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IS 2.3 Software User Manual.book

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1. Figure 10 Message Log The log displays actions in color coded text and shading Items in the Message Log appear in the following color codes PN 89 00002 00 110 Rev A 11 Luminex IS Software Manual for Version 2 3 xMAP Technology e Green text represents a successful system calibration verification command acquisition or maintenance functions e Red text represents failed commands errors or warnings Black text represents normal processes and actions e Yellow shading indicates that a detailed description about the processes or actions is available This color may vary depending on your tool tip color system settings To view details of a message double click the shaded row A dialog box opens providing details To clear the Message log right click in the Message Log area and click Clear on the menu Acquisition Detail The Acquisition Detail tab offers advanced batch sample monitoring Tab and on the fly data acquisition without templates The primary function is real time monitoring of batch sampling during acquisition through a display of sample bead statistics histogram and dot plot data During batch acquisition 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 bead concentration or if other assay problems are present The Acquisition Detail tab provides acc
2. 1 On the Tools menu click Options 2 Click on the tab in which you want to set options A full description of each tab and its options is listed below 3 After you have entered and selected all of your preferences click OK Define General You define the following options on the General tab Tab Information Default Batch Directory Names the default directory to store batch information Click the browse button and navigate to the desired folder directory Current User Enter the name of the current user or operator The name appears on reports 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 Enables confirmation dialog boxes to display when you initiate many maintenance commands If you disable the confirmation screen display option 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 Replay Batch Report Raw Fluorescence Select this feature to enable the med
3. This term is used to refer to the Luminex 200 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 samples that are processed using a selected template Shorthand terminology for an xMAP microsphere a set of xMAP microspheres that have a uniquely identifiable ratio of two classification dyes The unique ratio is identified by a unique spectral address A process used to normalize the settings for the reporter channel both classification channels and the doublet discriminator channel for the Luminex System 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 System 93 Luminex IS Software Manual For 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 immunofluore
4. i gt I Eject m Mie ooo Warmedup 0 Standby tating 1 Microtiter plate reservoir image 2 Temperature and Pressure Gauges 3 Command List Figure 4 Run Batch Tab The command buttons on the Run Batch tab are e Print Worklist e Bject Retract e Start Plate e Resume Cancel Command e Pause e Cancel all For more information on these commands see the Commands section starting on page 28 For more information on setting up batches see See Batch Setup Procedures on page 48 The microtiter plate and reservoir image represents where you place samples or other fluids used in running or maintaining the system Samples are analyzed vertically from top to bottom within the column and then from left to right for subsequent columns The Temperature and Pressure Gauges show information about the analyzer and the X YP instrument The X YP heater temperature measures the internal Luminex XYP instrument plate temperature The DD temperature measures the doublet discriminator temperature DD temperature shifting indicates a need for system recalibration If you have not calibrated the arrows showing the temperature range 6 PN 89 00002 00 110 Rev A xMAP Technology PN 89 00002 00 110 Rev A Luminex 2 3 Software for the DD temperature both appear at the bottom of the thermometer and the thermometer appears in red An out of range temperature logs an error but does not halt t
5. Click Start Plate to being acquiring data from the multiple batches in the sequence that you set up 55 Luminex IS Software Manual for Version 2 3 xMAP Technology To create a multi batch with existing batches 1 Click New Multi Batch 2 Inthe Luminex Multi Batch dialog box click Add Batch to add an existing batch to the multi batch See Figure 30 3 Select the first batch to add and click Select The batch appears beginning in well A1 of the microtiter plate on the Luminex Multi Batch Setup dialog box Red lines separate this batch from subsequent batches 4 Repeatsteps 2 and 3 to add additional batches 5 Enter the Multi Batch name and Created By then click Finish The Run Batch tab opens representing the batches you selected or created on the microtiter plate 6 Click Eject and load the first plate of the multi batch 7 Click Start Plate to being acquiring data from the multiple batches in the sequence that you set up Open a Multi Use this procedure to open an existing multi batch Each batch in a Batch multi batch appears on the list of available multi batches The software differentiates them according to batch ID name and description The software gives all batches comprising a multi batch the same multi batch ID number and name To open a multi batch 1 Click Open Multi Batch The Open Multi Batch dialog box opens listing the available multi batches 2 Double click on the multi batch you w
6. New B 5 CORREA TAT ATAR VERSTAAN CRR SER VIVECA VOIRE Mig Wido 05 5 5 0 0 0509 050000 1 Title bar 4 Tabs 2 Menu bar 5 Status bar 3 Tool bar Figure 1 Luminex IS 2 3 Main Window There are five major parts in the Main window Title bar Menu bar Tool bar Tabs and Status bar A brief description of each of these components is shown below The Title Bar displays the name of the software The Menu Bar contains three menus File Tools and Help menu A more thorough description of the Menu is shown on page 3 The Toolbar has shortcut buttons for frequently used commands A more thorough description of the Toolbar is shown on page 4 There are five Tabs organized by function The tab that displays when the software starts up is the Home tab A more thorough description of each of these tabs begins on page 4 The Status bar displays the system status at the bottom of the main window A more thorough description of the Status bar is shown on page 16 2 PN 89 00002 00 110 Rev A xMAP Technology Menu Bar PN 89 00002 00 110 Rev A Luminex 2 3 Software The menu bar contains the following menus File Menu Tools Menu and Help Menu File menu contains the following commands Import Template New Batch Open Batch Delete Batch Edit Patient List Open Incomplete Batch Batch Comment New Multi Batch Open Multi Batch Data Analysis Export Batch Data Print Report
7. To calibrate your system with xMAP calibrators 1 Vortex the xMAP calibrator and control containers to ensure homogeneity Do not dilute xMAP calibrator or control reagents 2 Load a microtiter plate with at least five drops of each CAL1 in well Al CAL2 in well B1 CONI in well C1 CON2 in well D1 and distilled water 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 3 Click Eject Retract then place the plate on the plate holder 4 Fillthe Luminex XYP reservoir with a solution of 7096 isopropanol or 70 ethanol 5 Click Eject Retract 43 Luminex IS Software Manual for Version 2 3 xMAP Technology On the Maintenance tab click Prime Click OK and wait for the Prime to finish about 1 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 Click New CAL Targ to enter or confirm calibration lot numbers in the Update CAL Targets dialog box See Figure 25 Enter the CAL1 lot number and expiration date as printed on the bottle Enter the values listed on the Certificates of Quality COQ included with your calibrators into the CAL1 boxes If you are using a previ
8. To scan samples into the system using the barcode reader 1 Aim the barcode reader s beam to read the middle of the barcode series horizontally The beam must encompass the entire set of bars See the shaded area in Figure 32 Figure 32 Barcode Reader Beam Aimed Across Code 2 Squeeze the barcode reader s trigger The beam activates and reads the barcode The barcode 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 Add a Patient List You can apply a Patient List to any batch or multi batch only during batch setup in the Luminex Batch Setup dialog box You can create a Patient List text file using Windows Notepad or a text editor The text file must meet the following requirements e 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 The dilution factor is optional but if entered must be a numeric value e Ifthe 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
