer examples when necessary Procedures are presented as step by step instructions Glossary and index sections assist as references The conventions in this manual assume that the reader has a basic familiarity with computers xMAP technology and a knowledge of Microsoft Windows software We typically document the common methods of accessing a command such as from the main menu bar from the toolbar and from menus that appear when you right click an area of the screen Refer to the Glossary appendix for unfamiliar terminology The Luminex 100 IS 2 3 system is a benchtop system consisting of the Luminex 100 analyzer computer monitor keyboard mouse Luminex XY Platform instrument Luminex XYP Luminex Sheath Delivery System Luminex SD
170. ft Corporation 1 Components System Name PETEB LAP E Software Environment System Manufacturer TOSHIBA E Internet Explorer System Model Satelite Pro 4600 E Applications System Type XB6 based PC Processor x86 Family 6 Model 8 Stepping 10 GenuineIntel 897 BIOS Version Satelite Pro4600 v2 50 TOSHIBA Windows Directory C WINNT Locale United States Time Zone Central Daylight Time Total Physical Memory 523 184 KB Available Physical Memory 229 492 KB Total Virtual Memory 1 210 440 KB Available Virtual Memory 653 352 KB Page File Space 687 256 KB Figure 5 115 System Information Dialog Box PN 89 00002 00 071 Rev A 5 119 Luminex 100 IS User Manual Version 2 3 xMAP Technology S hut Down the Luminex recommends sanitizing with 10 to 20 household bleach An alyzer as part of your daily shutdown routine after biohazard contact Sanitizing uses the Luminex XYP reservoir to accommodate the amount of fluid necessary to sanitize the Luminex 100 analyzer After sanitizing perform a soak command to soak the probe in distilled water to prevent crystal formation in the Luminex XYP sample probe To shutdown the Luminex 100 analyzer 1 7 5 120 On the Maintenance tab click Sanitize A confirmation dialog box opens prompting you to place sanitize solution 1096 to 2096 bleach in the XYP reservoir Click Eject Retract The plate holder ejects Place the solution in the XYP reservoir and click Eject Retract
171. ft section of the Acquisition Detail tab See Figure 5 37 The histogram defaults to display the Doublet Discriminator DD on the X axis and Events on the Y axis Doublets appear when two microspheres stick together creating undesired results When you enable the gate two vertical red dashed lines appear to represent gate positions determined by the template or settings established within the New Advanced Batch After setting the gate everything outside the gate is ignored Show Bead al X e o tz 150 Events 100 50 10 100 1000 10000 Doublet Discriminator sooo ag 1 750015000 1 Gate Boundaries 2 Aggregate Beads 3 Numerical Gate Position Figure 5 37 Set DD Gate Example Four buttons and the Show Bead entry box appear at the top of the histogram Select an entry from the drop down list to set the histogram to show events for only one bead set bead set number all gated events Note The calculated data uses only all gated events to determine the final result E Auto Scale 2 Zoom within the gate or all events inside and outside the gate Select all default before setting the gate Select to automatically adjust the maximum number of events shown on the Y axis Click during acquisition to readjust the Y axis scale Select to zoom or enlarge a specific area on the histogram display Click and drag right to left to adjust the graph s range
172. ges If any of these situations are evident on the report Contact Technical Support Zero events collected during calibration There is a problem with fluid levels Check the fluid levels in the sheath and waste containers Verify that both bottles are tightly connected to the instrument Check that the waste bottle cap is vented Laser related issue Verify fluid is moving through the system by performing a wash A wash function will cause fluid to go out to waste in five distinctive spurts If there s not fluid going to waste clean the sample probe see page 6 4 Run 3 backflushes 3 drains 2 alcohol flushes and 3 washes with distilled water If the issue does not resolve contact Technical Support Analyzer fails Controls The control microspheres are not fully suspended Wrong control lot number or target values are entered in Update CON Targets dialog box The system calibrators are in the wrong well on the plate Vortex the control vials to resuspend the microspheres Verify that the correct lot number and target values are used See page 5 28 for further information Verify that you placed the control microspheres into the correct well See page 5 28 PN 89 00002 00 071 Rev A xMAP Technology Not enough control microspheres added to the well Control lot is expired The sample probe height is incorrect The sample probe is clogged There is air in the system P
173. h Multi batches can consist of any number of batches that have been setup from different assay templates and are processed consecutively The assay kit manufacturer may provide templates in the kits which they distribute on diskette or CD ROM Templates typically include assay standards controls and maintenance commands such as Luminex 100 IS User Manual Version 2 3 Note Common sample errors are due to lower number of events acquired than established in the template Batch Commands and Procedures Create a New Batch xMAP Technology washes or primes to acquire along with samples OEM manufacturers may provide templates pre installed with your system The kit manufacturer includes assay reagents in the assay kit You must provide information about these reagents such as lot numbers and concentration values for the standards and assay controls A batch can include samples across more than one plate When setting up a batch if the number of samples exceeds the wells in one microtiter plate another plate appears for additional samples The new plate appears to the immediate right of the existing plate image on the screen with a dark line between the adjacent columns of the two plates During acquisition the Run Batch tab displays the wells containing the samples in the microtiter plate Colors indicate the progress in analyzing the samples The following well colors indicate well acquisition states e Green well wit
174. h Session in other versions of Luminex Software The OUTPUT CSV file contains two blocks of information The first is the header which contains general batch information The second block of information is the results section which contains several subsections displaying statistical analyses in a Sample versus Test format as illustrated in the following example Batch Header Results Stati Stati Header Sample Location Sample Name Test1 Test2 TestN Total Count Notes Sample1 Sample2 SampleM Stat2 StatN Header Sample Location Sample Name Test1 Test2 TestN Total Count Notes Sample1 Luminex 100 IS User Manual Version 2 3 xMAP Technology Sample2 SampleM StatN StatN Header Sample Location Sample Name Test1 Test2 TestN Total Count Notes Sample1 Sample2 SampleM Blank Lines e Field Definitions There is one blank line between the Date and SN fields There are four blank lines between the Operator field or last optional field and Samples field There is one blank line between the Samples and Results fields There is one blank line between the Results field and the first statistical data block There is one blank line between each of the statistical data blocks Table D 1 Field Definitions Field Name Field Value Description Program value lt CC gt The name of the Luminex application that created the OUTPUT CSV file If the file is generated
175. h command number sample not acquired e Yellow well sample currently in acquisition e Red well sample failed Check the system monitor for more information e Green background with check mark successfully completed The System Monitor on Diagnostic tab also indicates the well acquisition status and highlights the current well in progress To create a new batch 1 Read the instructions provided with the assay kit you are using Follow the instructions for any preparations 2 Onthe Home tab click New Batch The Open Template dialog box opens See Figure 5 40 PN 89 00002 00 071 Rev A xMAP Technology PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software Open Template Ei ID Template Name Version Description 3 Template 1 28 02 9 32 13 Template 2 602 11 02 bwh vbby h 4 Template 1 28 02 10 22 21h 5 Template 1 29 0212 2 2 90 B Template 1 29 02 12 25 123 7 Template 2 5 02 16 42 2 2 100 8 Template 2 6 02 10 04 22 101 9 Template 2 6 02 10 55 22 101 10 Template 2 6 02 10 58 2 2 101 11 Template 2 6 02 11 00 22 101 12 Template 2 6 02 11 01 2 2 101 2 2 101 Select Cancel Figure 5 40 Open Template Dialog Box 3 Select the template you want to apply to the new batch and click Select The template loads and the Luminex Batch Setup dialog box opens Lumines atch Setup See Figure 5 41 Please establish the starting location for the batch and
176. h date that you perform the item Note Follow your standard laboratory safety practices when cleaning or maintaining the system Do not remove the instrument cover under any circumstances Dates Daily maintenance Startup Initials for each item listed at the left fill in your initials under each date that you perform the item Laser warmup Check sheath fluid Check waste level Tighten sheath cap Alcohol Flush 70 isopropanol or 70 ethanol Wash twice sheath fluid or distilled water Shut down Initials for each item listed at the left fill in your initials under each date that you perform the item Sanitize 10 to 20 household bleach solution Wash twice water Loosen sheath cap Tum system off optional Weekly Visual inspection Date I nitials Date lnitials Date nitials Date lnitials Monthly Clean sample probe Date I nitials Wipe exterior surfaces Date I nitials Calibrate and verify Date nitials Every six months Replace air intake filter Date I nitials analyzer Replace air intake filter XYP Date I nitials Replace syringe plunger seal or Date I nitials syringe Check analyzer ventilation filter Date I nitials Yearly Replace sheath filter Date I nitials As required Replace fuses Date I nitials
177. h o 74 El crviewer dll IVD MainRepart ocx E IvDInterpGraphD x Datalnterpretation2 ocx x IVD PSReport ocx E IVDMachineCalib Desktop Es GenFormulaDisplayLib ocx amp IVDBackup ocx E IVDMath dll EX GraphObjects dll IVDBeadSelect ocx i IVDMathCommon zug E Graph bjectsInterface dll IVDDevice dll E IVDMathE sp dll My Documents E IVD CalReport oc EJ IVDGraphWrapper oc E IVDMathlnterface HUS i My Computer R D R PUE Fie name z Files of type Cancel Z My Network pe Figure 5 43 Open Patient List File Dialog Box 5 52 PN 89 00002 00 071 Rev A xMAP Technology Note If any of the acquire sample commands within the template of the batch has an unassigned Sample ID the system applies the first patient ID in the list to the unassigned sample acquisition command The system appends any remaining patient IDs to the end of the command list in the order as they appear in the patient list Insert Menu Note When you use the Load Patient List feature all the Sample IDs and Dilution Factors are predefined See Add a Patient List on page 5 61 for additional information PN 89 00002 00 071 Rev A 10 11 12 13 Using Luminex 100 IS 2 3 Software Select a patient file to append to the batch and click Open The system appends the patients to the batch If all patient IDs in the batch are identified the system appends the patient list items to the f
178. he number of gated events that fell within the test s specified region Mean Optional The sum of the data points in the distribution divided by the number of data points Mean 2x N PN 89 00002 00 071 Rev A xMAP Technology Table D 2 Statistics Definitions Statistic Description CV Optional The measure of relative dispersion within the distribution CV 100 x Std Dev Mean Peak Optional The value that is equal to the largest number of data points within the distribution For example in data set 1 2 2 3 3 3 4 5 3 is the peak because it occurs the most number of times in the distribution list Std Dev Optional The measure of dispersion within the distribution Std Dev NZX x N N 1 1 Trimmed Count Trimmed Mean Optional The number of data points in the trimmed distribution Nj Optional The sum of the data points in the trimmed distribution divided by the number of data points Trimmed Mean 2x Ni Trimmed CV Optional The measure of relative dispersion within the trimmed distribution Trimmed CV 100 x Trimmed Std Dev Trimmed Mean Trimmed Peak Optional The value that is equal to the largest number of data points within the trimmed distribution Trimmed Std Dev Optional The measure of dispersion within the trimmed distribution Trimmed Std Dev N x Ex Ny N 1 Avg Result Statistics Column
179. he replicate standards and or controls are invalidated the Avg results reflects the average of the remaining standard and or control replicates The system flags the failed sample so you may calculate the replicate set s average without including the failed result in the equation You can sort the batch samples on the Standards tab and Sample tab See Figure 5 85 Sort Sequentially by order acquired C Alphabetically by Sample ID Figure 5 85 Analysis Window Batch Sort Feature You will find this feature helpful in viewing batches containing replicate samples Replicate samples are defined as samples with identical sample identifications Replicate standards controls and unknown samples are not always acquired in sequential wells and thus make sample viewing difficult When viewing samples alphabetically all replicate samples are displayed together with the replicate sample s average AVG then individual samples If you view replicate batches sequentially each sample displays in the order it was acquired followed by a replicate average summary section Choose from two sorting methods Sequentially by order acquired This feature arranges sample data progress beginning with data acquired from the first sample in your batch and continues chronologically until the last sample with the AVG section at end Alphabetical by sample ID This feature arranges sample data progress alphabetically according to the
180. he system Microspheres appear as a long diagonal line The xMAP microspheres have agglutinated The solvent is incompatible Add additional detergent to the assay buffer For example add 02 to 0 1 Tween 20 Triton X100 or SDS View a list of incompatible solvents at the Luminex Technical Support website http luminexcorp custhelp com If the solvent you are using is listed switch solvents PN 89 00002 00 071 Rev A xMAP Technology You are using incompatible sheath fluid Troubleshooting Use only Luminex sheath fluid in the Luminex 100 analyzer Other fluids may damage your analyzer Error States The following error states display on the Status Bar on the Run Batch tab when an error occurs during system operation Error Message Possible problem Solution Disconnected The software hasn t made initial On the toolbar click Connect connection wait for the status to change The communication cables are Remove and reconnect the cable not connected connections Close the software application and reopen it Close the software application then turn off the Luminex system Power on the system and check the status Refill Sheath Sheath fluid is low Refill the sheath container then click Resume Running Sheath Empty Sheath fluid is empty Replace or fill the sheath fluid System Error Messages PN 89 00002 00 071 Rev A container with sheath fluid Run two Prime comma
181. his data click Yes The system deletes all events stored before the day you select Restore Database Restore the database from a previously saved database Data To restore information to the database 1 Onthe Tools menu click Database Restore The Restore Database dialog box warns you that the Luminex 100 IS software will shut down after restoring the database See Figure 5 104 Restore Database E 9j The Luminex100 IS Software will be shut down after the database is restored Do you wish to continue No Figure 5 104 Restore Database Dialog Box 2 Click Yes to continue to restore a database 3 From the Restore Database From dialog box select a database backup file to restore and click Open See Figure 5 105 The system restores the previously saved database Notice that the files are organized by date month day year axi Look in a Backup J rr Ea a LX1001504232002 bak a LX100I506112002 bak e L 1001507032002 bak History Desktop DN zs My Documents us My Computer b s Eu File name I X on Files of type Backup g Cancel My Network P Open as read only Figure 5 105 Restore Database From Dialog Box 5 114 PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software A Database Restored dialog box opens the next time you start up the system The dialog box prompts you to verify that the lot information for CAL 1 CAL2 CON
182. hows the details of typical messages that appear in the status bar Table 5 2 Status Bar Communication Message Details Status Bar Color Green Message Indicates Idle Appears when the software is waiting to process the next command Standby Appears when the Luminex 100 analyzer is ready and waiting to perform a command Yellow Connecting Appears when the software attempts to connect to the instrument Processing Appears when instrument communicates with the software as it processes commands Pausing Appears when the software tells the instrument to stop processing the list of commands and the instrument finishes up the active command Paused Appears when the software stops processing the list of commands A resume function becomes available to change the state back to processing Busy Appears when the instrument is processing a maintenance command Red Disconnected Appears when the software has not yet attempted to connect or fails to connect to the instrument Locked Out Appears when another application currently has control of the instrument The software locks out as long as the other application runs To remove the locked out status close the other application or wait until the application completes PN 89 00002 00 071 Rev A xMAP Technology Tabs Home Tab Favorites List PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software
183. iew the expiration date of calibrators and system controls in these reports These trend reports display a history of calibrations or system controls for a selected date range You can PN 89 00002 00 071 Rev A xMAP Technology Print or View Calibration or System Control Trend Reports PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software print the trend reports However you must install the printer on the computer system prior to initiating the print command You must enter information about the date range you want to print a report about To create a trend report for a date range 1 Click Print Report The Report Selection dialog box opens See Figure 5 26 i Report Selection loj xl r Select a report Analyte Report C Maintenance Report Clinical Patient Report C Batch Summary Report C Patient Summary Report Calibration Trend Report C Quality Control Report C System Control Trend Report Cancel Figure 5 26 Report Selection Dialog Box 2 Select Calibration Trend Report or System Control Trend Report and click Next The product selection dialog box opens displaying the selected report See Figure 5 27 iw Product Selection loj xi Select one product to include in the Calibration Trend Report L100 CAL1 L100 CAL1 LIOO CAL2 L100 CAL2 CAL2 Figure 5 27 Product Selection Dialog Box 3 Select the product for the trend report then click Next The Lot and Date Selection
184. ify that the delta cal temperature is within 3 0 degrees Recalibrate if outside these limits and retry Verify that the system is functioning properly by running the system controls Run system controls If they pass contact the kit manufacturer PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 Cannot calculate inverse function xMAP Technology This error message encompasses a range of mathematical errors often indicating that the sample result was negative or invalid This is according to the parameters defined by the formula used to analyze the sample results Standards assay controls and unknowns may all be flagged with Unknown Formula Failure A standard curve is plotted using the MFI and expected concentration value An Unknown Formula Failure message may occur when the system is unable to calculate a standard concentration from the standard curve You are using the wrong Verify that you are using the template correct template See Templates on page 5 73 You are using incorrect lot Verify that you have entered the information correct lot information See page 5 28 There is a problem with the kit Run system controls If they pass contact the kit manufacturer Luminex SD Problems Filter Malfunction Draining the Reservoir If the empty sheath fluid container is not replaced and the system continues to operate the Luminex SD system eventually vents pressure to prevent air f
185. igure 5 33 Message Log The log also displays actions in color coded text and shading Items in the Message Log appear in the following color codes e Green text represents a successful system calibration verification command acquisition or maintenance functions e Red text represents failed commands or errors e Black text represents normal processes and actions e Yellow shading behind the text represents that a detailed description about the processes or actions is available This color may vary from system to system depending on your tool tip color system settings The color shading appears only when a more detailed explanation exists for the item To see this detailed description double click the row that is shaded in yellow A dialog box opens providing details about that action or process This function is particularly helpful if you need to diagnose a problem with the system or reagents If an error occurs during the batch it is recorded in the Message Log Clear the Message This command clears the Message Log on the Diagnostics tab It Log does not erase the message log file in the database To clear the Message Log Right click in the Message Log From the menu select Clear Click Yes to confirm your selection See Figure 5 34 5 40 PN 89 00002 00 071 Rev A xMAP Technology Error Messages Acquisition Detail Tab PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software 2 Are you sure
186. inex if you do not comply with any of the terms or conditions of this EULA Upon any termination of this EULA you agree to destroy the SOFTWARE PRODUCT and erase any copies residing on your computer equipment 4 RIGHTS IN SOFTWARE All rights and title in and to the SOFTWARE PRODUCT and any copies thereof are owned by Luminex or its suppliers This EULA is not a sale and does not transfer to you any title or ownership interest in or to the SOFTWARE or any patent copyright trade secret trade name trademark or other intellectual property right therein You shall not remove alter or obscure any proprietary notices contained on or within the SOFTWARE and shall reproduce such notices on any back up copy of the SOFTWARE All title and intellectual property rights in and to the content which may be accessed through use of the SOFTWARE PRODUCT is the property of the respective content owner and may be protected by applicable copyright or other intellectual property laws and treaties This EULA grants you no rights to use such content 5 EXPORT RESTRICTIONS You agree that you will not export or re export the SOFTWARE PRODUCT to any country person entity or end user subject to U S A export restrictions You hereby warrant no state or federal agency has suspended revoked or denied your export privileges 6 NO WARRANTY THE SOFTWARE PRODUCT IS LICENSED AS IS ANY USE OF THE SOFTWARE PRODUCT IS AT YOUR OWN RISK THE SOFTWARE PRODUCT IS PROVIDED
187. information appears in the appropriate row 3 Visually verify that the barcode data scanned correctly It is critical that you scan or enter the correct identification number You can apply a Patient List to any batch or multi batch only during batch setup in the Luminex Batch Setup dialog box The Patient List text file must meet the following requirements The first line of text in the file must be LX100IS Patient List The second line of text in the file must be Accession Dilution Factor e Any following lines of text should be only in the format x y Where x accession ID number for the patient patient identifier string and y dilution factor e The dilution factor is optional but if entered must be a numeric value e If the dilution factor is omitted the system defaults to one e Patient list entries are case sensitive This applies to entries made through the graphical user interface or in a file Review the file before saving for the batch The format must be like the following example or it will not load properly Once you load the patient list to the new batch then you may make edits to the dilution box Before you save the newly created batch you need to double check all Sample IDs before clicking Save Only or Save and Load prior to clicking Finish An example of a typical patient list file LX100IS Patient List Accession Dilution Factor a001 1 a002 2 a003 1 b001 4 b0
188. ing from Luminex 100 Version 1 7 replace the serial interface cable with USB cable supplied in the upgrade Luminex 100 IS User Manual Version 2 3 Luminex XYP Instrument Firmware Update Update Firmware Note If you are directed by Technical Support or by upgrade kit instructions to upgrade to a specific firmware version then click the Browse button and select the desired firmware version from the Open dialog box Note If you are upgrading the Luminex 100 firmware consider doing it at this time then verify the Luminex 100 analyzer and the Luminex XYP instrument at the same time Verify Successful Firmware Upgrade xMAP Technology If you are upgrading from Luminex 100 IS Version 2 1 or 2 2 continue to use the USB cable Follow the steps in this section to update and verify the Luminex XYP instrument firmware To update the Luminex XYP instrument firmware 1 2 Close any open applications On the PC desktop click Start gt Programs gt Luminex gt LXR gt LX Firmware The LX Firmware Update Tool dialog box opens See Figure B 19 Notice in the Movement Device text box item 3 in Figure B 19 that the top line displays the current version of the Luminex X YP analyzer firmware and that the second line displays its status If the second line indicates that the firmware is up to date then click Close No further action is required If an update version is available then continue with step 4 Click Upgrade a
189. instructions provided by the PC manufacturer Place the monitor on top of the PC Unpack the Luminex 100 analyzer and the Luminex XYP instrument Review Hardware page 3 2 to verify that each system component came with the system Place the Luminex X YP instrument on a clean flat surface to the left of the PC Figure B 2 Red Shipping Pin Remove the red shipping pin from the X YP Leave the silver knob in the Luminex XYP instrument See Figure B 2 Place the Luminex 100 analyzer onto the Luminex XYP instrument See Figure B 1 and Figure B 3 for positioning Thread the alignment guide translucent plastic tube through the opening on the Luminex analyzer into the Luminex XYP instrument See Figure B 3 Adjust the position of the Luminex 100 analyzer with the Luminex XYP instrument until the alignment guide threads screw in completely Luminex 100 IS User Manual Version 2 3 Note The cable that connects the analyzer to the PC is 5 feet long the cable that connects the SD to the analyzer is 2 5 feet long 10 xMAP Technology Luminex19 Figure B 3 Install Alignment Guide Ensure that the power switches on the analyzer and XYP instrument are in the off position Attach the power cord to the power input module of the Luminex XYP instrument and attach the serial cable to the Luminex XYP instrument Do not plug the Luminex XYP instrument into the power outlet Attach the power cord to the input module of the Luminex 1
190. irst empty location following the batch s last command list activity See Add a Patient List on page 5 61 for information regarding the patient file format Ensure that the dilution factor settings are correct for the samples in the batch If any are incorrect enter the appropriate dilution factor See page 5 65 for more information Select Save and Load or Save Only Click Finish If you selected Save and Load the Run Batch tab opens displaying the batch including the samples you added If you selected Save only the system becomes idle as it waits for you to initiate a command If you selected Save and Load load the microtiter plate using the Eject Retract button then click Start Plate to initiate batch acquisition The Insert menu allows you to add a user defined number of patients to the command list or skip a defined number of wells on the microtiter plate See Figure 5 44 The Insert menu contains a list box multiplier box and Apply button In the list box you select Acquire Patient or Skip well command Acquire Patient Use this command to add patients to the command list After adding the patients you define the Sample ID and Dilution Factor for each new patient The Dilution Factor defaults to 1 Skip wells Use the Skip command to deliberately bypass specific wells during batch acquisition This may be useful where a certain sample failed Insert Acquire Patient x fi Apply Figure 5 44 Inse
191. itle Arial b Sub Title Times New Roman v bold italic underline Subset Point Axis Labels aria v bold italic underline sample AaBbCcDdEeFfGg Cancel Apply Original Export Maximize Figure 5 90 Customization Dialog Box Font Tab Color Tab Use the Color tab to define the various color parameters on the analysis graph See Figure 5 91 Desk Foreground this is the color that is used when placing text onto the Desk Background It includes the main title sub title subset point labels grid numbers Desk Background this is the color that surrounds the bounding rectangle of the graph s grid That is the color of the border that appears behind the text labeling Shadow Color the rectangles that make up the graph s grid and table and bounded at the bottom right edges with shadows 5 104 PN 89 00002 00 071 Rev A xMAP Technology PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software To remove the shadows choose the same color as the Desk Background Graph Foreground this is the color used for the bounding rectangles of the grid the grid lines of the graph and lines that are used to bound some of the plotting methods like the bounding line around bars of the Bar Plotting Method Graph Background this is the color that is used as the background color of the graph s grid Table Background This is the color used in filling the table s rectangle Currently
192. ive you want to clean up Drives a e Figure 5 108 Select Drive Dialog Box Disk Cleanup x Disk Cleanup is calculating how much space you will be able to free on C Calculating TIT Scanning Compress old files Figure 5 109 Disk Cleanup Dialog Box 3 When Windows finishes calculating the cleanup it displays the Disk Cleanup for dialog box See Figure 5 110 Check or uncheck the desired files to delete and click OK Windows deletes the files and closes the dialog box 2 Disk Cleanup for C A xl Disk Cleanup More Options You can use Disk Cleanup to free up to 858 175 KB of disk mm space on C Eiles to delete oe Downloaded Program Files a8 Temporary Internet Files 765 KB AFA Recycle Bin 119KB Ea Temporary files 64 KB v 53 Temporary Offline Files OKB v Total amount of disk space you gain 858 111 K r Description Downloaded Program Files are ActiveX controls and Java applets downloaded automatically from the Intemet when you view certain pages They are temporarily stored in the Downloaded Program Files folder on your hard disk View Files Cancel Figure 5 110 Disk Cleanup for Selected Drive PN 89 00002 00 071 Rev A xMAP Technology Delete MsgLog Directory Delete Batch Directory Help Menu Online Help Structure Topic PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software To delete the Message Log directo
193. l Danger The syringe arm does not deactivate when changing the plunger injury could result if the system is not unplugged 1 Disconnect the Luminex 100 analyzer from ac power by turning off the power switch on the rear of the analyzer then unplugging the power cord from the wall source 2 Open the center most door on the front of the Luminex 100 analyzer 3 Locate the syringe a glass cylinder with a metal rod See Figure 6 5 1 Syringe Seal 2 Syringe Figure 6 5 Syringe and Syringe Seal 4 Unscrew the knob on the syringe arm at the bottom of the syringe and forcefully push the syringe arm down 5 Unscrew the syringe from the top of its housing 6 Pull the plunger out of the syringe 7 Remove and replace the plunger seal Keep the black O ring 8 Return the plunger to the syringe 9 Screw the syringe back into its housing 10 Return the syringe arm to its original position PN 89 00002 00 071 Rev A xMAP Technology Luminex 100 Analyzer Ventilation Filter PN 89 00002 00 071 Rev A 11 12 13 14 Maintenance and Cleaning Hand tighten the screw on the syringe arm Plug in the power cord and turn the Luminex 100 analyzer power on Prime the system twice watching for any leaks in the syringe area When the prime finishes close the center door To clean the Luminex 100 analyzer ventilation filter Disconnect the Luminex 100 analyzer from ac power by turni
194. lated information Figure B 1 shows the components of the system and how they should be placed Perform the following procedures to set up the system Each of these steps can be found on the page number shown in parentheses 1 Connect the Luminex 100 analyzer and Luminex XYP to the PC page B 3 2 Install the Luminex XYP Instrument Sample Probe page B 6 3 Power On System Components page B 8 4 Accept the Luminex 100 IS 2 3 Software License Agreement page B 8 5 Adjust the Sample Probe Vertical Height page B 8 6 Install the Luminex XYP Instrument Reservoir page B 9 7 Calibrate and Verify the System page B 10 8 Install the SD System page B 10 9 Install the Luminex XYP Instrument Heater Block page B 13 1 Monitor 4 Barcode Scanner 2 PC 5 Luminex SD system 3 Luminex XYP Instrument 6 Luminex 100 Analyzer Figure B 1 Luminex 100 IS System Setup PN 89 00002 00 071 Rev A xMAP Technology Connect the Luminex 100 analyzer and Luminex XYP to the PC A Caution Due to the weight of the analyzer use two people for lifting Note Do not place the PC or monitor on top of the Luminex 100 analyzer or XYP instrument PN 89 00002 00 071 Rev A Luminex 100 IS System Setup You must set up and calibrate the Luminex 100 analyzer and Luminex XYP instrument before you can install the Luminex SD system To connect and power on the system 1 Install the PC and monitor according to the
195. lled Do not place the waste container on top of the instrument Warning If biological samples have been tested with the system use your standard laboratory safety practices when handling system waste The Luminex 100 IS system classifies per FDA 21 CFR 1040 10 and 1040 11 as a Class II laser product consisting of a Class I laser product Luminex 100 analyzer and a Class II laser product barcode reader Figure 2 5 Laser Product Class Label United States and international regulations require the following warnings to appear on the instrument during operation and maintenance This label appears on the back panel of the Luminex 100 analyzer Figure 2 6 Laser Radiation Caution Label Under NO circumstances should you remove the Luminex 100 analyzer cover When performing routine maintenance turn power to the Luminex 100 analyzer OFF and the disconnect the power cord Luminex 100 IS User Manual Version 2 3 Barcode Reader Laser xMAP Technology All laser apertures are located within the Luminex 100 analyzer and are contained within a protective housing This label appears on the optics cover within the Luminex 100 analyzer Figure 2 7 Laser Class Label Warning Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure utilisation des commandes ou r glages ou l ex cution des proc dures autres que celles sp cifi es dans les
196. lock Sample uptake volume 5 Classification of xMAP microspheres gt 80 Misclassification of xMAP microspheres lt 0 5 may vary by xMAP microsphere product lines Refer to the specific product information sheet for further details Temperature control 0 C to 2 C of target Internal sample carry over 0 9 Soluble background fluorescence emission at 575 nm automatically subtracted from fluorescence intensity values Detect 1000 fluorochromes phycoerythrin PE per xMAP microsphere Reporter channel dynamic range 3 5 decades of detection The specifications below reflect minimum capacity values 10 GB hard drive Store data for up to 240 000 test results 1 4 MB 377 diskette 100 MB read write CD ROM Analyze multiple 96 well plates per batch Analyze multiple assay templates per plate Distinguish a minimum of 1 to a maximum of 100 unique xMAP microsphere sets in a single sample Detect and distinguish surface reporter fluorescence emissions at 575 nm on the surface of 1 100 unique xMAP microspheres sets in a single sample Sample core 15 20 um core at 1 uL sec sample inject rate Maintain samples at a constant temperature from 35 C to 55 C 95 F to 131 F Automatic sampling from a 96 well plate Start sampling from any well position Sheath container and waste container hold enough volume to run up to two 96 well plates between refills Microtiter plates with 96 wells must be compatible with the Lumine