9. e nvalidate Standard F4 e Validate Standard F5 e nvalidate Control F6 e Validate Control F7 e Change Standard only if Developer s Workbench is installed e Change Lot Alt F8 e Recalc Standards tab only only available on the Standards tab and only if the Auto checkbox is not selected For a description of these commands see Commands on page 28 For information on procedures using these commands see Validating or Invalidating Standards and Controls on page 79 and Change Lot on page 81 In addition to the function buttons you can choose to sort data sequentially by order acquired or alphabetically by Sample ID These options are available in the Sort group box next to the function buttons These sorting functions are 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 21 Luminex IS Software Manual for Version 2 3 xMAP Technology Errors Tab The Errors tab displays a list of errors that occur
10. 1 2T2T4 s e 7 e 9 sols 12 S Save end Load Replicate Simplex Quant Z EEA E New Lot r Standard Info ud Product No 3000 Product Name 36 RepOt Kit Version No Lot Name 36Repotsed Fr E Expiration Date 06 10 2005 Control Info Developing Co Produet No 3000 Product Name 36 RepOt Kit mny Lot Namik 38RepQtcon Expiration Date 08 10 2005 Figure 27 Luminex Batch Setup Window 4 Enter the batch name if different from the default name a description optional and the creator s name optional 5 If you want to insert an Acquire Patient or Skip command select the command from the Insert menu In the 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 Skipped wells and patient wells added to the batch are shown as green wells on the microtiter plate image 6 If you are running a maintenance template add any samples for processing Then click Save and Load default or Save Only Otherwise continue with step 7 7 Ifyou want to change the well location where you begin acquiring samples drag the highlighted starting well default is A1 to the desired location on the microtiter plate 8 Click the field in the Sample ID row that represents the last empty well on the microtiter plate 9 Enter the sample ID for the sample to add Repeat this step to add all of the additional samples to the batch You can enter the sample m
11. 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 information 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 00 110 Rev A 99 Luminex IS Software 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 CSV file DataType type This field is the name of the statistic represented in the Sample versus the Test data block immediately below th
12. Total Events Notes 1 Std s 240 733333333333 75 2 Std m 503 213333333333 75 PN 89 00002 00 110 Rev A 105 Luminex IS Software Manual Version 2 3 3 Std 4450 92 75 xMAP Technology 4 Std xl 13478 6666666667 75 5 Std xxl 24817 8933333333 75 6 Low Control 60 75 7 Patient 1 561 12 75 Sample Comment for Patient 1 8 Patient 2 14402 3466666667 75 Sample Comment for Patient 2 DataType CV Location Sample Test 22 Total Events Notes 1 Std s 662 110761559013 75 2 Std m 42 0677216044823 75 3 Std 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 1 3985 75 4 Std xI 31 76 75 5 Std xxl 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 Loc
13. r Test Controls 2000 Current Lot B3654QtCon Current Lot B3654QtCon E NewLot Delete Lot Exp Date 03 07 2008 Low Limit Expected Values High Limit Test86 Test64 mg dL mg dL 150 405 Figure 44 Update Lot Information Dialog Box Change or edit the expiration date and the lot concentration values Click Save The system updates the lot changes and applies them to the template 69 Luminex IS Software Manual for Version 2 3 xMAP Technology 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 2 Double click the template that you want to edit An Update Lot Information dialog box opens See Figure 44 3 Change or edit the lot concentration values 4 Click Save A dialog box opens alerting you that this lot has been used to set up a batch and that you must create a new lot to continue 5 Respond to the Create New Standard Lot or Create New Control Lot with Yes Rename it in the New Lot Number dialog box Import 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 2 Select the template to receive the imported lot and clic
14. 110 Rev A Luminex 2 3 Software Table 11 Maintenance Operations Recommended Use Schedule Continued Operation Recommended Use Schedule Drain For troubleshooting and preventative maintenance purposes only drain the cuvette and refill in preparation for running Draining the system removes debris from the bottom of the cuvette when draining you do not supply solution Draining takes approximately two minutes and should be followed by an alcohol flush using 70 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 verify system operation Diagnostics 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 X YP 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 Ensure that the location you select to expel fluid has the reserve capacity to hold the volume expelled To drain the system 1 On the Maintenance tab click Eject Retract Ensure that the reservoir is empty or inser
15. Click OK to verify that the lot information is accurate Maintenance Procedures Table 11 shows a recommended schedule for maintenance operations Table 11 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 performing these actions refilling the sheath container removing and replacing sheath container changing the sheath fluid filter changing the syringe seal Backflush Troubleshooting and preventative maintenance 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 Before system calibration e After changing the sample probe e To remove 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 Wash As needed using distilled water Four times after system calibration Twice after sanitize 88 PN 89 00002 00 110 Rev A xMAP Technology Drain the Analyzer Run Self Diagnostics PN 89 00002 00
16. Click the name of the template Click Open to load the template To create a new batch Read the instructions provided with the assay kit you are using Follow the kit instructions for any preparations Click New Batch The Open Template dialog box opens Double click the template you want to apply to the new batch The template loads and the Luminex Batch Setup window opens See Figure 27 49 Luminex IS Software Manual for Version 2 3 xMAP Technology Lumines latch Setup Please establish the starting location for the batch and enter the appropriate patient information Note indicates a required field Inset Acqure Patient X 1 Apply Batch Info Command Sample ID Dil Factor Name 11A1 Platel Acquire Standard StdM 1 Y Batch 5 3 02 16 38 2 81 Plate1 Acquire Standard Std M 1 d a 3 C1 Plete1 Acquire Standard StdL 1 Finish Descnption B 4 D1 Plate Acquire Standard StdL 1 None z 8 5 E1 Platel Acquire Standard Std XL 1 a 6 F1 Plato1 Acquire Standard Std XL 1 E z A 7 G1 Plete1 Acquire Control Conk 1 i 8H1 Plate1 Acquire Control Conl 1 Crested By 9 A2 Plate1 Acquire Patient 2 L Name 10 62 Plate 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 meme 14 F2 Plate Acquire Patent 1 Help 835 Repat Assay 15 G2 Plate1 Acquire Patient tN Description
17. E Luminex Luminex100 Integrated System 2 3 System Monitor Property Detailed Sample Progress Value Air Pressure pesas 06 06 2002 4 42 43 PM Sheath Pressure 06 06 2002 4 44 04 PM Delta Cal Temp 06 06 2002 4 45 42 PM Board Temp 06 06 2002 4 46 45 PM DD Temp Complete 288 CL1 Temp 285 CL2 Temp 275 XYP Board Temp 288 XYP Htr Temp 285 XYP Htr In Range 275 18 Device State Change 17 Command Completed Old State Proc g Ne e CommandName CON2 CommandNo 1 of 1 Plate Location D1 Plat Time 06 06 2002 4 46 45 PM Time 06 06 2002 4 46 45 PM 16 Command Started 15 Device State Change 14 Device State Change 13 Command Completed 12 Command Started 11 Device State Change 10 Device State Change 9 Command Completed 2 Parnmand Ctartad Time 06 06 2002 4 46 07 PM Time 06 06 2002 4 46 01 PM Time 06 06 2002 4 45 43 PM Time 06 06 2002 4 45 43 PM Time 06 06 2002 4 45 03 PM Time 06 06 2002 4 44 56 PM Time 06 06 2002 4 44 04 PM Time 06 06 2002 4 44 04 PM Tima ARIARISANA AANS DNA CommandName CON2 Old State Idle Old State Processing CommandName CON1 CommandName CON1 Old State Idle Old State Processing CommandName CAL2 Cammandiiama CAIA CommandNo 1 of 1 New State Processing New State Idle CommandNo 1 of 1 CommandNo 1 of 1 New State Processing New State I