197. lockwise Be careful that the threads are correctly aligned Hand tighten only See Figure B 7 1 Cheminert Fitting 3 Sample Probe 2 Sample Probe Holder Figure B 7 Insert Sample Probe and Cheminert Fitting 5 Push the light housing back into place 6 Install the clear plastic shield that covers the sample probe area See Figure B 8 Luminex19 Figure B 8 Sample Probe Area with Clear Plastic Shield in Place PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 Power On System Components Accept the Luminex 100 IS 2 3 Software License Agreement Adjust the Sample Probe Vertical Height xMAP Technology 7 Plug the Luminex XYP instrument and the Luminex 100 analyzer into an approved outlet Power on the system components e The Luminex 100 analyzer switch on back The Luminex XYP instrument switch on back e The PC and monitor switches on front After you power on the PC Windows automatically starts up and then the Luminex 100 IS software automatically starts up Continue with Configure the Luminex 100 IS 2 3 Software section The first time the Luminex 100 IS 2 3 software starts up you have to acknowledge the License Read the agreement and click Accept to continue You must adjust the sample probe vertical height each time you change the type or style of microtiter plate Since this is a new installation you need to adjust the sample probe for your microtiter plates See Figure B 9
198. lti analyte microspheres Light Amplification by Stimulated Emission of Radiation laser This highly purified source of light is an efficient way to excite fluorochrome electrons A solid substance with a diameter in the micrometer range Often used as a synonym for a microsphere Polystyrene spheres with a diameter in the micrometer range Also called beads Several assays or tests performed simultaneously in the same reaction container A set of batches to be processed consecutively The process in which light absorption converts the fluorochromes inside the beads into different fluorescent or nonfluorescent compounds Photobleaching prevents beads from being properly classified Photomultiplier tube measures the excitation emission intensity of the reporter dye bound to the surface of the xMAP microspheres Pertaining to calculations that determine the absence or presence of an analyte Pertaining to calculations that determine the precise numerical measurement of an analyte A molecule or combination of molecules with a specific range of excitation and emission wavelengths that is used to identify or quantify an analyte Examples of acceptable reporters for the Luminex 100 IS are Phycoerythrin and Alexa 532 A specific range of wavelengths that includes the emission wavelength of a designated reporter molecule Refers to the dyes bound to the surface of the xMAP microsphere Also see reporter channel See reporte
199. lysis the sample path is automatically purged with sheath fluid by the second fluidics path This process effectively removes residual sample within the tubing valves and probe Approximately 160 uL of sheath fluid is dispelled into each well following sample acquisition The second fluidics path is driven under positive air pressure and supplies sheath fluid to the cuvette and sample path The excitation system in the Luminex 100 analyzer involves two solid state lasers A reporter laser excites fluorescent molecules bound to biological reactants at the x MAP microsphere surface and a classification laser excites fluorochromes embedded in the xMAP microsphere The lasers illuminate the xMAP microspheres as they flow single file through the cuvette RP1 refers to the excitation wavelength CL1 and CL2 refer to the dyes embedded in the microsphere DD refers to the channel that discriminates against doublets based on size Luminex 100 IS User Manual Version 2 3 xMAP Microspheres Software Overview xMAP Technology Photodiodes and a photomultiplier tube receive fluorescent signals from xMAP microspheres The Luminex 100 analyzer digitizes the waveforms and delivers the signals to a digital signal processor DSP Proprietary algorithms function with the DSP to greatly increase sensitivity The xMAP microspheres are highly uniform polystyrene particles that have been crosslinked during polymerization for physical and thermal stability
200. m loads the batch and the Analysis window displays the Standards tab See Figure 5 74 mem lolx Open Batch Export Data Print Report close Protein Batch IL 4 Errors F9 Standards F11 Samples F12 Test Name System Comments y 1 48E 02 2 85E 04 1 x 4 85E 03 1 26E 00 6 69E 01 lt 14 Olews R 2 0 9999 Sample High Low Logitis p yart Ive yt OEL R 2 0 9994 Sample High Low 20500 I 17500 15000 12500 o 1000 2000 3000 4000 sooo 5000 7000 sooo 9000 10000 pomt Loc Standard Expected Conc MFI TestResult CV Unit Li ct 10 10 62 14 66 pg mL D1 10 10 68 15 11 polmL Et 316 316 212 27 70 polmL F1 316 316 208 2730 polmL ot 100 100 853 93 05 pgimL HI 100 100 833 90 84 pgimL A2 316 316 2824 34457 gdm v Loc Control Expected Conc MFI LowLimit HighLimit TestResult CV Unit A3 Con100 100 797 75 125 8689 pg mL B3 Con100 100 815 75 125 88 86 pg mL c3 Con 1000 1000 6390 850 1150 934 46 pg mL D3 _ Con 1000 1000 6874 850 1150 102827 pg mL Avg Con 100 806 87 87 1 587 pom Avg Con 1000 6632 98136 6 759 pgimL B Hext Test F2 Invalidate Standard F4 Invalidate Control FG i tenen aS Previous Test F3 Validate Standard F5 _ Validate Control F7 Change Lot ait F8 C Alphabeticall
201. m this analysis The Daily Shutdown section consists of two operations typically recommended during daily shutdown procedures This section lets you sanitize and soak the system We recommend that you sanitize with 10 to 20 bleach wash twice with distilled water and then soak with distilled water The Run Batch tab contains a command list displaying batch commands and their status a microtiter plate image plate command buttons and XYP command buttons and settings See Figure 5 13 V Luminex 100 IS Software DEV E sloj xj Fie Tools Help keine x Fae os BS 4 amp 9 ew ome Run Batch Vainenance EL Diagoslios Aca Detail Luminex100 Integrated System 2 3 Batch Name Batch 7 16 02 11 07 Batch Description None LLL UH 4j Acquire StdL B1 Plate1 Pending 3 Acquire Std XL_ C1 Plate Pending 4 Acquire ConL 01 Platel Pending Fal a Ar 1 Microtiter Plate Image 4 Progress when running 2 XYP Reservoir 5 Print Batch Worklist Button 3 Pressure Range 6 Command List Figure 5 13 Run Batch Tab There are six buttons on the Run Batch tab These commands are also available on the Acquisition Detail toolbar Click to initiate data acquisition on new advanced and batches set up using system templates Click to cancel the process for the last command initiated Click to cancel all the commands in process It essentially performs an abort operation PN 89 00002 00 071 Rev A xMAP Techn
202. mation dialog box opens See Figure 5 67 3 Change or edit the lot concentration values 4 Click Save The system alerts you that this lot has been used to setup a batch and that you must create a new lot to continue See Figure 5 69 Create New Standard Lot xi C1 You have selected an old standard lot and changed its data However this lot has Ly already been used in a batch To use the new data you must create a new lot Do you wish to create a new lot Create New Control Lot xi C You have selected an old control lot and changed its data However this lot has a already been used in a batch To use the new data you must create a new lot Do you wish to create a new lot Figure 5 69 Updating Used Template Notification Dialog Boxes 5 Respond to the Create New Standard Lot or Create New Control Lot with Yes or No and rename when the New Lot Number dialog box opens PN 89 00002 00 071 Rev A 5 79 Luminex 100 IS User Manual Version 2 3 xMAP Technology Import a Lot to an Use this procedure to import a lot to an existing template from Existing Template another computer from a diskette or from a CD ROM To import a lot to an existing template 1 On the Home tab click New Lot The Open Template dialog box opens See Figure 5 66 2 Select the template to receive the imported lot and click Select The Update Lot Information dialog box opens See Figure 5 70 3 Click Import Lot The Open dialog b
203. mment for Patient 2 DataType Trimmed Peak Location Sample Test 22 Total Events Notes 1 Std S 45 75 2 Std m 447 75 3 Std I 3985 75 A Std xl 371 5 75 5 Std xxl 1 5788 75 6 Low Control 58 75 7 Patient 1 430 75 Sample Comment for Patient 1 8 Patient 2 8163 75 Sample Comment for Patient 2 PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 DataType Trimmed StdDev xMAP Technology Location Sample Test 22 Total Events Notes 1 Std s 13 6634901596136 75 2 Std m 130 732391650918 75 9 Std 925 292874765645 75 4 Std xI 3467 39037575852 75 5 Std xxl 3533 78728678387 75 6 Low Control 12 9976389750536 75 7 Patient 1 117 063202011273 75 Sample Comment for Patient 1 8 Patient 2 2992 81871196887 75 Sample Comment for Patient 2 DataType Avg Result Location Sample Test 22 Total Events Notes 1 Std s 2 99 pg mL 75 2 Std m 15 79 pg mL 75 3 Std 126 71 pg mL 75 A Std xI 61 6 93 pg mL 75 5 Std xxI 31 94 84 pg m L 75 6 Low Control 3 02 pg mL 75 7 Patient 1 15 98 pg mL 75 Sample Comment for Patient 1 8
204. mmunication Messages 2 2000 5 10 Tabs tes Saco ite ER Rio ogg G84 CE ER AME ROLE 5 11 Home Tab e rent ere Rhe store aoa As 5 11 Favorites DASC S icc boe dvdague Red ed bods 5 11 Add Templates to Favorites 0000005 5 12 Add Commands to Favorites 00000 00s 5 12 Remove Items From Favorites 0000005 5 13 Data Acquisition Categories 0 0 00 02 eee 5 13 Run Batch Tab 22s lb e A Re RE c ae 5 14 Run Batch Tab Buttons 5 14 Start Plate ntact icc ba ies dS OR eS wu de 5 14 Cancel Command 0 00000 eee eee ee ees 5 14 Cancel AIL 2 iste ER T Malan a AUR 5 14 BjecURettact clot cbe er edes red ADR te 5 15 Pause cesa ppc pe Al eed durs cw dos RR d 5 15 Res mee xoci eed daa CR RUE v ee Bea 5 15 Microtiter Plate uc sse ee 5 15 Luminex XYP Instrument Reservoir 5 15 Temperature and Pressure Gauges 20 0000 5 15 Set Luminex XYP Instrument Heater Temperature 5 16 Command List agir awii eie e a eeta ea a i a 5 17 Print Batch Worklist Button 0008 5 18 Maintenance Tab 0 0 0 00 ccc e 5 19 Maintenance Commands 0 0000 cece eee eee 5 19 Warmup Command 0 00 c eee eee ee 5 21 Prime Command 00000 0c eee eee eee 5 22 Backflush Command 00000 00 ee eens 5 22 Alcohol Flush Command 000 00 eee 5 23 Sanitize Command 0 00 eee 5 23 Wash Command
205. mperature 15 C to 30 C 59 to 86 F Humidity 20 to 80 noncondensing Altitude designed to operate at up to 2400m 7874 feet above mean sea level Physical dimensions 20 cm 8 inches W x 30 cm 11 75 inches D x 24 75 cm 9 75 inches H Weight 9 kg 20 Ibs UL installation category UL Installation Category II as defined in Annex J of UL 61010A 1 Pollution degree UL Pollution Degree 2 as defined in Section 3 7 3 2 of UL 61010A 1 Input voltage range 100 240 V 10 0 4 Amps 47 63 Hz AC inlet fuse 2 Amp 250 V time lag These specifications reflect minimum capacity values Computer an Intel Pentium IV or equivalent class PC minimum speed 933 MHz Main memory minimum of 256 MB Hard disk drive 10 GB minimum storage capacity PN 89 00002 00 071 Rev A xMAP Technology Note Contact Techni cal Support for addi tional operating system information Recommended Additional Equipment Uninterruptible Power Supply UPS Surge Protector Printer Barcode Labels Vortex Bath Sonicator PN 89 00002 00 071 Rev A The System e Communications parallel pointing device and serial ports Minimum of 1 parallel 1 PS 2 compatible pointing device and 2 RS 232 compatible serial ports e Communications USB port Minimum of one USB Version 1 1 compatible high speed port e Read write removable media CDR W type drive standard 1 44 MB 3 5 inch disk drive e Operating system support Microsoft
206. n C SD Device 3 c XYP E f 21 15 Fmwaeisuptodte Ius I Browse Status 4 _ 1 LXR Runtime Version 4 Status of Upgrade 2 Luminex 100 analyzer firmware version 5 Movement Device SD Device selection button 3 Luminex XYP SD instrument firmware version Note If you are upgrading the Luminex XYP instrument firmware consider doing it at this time then verify the Luminex 100 analyzer and the Luminex XYP instrument at the same time Verify Successful Firmware Upgrade Update Interface Cable PN 89 00002 00 071 Rev A Figure B 19 LXFirmware Update Tool Dialog Box 4 Click Upgrade adjacent to the Detector Device text box The Confirm LX100 Firmware Download dialog box opens Click Yes to continue with the upgrade Click No to return to the previous dialog box 5 The Download In Progress dialog box opens displaying the progress Read the information presented on the dialog box When the download is finished the Status text box displays Download Complete Click OK 6 Turn off the power for 5 seconds then turn the power to the Luminex 100 back on 7 Next verify the upgrade See note 1 Start up the Luminex 100 IS software 2 On the Help menu click About the Device The About the Luminex 100 amp Luminex XYP Devices dialog box opens 3 Verify that the Controller Version entry for the Luminex 100 Device Information section on the dialog box displays the upgrade version If you are upgrad
207. n logged just prior to and anytime during batch acquisition AssayLotlnfo Optional Indicates the start of the Lot information for any standards and or controls associated with the batch Samples num MinEvents 0 Samples indicate the number of samples run in the batch The MinEvents field is unused and will always be zero Note that this field is adjacent to the Samples field Samples 28 Min Events 0 rather than below it to maintain compatibility with previous versions of software Min Events See Samples field above PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 xMAP Technology Table D 1 Field Definitions Continued Field Name Field Value Description Results This field has no associated value It is used to indicate the beginning of the statistical results section of the OUTPUT CSY file DataType type This field is the name of the statistic represented in the Sample versus the Test data block immediately below this field Possible values for DataType include Median Result Count Mean CV Peak Std Dev Trimmed Count Trimmed Mean Trimmed CV Trimmed Peak Trimmed Std Dev and Avg Result See Table 2 Statistics Definitions CRC Entry Optional CRC indicator for the file data Used to detect external changes to the file Statistics Definitions Statistical calculations are performed for each test in each sample
208. n the Analysis window Proceed with your analysis as desired The executable version of this analysis feature has the same functionality as that within the Luminex 100 IS 2 3 software To access the Standards tab from Analysis using Microsoft Explorer Right click on the desktop Start button to display the menu and click Explore Browse through Explorer to access the following location C Program Files Luminex Luminex1001S DatalnterpApp exe Double click the DataInterpApp executable file The Analysis window opens Click Open Batch to open a file for analysis Select a batch for analysis from the available batches list then click Select The data for the batch you select appears in the Analysis window Proceed with your analysis as desired The executable version of this analysis feature has the same functionality as that within the Luminex 100 IS software 5 107 Luminex 100 IS User Manual Version 2 3 Data Output Report Types Analyte Report Clinical Patient Report Patient Summary Report Quality Control Report Maintenance Report Batch Summary Report Calibration Trend Report System Control Trend Report 5 108 xMAP Technology You can output data by printing reports and exporting batch data The Luminex 100 IS 2 3 software can format your batch or multi batch results in a variety of report formats and provide different types of information in different types of reports See Figure 5
209. n the Luminex website Search on the desired topic or navigate through menus Also review the website s FAQ section To access Luminex website FAQ section In your browser s address field enter http luminexcorp custhelp com This address takes you directly to the FAQ section PN 89 00002 00 071 Rev A Safety Symbols Please become familiar with the information in this chapter before using the equipment Do not perform procedures on your Luminex 100 IS 2 3 system that are not specifically contained in this manual unless you are directed to do so by Luminex Technical Support These symbols describe warnings cautions and general information used in the operation of this instrument These symbols are further defined under Safety Precautions Number Symbol Description Number Symbol Description 1 NY Alternating current ac 7 A Warning refer to manual 2 Protective ground 8 A Warning refer to manual 3 On 9 A Warning refer to manual 4 Off 10 A Warning refer to manual O 5 SN Serial number 11 A Warning refer to manual A Warning refer to manual PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 Warnings and Notes Safety Precautions xMAP Technology Informational notes and warnings appear in this manual Note A note provides general helpful information No safety or performance issues are involved Caution This message is use
210. nalyzer The communication cable is Check the communications unplugged or plugged into the cable connections wrong port PN 89 00002 00 071 Rev A xMAP Technology The XYP or the LX 100 power is not turned on Troubleshooting Turn off the PC and then turn on the LX100 X YP and then the PC Pressurization Normal air and sheath pressure readings vary between 6 9 psi while the compressor runs If the system pressure is out of range your sample acquisition will fail or return poor results Symptom Possible problem Solution Pressurization fails or pressure is too low The sheath and waste lines are not fully connected An air leak is present in the sheath bottle The sheath or waste bottle fittings are cracked There is a leak in the system The compressor does not engage The Cheminert Fitting is loose Fluid leaks in the system The sheath bottle has an air leak Make sure the lines between the sheath and waste bottles and the analyzer are fully connected Remove and retighten the sheath bottle cap Inspect the fittings to be sure they form a tight seal Check for system leaks Run a Prime command If you do not hear the compressor turn on call Technical Support Ensure that the fitting connects tightly above the sample probe below the blue light See Fluid Leak on page 7 4 Disconnect the sheath and waste bottle connections from the analyzer Run a Prime Command If p
211. nd the pressure has stabilized select Prime from the Home or Maintenance tab Then at the Diagnostic tab System Monitor section record the air and sheath pressure Air pressure psi Sheath Pressure psi Save this information You will need it later in the installation procedure and also if you return to the original sheath fluid and waster bottle configuration 2 Atthe end of the Prime cycle disconnect the sheath fluid bottle Store it in a safe place If you plan to use the Luminex SD system waste line disconnect the waste bottle Connect the system waste line to the instrument and insert the end into a large waste container B 10 PN 89 00002 00 071 Rev A xMAP Technology Note Do not place the Luminex SD on top of the Luminex 100 Analyzer PN 89 00002 00 071 Rev A Luminex 100 IS System Setup Place the Luminex SD system near the sheath fluid connection on the left side of the Luminex 100 analyzer Make the following connections refer to Figure B 11 as needed e Connect the sheath fluid line blue fitting to the Sheath Out connector on the front of the Luminex SD system e Connect the air line green fitting to the Air In connector on the front of the Luminex SD system e If you are using the Luminex SD system waste line connect the waste line tubing to the waste connector on the left side of the Luminex 100 analyzer orange fitting Place the other end of the waste line into a large waste receptacle Cut
212. nds There are two types of error messages system error messages and sample error messages System error messages are displayed in three places the Message Log on the Diagnostics Tab the message log located in the Windows message log folder the Errors tab Luminex 100 IS User Manual Version 2 3 xMAP Technology Error Message Possible problem Solution Unknown Diagnostic Error Unknown varied Record the error code number and message Contact Luminex Technical Support XYP Instrument Heater Stability Range Exceeded The heater block temperature is not hitting the target value Low Voltage Detected Possible laser failure Turn off the analyzer XYP and PC then turn them back on Calibrate and verify the system If the error message occurs again contact Luminex Technical Support Runtime Sheath Pressure out of Limits Too High The sheath fluid pressure is too high Ensure that the sheath fluid container is at the same level as the analyzer On systems with a Luminex Sheath Delivery system ensure that the sheath fluid pressure reading is equal to the original ready by adjusting the regulator as outlined in Install the SD System on page B 10 Calibrate and verify the system Runtime Sheath Pressure Out of Limits Too Low There is a pressurization problem with the sheath fluid See Pressurization on page 7 3 Low Laser Power Detected The system isn
213. nex SD system the Luminex SD system automatically primes itself You hear the Luminex SD system pump turn on When the Luminex SD reservoir is about 2 3 full it automatically stops priming Open the center access door on the Luminex 100 analyzer Use a screwdriver to turn the regulator fully clockwise This typically takes three to six full turns Regulator is under arrow as Figure B 13 shows PN 89 00002 00 071 Rev A xMAP Technology Install the Luminex XYP Instrument Heater Block PN 89 00002 00 071 Rev A Luminex 100 IS System Setup EH EH EH F ss lt ss w lt i oe Figure B 13 Luminex 100 Analyzer Regulator Adjustment 6 From the Home or Maintenance tab select Prime During this prime cycle use a screwdriver to adjust the regulator on the front of the Luminex SD system See Figure B 13 Adjust it until the sheath pressure displayed on the Diagnostic tab System Monitor section reads the same as the sheath pressure you recorded in step 4 The system should stabilize at this sheath pressure The air pressure should be the same as you recorded in step 4 within 0 1 psi If the Prime cycle ends before you have completed the adjustment select Prime again and continue to adjust the regulator 7 Calibrate the system again Observe the sheath pressure displayed on the Diagnostic tab System Monitor section during the calibration cycle The pressure should be within 0 1 psi of the pressure record
214. ng off the power switch on the rear of the analyzer then unplug the analyzer power cord from the wall source While facing the Luminex 100 analyzer push your index finger up under the right side of the analyzer in the space between the Luminex 100 analyzer and the Luminex XYP instrument When you feel the filter push the filter toward the left of the analyzer See Figure 6 6 Remove the filter from the left side of the Luminex 100 analyzer Figure 6 6 Luminex 100 Analyzer Ventilation Filter Clean the filter with a vacuum or with distilled water Stand the filter upright to air dry Re install it with the arrows facing up The filter should click into place Plug in and turn on the Luminex 100 analyzer power Luminex 100 IS User Manual Version 2 3 Annually Sheath Filter xMAP Technology To change the Luminex 100 analyzer sheath filter 1 B1 9 mM Disconnect the Luminex 100 analyzer from ac power by turning off the power switch on the rear of the analyzer then unplugging the analyzer power cord from the wall source Disconnect the sheath fluid tubing before changing the filter Open the left door on the Luminex 100 analyzer Disconnect the filter by pushing down on the metal clamps on each connection See Figure 6 7 Figure 6 7 Sheath Filter Connect the new sheath filter matching up the color coded fittings The arrow on the sheath filter should be pointing up Reconnect the sheath fluid tubing
215. nning The Device Activity box on the Status Bar indicates that the system is sanitizing Upon completion the command list indicates whether the command succeeded with green text or the command failed with red text Sanitize the system with 1096 to 2096 household bleach to decontaminate the sample lines and the cuvette after biohazard contact Luminex recommends sanitizing as part of your daily shutdown routine after biohazard contact Sanitizing uses the Luminex XYP reservoir location because only the reservoir can accommodate the amount of fluid necessary to sanitize the instrument Luminex 100 IS User Manual Version 2 3 Wash Command xMAP Technology To sanitize for decontamination 1 Click Sanitize A confirmation dialog box opens prompting you to place sanitize solution in the reservoir Click Eject Retract The plate holder ejects Place the solution in the reservoir and click Eject Retract to retract the plate holder Click OK The command list on the Run Batch tab indicates that the system is running The Device Activity box on the Status Bar indicates that the system is sanitizing Upon completion the command list indicates whether the command succeeded with green text or the command failed with red text Use the wash cycle as needed For example wash four times with distilled water or sheath fluid after calibration Place at least 200 uL in a microtiter well or fill the Luminex XYP reservoir with the sheath fl
216. ntation with fluorescently labeled microsphere beads authorized by Luminex by purchasing such beads from Luminex or an authorized Luminex reseller 2 RESTRICTIONS e You must maintain all proprietary notices on all copies of the SOFTWARE PRODUCT e You may not distribute copies of the SOFTWARE PRODUCT to third parties You may not reverse engineer decompile disassemble or otherwise attempt to derive source code from the SOFTWARE PRODUCT You may not copy other than one backup or archival copy distribute sublicense rent lease transfer or grant any rights in or to all or any portion of the SOFTWARE PRODUCT e You must comply with all applicable laws regarding the use of the SOFTWARE PRODUCT e You may not modify or prepare derivative works of the SOFTWARE PRODUCT e You may not use the SOFTWARE PRODUCT in a computer based service business or publicly display visual output of the SOFTWARE PRODUCT You may not transmit the SOFTWARE PRODUCT over a network by telephone or electronically by any means 3 TERM AND TERMINATION Your rights under this EULA are effective until termination You may terminate this EULA at any time by destroying the SOFTWARE PRODUCT including all computer programs and documentation and erasing any copies residing on your computer equipment Luminex may terminate this EULA upon thirty 30 days written notice to you Your rights under this EULA automatically terminate without further action on the part of Lum
217. nual Version 2 3 Expected Concentrations Note Restrict editing lot values for use only in correcting user entry errors for standards and control lot values Change Lots xMAP Technology The Standards tab displays an Expected Concentration column for standard and control samples The Standards Expected Concentration column allows users to edit the standard concentrations You can edit controls however you must select the control name or Expected Concentration box for that control then select the Change Lot Alt F8 button When editing standard and control lot values the system may prompt you for a new lot number If this is the first batch you analyze using this lot number the system allows editing without requiring a new lot name However if you have analyzed a previous batch using this lot the system will require that you rename the lot if edited or modified Use this feature to edit the lot that is applied to the batch currently opened in data analysis To change the lot that is applied to a batch 1 Click Change Lot Alt F8 located at the bottom of Analysis window to display the Choose Lot dialog box See Figure 5 82 2 The dialog box displays a list of available standard and control lots that you can apply to a batch Highlight the desired lot and click OK to apply the selected lot to the batch opened in data analysis Figure 5 82 shows standard and control Figure 5 83 shows standard only Choose Lot
218. o associated lot information a New Standard Lot or New Control Lot dialog box opens as appropriate You must enter the standard and control names to continue See Figure 5 64 Once you enter the names the Update Lot Information dialog box opens See Figure 5 65 b If this is a template with associated lot information the Update Lot Information dialog box opens To create a new lot when there is an existing lot select the New Lot button from the Standard or Control section of the dialog box See Figure 5 65 A New Standard Lot or New Control Lot dialog box opens Enter the standard or control lot name See Figure 5 64 Click OK ini xi Bl x New Standard Lot New Control Lot Number D NENNEN OK Cancel Cancel Figure 5 64 Add Lot Standard and Control Dialog Boxes PN 89 00002 00 071 Rev A xMAP Technology Edit Lot Information on an Unused Template PN 89 00002 00 071 Rev A l Using Luminex 100 IS 2 3 Software Update Lot Information Import Export mm Cal x Lot Lot Revert Save Cancel Change the current lot by saving selected lot r Test Standards 2000 Current Lot B3654QtStd Current Lot B36540tSta NewLot Delete Lot Exp Date 06 05 2008 Test 36 r Test Controls 2000 Current Lot B3654QtCon Current Lot B36540tCon NewLot Delete Lot Exp Date 03 07 2008 z Low Limit Expected Values High Limit Test 36 Test 54 mg dL mg dL Con Normal 150 405
219. ocx El IVDGraphw rapper ocx E IvDMathinterface m My Pamper File name O Open Files of type x Cancel Open as read only My Network ps Figure 5 52 Open Patient List File Dialog Box 5 62 PN 89 00002 00 071 Rev A xMAP Technology Note If any of the acquire sample commands within the template of the batch has an unassigned value the system applies the first patient ID in the list to the unassigned sample acquisition command The system appends any remaining patient IDs to the end of the command list in order as they appear in the patient list Edit a Patient List Note Patient list entries are case sensitive For example John Doe John doe and john Doe are three unique entries This applies to entries made through the graphical user interface or in a file PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software 4 Double click on a patient list text file to append to the batch The patients from that list append to the first unassigned available well If all patient IDs in the batch or multi batch are identified the system appends the patient list to the first empty location after the batch s or multi batch s last command list activity Choose whether to save the batch or multi batch for later use Click Save only to save the batch or multi batch To run it after you finish creating it click Save and Load 5 Click Finish The system saves the batch or multi batch for later
220. of contents 5 118 high waste volume 6 3 histogram 5 45 buttons 5 45 home tab 5 11 idle 5 10 more than 4 hours 6 1 import lot 5 80 importing a template 5 74 5 85 improper system operation 3 3 incomplete batch 5 58 insert off plate commands establish 5 72 installing XYP heater block B 13 XYP reservoir B 9 XYP sample probe B 6 instrument calibration 5 13 operation 2 1 shutdown 5 120 status 2 8 instrument operation 2 7 integrity 4 2 intended use general system 1 1 interrupts acquisition 5 84 invalidate Standards and Controls 5 94 K kit manufacturer 4 2 5 49 L label type specifications 3 7 labels 2 3 2 6 2 7 laboratory reagents 3 3 laboratory testing 1 1 laser 4 1 analyzer 2 6 apertures 2 6 bar code reader 2 6 information 2 5 location 2 6 Index 4 xMAP Technology radiation 2 6 warnings 2 5 leaks 2 4 light protect from 4 2 light emission 2 8 load batch 5 54 multi batch 5 58 patient list 5 57 location 2 8 locked out 5 10 Log Linear 5 46 Lots Export calibration or control 5 35 import calibration or control 5 35 import to existing template 5 80 management 5 74 Select Existing Lots for Reuse 5 35 update information 5 79 lower sample probe 5 36 Luminex 7 1 Luminex 100 analyzer maintenance functions B 9 Luminex 100 IS 4 1 general laboratory use 1 1 specifications 3 7 Luminex 100 IS analyzer and XYP 2 3 Luminex 100 IS software 1 1 Luminex xMAP microspheres 4 2 Luminex xMAP technology 4
221. off excess tubing Ensure the waste receptacle is level with the Luminex 100 analyzer or no more than three feet below it e Connect the sheath fluid intake line white fitting to the Sheath In connector on the front of the Luminex SD system ooo OOS Luminex sp SAR EEEHHNENN 4 r EN SHEATH OUT A I ENS 5 EHE SHEATH IX NN IN O 6 7 1 Power and Fault indicators 5 Sheath Out connector blue 2 Prime button 6 Sheath In connector white 3 Regulator adjust 7 Reservoir window 4 Air In connector green Figure B 11 Luminex Sheath Delivery Device B 11 Luminex 100 IS User Manual Version 2 3 Note Ensure that the sheath fluid box is at least three feet below the system otherwise the Luminex SD system will overfill Note The regulator must be fully opened to work properly It is important to make sure that you turn it as far as it will go 3 xMAP Technology e Lower the stainless steel filter end of the sheath fluid line to the bottom of a full 20 liter box of sheath fluid Secure the cap on the sheath fluid box Place the sheath fluid container so that the cap is on the top e Attach the power cord to the input module on the back of the Luminex SD system Connect the P1 cable PN 85 10011 00 068 to the back of the SD and to P2 on the back of the analyzer Plug the power cord into the power outlet See Figure B 12 Figure B 12 Back of SD System P1 Port Turn on the power to the Lumi
222. ograms list select the Luminex Data Collector entry The entry expands to include the Change Remove button Click Change Remove The InstallShield Wizard dialog box opens Select Remove and click Next PN 89 00002 00 071 Rev A xMAP Technology Luminex 100 IS 2 3 Software Installation 5 Click OK in the Confirmation File Deletion dialog box If a Shared File Detected dialog box opens select the Don t display this message again checkbox then click Yes If a Self registration error dialog box opens Click OK 6 When the InstallShield Wizard Maintenance Complete dialog box opens click Finish 7 Click Close on the Add Remove Programs dialog box Click the X on the Control Panel to close 8 Ifthe LMAT and the Luminex Data Collector icons are still present on the desktop drag the icons to the Recycle Bin Install Luminex To install the Luminex 100 IS 2 3 software continue with Install 1001S 2 3 Luminex 100 IS 2 3 Software page B 15 Software Luminex 100 IS Version Overview of upgrade to Luminex IS 2 3 procedure 2 1 2 2 to Luminex 100 IS e Backup your Luminex 100 IS 2 1 or 2 2 database Version 2 3 Remove Luminex 100 IS Version 2 1 or 2 2 e Install Luminex IS 2 3 software e Verify successful upgrade Backup Luminex Important Backup your database before you uninstall 100 IS 2 10r 2 2 Version 2 1 or 2 2 software Database To back up your Luminex 100 IS 2 1 or 2 2 database On the Tools menu click D
223. ology Eject Retract Pause Resume Microtiter Plate Luminex XYP Instrument Reservoir Temperature and Pressure Gauges PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software If retracted click to direct the Luminex XYP to eject the microtiter plate If ejected select to direct the Luminex XYP to retract the microtiter plate Click to pause or interrupt the command that the system is currently processing Click to resume or continue the process that was paused The Run Batch tab shows an image representing the microtiter plate where you place the samples The system analyzes microtiter plate samples in the following order vertically from top to bottom within the column and left to right after each column See Figure 5 14 Figure 5 14 Microtiter Plate Image The removable Luminex XYP instrument reservoir 4 mL holds the fluids used in system maintenance operations such as washing draining or sanitizing The Luminex XYP instrument reservoir is located at the top right of the Luminex XYP instrument plate holder The vertical rectangle to the right of the microtiter plate represents the Luminex XYP instrument reservoir on the Run Batch tab See Figure 5 13 Proper temperature and sheath pressure are essential for optimal system performance These must be stable before you calibrate and verify the system The system performs temperature compensation on all samples
224. ology The InstallShield Wizard Welcome dialog box opens See Figure B 17 InstallShield wizard gt XI Welcome Madify repair or remove the program amp e Welcome to the LMAT Setup Maintenance program This program lets you modify the current installation Click one of the options below C Modify l Select new program components to add or select currently installed components to remove Cc D Ep Reinstall all program components installed by the previous setup gh ge Remove all installed components Figure B 17 InstallShield Wizard Dialog Box Remove Select Remove and click Next The Confirmation File Deletion dialog box opens Click OK If the Shared File Detected dialog box opens select Don t display this message again then click Yes If the Registry Editor dialog box opens click OK When the InstallShield Wizard Maintenance Complete dialog box opens click Finish Do not close the Add Remove Programs dialog box Continue with the following Remove Luminex 100 Version 1 7 Software section You remove the Luminex 100 Version 1 7 software through the Windows Control Panel If you are continuing from the previous section then skip to step 3 1 On the PC desktop select Start gt Settings gt Control Panel The Control Panel dialog box opens on the desktop Double click the Add Remove Programs icon The Add Remove Programs dialog box opens Under the Currently installed pr