18. Eont Size C Lage Med Small Figure 46 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 73 Luminex IS Software Manual for Version 2 3 xMAP Technology 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 47 Exporting Test 36 x r Esport MetaFile C BMP C Test Data Only r Export Destination ClipBoard ME S C Printer Object Size C No Specific Size C Milimeters inches C Points pues Cancel Width 5177083 384375 Inches Figure 47 Exporting Dialog Box Maximize Click to maximize the graph to full screen Restore to original size by pressing Escape on the keyboard or by clicking in the title bar Customization dialog box tabs 74 General Tab Use this tab to define general parameters See Figure 46 Main and Sub Titles These ed
19. Luminex IS Software Manual for Version 2 3 xMAP Technology 2 Double click on the desired batch The system loads the batch as you created it in the Run Batch tab 3 Click Start Plate to initiate batch acquisition Copying and To export Batch Data Exporting Batch Dat Right click in the Batch Data area of the Acquisition Detail tab ata In the right click menu click Copy to copy the currently displayed data to the clipboard Click Export to manually export the currently loaded batch to the appropriate Output csv file Clear a Batch from The Clear Batch command clears the entire batch from the Run the System Batch tab or the Message Log on the Diagnostic tab Once you choose to clear the batch and verify that you want to continue with the command you can recover the cleared batch if it has not been run by clicking Open Batch 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 Replay a Batch 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 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 The initial batch data and output file alway
20. Maintenance tab click Eject Retract 2 Click Wash A confirmation dialog box opens telling you to place solution in the reservoir 3 Putdistilled water in the reservoir 4 Click OK The plate holder retracts and the system performs the Wash command Perform a Soak Soak the sample probe to prevent the sheath fluid crystals from Command forming in the sample probe To perform a soak command 1 On the Maintenance tab click Eject Retract 2 Select Reservoir from the dropdown menu next to the Soak button then click Soak A confirmation dialog box opens telling you to place solution in the reservoir 3 Put distilled water in the reservoir 4 Click OK The plate holder retracts and the system performs the Soak command Exit Luminex IS When you exit the system a confirmation dialog box prompts you to 2 3 Software verify that you really want to exit the system To exit the system On the File menu click Exit then click Yes 92 PN 89 00002 00 110 Rev A Glossary agglutination ambient temperature analyte analyzer APD background noise batch bead bead set calibration calibrators PN 89 00002 00 110 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
21. O no timeout 5 Click the arrow down next to 100 regions to select the desired bead map you want to view The available 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 at least the minimum events as determined on the Bead Set tab 62 PN 89 00002 00 110 Rev A xMAP Technology Luminex 2 3 Software 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 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 Selected Events Caption Select All oO 100 001 O 100 002 Deselect All O 100 003 O 100 004 Default Events 110 Ls O 100 006 100 O 100 007 m 100 008 Apply to All O 100 009 O 100 010 O 100 011 O 100 012 y Bead Events 100 regions Y Per Bead Total Beads 1000 OK Cancel Figure 36 Options Dialog Box Bead Set Tab 7 Editthe Events and Caption information for each bead set Edit the Default Events box to change the defa
22. Sample Test 22 Total Events Notes 1 Std s 2 99 pg mL 75 2 Std m 1 5 79 pg mL 75 3 Std 1 126 71 pg mL 75 4 Std xI 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 qu 5 98 pg mL 75 8 Patient 2 636 38 pg mL 75 DataType Count Location Sample Test 22 Total Events Notes 4 Std s 75 75 2 Std m 75 75 3 Std 075075 4 Std xl 75 0750 5 Std XxI 75 75 6 Low Control 75 75 7 Patient 1 75 75 8 Patient 2 75 75 PN 89 00002 00 110 Rev A 103 Luminex IS Software 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 lt Name gt BatchStartTime 7 28 2004 2 06 44 PM BatchStopTime 7 28 2004 2 10 50 PM BatchDescription Software Testi
23. after calibration and verification between batches and multi batches after sanitize and before daily shutdown To perform a Wash command Onthe Maintenance tab click Eject Retract 2 Select Reservoir from the dropdown menu next to the Wash button then click Wash A confirmation dialog box opens telling you to place solution in the reservoir 3 Putdistilled water in the reservoir 4 Click OK The plate holder retracts and the system performs the Wash command 41 Luminex IS Software Manual for Version 2 3 xMAP Technology Set Luminex XYP Refer to your assay kit instructions to see if the assay needs to be Instrument Heater analyzed at a particular temperature If the instructions indicate that Temperature the Luminex XYP instrument heater is needed 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 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 Luminex System Do not use standard 96 well microtiter plates if you are using the heater block Any temperature that you set remains in effect until you set another temperature or turn off the Luminex XYP instrument plate heater or exit the software The system displays the target temperature in the box below the Turn ON button Before the heater block temperature reaches the new t
24. 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 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
25. 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 Sequentially by the order in which they are acquired or Alphabetically by sample ID Select the sorting method in the Sort group box 27 Luminex IS Software Manual for Version 2 3 Commands Acquire Patient Add Batch Alcohol Flush Autoscale Autosize Backflush CAL1 CAL2 Cancel Command Cancel All Change Lot CON1 CON2 Connectto Instrument 28 xMAP Technology This section describes the different commands used in the Luminex IS 2 3 software They are grouped Alphabetically This command which is part of the Insert command menu adds 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 When creating a multibatch adds an existing batch to a multi batch Removes air bubbles from the sample tubing and the cuvette using 70 isopropanol or 70 ethanol The alcohol flush takes about five minutes Uses the Luminex XYP reservoir due to volume requirement Automatically adjusts the maximum number of events shown on the Y axis on the histogram Click during acquisition to readjust the Y axis scale Automatically adjusts column widths to fit the data and header sizes Rem
26. exported data file Click OK 84 PN 89 00002 00 110 Rev A xMAP Technology Print Data Analysis Report PN 89 00002 00 110 Rev A Luminex 2 3 Software A printed batch report includes the following criteria that is applied to the batch during analysis batch name and test name formula used curve fit standards controls 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 window click Print Report The Data Interpretation Report displays a print preview See Figure 61 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 85 Luminex IS Software Manual for Version 2 3 Database Management Procedures Back Up the Database 86 xMAP Technology Data Interpretation Report X M p Q d umnliahe Balch TH ye 1456 019 CBSTESDR LK 1 0 x 401803 9 70E01 Test ines ty s Figure 61 Data Interpretation Report Print Preview To manage the system database back up and delete saved data and files The system stores data results for instrument calibrators instrument controls assay calibrators and assay controls It records acquisition and maintenance data i