225. ommand during troubleshooting to help remove debris from the bottom of the cuvette Luminex does not recommend routinely draining the cuvette When draining you do not need to supply solution Draining takes approximately two minutes and should be followed by an alcohol flush with 70 isopropanol or 70 ethanol Any fluid that drains from the system drains to the Luminex XYP reservoir as the default However you can set the system to drain to any unused well on the microtiter plate The drain function normally expels 125 uL of fluid To drain the system 1 Onthe Maintenance tab click Drain A confirmation dialog box opens 2 Ifa different location is desired than what is shown in the dialog box click the drop down arrow to the right of the Eject Retract button within the confirmation dialog box An image of the microtiter plate and Luminex XYP reservoir appears 3 Select a location on the image of the microtiter plate and reservoir to receive the drain fluid and then click Eject Retract The plate holder ejects Luminex 100 IS User Manual Version 2 3 xMAP Technology 4 Verify that the location you indicated is empty and click Eject Retract to retract the plate holder 5 Click OK The command list on the Run Batch tab indicates that it is running The Device Activity box on the Status Bar indicates that the system is draining Upon completion the command list indicates whether the command succeeded with green text or th
226. on about 5 118 PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software the system software This includes software version build number and the system copyright information See Figure 5 114 Click OK to close the dialog box About Luminex100 IS Software Luminex100 IS Software Version 2 3 147 Data acquisiton application for Luminex100 IS 1996 2004 Luminex Corporation All rights reserved Warning This computer program is protected by copyright law and international treaties Unauthorized reproduction or distribution of this program or any portion of it may result in severe criminal and civil penalties and will be prosecuted to the maximum extent possible under law E Info Figure 5 114 About Luminex 100 IS Software Dialog Box System To display system information Information 1 On the Help menu click About the Software The About Luminex 100 IS Software dialog box opens that displays software information 2 Click System Info The System Information dialog box opens See Figure 5 115 3 Click X in the top right corner to close the dialog box 4 Click OK on the About Luminex 100 IS Software dialog box zaxi Action vew Tos e gt Ames 3 C3 2 Ge oy Tree Item value Kj system information OSName Microsoft Windows 2000 Professional fax system Summary Version 5 0 2195 Service Pack 4 Build 2195 Gy Hardware Resources OS Manufacturer Microso
227. on dialog box opens See Figure 5 94 3 Continue as explained in the Print from within Luminex 100 IS 2 3 on page 5 109 To print reports using Explorer 1 Use Explorer to navigate to Luminex Luminex100IS ReportA pp exe 2 Double click ReportApp exe The Report Selection dialog box opens See Figure 5 94 3 Continue as explained in the Print from within Luminex 100 IS 2 3 on page 5 109 Export Batch Data To export batch data On the File menu click Export Batch Data The Open Batch dialog box opens See Figure 5 98 cI amp X ID Batch Name cU Multi Batch ID Name cS 2 B3554 Qua s t B Mean SD Trimmed Mean lean SD Trimmed Mean F DE FILEMODE lt h 02 14 17 FILEMODE None 14 Batch amp 3 02 14 17 FILEMODE None 16 Batch RAM 14 10 Ell EMODE None zi Figure 5 98 Open Batch Dialog Box Select Batch 2 Select the desired batch to export 3 Click Select The system exports the information The Export Batch dialog box opens showing the name and location of the exported data file Click OK See Figure 5 99 Batch data exported CAMy BatchesiBatchblBatchb ids Figure 5 99 Batch Data Exported Dialog Box PN 89 00002 00 071 Rev A 5 111 Luminex 100 IS User Manual Version 2 3 Database Management Back Up the Database 5 112 xMAP Technology You manage the system database by backing up and deleting saved data and files
228. opanol or 7046 ethanol Click Eject Retract On the Maintenance tab click Prime Click OK and wait for the Prime to finish about 1 2 minutes Click Alcohol Flush Click OK and wait until the alcohol flush completes The Device Status section in the status bar changes from yellow to green and displays Standby This takes about five minutes Click New CAL Targ to enter or confirm the calibration lot numbers The Update CAL Targets dialog box opens See Figure 5 23 Enter the CALI lot number Enter the expiration date Click the Expiration Date box A Select Calendar button appears on the right side of the box Expiration Date 102 06 2003 iv Select Calendar Click the Select Calendar button to display the calendar September 2002 3 Sun Mon Tue Wed Thu Fri Sat 7 2 949897 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 27 28 29 30 1 4 5 Z Today 08 13 2002 Type in the date or use the arrows at the top left and right side of the calendar to select past or future months Alternately select the month in header To select the year click the displayed year in the header Use the up and down arrows that appear to select a past or future year Once you select the correct month and year click the desired expiration day on the calendar The calendar closes and the new month and year appear in the Expiration Date box xMAP Technology Luminex 100 IS User Manual Version 2 3 Note Ensure
229. opics Hyperlink Hyperlinks provide instant access to another topic or subtopic with related information to the linked subject or term Use Online Help Open System Help 4 To open the system s online help On the Help menu click Contents 2 Inthe Help dialog box scroll through the contents and select the desired topic Also consider the index to locate information 3 Double click the help topic that you want to view A topical dialog box opens with information on that topic About the Device To display device information about the Luminex 100 analyzer Luminex XYP instrument and the Luminex LXR SDK 1 Onthe Help menu click About the Device The About the Luminex 100 amp Luminex XYP Devices dialog box shows information that may be helpful when contacting Luminex Technical Support See Figure 5 113 Luminex1006 Device Information Serial Number LX10001298011BE M Revision A Controller Version 2 3 8 19 05 2004 LuminexXYP Device Information Serial Number LXY03118002 Revision E Controller Version 2 1 15 16 07 2004 Lxr Component SDK Information Version 2 0 678 1996 2004 Luminex Corporation All rights reserved Figure 5 113 About Device Dialog Box 2 Click OK to close the dialog box About the To display information about the system software Luminex 100 IS 2 3 On the Help menu click About the Software The About Software Luminex 100 IS Software dialog box shows informati
230. or messages Review reports routinely to detect trends Use system xMAP control microspheres to check the success of the system calibration and for troubleshooting purposes If there is a problem with your kit results xMAP controls can help determine if the problem is analyzer related If Calibration and Controls are successful contact the kit manufacturer A normal bead detail display is shown below It depicts a tight bead population within a white region Bead Details Figure 7 1 Normal Bead Detail The histogram for the bead detail above looks like this Figure 7 2 Normal Histogram PN 89 00002 00 071 Rev A 7 11 Luminex 100 IS User Manual Version 2 3 xMAP Technology Symptom Possible problem Solution Calibration microspheres classify too high amp You may be using photobleached calibration microspheres Replace the microspheres with a fresh batch To avoid photobleaching protect your microspheres from light xMAP microspheres hit the lower right of the region You may be using photobleached xMAP microspheres Replace microspheres with a fresh batch To avoid photobleaching protect your microspheres from light Beads appear scattered T PA There is air in the system The sheath fluid is empty Verify sample probe height Run 2 3 Alcohol Flush commands Make sure there is sheath fluid in the sheath container Prime the system until all air is out of t
231. ort net median fluorescence intensity MFD If a batch contains more than one background sample the fluorescence values of the two background samples are averaged together and subtracted from the other samples to obtain a net fluorescence intensity MFI When creating batches or multi batches you must select a template to associate to the batch Templates are predefined command sequences set by assay kit manufacturers to use during batch acquisition Refer to the Luminex 100 IS Developer Workbench Guide Version 2 3 for template details Caution Do not alter predefined templates Luminex 100 IS User Manual Version 2 3 Import a Template Assay Lot Management xMAP Technology Your assay kit may provide a kit specific template supplied on a diskette or CD You need to import new templates to the system only once Templates include standards controls both standards and controls maintenance commands and acquisition commands To import a template from a diskette or CD 1 Insert the kit s diskette or CD into the appropriate drive 2 Onthe File menu click Import Template The Import Template dialog box opens See Figure 5 62 Import Template x Look jn C Luminex 10015 J e amp metE MessageLoa Temp a Cal Con dt a Calibration Only idt a Control Only idt a Startup idt MM rie name po H Files of type Template idt Cancel Open as read only Figure 5 62 Impor
232. orter probe is provided for shipping and troubleshooting Warning During operation this system contains exposed moving parts that can result in a puncture hazard Risk of personal injury is present Keep hands and fingers away from the sample probe The shield should be in place This fitting attaches the Luminex 100 analyzer sample arm tubing to the sample arm Disconnect this fitting when you remove the sample probe See Figure 3 2 The alignment guide directs the sample probe into the Luminex XYP instrument 1 Cheminert Fitting 2 Sample Arm 3 Luminex XYP Instrument Sample Probe 4 Shield 5 Alignment Guide Figure 3 2 Cheminert Fitting Luminex 100 IS User Manual Version 2 3 xMAP Technology Access Doors The Luminex 100 analyzer has three access doors Two of the access doors are on the front and the third is on the back The front left access door supplies access to the sheath filter The front center access door supplies access to the syringe The rear access door supplies access to the air intake filter See Figure 3 3 and Figure 3 4 Luminex199 1 Left door access to service panel 2 Center door access to syringe Figure 3 3 Luminex 100 Analyzer Access Doors Air Intake Filler A replaceable air intake filter cleans the air used to pressurize sheath fluid This filter is enclosed behind an access door located on the back of the Luminex 100 analyzer See Figure 3 4 Figure 3 4 Air Intake Filter S
233. ossible problem with the lasers Troubleshooting Make sure that you use at least four or five drops of control microspheres to the well Use a new bottle of control microspheres Adjust the sample probe height See page B 8 Clean the sample probe See page 6 4 Run a prime and alcohol flush View the system control trend report Check for dramatic changes in temperature sheath pressure or voltages If any of these situations are evident on the report Contact Technical Support Acquisition Problems Symptom Possible problem Solution Acquisition fails or slows PN 89 00002 00 071 Rev A The air pressure is out of range The sample probe is not vertically aligned The sample probe is clogged The sheath bottle has a leaky seal The sheath or waste lines are not fully connected The Calibration microspheres have expired See Pressurization on page 7 3 Adjust the sample probe height See page B 8 Clean the sample probe See page 6 4 Make sure that the sheath bottle lid is tightened Remove and replace the sheath bottle lid Check to make sure all tubes are tightly connected Replace old microspheres with a fresh lot Luminex 100 IS User Manual Version 2 3 The calibration lot number selected in setup is incorrect Target values for chosen calibration lot number are incorrect The wrong wells are selected in the Setup XY tab xMAP Technology Enter the
234. ottom half of the screen displays sample related errors The error is displayed as Test Name Sample ID and Errors See Figure 5 86 and Table 5 11 PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software Open Batch Export Data Print Report Close Test 1 TestHame SamplelD Sample Errors Test2 Patient 2 A2 Sample HighiLow H1 Sample HighiLow Customize Data Analysis Settings Customization Dialog Box PN 89 00002 00 071 Rev A Figure 5 86 Analysis Window Errors Tab You can customize how the sample data results are displayed in the analysis graph on the Standards tab There are two options that allow you to customize the display Use the Customization dialog box and the Graph Menu items some items are available on both You can define the general features of the graph axis settings and increments fonts colors and styles presented in the graph representing the sample data results You also can export the analysis to a graphic file clipboard and so on To modify the general features of the Standards tab graph 1 On the File menu click Data Analysis 2 Double click the desired batch The Analysis window opens displaying the Standards tab See Figure 5 76 3 Double click anywhere within the graph to display the Customization dialog box See Figure 5 87 Notice across the dialog box are five tabs General Axis Font Color
235. ox opens 4 Navigate to the desired drive s folder and select the lot that you want to import and click Open The lot imports into your template Update Lot Information Change the current lot by saving selected lot r Test Standards 2000 Current Lot B3654QtStd Current Lot EERIE _NewLot Delete Lot Exp Date 06 05 2003 Test 36 Import Export xk ac x Lot Lot Revert Save Cancel Test 54 r Test Controls 2000 Current Lot B3654QtCon Current Lot B36540tCon NewLot Delete Lot Exp Date03 07 2008 z Low Limit Expected Values High Limit Test 54 mg dL 405 Figure 5 70 Update Lot Information Dialog Box Export a Lot from Use this procedure to export a lot for use on another instrument an Existing Template PN 89 00002 00 071 Rev A xMAP Technology Note Depending on the template and its associated products you may have standards and controls or only standards Standards and controls can be grouped into the same lot number Replicates PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software To export a lot from an existing template 1 Onthe Home tab click New Lot The Open Template dialog box opens See Figure 5 66 2 Double click the template containing the lot to export The Update Lot Information dialog box opens See Figure 5 70 3 Click Export Lot A standard or control confirmation dialog bo
236. pecific Size Millimeters Points Cancel Width 5 177083 3 84375 Inches Figure 5 88 Exporting Dialog Box Maximize Click to maximize the graph to full screen Restore to original size by pressing Escape or by clicking in the title bar 5 102 PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software Customization dialog box tabs General Tab Use this tab to define general parameters See Figure 5 87 Main and Sub Titles These edit boxes allow you to add edit or delete these titles If no title is present you can enter one Delete all characters from a title to remove it Viewing Style The Graph supports three viewing styles Color Monochrome Monochrome with Symbols This customization allows you to quickly adjust the image to best suit printing on a monochrome printer If you include fewer than four subsets in a graph then the Monochrome setting will probably be the best choice If four or more subsets are included in the graph then Monochrome with Symbols will help distinguish the different subsets Font Size The Graph supports three font sizes Large Medium and Small When printing the graph a font size of Medium or Small is suggested On occasions the graph may automatically reduce the size of the font to produce a higher quality image Show Annotations Currently this feature is not used This check box allows you to remove or add the annotations from the image N
237. processing the batch s template commands It acquires the samples from the wells as the commands appear on the template The system takes the specified volume for testing A horizontal progression bar appears on the Run Batch tab to show the status of each sample acquisition After each sample is analyzed approximately 160 uL of sheath fluid is dispensed into each well As the system analyzes each well the well shows either a check mark in a green well for successful acquisitions or an X mark in a red well for failed acquisitions Samples may fail for many reasons PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 Pause Resume Cancel Command Cancel All xMAP Technology including lack of sufficient events Cancel command heater out of range or plate cancellation If Auto Start Acquisition is selected the system analyzes samples according to the kit manufacturer s template commands Once you start processing a batch you cannot reacquire data If you have used a batch for acquisition before the system will not display it in the open batch list The Pause command temporarily stops the acquisition process Some examples to pause the system are e the temperature goes out of the designated range during acquisition e to add sheath fluid e to add a new reagent to your sample group To pause a command On the Run Batch tab click Pause The system completes the current command in process and
238. provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and the receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help This system contains fluidics In the event of a fluid leak turn off all power to the system and disconnect all power cords Remember that the on off switch is not a disconnect means the power cord must be removed from the outlet Contact Luminex Corporation for further information PN 89 00002 00 071 Rev A xMAP Technology Luminex 100 Analyzer Laser PN 89 00002 00 071 Rev A Safety You must monitor waste levels manually Do not allow the waste container to overflow Empty the waste container each time the sheath fluid container is fi
239. r channel Luminex 100 IS User Manual Version 2 3 sample sample reaction signal standards microspheres assay suspension system controls template verification xMAP xMAP Technology The mixture of assay components microspheres reporter patient diluent that are analyzed The reaction that occurs between your reagents and the beads Detectable measurement unit of the reporter molecule Assay standards are substances of know concentrations used to derive a standard curve with which unknown samples and controls are compared to determine their concentration or quantity See control microspheres assay Solution consisting of homogeneously dispersed microspheres in an aqueous medium Include the xMAP reporter and classification control microspheres They are used to verify the calibration of the Luminex 100 analyzer A sequence of commands and predetermined settings defined by the kit manufacturer The process using system controls to ensure the analyzer is functioning properly with current calibration settings See Luminex xMAP microsphere set PN 89 00002 00 071 Rev A Luminex 100 IS System Installation Overview Luminex 100 IS System Setup PN 89 00002 00 071 Rev A This appendix provides hardware firmware and software installation procedures as required for new or system updates On new systems the factory preinstalls the latest versions of the firmware and software you perform only the h