27. lt Name gt Insert Acquire Patient x fi Apply Template Info Name pae RepQt Assay Description Replicate Simplex Quant Ez Version No p2227 Developing Co NAO PN 89 00002 00 110 Rev A A B c D E E G H No Location Command Sample ID Dil Factor zi 8 1 A1 Plate1 Acquire Standard Std M 1 Y 8 2 B1 Plate1 Acquire Standard Std M 1 ves B 3 C1 Plate1 Acquire Standard StdL 1 Finish 8 4 D1 Plate1 Acquire Standard Std L 1 8 5 E1 Plate1 Acquire Standard Std XL 1 X 8 6F1 Plate1 Acquire Standard Std XL 1 Banca 8 7 G1 Plate1 Acquire Control ConL 1 anco amp 8 H1 Plate1 Acquire Control ConL 1 9 42 Plate1 Acquire Patient 2 10 B2 Platel Acquire Patient 2 Load Pa List 11 C2 Plate1 Acquire Patient 2 12 D2 Plate1 Acquire Patient 1 13 E2 Plate1 Acquire Patient 1 9 14 F2 Plate1 Acquire Patient 1 Help 15 G2 Plate1 Acquire Patient 1 ADILA Mlata A Aamen Mati ant A Ly Q Q C Save only DIE Standard Info Product No 3000 Product Name 36 RepQt Kit Lot Name 3BRepGtStd Expiration Date 06 10 2005 Control Info Product No 3000 Product Name 36 RepQt Kit Lot Name 36Rep tCon Expiration Date 06 10 2005 The following features are part of the Batch Setup Window Batch Info group box Template Info group box nsert command Command list Microti
28. 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 On the Home tab click Analysis The Open Batch dialog box opens showing only processed batches 2 Selecta batch to analyze and click Select The system loads the batch and the Analysis window displays the Standards tab To view detailed test analysis 1 On the Home tab click Analysis The Open Batch dialog box opens 2 Clickon 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 Each test displays Analyzing as the system calculates 3 Onthe 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 You can invalidate or validate a standard or control in either of two ways In the Analysis window use the associated buttons on the bottom of the window or right click in the row containing the standard or control you want to validate or invalidate Invalidating standards You can invalidate or remove a standard if doing so improves the curve fit Obs
29. 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 To display device information about the Luminex analyzer Luminex XYP instrument and the Luminex LXR SDK On the Help menu click About the Device The resulting dialog box shows information that may be helpful when contacting Luminex Technical Support Click OK to close the dialog box To display information about the system software On the Help menu click About the Software The resulting dialog box shows information about the system software This includes software version build number and the system copyright information Click OK to close the dialog box To display system information 1 On the Help menu click About the Software The resulting dialog box opens that displays software information 2 Click System Info The System Information dialog box opens Click X in the top right corner to close the dialog box 3 Click OK to close the dialog box 35 Luminex IS Software Manual for Version 2 3 xMAP Technology Setting Software Options Set up and customize the system software and enter your company information in the Options dialog box The Software Options dialog box has three tabs the General tab the Company Information tab and the Data Export tab To configure software options
30. see the dot plot you must use the default axis To display the bead set information hover the mouse pointer over the desired region You can change the X axis and Y axis of the dot plot for troubleshooting purposes although you should use the default settings in all other scenarios s 10000 Classification 2 100 1000 10 1 10 100 1000 10000 Classification 1 Figure 14 Dot Plot Display Example Four buttons appear at the top of the frame to control the display Density Decaying Log Linear Zoom Maximize You can toggle between two types of dot plots using the Density Decaying button The Decaying Dot Plot plots only the 100 most recent acquired events The Density Dot Plot displays a constant Luminex IS Software Manual for Version 2 3 xMAP Technology Status Bar accumulation of events Increasing density is indicated by contrasting colors See Table 2 for the density dot plot color legend Table 2 Dot Plot Color Legend Layer Color none dark blue pink dark green cyan light blue light green orange dark red 0 Y O 04AO0DN 0O0 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 The Status Bar displays information
31. test column headers in the Output CSV file Limited to 30 characters PN 89 00002 00 110 Rev A 101 Luminex IS Software Manual Version 2 3 102 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 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 00 110 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 4341 vuam 4 Std xI 1 431 6 75 5 Std xxl 25694 75 6 Low Control 58 75 7 Patient 1 532 75 a Patient 2101 4567 75 DataType Result Location
32. 2 coria Pee neei a hee does 32 Recalez it UR Pee RC P dente 32 Replay Batch ilb EEUU Aca 32 Report Raw Fluorescence 0 0 0c eee eee o 32 Res mee passera na A eee E anaes nee ce eee 32 Sample Probe Down 0 0 cece ee eee 32 SanitiZ6 s ds da oT RORIS 32 saveand Load uci sed He T ERE ewe n 32 Save Onlyz oos aa 32 Self Di gnosties eit tenet el ine ea Re 33 SHOW Bead besote tals Ma he eee dae std Nh Se e 33 A Sh ion tet i be Bata elds 33 Skip wells 5 239 RR as ER 33 SO is Qe VER QVE Den eee 33 Start Analysis es owes a Ru etx Ed DA eed E uda 33 Start Plate eed SNR ead s 33 Statistics iic oos DUO EUIS RACER NOS PR NE 33 Test Sort Orders neos eee Re ER SEE E RENS 34 Validate Control cosy eene niaaa cece nee 34 ii PN 89 00002 00 110 Rev A xMAP Technology Contents Validate Standard 0 0 0 cece cee eren 34 View Batch Datace eia einemi e ei e oe E Ea aA 34 Warmup ie ee aae ea ette rem ce ect cei sa 34 Mash c bees id lira 34 yu PD LUI 34 Procedutes etuer dos eS 35 Using the Online Help 0 0 0 0 ee eee eee 35 Setting Software Options 0 0 0 0 e eee eee eee 36 Setting up the Favorites LiSt ooooooooooooomoo 39 Startup Procedures 0 0 eee eee eee eee 40 Calibration Procedures 0 0 0 ce eee eee eee 42 Batch Setup Procedures 02 0 c eee eee eee 48 Managing Assay Lots 0 0 00 ce eee ee eee eee 67 Analyzing Batche
33. 24 344 57 gil s Loc Control Expected Conc MFI Low Limit HighLimit TestResult CV Unit n A3 con100 100 797 75 125 86 89 pgimL B3 Con100 100 815 75 125 88 86 pgimL C3 Coni000 1000 6390 850 1150 934 46 pin D3 Con1000 1000 6874 850 1150 1028 27 pgimL Avg Con 100 806 8787 1 587 pg mL Con 1000 981 36 ls Sequentially by order acquired ReCalc v Auto Previous Test F3 Validate Standard F5 Validate Control F7 Change Lot Alt F8 Alphabetically by Sample 1D PN 89 00002 00 110 Rev A Figure 17 Analysis Window Standards Tab Open When a median fluorescence intensity MET value for an unknown sample or control lies outside the standard curve MFI range the concentration is not calculated The unknown sample or control result is reported as less than lt or greater than gt next to the corresponding standard expected concentration The 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 displays in the comments column This error condition usually occurs when a standard curve flattens out at the 23 Luminex IS Software Manual for Version 2 3 xMAP Technology high or low end Examples of out of range sample
34. 30 days written notice to you Your rights under this EULA automatically terminate without further action on the part of Luminex 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 SO
35. 58 PN 89 00002 00 110 Rev A xMAP Technology PN 89 00002 00 110 Rev A Luminex 2 3 Software The format must be like the following example or it will not load properly Double check all Sample IDs before you save the newly created batch An example of a typical patient list file LX100IS Patient List Accession Dilution Factor a001 1 a002 2 a003 1 b001 4 b002 0 6 c917 4 cee4of 1 To add a Patient List 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 3 Click Load Patient List The Open Patient List File dialog box opens 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 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 p
36. 92 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 1 126 71 pg mL 75 4 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 SOR CRC32 A398CCAD 108 PN 89 00002 00 110 Rev A Index A analysis 36 view 79 Analysis window function keys 21 assay errors 22 assigning dilution factors to samples 60 auto start analysis 36 B back up the database 86 batch analyze processed batch 79 data export 84 reprocess 52 Batch Summary Report 82 C calibration definition 93 trend report 82 verification 43 Clear Preliminary Off plate commands 65 Clinical Assay Report 82 commands off plate 65 confirmation screen 36 create new session 48 D database backup 86 management 87 restore 87 decontamination 41 92 detailed sample progress 11 dilution factor 60 draining the system 89 E enable raw data storage 36 erasing data from database 87 errors tab 21 establish insert off plate commands 66 exit the Luminex 100 IS software 92 export batch data 84 batches 38 F fluorescence 36 H heater block 42 help menu 35 I ins