240. r the required information and add batches to the Multi Batch list You may double click a batch for detailed information Note indicates a required field Ned Batch Batch 4 ES r Multi Batch Name By 4 L3 4 5 Lz 8 3 10 11 12 QOQQOQOQQOQQOO COCOCOO OO COO QQOOOOOO0O00O0 QOOOOOOO0O000 QQOOOOOO0O000O QQQOOOOOOO00O0 QQOOOOOO000O0 OQOQOOOO0O000000 No ID Batch Name Batch Description No Cmds el 7 mo ols Figure 5 46 Luminex Multi Batch Setup Dialog Box 3 Select the batch that you want to process first in the multi batch and click Select The batch appears beginning in well A1 of the microtiter plate on the Luminex Multi Batch Setup dialog box A thick red line appears above well A1 and another thick red line below the last well in the batch These lines separate this batch from subsequent batches that you add to the multi batch All wells in the batch are labeled with a 1 to denote it as the first batch in the multi batch Subsequent batches that are added to the multi batch will contain 2 3 and so on to show these locations in the multi batch Repeat steps 2 and 3 as often as you need to add all the batches you want in the multi batch To create a new batch to add to the multi batch click New Batch In the Open Template dialog box select the template that you want to use in your new batch and then click Select In the Luminex Batch
241. ram bar with the highest value Std Deviation Standard deviation from the mean SD Formula a IX x i n 1 Median The middle value in a list of ascending ordered values Mean Average of all values in the list Trimmed All trimmed statistics remove the lower and upper five percent of the extreme statistic values then used for the CV Count Mean Peak or StdDev 5 44 PN 89 00002 00 071 Rev A xMAP Technology Histogram and Gates Note You cannot change the gate position during batch acquisition You can change the gate positions before data acquisition after the system finishes acquiring data or after pausing the system However the change is visual The data is still collected according to the gate positions set in the assay template or New Advanced Batch set up Note The gate in effect when the system collects data determines which values to use to obtain the result Applying a gate or changing a gate for existing data does not change your calculated values The gate positions used while collecting data are the numerical values selected in the template or the New Advanced Batch also located in the lower corner of the histogram Histogram Buttons Show Bead Using Luminex 100 IS 2 3 Software This section provides an overview of the Histogram and Gates Details are provided in the Luminex 100 IS Developer Guide for xMAP Technology Version 2 3 The histogram appears in the lower le
242. re Patient 1 13 E2 Plate1 Acquire Patient 1 amp Name 14 F2 Plate1 Acquire Patient 1 Help B36 Repat Assay 15 G2 Plate1 Acquire Patient 1 a AUER Sa EMEN SERENE ail Description 1 12 z Replicate Simplex Quant Bo New Lot Standard Info irl Product No 3000 Product Name 36 Rep t Kit Version No Lot Name 36Repatstd 2327 Expiration Date 06 10 2005 M r Control Info Developing Co eGeeooooOoOoOOO Product No 3000 V Product Name 36 RepQt Kit LMNX 96O0O0O0OOO QOO Lot Name 36Rep tCon Expiration Date 06 10 2005 Figure 5 42 Entering Additional Samples 7 Enter the sample ID for the sample to add to the batch Repeat Note Batches may span this step to add all of the additional samples to the batch You more than one plate When the first plate d s Bla can enter the sample manually through a patient list or scanned line appears separating the in using the system barcode reader columns of the first plate with those of a second plate 8 To add a patient file to the batch click Load Patient List An Open Patient List File dialog box opens See Figure 5 43 If you do not want to add a patient list to the batch skip to step 11 pen Patient List File 2 x Look in fa Common ex E3 ExportedT emplates x IVD ConRepart ocx E IVDImplements dll E BrowseDB ocx x IVD CPReport ocx E IVDInterfaces ll History cbMsgbox ocx x IVD LVJTReport oc E IvDInterpGrap
243. red text for failed events See Figure 5 31 Luminex 100 IS User Manual Version 2 3 xMAP Technology System Monitor Property Value Property Value Air Pressure 7 803 Last CAL1 5 25 2002 10 47 19 AM Sheath Pressure 5 997 Last CAL2 5 25 2002 10 51 08 AM Delta Cal Temp 0 002 Last CON 5 25 2002 10 52 45 AM Board Temp 27431 Last CON2 5 25 2002 10 54 28 AM DD Temp 26 128 Total Events s 99 CL1 Temp 25 911 Gate Events s 91 CL2 Temp 25477 Rgn Events s 89 XYP Board Temp 37 413 TotalEvents 99 XYP Htr Temp 25 725 Gate Events 91 XYP Htr In Range N A Rgn Events 89 Figure 5 31 The System Monitor The system can diagnose real time system problems related to fluid input and output The system can also detect and report if the Luminex XYP heater block temperature is out of range or unacceptable temperature conditions including these items e Luminex XYP heater block temperature time out e heat circuit failure e temperature out of range sensing e temperature change since calibration or a change in channel temperature Table 5 4 defines the values listed in the System Monitor These values are useful for diagnostic purposes when communicating with Luminex Technical Support Table 5 4 System Monitor Values Property Value Units of Measure Air Pressure PSI air pressure to the sheath container from the air pump Sheath Pressure PSI sh
244. ressure builds remove and retighten the sheath fluid bottle cap then reconnect fluid lines to the analyzer If pressurization fails again replace the sheath bottle PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 Pressure too High Fluid Leaks Problem internal to the instrument The sheath bottle 1s overfilled Regulator not adjusted properly xMAP Technology Determine if the problem is with the analyzer or the SD or bottles by disconnecting the sheath line from the analyzer and running a prime Check the air pressure on the Diagnostic tab If air pressure builds the problem is with the SD or sheath fluid bottle Ensure that the sheath bottle is not filled above the fill line If using bottles open the center door on the Luminex analyzer Use a screwdriver to adjust the regulator to fit in the center of the green region on the Run Batch tab If you are using an SD see Appendix D of this manual Fluid leaks can result in poor pressurization and failed sample acquisition Symptom Possible problem Solution Pressure too low The sample probe is clogged The syringe seal leaks The syringe valve leaks Clean the sample probe See page 6 4 Replace the syringe seal See page 6 8 Hand tighten the syringe connection silver knob on the syringe valve Run a Prime command If leaks continue call Technical Support Large amount of fluid pooled around ins
245. rom being introduced into the Luminex 100 analyzer This may interrupt a sample and prevent further samples from being collected If the filter attached to the sheath intake line becomes clogged from extended use an alarm will sound even though the bulk sheath container is not empty If this happens contact Luminex Technical Support for a replacement filter If the alarm sounds even though the bulk sheath container has fluid and the sheath filter is in good condition the system is reporting a malfunction If this happens contact Luminex Technical Support If you need to ship the Luminex SD system back to Luminex Corporation drain the reservoir before you pack the system Call Technical Support for additional information PN 89 00002 00 071 Rev A xMAP Technology Verification PN 89 00002 00 071 Rev A Troubleshooting To verify your system from the Maintenance tab 1 2 10 11 12 13 14 Vortex xMAP reagent containers to ensure homogeneity Load a microtiter plate with CON1 CON2 and four wells with sheath fluid in the six desired wells Click Eject Retract The plate holder ejects Place the plate on the plate holder Fill the Luminex XYP reservoir with a solution of 70 isopropanol or 70 ethanol Click Eject Retract The plate holder retracts If you are using a new lot click New Control Targets from the Maintenance tab fill in the required information and click OK Click Prime
246. rt Menu Section To insert the Acquire Patient or Skip command 1 On the Home tab click New Batch Luminex 100 IS User Manual Version 2 3 Open a Batch Note You can open Saved Only batches using Open Batch xMAP Technology 2 In the Open Template dialog box select the desired template 3 The Luminex Batch Setup window opens with the Insert menu section at the top See Figure 5 44 and Figure 5 45 4 Click the drop down arrow and select the desired command 5 Inthe multiplier box enter the number of patients that you want to add to the list or the number of wells that you want to skip and click Apply 6 The Luminex Batch Setup dialog box reflects the new information Figure 5 45 shows that eight patients were added The Dilution Factor defaults to 1 Skipped wells and patient wells added to the batch are shown as green wells on the microtiter plate image The yellow wells indicate sample commands performed from a well that were locked into the batch from template commands Luminex Batch Setup Please establish the starting location for the batch and enter the appropriate patient information Note indicates a required field Insert Acquire Patient v X 1 Apply pesi TO No Location Command Sample ID Dil Factor Damen A 1 A1 Plate1 Acquire Standard Std M 1 vA Batch B 3 02 16
247. rts up it displays the End User License To continue click Accept Uncheck the Show Next Time checkbox to bypass this dialog box on the next startup If you click Decline the application closes Start up software The main screen of the IS software appears Verify software upgrade information From the Help menu click About the Software The About Luminex 100 IS Software dialog box opens Verify that the version number on your screen begins with 2 3 as shown in Figure B 16 The numbers after the 2 3 do not need to match those in Figure B 16 PN 89 00002 00 071 Rev A xMAP Technology Luminex 100 Version 1 7 with Windows 2000 to Luminex 100 IS Version 2 3 Archive My Sessions folder Remove Luminex LMAT Software Note During the LMAT software removal error dialog boxes may open They are of no consequence to the uninstall Just click OK or Yes in response and continue with the uninstall PN 89 00002 00 071 Rev A Luminex 100 IS 2 3 Software Installation About Luminex100 IS Software Luminex100 IS Software Version 2 3 147 Data acquisiton application for Luminex100 IS 1996 2004 Luminex Corporation All rights reserved Warning This computer program is protected by copyright law and international treaties Unauthorized reproduction or distribution of this program or any portion of it may result in severe criminal and civil penalties and will be prosecuted to the maximum extent possible und
248. ry 1 Inthe Cleanup Utility dialog box click Delete MsgLog Directory See Figure 5 107 2 Inthe Cleanup Utility confirmation dialog box click Yes to delete the Message Log See Figure 5 111 Luminex100 IS Software Cleanup Utility 9 You are about to delete all message log files in CAProgram FilesiLuminexiLuminex 100 IS MessageLog Are you sure Figure 5 111 Cleanup Utility Confirmation Dialog Box To delete the batch folders 1 Inthe Cleanup Utility dialog box click Delete Batch Directory See Figure 5 107 2 Inthe Cleanup Utility confirmation box click Yes to delete all the batch folders See Figure 5 112 All the folders under C My Batches are deleted The C My Batches folder remains Luminex100 IS Software Cleanup Utility Q You are about to delete all batch folders in CAMy Batches Are you sure men Figure 5 112 Cleanup Utility Confirmation Dialog Box The system has an array of help files regarding various Luminex 100 IS features and capabilities You may find these topics by searching the contents of books and topics or by searching an alphabetic listing of the topics and books Topics provide information and details regarding software features system capabilities and any number of related material 5 117 Luminex 100 IS User Manual Version 2 3 xMAP Technology Book Books usually contain a group of topics These topics are grouped together because they discuss similar or related t
249. s that are processed using a selected template Shorthand terminology for an xMAP microsphere A process used to normalize the settings for the reporter channel both classification channels and the doublet discriminator channel for the Luminex 100 IS Calibration ensures optimal and consistent microsphere classifications and reporter readings xMAP microspheres used to normalize the settings for the reporter channel both classification channels and the doublet discriminator channel for the Luminex 100 IS Luminex 100 IS User Manual Version 2 3 CL1 CL2 classification channel control microspheres assay control microspheres system cuvette data reduction delta cal temperature DD temperature emission spectrum event excitation spectrum fluorescence fluorochrome fluorophore immunofluorescence xMAP Technology Refers to dyes embedded in the microsphere Also see classification channel Refers to dyes embedded in the microsphere Also see classification channel A specific range of wavelengths in which light intensity is measured Includes the emission of a given classification dye Classification channels are abbreviated as CL1 and CL2 Used to verify standards within the kit Tells you that the curve or thresholds are correct xMAP microspheres used to verify the calibration and optical integrity for the Luminex 100 analyzer Principal fluid pathway within the optics component of the system
250. ssible components of each subsystem Electronics Power Input The power input modules contain the on off switch and fuses Module Communications The communications port connects the Luminex 100 analyzer or the Ports SB9 PIN Luminex XYP instrument to the computer and the Luminex SD system to the Luminex 100 analyzer Luminex 100 Located on the bottom of the Luminex 100 analyzer the filter must Analyzer be checked and cleaned as necessary For proper ventilation do not Ventilation Filler obstruct the area below and allow at least two inches 5 cm of clearance around the Luminex 100 analyzer Luminex XYP The XYP instrument ventilation filter cleans the air that cools the Instrument internal parts of the Luminex XYP instrument See Figure 3 1 Ventilation Filter 1 4 5 6 7 1 Air intake filter access door 5 Communication Ports DB9 2 Power Switch 6 XYP Communication Port DB9 3 Power Input Module 7 Analyzer ventilation filter on bottom of analyzer 4 XYP ventilation Filter Figure 3 1 Back of the Luminex 100 Analyzer and Luminex XYP Instrument 3 8 PN 89 00002 00 071 Rev A xMAP Technology Fluidics Sample Arm Luminex XYP Instrument Sample Probe Cheminert Fitting PN 89 00002 00 071 Rev A The System The sample arm transports the sample from the sample tube to the cuvette The carriage drops to the microtiter well for sample retrieval A Stainless steel sample probe acquires the sample A sh
251. st e At the Run Batch tab the microtiter plate image e At the Diagnostic tab you can copy the Message Log To copy information from the current batch 1 Click over the desired area to copy 2 Press the Ctrl C keys on the keyboard or right click and select Copy from the menu 3 Atthe Command Information dialog box click OK The information is copied to the clipboard If you copy the microtiter plate image or Command List areas on the Run Batch tab the Command Information dialog box does not appear To paste information from the current batch into a document 1 Open the document where you want to paste the information Click the cursor at the insertion point in the document 2 Press the Ctrl V keys on the keyboard or right click in the document and select Paste from the drop down command list The copied information appears at the insertion point in the document The Clear Batch command clears the entire batch from the Run Batch tab or the Message Log on the Diagnostic tab To clear a batch from the system 1 Right click on the area to clear 2 Click Clear in the dialog box 3 Click Yes to confirm that you want to clear the batch Use New Advanced Batch to acquire data without creating a template It writes raw data results to a simple csv file format You can define parameters for samples gates regions events on plate and off late commands This feature does not store the results in the Luminex 100
252. stablish the offplate commands to run after well C1 Cmd Name OK Warmup 1 Reservoir Wash Prime Backflush Sanitize R Acquire Data CALI C1 CAL2 c2 CON1 N1 CON2 N2 Wash wW Drain D Soak S Cancel Clear All EU Reservoir Soak Self Test OK Cancel Figure 5 60 Plate Layout Tab Off Plate Commands Clear preliminary off plate commands To clear preliminary off plate commands right click on the corner marker or plate layout and select Clear Off Plate Cmd s See Figure 5 61 1 i Preliminary Off Plate Cmd s E X Clear Off Plate Cmd s mvavavavave 1 Corner marker Figure 5 61 Preliminary Off Plate Command Marker 12 Establish insert off plate commands You can establish insert off plate commands that run after a single well after a range of wells or after rows or columns of wells The prompt sentence displayed should be appropriate for your selection For example if you select row B the prompt Establish the off plate commandis to run after wells B1 through B12 appears To establish insert off plate commands select the desired wells then right click over the plate layout Select Insert Off Plate Cmd s from the menu Select the desired commands and click OK The background of the established wells turn green Clear insert off plate commands To clear insert off plate commands select the wells to clear right click over the plate layout and s
253. t Template Dialog Box 3 Click the Look in drop down arrow and navigate to the diskette or CD drive containing the template The diskette drive is typically drive A and the CD drive is typically drive D 4 The kit manufacturer s template appears on the selection list Click the name of the template 5 Click Open to load the template You can edit standard and control lot information Once a lot is used changing or modifying it will prompt you for a new lot name This includes batches that have been setup but not yet acquired You can modify known lot concentration values If you change the known concentration for a used lot the system prompts you to enter a new lot name If you change the lot concentration values for an unused lot the system updates the lot with the new lot concentration values PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software Once you import a template you must enter lot information for the standard and control reagents as specified in the template This lot information is used for every batch setup using this template until changed For assay reagents specified in templates the system allows you to create new lots edit lot information select pre existing lots for reuse or import and export lots When editing lot numbers follow these lot handling rules If you have entered lot information for a template but you have not used the template to setup a batch then you can e