37. 98 PN 89 00002 00 110 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 of 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 2 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 2 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
38. Click Print Report The Report Selection dialog box opens i Report Selection 2 Bl xl r Selecta report Analyte Report C Maintenance Report C 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 57 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 58 For the Quality Control Maintenance Calibration Trend and System Control Trend Reports a dialog box related to the specific report opens The system information may vary depending on the type of report you select Batch Selection Select the batch that contains the patient information Batch Name Batch Date DNA Batch 1 25 2002 11 53 09 AM DNA Quant Run by 5P formula Figure 58 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 59 shows a Patient Selection example PN 89 00002 00 110 Rev A 83 Luminex IS Software Manual for Version 2 3 xMAP Technology Patient Selection xl Select available Patients from the list on the left Patient Name Accession Number Patie
39. Exit Tools menu contains the following commands Connect Disconnect Database Backup Database Restore Erase Database Update CAL Targets Update CON Targets New Assay Lot Options Cleanup For information on each of these commands see the Commands section beginning on page 28 Help menu this contains menu selections that open the online help and describe the software and hardware Contents opens the online help About the Device opens a dialog box that shows the version and serial numbers of the Luminex instruments you are using About the Software opens a dialog box that shows the version of the Luminex Software you are using Luminex IS Software Manual for Version 2 3 xMAP Technology Toolbar The shortcut buttons on the toolbar can be found in other locations in the software The Help button opens the online help The Single Step option on the toolbar allows you to pause the system in between each command or sample acquisition within a batch Lam y y Ma Qe CT sese PL 12 34 5 6 7 8 9 10 d1 12 13 1 Import Template 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 File 6 Start Analysis 13 Single Step 7 Export Batch Data Figure 2 Luminex IS 2 3 Toolbar Tabs This section describes the tabs in the Main window Home tab This is the default tab It is organized
40. FTWARE PRODUCT IS LICENSED AS IS ANY USE OF THE SOFTWARE PRODUCT IS AT YOUR OWN RISK THE SOFTWARE PRODUCT IS PROVIDED 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 s
41. Luminex Luminex IS Software Manual For Version 2 3 LUMINEX CORPORATION 2001 2005 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 i LUMINEX CORPORATION Luminex IS Software Manual for Version 2 3 CN M007 01 PN 89 00002 00 110 Rev A July 2005 ES Paul A Rowden 33 Stapleford Road Middlesbrough Cleveland TS39ES Angleterre TQMUK aol com 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 Luminex 200 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 softwa
42. PM 104 PN 89 00002 00 110Rev 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 4341 iy 4 Std xI 1 431 6 75 5 Std xxl 25694 75 6 Low Control 58 75 7 Patient 1 532 75 Sample Comment for Patient 1 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 4 Std xI 61 6 93 pg mL 75 5 Std xxl 3194 84 pg mL 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 0750750 4 Std xI 75 75 5 Std xxl 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
43. Targets xMAP Technology CON 1 Product Information Lot Information Number Value L100 CON1 Lot Number E 682 Name Expiration Date 12 06 2002 y Classification Control n Target Information FUE Reference Target A1 Target B1 Target C1 umen 1 9861 769 218 Current CON1 Lot A1682 B 9835 75 3 66 4 3 10675 23422 5607 mam jue E 4 8946 2578 17803 Import CON 1 Export CON 1 SE 5 0986 288 5795 CON 2 Product Information Lot Information Number Value L100 CON2 Lot Number A1440 Name Expiration Date 09 21 2002 y Reporter Control Manufacturer Target Information Luminex Reference Target A1 Current CON2 Lot A1440 A1440 Import CON 2 Export CON 2 o Newbot Lot 2 3 4 1 Change the current lot by saving selected lot Figure 26 Update CON Targets Dialog Box Ensure that the analyzer is set to draw CON1 and CON2 beads from the wells you loaded in step 2 of Run System xMAP Calibrators on page 43 In the Maintenance tab click CONI 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 th
44. V 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 Xx xj Ny N 1 12 Avg Result Statistics Column 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 Test1 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
45. Wa rmup Warms up the system to prepare the optics prior to sample acquisition The system automatically begins warming up when you turn power on however you will need to use the Warmup command if the system is idle for four hours or longer Wash Washes fluidics line Sends fluid distilled water through the fluidic lines in the system Pulls the fluid from a well or the reservoir and runs it completely through the system to the waste receptacle Zoom Zooms or enlarges a specific area on the histogram or dot plot display Click and drag right to left to adjust the graph s range 34 PN 89 00002 00 110 Rev A xMAP Technology Procedures Using the Online Help PN 89 00002 00 110 Rev A Luminex 2 3 Software This section explains how to perform functions in the software Help files describe Luminex System 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 Books usually contain a group of topics These topics are grouped together because they discuss similar or related topics Hyperlinks provide instant access to another topic or subtopic with related information to the linked subject or term To open the system s online help 1 On the Help menu click Contents 2 Inthe Help dialog box
46. Window This section describes the main window of the Luminex IS 2 3 software including tabs and commands Use this section to become familiar with the main functions of the software e Secondary Windows This section describes the secondary windows in the Luminex IS 2 3 software including the Analysis Window and Batch Setup Window e Commands This section describes the functions of the commands in the Luminex IS 2 3 software e Procedures This section describes how to perform tasks using the Luminex IS 2 3 software When using microtiter plates 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 The Luminex IS 2 3 software starts automatically when you log into Windows When the first software User window opens the Main window is open with the Home tab displayed as shown in Figure 1 Luminex IS Software Manual for Version 2 3 xMAP Technology 1 Sh Luminex100 IS Software frm 2 File Tools Hel Luminex 3 mE 3 E y AA a mJ Single Step Home Run Batch Maintenance Diagnostics Acq Detail H Luminex100 Integrated System 2 3 Favorites Daily Startup Add Command Add Template Fon A e ty Bart x cd Fi me a instrument Calibration are Niger A Pod o eich Setup E T Reports and Analysis E hr EZ Daily Shutdown Ed Fed
47. ab use the Style tab for control of subset color subset line type and subset point type Subset 1 line type and Subset 2 data point See Figure 51 Test 36 Customization x General Anis Font Color Style Subset 2 Pay Po Point Type e Solid Circle Line Type l Cancel Apply Original Export Maximize Figure 51 Customization Dialog Box Style Tab To modify features using the Graph Menu Most of these menu items provide a shortcut for many of the features provided in the Customization dialog box Refer to page 73 for details 1 Right click anywhere in the graph on the Standards tab The graph menu opens See Figure 52 2 Select the desired menu item from the list and it is immediately applied PN 89 00002 00 110 Rev A 77 Luminex IS Software Manual for Version 2 3 Enable Automatic Analysis 78 xMAP Technology 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 LL rh XE MAL ES a Maximize Customization Dialog Export Dialog Figure 52 Graph Menu Items 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 or toolbar to analyze a batch Note that the Auto s
48. 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 IE Hg A p Figure 15 System Status Bar Table 3 describes the types of status bar messages in relation to the message color coding Table 3 Status Bar Color Coding Category Color Indicates Command Indicates communication status of the Luminex analyzer or State operations being processed Green Idle or processing Yellow Connecting pausing or paused Red Disconnected or locked out PN 89 00002 00 110Rev A xMAP Technology Luminex 2 3 Software Table 3 Status Bar Color Coding Continued Category Device Status Color Indicates Indicates the current process of or warning about the Luminex 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 analyzer is performing Note The device activity has no color code Idling waiting for a command Aspirating drawing in sample Collecting Data collecting data Sanitizing sanitizing the instrument Washing washing the sample line Priming priming the instrument Calibrating calibrating the instrument Canceling canceling a command Backflushing backflushi
49. an insert off plate commands 13 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 commands 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 To clear insert off plate commands select the wells to clear right click on the plate layout and select Clear Selection from the menu After you define the information on the General Bead Set and Plate Layout tabs click OK Click Cancel to abort Table 10 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 66 PN 89 00002 00 110 Rev A xMAP Technology Managing Assay Lots Create a New Lot PN 89 00002 00 110 Rev A Luminex 2 3 Software You can edit standard and control lot information Once a lot is used changing or modifying it will prom
50. and the beads Luminex xMAP Sheath Fluid is the delivery medium of the sample to the optics component Only Luminex approved sheath fluid should be used when operating the Luminex analyzer 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 200 analyzer A sequence of commands and predetermined settings defined by the kit manufacturer Each test represents an analyte and corresponds to a bead set which is represented by a bead ID The process using system controls to ensure the analyzer is functioning properly with current calibration settings See Luminex xMAP microsphere set PN 89 00002 00 110 Rev A Output CSV Overview Overall Design PN 89 00002 00 110 Rev A This chapter describes the file specification for the Luminex 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 CS V file for the Luminex IS 2 3 software Although this chapter was prepared to ensure accuracy Luminex assumes no
51. ant to open 3 Click Eject Retract to eject the plate holder 4 Load the first microtiter plate onto the plate holder 5 Click Start Plate to retract the plate holder and begin acquiring the multi batch data Process Multiple You can process multiple plates per batch or multi batch After Plates loading a batch or multi batch that spans more than one plate a new plate appears to the immediate right of the existing plate image on the screen A dark blue line separates the adjacent columns of the two plates You can use the scroll bar to see additional plates See Figure 31 56 PN 89 00002 00 110 Rev A xMAP Technology Re Run or Recover Incomplete Batch PN 89 00002 00 110 Rev A Luminex 2 3 Software m 100 FS Software e m Batch 3 20 02 13 42 Batch Description Protein Demo 2 8 46 6 7 8 9 1011 12 1 2 AOQOOOOO0O00006 BOOOO0O0O000006 IcOODOOOO0O0O00006 a 90000000006 CmdNo Command Plate Loc 1 Warmup none Plate Pending 2 Prime lt none gt Platet Pending 3 Prime none gt Plate Pending 4 Prime none Platel Pending 5 wash Reservoir Plate Pending 6 Calibrate CAL1 E11 Platet Pending 7 Wash Reservoir Plate1 Pending m Calibrate CAL2 E n di Pa es Pending Mg Medio m Figure 31 Processing Multiple Plates After the first microtiter plate in a multiple plate batch has been acquired the system pauses and prompts you to insert the next plate To p
52. anually through a patient list or using the system barcode reader Batches may span more than one plate When the first plate is full a blue line separates the columns of the first plate with those of a second plate To add a sample ID to the end of the list press the Enter key or double click in the last line 50 PN 89 00002 00 110 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 Open a Batch PN 89 00002 00 110 Rev A Luminex 2 3 Software 10 To add a patient file to the batch click Load Pa List An Open Patient List File dialog box opens See Figure 28 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 a Common y e E3 e ExportedT emplates amp IWD_ConReport ocx El IvDImplements dll E El BrowseDB ocx a IWD_CPReport ocx El IvDinterfaces dil History E cbMsgbox ocx a IWD_LWJTReport ocx El IvDInterpGraph o 1 E crviewer dll a IVD MainReport ocx E IvDInterpGraphD 144 5 Datalnterpretation2 ocx E IVD PSRepart ocx El IVDMachineCalib Desktop H GenFormulaDisplayLib ocx E IVDBackup ocx E IVDMath dll on E GraphObjects dll E IVDBeadS
53. anup The Cleanup Utility dialog box opens See Figure 62 Luminex100 IS Software Cleanup UGE m oj x Disk Delete Delete E MsgLog Batch leon Directo Directo Figure 62 Cleanup Utility Dialog Box To perform a disk cleanup 1 Inthe Cleanup Utility dialog box click Disk Cleanup 2 Inthe Select Drive dialog box select the desired drive and click OK The Disk Cleanup dialog box opens showing it is calculating progress This can take several minutes 3 When Windows finishes calculating the cleanup it displays the Disk Cleanup for dialog box See Figure 63 Check or uncheck 90 PN 89 00002 00 110 Rev A xMAP Technology Daily Shutdown Procedures Sanitize the System PN 89 00002 00 110 Rev A p9 Luminex 2 3 Software the desired files to delete and click OK Windows deletes the files and closes the dialog box Disk Cleanup for C 31 xl Disk Cleanup More Options You can use Disk Cleanup to free up to 858 175 KB of disk space on C Files to delete Ma Downloaded Program Files Ma Temporary Internet Files 765 KB FA Recycle Bin 119KB Ola Temporary files 64 KB M Temporary Offline Files OKB y 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 d
54. aphics are drawn on top of the grid e 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 If you select Log use Auto or ensure that the Min value is greater than zero See Figure 48 Test 36 Customization x General Axis Font Color Style Min 904 078 Max 12506 6 A Axis Linear Log C Auto C Min C Max Min Max Min 6 77 Max 420 Cancel Original Esport Maximize Figure 48 Customization Dialog Box Axis Tab e 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 of the dialog box displays a sample of the font as you select it See Figure 49 PN 89 00002 00 110 Rev A 75 Luminex IS Software Manual for Version 2 3 76 xMAP Technology Test 36 Customization x General Axis Font Color Style Main Title arial I bold italic 7 underline Sub Title Times New Roman v bold italic underline Subset Point Axis Labels aria v bold italic underline sample AaBbCc DdEeFfGg Cancel Apply Original Export Maximize Figure 49 Customization Dialog Box Font Tab Color Tab Use the Color tab to define the various color parameters on the analysis graph See Figure 50 Desk Foreground this is the color that is used when plac
55. ard F5 Validate Control F7 Change Lot Alt F8 C Alphabetically by Sample ID A start fiy Luminex100 15 Software 7 analysis S Fullshot 99 J HE Ed 4 28PM Figure 20 Analysis Window Samples Tab Open 26 PN 89 00002 00 110 Rev A xMAP Technology Replicate Averaging PN 89 00002 00 110 Rev A Luminex 2 3 Software Standard and control replicates are predefined in the template You define unknown sample replicates in batch setup indicated by replicate Sample ID The data analysis function supports replicate sampling It calculates each sample as an individual sample which is then averaged to obtain a replicate average Standards tab displays standard and control average values Samples tab displays sample 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 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 Be aware that this fixes standards and controls not patient sample If any of the replicate standards and or controls are invalidated the Avg results reflects the
56. atch 6 3002 14 17_FILEMODE None 14 Batch 6 3 002 14 17_FILEMODE None 16 Ratch RAMI 14 10 EN FMODE Mona zi Figure 29 Analyze Open Batch The Analysis window opens showing the Batch info in the Standards tab To close the Analysis window click Close See Analyzing Batches and Multi Batches on page 72 You can only delete unprocessed batches Batches are deleted from the Open Batch list and moved to the Open Incomplete Batch list To delete an unprocessed batch 1 On the File menu click Delete Batch A dialog box opens listing the unprocessed batches in the database 2 Select the unprocessed batch that you want to delete 3 Click Select to delete the batch If you need to recover a deleted batch select Open Incomplete Batch from the File menu 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 The software does not limit you to a certain number of batches per multi batch Different batches within the multibatch are separated by thick red lines above the first well and below the last well of each batch Multi batches may span more than one plate A blue line separates the graphical representation of the plates A scroll bar appears along the bottom of the microtiter plate image so you can view additional p