254. t corner or click Cancel 5 34 PN 89 00002 00 071 Rev A xMAP Technology Select Existing Lots for Reuse Import System Calibration or Control Lots Export System Calibration or Control Lots PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software You can select existing previously used lots for reuse 1 4 1 To select an existing previously used lot On the Maintenance tab click New CAL Targ or New CON Targ Select a lot using the arrows located to the right of the Import and Export buttons in the Update CAL Targets and Update CON Targets dialog boxes Review the lot information and press OK to select the calibration lot To import system CAL or CON lots On the Maintenance tab click New CAL Targets or New CON Targets as appropriate An Update CAL Targets or Update CON Targets dialog box opens Click Import CAL or Import CON as appropriate The Open dialog box opens To select the calibration lot or control lot to import click the drop down arrow for the Look in box Browse for the appropriate folder diskette or CD location After you select the location the available lots display in the selection list Click the name of the lot to import and click Open The lot name appears the product information box The lot and target information is displayed on the Update dialog box Click OK to complete the operation To export system CAL or CON lots On the Maintenance tab click
255. t results labeled as AVG The system acquires samples based on various plate commands The plate commands are Start Plate Pause e Resume Cancel Command PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software Cancel AII e Eject Retract You can perform plate commands during sample acquisition You can perform nonplate commands Prime Reservoir Wash Sanitize between samples Start Plate The Start Plate command begins the acquisition process During acquisition the system draws sample from the microtiter plate for processing As the system processes data the system analyzes whether the sample passes predetermined criteria or not If a sample fails the system flags that sample and acquisition continues on to the next sample To start acquiring sample from a microtiter plate 1 Check the sample probe vertical height adjustment and adjust if needed Refer to Appendix B for sample probe adjustment procedure Create or open the batch that you want to process Refer to Create a New Batch on page 5 50 or Open a Batch on page 5 54 for directions Prepare the microtiter plate with samples for processing Click Eject Retract Place the microtiter plate on the plate holder with well A1 in the upper left corner Ensure that you carefully follow the kit manufacturer s directions On the Run Batch tab click Start Plate The system retracts the plate and begins
256. te1 Acquire Patient 3 Ld Nam B2 Plate1 Acquire Patient 1 eee r Template Info e Name Help fQuantitativeT 5 Description E Save and Load Quantitative 5 Stadards 1 B New Lot Control Save only r Standard Info Expired Iri Product No 1 Product Name Product Version No Lot Name A123456 Raw Expiration Date 05 30 2002 r Control Info Expired Developing Co Product No 1 Product Name Product fluminex Lot Name A123457 Expiration Date 05 30 2002 Figure 5 55 Luminex Batch Setup for Dilution 4 To change the dilution factor click the Dil Factor box The white background indicates that you can enter text Enter each dilution factor as a decimal not as a ratio 5 Click Finish The system saves the information you entered PN 89 00002 00 071 Rev A xMAP Technology Copy Batch Information to Clipboard Note The system does not allow you to copy or paste information while interpreting or analyzing data Paste Batch Information to a Document Clear a Batch From the System Note Once you choose to clear the batch and verify that you want to continue with the command you can regain the cleared batch if it has not been run by clicking Open Batch Create a New Advanced Batch PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software You can copy the following information to the clipboard At the Run Batch tab the four columns in the batch command li
257. tests defined and the batch had counts of 100 102 and 105 for the tests then the total count would be 307 even though more events may have been detected that did not fall within the DD gate or Notes Sample notes PN 89 00002 00 071 Rev A xMAP Technology Luminex 100 IS OUTPUT CSV file with no additional features enabled Program Luminex 100 IS 409 Build 2 3 BETA Date 7 28 2004 2 12 01 PM SN LX10001298011BE Session Bead 22 Quant Batch Operator Joe User Samples 8 Min Events 0 Results DataType Median Location Sample Test 22 Total Events Notes 1 Std S 57 75 2 Std m 525 75 3 Std l 4341 75m A Std xI 1 431 6 75 5 Std xxl 25694 75 6 Low Control 58 75 7 Patient 1 532 75 8 Patient pu 4567 75 DataType Result Location Sample Test 22 Total Events Notes 1 Std s 2 99 pg mL 75 2 Std m 5 79 pg mL 75 3 Std I 126 71 pg mL 75 A Std xl 61 6 93 pg mL 75 5 Std xxl 31 94 84 pg mL 75 6 Low Control 3 02 pg mL 75 7 Patient 1 1 5 98 pg mL 75 8 Patient 2 636 38 pg mL 75 DataType Count Location Sample Test 22 Total Events Notes
258. then pauses the system The Resume command continues an interrupted acquisition process To resume a batch On the Run Batch tab click Resume The system resumes processing the command list from where it was paused The Cancel Command button cancels the current command in progress You cannot cancel the Warmup command Tocancel a command On the Run Batch tab click Cancel Cmd The Cancel All command cancels the entire batch To cancel an acquisition once it has begun On the Run Batch tab click Cancel All The current series of commands or batch acquisition is cancelled PN 89 00002 00 071 Rev A xMAP Technology Note To recover an incomplete batch click Open Incomplete Batch on the File menu In the Open Run dialog box click Start to continue where the batch left off Eject Retract Analyze Batches and Multi Batches PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software Upon cancelling the system stops its activity regardless of its status The system highlights the well in yellow indicating the ending acquisition process The Eject Retract command ejects or retracts the microtiter plate from its current position To eject or retract the microtiter plate On the Run Batch tab click Eject Retract You can analyze an acquired batch using the analysis features of Qualitative and Quantitative algorithms The algorithm is determined by the kit manufacturer during template cr
259. this feature is not used Table Foreground This is the color used in bounding the table s rectangle and for the text inside the table Currently this feature is not used Test 36 Customization x General Axis Font Color Style r Graph Attributes Desk Background a LJ a O L L n LEN C Graph Foreground Graph Background Table Foreground C Table Background Cancel Apply Original Export Maximize Figure 5 91 Customization Dialog Box Color Tab Style Tab use the Style tab for control of subset color subset line type and subset point type See Figure 5 92 To edit the Style tab 1 Select the desired subset in the Subsets list box The corresponding color and possible line and point types are then highlighted in their respective controls 2 To change the color use the mouse to click an alternate color or use the keyboard arrow keys to move to adjacent colors Adjust the subset line and point types as desired 3 Click OK to update the graph s image 5 105 Luminex 100 IS User Manual Version 2 3 xMAP Technology x General Anis Font Color Style Subset 2 BHs EBBNU Point Type e crm Circle Line Type Cancel Original Esport Maximize Figure 5 92 Customization Dialog Box Style Tab Graph Menu Most of these menu items provide a shortcut for many of the features provided in the Customi
260. tically disabled when processing a multi batch To automatically begin analysis upon completing sample acquisition 1 Onthe Tools menu click Options and then click on the General tab See Figure 5 73 Luminex100 15 Software Option ic xl General Company Information Data Export Default Batch Directory CAMy Batches ERI Current User Analysis Display Digits 2 Iv Display Confirmation Screens I Enable Raw Data Storage F Report Raw Fluorescence I Auto start Analysis Feri Figure 5 73 Options Dialog Box Select Auto start Analysis 2 Onthe General tab click the Auto Start Analysis checkbox then click OK When the system completes the batch acquisition it will automatically begin analyzing data You can analyze only processed batches If you acquire or process batches as a multi batch the system lists them separately and they must be analyzed separately and manually by the user All batches within a multi batch have the multi batch name listed under the multi batch ID name column This allows you to see the batches that have been processed as a multi batch To analyze data from processed batches and multi batches 1 Onthe Home tab click Analysis The Open Batch dialog box opens showing only processed batches PN 89 00002 00 071 Rev A Luminex 100 IS User Manual Version 2 3 Print Data Analysis Report xMAP Technology 2 Selecta batch to analyze and click Select The syste
261. trument Fittings or fluid lines are damaged Call Technical Support Fluid dripping from the sample probe The sample probe is clogged The sample three way valve is faulty Clean the sample probe See page 6 4 Contact Technical Support PN 89 00002 00 071 Rev A xMAP Technology Fluid is leaking from the front of the analyzer The syringe seal leaks The syringe valve leaks Troubleshooting Replace the syringe seal See page 6 8 Hand tighten the syringe connection silver knob to the white syringe valve Run a Prime If leaks continue contact Technical Support Sample Probe Problems with the sample probe can lead to fluid leaks and pressurization problems as well as inhibit sample acquisition Symptom Possible problem Solution Sample probe leak Sample arm is stuck in the up position The sample probe is clogged The system isn t properly pressurized Clean the sample probe See page 6 4 Ensure that the sample probe is not clogged and there are no leaks in the syringe seal or syringe valve PN 89 00002 00 071 Rev A xMAP Technology Luminex 100 IS User Manual Version 2 3 Sample arm stuck in the down position The sample probe height is too low or the path to the well is blocked DO NOT turn off the Luminex XYP instrument 1 Remove the blue light housing from the Luminex 100 2 Unscrew the tubing connector that connects the sampl
262. uid Washing takes about 30 seconds Luminex recommends that you wash after calibration and verification between batches and multi batches after sanitize and before daily shutdown To wash the system 1 2 On the Maintenance tab click Eject Retract Put the wash solution into the reservoir or into a well on a microtiter plate Click Wash A confirmation dialog box opens If you put the wash solution somewhere other than the default location click the down arrow on the far right of the dialog box to select the location of the wash solution A microtiter plate and reservoir image opens as shown in Figure 5 20 Click on the location in the image PN 89 00002 00 071 Rev A xMAP Technology Drain Command Note Ensure that the location you select to expel fluid has the reserve capacity to hold the volume expelled PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software A9 amp 10 amp 11 88 B9 Bid Bri cg C1Q C11 D9 Did D11 8 E9 E10 1 Fa F10 F11 68 69 610 611 Ha fag fi Figure 5 20 Microtiter Plate and Reservoir Image 5 Click OK The command list on the Run Batch tab indicates that the system is running The Device Activity box on the Status Bar indicates that the system is washing 6 Wait for the wash to complete Upon completion the command list indicates whether the command succeeded with green text or the command failed with red text Use the Drain c
263. uisition and analysis as the system collects data from the sample The tab presents the information in different formats including a session detail table histogram and dot plot display The Menu Bar on the Luminex 100 IS Main window has three menus File Tools and Help See Figure 5 3 Many of the menu items repeat on other toolbars and in dialog boxes Their use is described throughout the chapter 1 2 3 I Import Template Ciri T es r Contents Wil New Batch XEM 8 Disconnect About the Device n Batch Chio a o Ts Database Backup 2 About the Software WA Delete Batch IE 3 Edit Patient List GT Database Restore Open Incomplete Batch F Erase Database B Batch Comment Update CAL Targets qp New Mutt Batch Update CON Targets 4 Open Multi Batch Ctr M A New Assay Lot Bl vata Anaysis F8 Z Opt ions at Export Batch Data F3 AC Prot Roport Cte Smp Ext 1 File Menu 2 Tools Menu 3 Help Menu Figure 5 3 Menu Bar Menus Set up and customize the system software and enter your company information in the Options dialog box You can change or update this information as often as you like The Software Options dialog box has three tabs the General tab the Company Information tab and the Data Export tab See Figure 5 4 You define the following options on the General tab Default Batch Directory Select the default directory where you store batch information Click the browse button and navigate to the desired
264. ument Run 3 backflushes 3 drains 2 alcohol flushes and 3 washes with distilled water Danger Be sure that the system is not performing an operation when you remove the sample probe Caution The Luminex XYP instrument sample probe should slide up easily while removing it from the sample arm If you feel resistance do not force the probe up Contact Luminex Technical Support To clean the sample probe 1 Remove the sample probe as follows First unsnap the light housing located above the probe Then unscrew the Cheminert fitting on top of the probe completely Next gently grasp the probe and push up Remove the probe out of the top of the sample arm PN 89 00002 00 071 Rev A xMAP Technology Maintenance and Cleaning 2 Clean the sample probe using a bath sonicator or using a 10 mL syringe If you are using a bath sonicator place the smaller end of the sample probe in the bath sonicator for 2 to 5 minutes If you are using a syringe force 10 to 20 bleach through the larger end of the sample probe 3 Replace the sample probe and adjust the vertical height You should adjust the vertical height anytime the probe is removed 4 Alcohol Flush the system with 70 isopropanol or 70 ethanol Clean Exterior Surfaces To clean exterior surfaces follow these steps 1 Disconnect the system from ac power by turning off the power switches and unplugging the Luminex 100 analyzer the Luminex XYP instrument and the
265. umeric Precision When exporting text and data from the Export Dialog you can define the number of decimal positions at 0 1 2 or 3 Grid Lines The Graph can contain vertical grid lines horizontal grid lines both vertical and horizontal grid lines or no grid lines Select the appropriate radio button Grid in front of data Check this option to place the grid in front of the data graphics Otherwise the data graphics are drawn on top of the grid Axis Tab Use the Axis tab to change your X axis and Y axis values and specify whether to display them as linear or log See Figure 5 89 PN 89 00002 00 071 Rev A 5 103 Luminex 100 IS User Manual Version 2 3 xMAP Technology Note If you select Log use Auto or ensure that the Min value is greater that zero Test 36 Customization x General Axis Font Color Style j g C Auto C Min C Max Min Max Min 904 078 Max fi 2506 6 X Axis Linear Log C Auto C Min C Max Min Max Min 5B 77 Max 420 Cancel Apply Original Export Maximize Figure 5 89 Customization Dialog Box Axis Tab Font Tab Use the Font tab to change the appearance of the fonts that appear in the Main Title Sub Title and Subset Point Axis Label boxes The bottom the of the dialog box displays a sample of the font as you select it See Figure 5 90 Test 36 Customization J x General Axis Font Color Style Main T
266. use 2 ULiseG c zarast 39m Figure 2 1 Fuse Caution Label PN 89 00002 00 071 Rev A xMAP Technology PN 89 00002 00 071 Rev A Safety Do not perform any maintenance or cleaning of the system s electrical components with the exception of replacing fuses This label appears on the back panel of the Luminex 100 analyzer and on the back panel of the Luminex XYP instrument Ce 1 ee MCS 800 748 0241 CE D Figure 2 2 CE Label The Luminex 100 analyzer and the Luminex XYP instrument comply with European Union EU safety requirements and therefore may be marketed in the Europe Single Market This voltage label appears on the back of the Luminex 100 analyzer Model No o Luminex 09 S N LX10003101301 Luminex Corporation Laboratory 12212 Technology Blvd Austin Texas 78727 Manufactured in USA e US LISTED April 2003 69uF 100 120V 200 240 1 4A 47 63 Hz Figure 2 3 Luminex 100 Serial Number Label The Luminex 100 analyzer has been tested by Underwriter Laboratories Inc UL Luminex 100 IS User Manual Version 2 3 FCC Label Fluidics xMAP Technology The following label appears on the back of the Luminex XYP instrument Figure 2 4 Luminex XYP Serial Number Label The Luminex XYP instrument has been tested by UL This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to
267. ute to complete The Command List on the Run Batch tab indicates that Self Diagnostics is running The Status Bar indicates that the system is self diagnosing Upon completion the command list indicates whether the command succeeded with green text or command failed with red text Luminex 100 IS User Manual Version 2 3 View Self Diagnostic Details Calibration and Verification Run System xMAP Calibrators Note Lasers must be in the warmed up state to calibrate xMAP Technology If the self diagnosis fails you can obtain detailed information regarding the results of the self diagnostic test See the following View Self Diagnostic Details section To view details of the self diagnostics test that passed or failed 1 Click on the Diagnostics tab and view the Message log At least one error from a failed self diagnostics test appears with a yellow background 2 Double click the yellow row to see a detailed description An Errors dialog box opens showing a list of passed and failed self diagnostic tests Click OK to close this dialog box See the Troubleshooting chapter in this manual for additional information about the self diagnostic failure Calibrator xMAP microspheres are used to normalize the settings for the reporter channel both classification channels and the doublet discriminator channel Control xMAP microspheres are used to verify the calibration and optical integrity for the system Calibrate