57. atient IDs to the end of the command list in order as they appear in the patient list 5 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 6 Click Finish The system saves the batch or multi batch for later use or it loads it for immediate use according to the decision you made when creating it 59 Luminex IS Software Manual for Version 2 3 xMAP Technology Edit a Patient List 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 Patient list entries are case sensitive Figure 33 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 33 3 Edit the desired patient and associated dilution factor information Click Fin
58. ation Sample Test 22 Total Events Notes 1 Std s 1593 82742065973 75 2 Std m 211 690384143302 75 3 Std l 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 Patient 2 DataType Trimmed Count Location Sample Test 22 Total Events Notes 106 PN 89 00002 00 110 Rev A xMAP Technology 1 Std s 69 75 2 Std m 69 75 3 Std I 69 75 4 Std xI 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 xl 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 Trimm
59. by the order of system use It contains a Favorites list and five button groups representing data acquisition and maintenance categories Eile Tools Help Luminex 2 m x T PEET Single Step Home Home Run Batch Maintenance Diagnostics al Acq XU t 5 Luminex100 Integrated System 2 3 1 Favorites Daily Startup o Daly Startup ee Ed pe E r at Fo H RA el n Template ui x ol wen sm Instrument Calibration od o lik dva O dl a du a lt p ey Reports and Analysis Daily Shutdown Kuzi 1 Favorites List 2 Button Groups Figure 3 Home Tab PN 89 00002 00 110 Rev A xMAP Technology Run Batch Tab PN 89 00002 00 110 Rev A Luminex 2 3 Software Favorites You can use the Favorites list to create a customized list of often used commands and templates Items appear in alphabetical order for easy locating For more information on setting up the Favorites list see page 39 Button Groups Button groups are grouped according to function The Daily Startup group contains the Warmup Prime Alcohol Flush and Wash Commands For more information on daily startup see page 40 For more information on the commands see the Commands section on page 28 The Instrument Calibration group contains the CAL1 CAL2 CONI and CON2 buttons For more information on calibrating the system see page 42 For more information about these commands see the Commands section on page 28 The Batch Setup
60. d templates to the Favorites list 1 2 On the Favorites list click Add Template In the Open Template dialog box double click the template to add to your Favorites list To add commands to the Favorites list Click Add Commands from the Favorites list The Command List dialog box opens ij Command List Oy x Location Reservoir ok a Cancel F Figure 24 Command List Dialog Box Select the command that you want to add to your Favorites list For certain commands you will need to select the location where you want to draw or expel fluid Use the Location drop down menu to open the microtiter plate image Click on the microtiter plate location on the image Ensure that the location you select is compatible with the volume intended for that location Click OK to add the command The command displays in the Favorites list 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 list 39 Luminex IS Software Manual for Version 2 3 xMAP Technology Startup Procedures Warm Up the Warm up the system to prepare the optics prior to sample acquisition System The system automatically begins warming up when you turn power on This procedure takes approximately thirty minutes Caution Failure to properly warm up the system will effect assay results and system performance After four hours of inactivity the stat
61. description The Batch Data area displays sample results The left column shows plate location and Sample ID description The remaining columns display selected bead sets for the assay Each row represents the data for each bead set from one well The Acquisition Detail Toolbar shown in Figure 12 provides functions to acquire raw data without using templates The toolbar has additional buttons if you have Developer s Workbench installed For more information about the commands on the Acquisition Detail Toolbar see the Command section beginning on page 28 Luminex IS Software Manual for Version 2 3 xMAP Technology Siam p xox A lll 1 2 3 4 567 1 Replay Batch 6 Cancel All 2 New Advanced Batch 7 Eject Retract 3 View Batch Data 8 Pause 4 Start Plate 9 Resume 5 Cancel Command Figure 12 Acquisition Detail Toolbar The Histogram in the lower left section of the Acquisition Detail tab 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 You cannot change the gate position during batch acquisition You can change the gate positions before data acquisition after the system f
62. dle CommandNo 1 of 1 ammande 1 af 4 Plate Location D1 Plat Plate Location C1 Plat Plate Location C1 Plat Plate Location B1 Plat Diata acatian R4 Diac T gt Figure 8 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 Luminex analyzer including lasers and system calibration status The values displayed are reported directly from the Luminex analyzer and the Luminex XYP instrument It shows whether the calibration or control results completed successfully by displaying green text for successful events and red text for failed events The system diagnoses real time system problems related to fluidics and optics The system also detects and reports if the Luminex XYP PN 89 00002 00 110 Rev A Luminex IS Software Manual for Version 2 3 xMAP Technology heater block temperature is out of range or experiencing unacceptable temperature conditions including these items e Luminex XYP heater block temperature time out e heat circuit failure temperature out of range sensing temperature change since calibration or a change in channel temperature Table 1 defines the values listed in the System Monitor These values are useful
63. ds and controls that you use to create a template Products are analogous to reagent kits They are used in the template s definition for the multi analyte assays that will be performed A value that determines a cutoff or threshold This in conjunction with ranges using the Lum Qual Formula Adv Qual Formula or an edited range specific for your assay helps to determine qualitative results for unknown samples 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 95 Luminex IS Software Manual For Version 2 3 reporter channel RP or RP1 RP1 RP sample sample reaction sheath fluid signal standards microspheres assay suspension system controls template test verification xMAP 96 xMAP Technology quantify an analyte Examples of acceptable reporters 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 reporter channel The mixture of assay components microspheres reporter patient diluent that are analyzed The reaction that occurs between your reagents
64. e analyzer is set to the draw distilled water from the well you loaded it in step 2 of Run System xMAP Calibrators on page 43 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 dropdown menu located to the right of the Wash button PN 89 00002 00 110 Rev A xMAP Technology Selecting Existing CAL or CON Lots Importing CAL or CON Lots Exporting CAL or CON lots PN 89 00002 00 110 Rev A 9 Luminex 2 3 Software Click OK and wait until the wash completes The device status section in the status bar changes from Running to Standby If an error occurs during system calibration or verification an X appears in front of the Diagnostics tab title and the title text turns red To select an existing lot 1 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 1 4 4 1 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 co
65. e are two main assay types non competitive such as a 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 is determined from this replicate average 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 PN 89 00002 00 110Rev A xMAP Technology Note Luminex does not recommend performing Data Analysis while the Luminex System is performing data acquisition on another batch Customize Data Analysis Settings PN 89 00002 00 110 Rev A Luminex 2 3 Software The system can analyze only batch