268. utput Dir I Prompt for Batch Comment I Write Sample Comments r Additional Export Stats Template a I Mean F Trimmed CV eame I 96CV I Trimmed Peak I e Lm M Peak F Trimmed Std Dev T Std Dev Avg Results I Trimmed Count I Trimmed Mean Sample Timeout Test Sort Order Export Location Label Style 3 Alphabetical by Test Name Sequential 1 23 C Sequential by Region ID C Plate Location A1 B1 C1 C Template Setup Order C Both 1 A1 2 B1 3 C1 rjr Figure 5 6 Options Dialog Box Data Export Tab Toolbar Figure 5 7 shows the Luminex 100 IS Main window toolbar 1 Import Templates 8 Print Report 2 New Batch 9 Connect to the Instrument 3 Open Batch 10 Disconnect from the Instrument 4 Create New Multi Batch 11 Eject Retract 5 Open Multi Batch 12 Open Help Files 6 Start Analysis 13 Single Step 7 Export Batch Data Figure 5 7 Luminex 100 IS System Toolbar The operation of these toolbar commands is described later in this chapter PN 89 00002 00 071 Rev A 5 7 Luminex 100 IS User Manual Version 2 3 Single Step Status Bar State Category Command xMAP Technology Select the Single Step option on the toolbar to pause the system in between each command or sample acquisition within a batch If you enable the single step option the system pauses between every command or a
269. vailable empty Location well Once you open a batch for processing you cannot change the location where data acquisition begins To establish where to begin acquiring data on the microtiter plate during batch creation 1 From the microtiter plate representation in the Luminex Batch Setup dialog box click the first well for sample acquisition 2 Drag the highlighted well to the desired start location on the microtiter plate The display updates to show the wells new location Empty wells in front of the new starting well now appear red When you process this batch the system starts acquiring data in the well indicated Change Start You can change the location for multi batches to begin acquiring Acquiring Data data Location in Multi oe m Batches To change the locations for beginning acquisition for batches in a multi batch On the toolbar click Create New Batch or Create New Multi Batch The Luminex Multi Batch Setup dialog box opens Refer to Create a New Batch on page 5 50 or Create a Multi Batch on page 5 55 for more information 5 64 PN 89 00002 00 071 Rev A xMAP Technology Using Luminex 100 IS 2 3 Software 2 From the microtiter plate representation in the Luminex Batch Setup or Luminex Multi Batch Setup dialog box click the first well for sample acquisition See Figure 5 54 Vif Luminex Multi Batch Setup zl xj Please enter the required information and add batches to the Multi Batch
270. verify the system If this message still appears after calibration contact Technical Support Failed Control in Batch PN 89 00002 00 071 Rev A One or more of the assay controls are not within the expected range Verify that you selected the correct template Verify that the correct assay lot number and concentration values were selected and entered correctly Luminex 100 IS User Manual Version 2 3 xMAP Technology Verify that the system is functioning properly by running the system controls If the system controls pass contact the kit manufacturer Failed Curve Fit The calculation could not occur for the assay standards for data interpretation Verify that you selected the correct template Verify that the correct control lot number and target values were selected and entered correctly Verify that the system is functioning properly by running the system controls If the system controls pass contact the kit manufacturer Sample High or Low The results do not fall within the highest and lowest standards The wrong control lot number or target values are selected Verify that you selected the correct template Verify that the correct control lot number and target values were selected and entered correctly Verify that the system is functioning properly by running the system controls If the sample is noted as High dilute the sample following the kit manufacturer s suggestions If
271. wave CW Classification laser 635 nm 9 1 mW x 696 maximum output 25 mW diode mode of operation continuous wave CW Reporter detector Photomultiplier tube detection bandwidth of 565 585 nm Classification detector Avalanche photo diodes with temperature compensation Doublet discrimination detector Avalanche photo diodes with temperature compensation Sheath flow rate 90 uL 5 uL second Cuvette 200 micron square flow channel Sample injection rate 1 uL second Sample uptake volume 20 200 pL Luminex 100 IS User Manual Version 2 3 Electronics Luminex XYP Instrument General Luminex SD System General PC Specifications xMAP Technology Reporter channel detection A D resolution 14 bits Communications interface USB Luminex XYP instrument communications interface RS 232 Ambient temperature 15 C to 30 C 59 F to 86 F Humidity 20 to 8096 noncondensing Altitude operation up to 2400 m 7874 ft above mean sea level Physical dimensions 44 cm 17 25 inches W x 60 cm 23 5 inches D x 8 cm 3 inches H Weight 15 kg 33 Ibs UL installation category UL Installation Category II as defined in Annex J of UL 61010A 1 Pollution degree UL Pollution Degree 2 as defined in Section 3 7 3 2 of UL 61010A 1 Heater operating range 35 C to 55 C 95 F to 131 F with tolerance 0 C to 2 C Input voltage range 100 240 V 10 1 8 Amps 47 63 Hz AC inlet fuse 3 A 250 V fast acting Ambient te
272. when the Wash cycle is complete The Run Batch tab indicates if the command succeeded or failed upon completion 16 Run four WASH commands PN 89 00002 00 071 Rev A Product Numbers Hardware Note These part numbers are subject to change without notice Note Common description of product is enclosed in brackets PN 89 00002 00 071 Rev A Product Description Customer Number Rear Air Filter CN 0001 01 Bottom Air Filter CN 0002 01 Air Filter Intake CN 0027 01 Alignment guide XYP instrument CN 0016 01 Bar Code Scanner CN PCO03 01 Serial Cable 5 feet CN 0005 01 PC Luminex 100 IS CN PC04 01 2 Amp 250 Volts Fast Acting Fuse Qty 10 CN 0019 01 3 Amp 250 Volts Fast Acting Fuse CN 0051 01 Heater Block XYP CN 0017 01 Wrench Hexdrive Ball Driver CN 0025 01 3 32 Luminex 100 IS Version 2 3 complete CN LO05 01 system Luminex 100 IS Version 2 3 complete CN L007 01 system with laptop Luminex 100 IS User Manual Version 2 3 xMAP Technology Luminex 100 IS Documentation Version 2 3 CN M032 01 Manuals on CD Luminex 100 IS User Manual Version 2 3 CN MO01 7 01 North American Luminex 100 IS User Manual Version 2 3 CN M018 01 International English Luminex 100 IS User Manual Version 2 3 CN M031 01 Danish Luminex 100 IS User Manual Version 2 3 CN MO01 9 01 French Luminex 100 IS User Manual
273. ws dialog box press Ctrl Alt Delete b In the Log On to Windows dialog box enter Administrator in the User Name box In the Password box enter the Administrator password If you do not know it see your IT representative or contact Luminex Technical Support In the Log on to box select the name of your local machine from the scroll list c Click OK to complete the log on procedure d Verify that all applications are closed Insert the Luminex 100 IS 2 3 software CD into the drive The CD autoplays and in a few moments displays the Luminex 100 IS 2 3 splash screen See Figure B 15 Luminex 100 IS User Manual Version 2 3 Note If the system displays a blank screen after it has rebooted press Alt Tab on the keyboard to display the software on the monitor Verify Successful Upgrade xMAP Technology Luminex100 IS 2 3 Luminex 1996 2004 Luminex Corporation All rights reserved Figure B 15 Luminex 100 IS 2 3 Startup Splash Screen At the Luminex 100 IS Setup Welcome dialog box click Next to continue At the Luminex 100 IS Setup License Agreement dialog box read the End User License Agreement EULA Use the scroll bar to display all the text Click Yes to continue At the Luminex 100 IS Setup InstallShield Complete dialog box remove any floppy disks from their drives and click Finish The system restarts Windows and auto starts the Luminex 100 IS software The first time Luminex 100 IS sta
274. x XYP instrument plate holder ejects 2 Click Eject Retract The Luminex XYP instrument plate holder retracts Manually raise or lower the sample probe to adjust the probe height This adjustment is recommended when using different microtiter plates or when changing sample probes See Adjust the Sample Probe Vertical Height on page B 8 for the adjusting procedure To lower the sample probe 1 On the Maintenance tab click the down arrow next to the Sample Probe Down button to select a well location 2 Click Sample Probe Down Red text appears above the Eject button in the XYP commands section warning you to raise the sample probe after the sample probe adjustment is complete 3 Click Sample Probe Up The sample probe raises back up to the ready position PN 89 00002 00 071 Rev A xMAP Technology Diagnostics Tab System Monitor PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software Use the Diagnostics tab to monitor the progress of commands you initiate within the system See Figure 5 30 Features on the tab also monitor specific details regarding each sample analysis and the state of system components The tab displays the System Monitor Message Log and Detailed Sample Progress chart PaE Luminex Luminex100 Integrated System 2 3 Detailed Sample Progress 123 Value 06 06 2002 4 42 43 PM M 106 0072002 GOD M 08 08 2002 4 4542 FM 06 06 2002 4 46 45 PM
275. x opens verifying that you want to export the current lot for the standard or control See Figure 5 71 LxrLotUpdate x would you like to Export the current lot For this Standard LxrLotUpdate xj would you like to Export the current lot For this Control Figure 5 71 Export Confirmation Dialog Box If you want to export the lot information for the standards click Yes If you only want to export the lot controls click No A second dialog box opens to verify if you want to export the current lot as a control After responding to the confirmation dialog boxes regarding standards or controls a Save As dialog box opens 4 Click the drop down arrow to select the Save in location where you want to save the lot information 5 Enter the lot file name into the appropriate box 6 Click Save The system saves the lot You can run any sample in replicate including standards controls backgrounds and unknowns Use this feature to run a single substance an unlimited number of times minimizing well to well handling errors thereby recovering a more accurate value for that substance Replicate samples are defined by their Sample ID Samples with identical Sample ID s are analyzed as replicates Luminex 100 IS User Manual Version 2 3 Generate a Standard Curve Plate Commands xMAP Technology For standards controls and background samples the kit manufacturer defines the number of replicates in the Template Setup
276. x XYP instrument plate holder The following microtiter PN 89 00002 00 071 Rev A xMAP Technology Luminex 100 Analyzer General Optics Fluidics PN 89 00002 00 071 Rev A The System plate types are compatible with the Luminex XYP instrument plate holder flatbottom conical round filter bottom half plates overall height no more than 0 75 19 mm any color Microtiter plates with 96 wells must be compatible with Luminex XYP instrument heater block temperature from 35 C to 55 C 95 F to 131 F when performing heated assays and using the heater block Indoor use only Operating temperature 15 C to 30 C 59 F to 86 F Humidity 20 to 80 noncondensing Altitude Operation up to 2400 m 7874 ft above mean sea level Physical dimensions 43 cm 17 inches W x 50 5 cm 20 inches D x 24 5 cm 9 5 inches H Weight maximum of 25 kg 60 Ibs UL installation category UL Installation Category II as defined in Annex J of UL 61010A 1 Pollution degree UL Pollution Degree 2 as defined in Section 3 7 3 2 of UL 61010A 1 Shipping and storage The allowable shipping and storage temperature and humidity ranges are 0 C to 50 C and 20 80 noncondensing respectively Input voltage range 100 120 V and 200 240 V 10 1 4 Amp 47 63 Hz AC inlet fuse 3 Amp 250 V fast acting Reporter laser 532 nm nominal output 10 16 5 mW maximum 500 mW frequency doubled diode mode of operation continuous
277. x website at http luminexcorp custhelp com 12 Enter the CAL2 lot number and expiration date as well as the values listed in the Certificate of Quality then click OK 13 Ensure that the Luminex 100 analyzer is set to draw the CAL1 and CAL2 beads from the wells you loaded in step 2 14 In the Maintenance tab click CALI then click OK The device status section in the status bar changes from Running to Standby 15 Click CAL2 then click OK Wait until CAL2 completes The Device Status section in the status bar changes from Running to Standby and the Diagnostics tab turns red The System Monitor on the Diagnostics tab displays the date and time in green if CAL1 and CAL2 are successful PN 89 00002 00 071 Rev A xMAP Technology Run System xMAP Controls PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software You must run system controls following calibration Continue with the following Run System xMAP Controls section To calibrate your system with controls 1 In the Maintenance tab click New CON Targ The Update CON Target Information dialog box opens See Figure 5 24 2 Enter the CONI lot number expiration date and the values listed from the Certificate of Quality included with your system controls into the CONI entry boxes The target value information is on the Luminex website at http Iuminexcorp custhelp com 3 Enter the CON2 lot number expiration date and the values listed from th
278. y by Sample ID Figure 5 74 Analysis Window Standards Tab Data Reduction Four buttons appear in the upper right corner of the Analysis window Open Batch Opens an existing batch that you want to analyze Export Data Exports the data to the output csv file in the batch folder After selecting this button there is no confirmation response Print Report Prints the data interpretation report including the Standards Controls graph of standards and Samples data See Print Data Analysis Report on page 5 88 Close Closes the Analysis window A printed batch report includes the following criteria that is applied to the batch during analysis e batch name and test name formula used e curve fit e standards e controls PN 89 00002 00 071 Rev A xMAP Technology PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software samples graph this is the only way to print a graph of standards To print data analysis reports On the Home tab click Analysis In the Open Batch dialog box select the desired batch to analyze In the Analysis dialog box click Print Report The Data Interpretation Report displays a print preview See Figure 5 75 Select any print options along the title bar and then click the print button printer icon At the Microsoft Windows Print window select your printer options and click Print Data Interpretation Report aa 11 sla Eana eb
279. yringe The syringe delivers a sample from the 96 well microtiter plate to the cuvette See Figure 3 5 3 10 PN 89 00002 00 071 Rev A xMAP Technology The System 1 Syringe Seal 2 Syringe Figure 3 5 Syringe and Syringe Seal Sheath Filter The sheath filter removes particles greater than ten microns in diameter from the sheath fluid See Figure 3 6 Figure 3 6 Sheath Filter Air Waste and The air waste and sheath connectors located on the left side of the Sheath Fluid analyzer connect to the SD system and waste fluid containers using Connectors clear tubing The air connector is green the sheath fluid connector is blue and the waste fluid connector is orange See Figure 3 7 PN 89 00002 00 071 Rev A 3 11 Luminex 100 IS User Manual Version 2 3 xMAP Technology 1 Sheath fluid connector blue 2 Air connector green 3 Waste connector orange Figure 3 7 Air Waste and Sheath Fluid Connectors Luminex Sheath For proper operation place the Luminex SD system at the same level Delivery System as the base of the Luminex XYP instrument Do not put it on top of Note If you are not using the SD the Luminex 100 analyzer system sheath fluid levels must be monitored manually Check the Warning If biological samples have been tested with the sheath fluid level before starting a system use your standard laboratory safety practices run or procedure Waste Fluid The waste fluid container receives waste from th
280. zation RMA number if they direct you to return the system They will explain how to return the system according to Luminex procedures The accessible surfaces and the internal fluidics system must be sanitized and decontaminated before returning the analyzer This is particularly important when biohazardous samples have been run Make a copy of this page to fill out and return with the system Complete the following checklist signed and dated and return it with the Luminex 100 analyzer 1 Remove all specimens disposables and reagents from the system 2 Disconnect the sheath line going from the SD system to the analyzer 3 Connect a sheath bottle filled with a solution of 10 to 20 household bleach and water to the analyzer 4 Sanitize the system using the Sanitize command on the main screen of the system Follow this by washing twice with distilled water 5 Disconnect the system from AC power by turning off the power switch on the rear of the system then unplugging the analyzer power cord from the wall source 6 Disconnect the SD system and waste and sheath containers 7 Rinse the waste container with 10 to 20 household bleach solution and drain 8 Wash all exterior surfaces with a mild detergent followed by a 10 to 20 bleach solution 9 Open both front doors of the analyzer and clean all accessible surfaces with mild detergent followed by a 1096 to 2096 bleach solution 10 Pack the system within a biohazar
281. zation dialog box Refer to Customization Dialog Box on page 5 101 for details To modify the general features of graph representations of the sample test result data 1 Right click anywhere in the graph on the Standards tab The graph menu opens See Figure 5 93 2 Select the desired menu item from the list and it is immediately applied Viewing Style Font Size Numeric Precision Plotting Method Data Shadows Grid Lines Grid in Front Include Data Labels Comparison Subsets as Normal Mark Data Points Ww po Maximize Customization Dialog Export Dialog Figure 5 93 Graph Menu Items Analyze Data Outside the There are two ways to access the data interpretation feature from IS Software outside the Luminex 100 IS software application e Through the desktop Start menu 5 106 PN 89 00002 00 071 Rev A xMAP Technology PN 89 00002 00 071 Rev A Using Luminex 100 IS 2 3 Software Through Microsoft Explorer To access the Standards tab from Analysis using the desktop Start menu Click Start at the bottom left corner of the desktop From the desktop Start menu select Programs Luminex Luminex 100 IS Data Interpretation Application From Explore select Luminex Luminex 100 IS DatalnterpApp exe At the Analysis window click Open Batch to open a file for analysis Select a batch for analysis from the available batches list Click Select The data for the batch you select appears i

Luminex 100 IS User Manual. To be used only by Scott Placke.

Contents

Download Pdf Manuals

Related Search

Related Contents