66. ecalc button manually recalculate is grayed out In the auto selection mode changes automatically trigger the system to reanalyze the affected test If you are not using the auto mode the ReCalc button is available after you make a change such as changing a formula or lot or invalidating or validating a standard or control Replays 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 data is not altered A new file is created The most common use is for system demonstration and training Enables the median fluorescence intensity MFI to appear on the Analyte Report Resumes the process that was paused Raises and lowers the sample probe to adjust the probe height This adjustment is recommended when using different microtiter plates or when changing sample probes Refer to the Luminex 200 System Manual or the Luminex 100 IS User Manual for Version 2 3 for the adjusting procedure Uses the Luminex XYP reservoir due to volume requirement The sanitize command performs a similar function as the alcohol flush command However the sanitize command uses 1096 to 2096 household bleach to decontaminate sample lines and the cuvette after biohazard contact If selected displays the run batch tab immediately after you set up batch information and click Finish Allows you
67. ection 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 The Diagnostics tab turns red if all substances CAL or CON have not been run and under the following conditions the first time the software is opened the first time a system is calibrated anew database is installed e an old database is restored a CAL or CON fails You must run system controls following calibration Continue with the following Run System xMAP Controls section Run System xMAP controls to verify calibration Dispense the Control microspheres into the microtiter plate at the same time that you dispense the Calibration microspheres See Run System xMAP Calibrators on page 43 To verify system calibration with controls 1 Inthe Maintenance tab click New CON Targ The Update CON Target Information dialog box opens See Figure 26 2 Enter the CONI lot number expiration date and the values listed from the COQ included with your system controls into the CONI entry boxes If you are using a previously entered lot select it from the drop down menu in the Current CON 1 group box or click Import to import the information See page 47 for more details on importing a lot 3 Repeat step 2 for the CON2 lot information 45 Luminex IS Software Manual for Version 2 3 46 Update CON
68. ed CV Location Sample Test 22 Total Events Notes 1 Std s 23 9771317653444 75 2 Std m 26 4392256987905 75 3 Std 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 Comment 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 1 3985 75 4 Std xl 371 5 75 5 Std xxl 15788 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 00 110 Rev A 107 Luminex IS Software 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 3 Std l 925 292874765645 75 4 Std xl 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 29
69. ed 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 Onthe Tools menu click Erase Database The Choose Date calendar opens 2 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 3 Click OK The Delete Database Entries dialog box opens and warns that you are about to delete database records 4 If you are sure you want to delete this data click Yes The system deletes all events stored before the day you select Restore the database from a previously saved database To restore information to the database 1 On the Tools menu click Database Restore The Restore Database dialog box warns you that the Luminex IS 2 3 software will shut down after restoring the database 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 The system restores the previously saved database Notice that the files are organized by date month day year 4 ADatabase Restored dialog box opens the next time you start up the system The dialog box prompts you to verify that the lot 87 Luminex IS Software Manual for Version 2 3 xMAP Technology information for CAL 1 CAL2 CONI and CON reagents are correct 5
70. elect oc E IVDMathCommon E GraphObjectsinterface dll E IVDDevice dll E IVDMathE xp dll My Documents E IVD CalReport oc Eil IvDGraphwirapper ocx E IVDMathinterface Im Nus H My Ci t a Cancel My Network P Open as read only Z Figure 28 Open Patient List File Dialog Box 11 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 first empty location following the batch s last command list activity See Add a Patient List on page 58 for information regarding the patient file format 12 Verify the dilution factor settings and adjust as necessary See page 60 for more information 13 Select Save and Load default or Save Only 14 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 15 If you selected Save and Load load the plate using the Eject Retract button then click Start Plate Use this procedure to open an existing batch The batch name and description appear on the Run Batch tab when you load the batch You can open Saved Only batches with this procedure To open a saved batch for an acquisition 1 Click Open Batch The Open Batch dialog box opens 51
71. elected To validate or invalidate a standard or control entry using the Invalidate and Validate Buttons 1 Select the desired standard or control name in the Standards or Controls grid 2 Click the appropriate buttons at the bottom of the Analysis window Invalidate Standard F4 Validate Standard F5 Invalidate Control F6 or Validate Control F7 3 The appropriate Standard or Control dialog box opens 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 Name box reverts to black text 4 Click Recalc to recalculate the results if the Auto option was not selected 80 PN 89 00002 00 110 Rev A xMAP Technology Luminex 2 3 Software Change Lot Use the Change Lot command to edit the lot that is applied to the batch currently opened in data analysis To change the lot to another available lot 1 Click Change Lot Alt F8 located at the bottom of Analysis window to display the Choose Lot dialog box See Figure 55 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 55 shows standard and control Figure 56 shows standard only Choose Lot The following is a list of lots that are available to apply to this batch Please choose
72. elp file Use this command if you need instructions on using a feature in the Luminex IS 2 3 software Opens a dialog box in which you select a calibration file that contains calibration lot information to import to use for calibrating the analyzer Opens a dialog box in which you select a control file that contains control lot information to import for use when verifying calibration Opens up the Import Template dialog box from which you select a template to import for use in a batch This combination menu command on the Batch Setup window 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 The two options on the menu are Acquire Patient and Skip Invalidates or removes a control from the data analysis Luminex does not recommend invalidating controls Removes a standard from the data curve Use this command if doing so improves the curve fit Use caution when doing so because invalidating a standard will greatly affect the curve fit and subsequently the sample results Opens the Open Patient List File dialog box from which you select a patient list text file to append to a batch Toggles the x axis scale on the histogram or dot plot between logarithmic and linear modes Toggles between maximum and minimum histogram and dot plot views This command is found in the Analysis window Use this command to view the next test in the batch Assay develop
73. emperature setting the XYP Heater Temperature thermometer is red Upon reaching the target temperature the thermometer turns green See page 9 for more information about the system monitor Warning The heater plate of the Luminex XYP instrument is hot when in use and may cause burns Do not touch the heater plate To set the Luminex XYP instrument heater temperature 1 Click Eject Retract to eject the plate holder 2 Set the Luminex XYP heater block on the plate holder 3 Click Eject Retract to retract the plate holder 4 Inthe Temperature and Gauges area of the Run Batch tab 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 Use the up and down arrows beneath the target temperature box to set the temperature you want the Luminex X YP 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 before processing samples The thermometer turns green when the temperature is stabilized Calibration Procedures Calibrator xMAP microspheres are used to normalize the settings for the reporter channel both classification channels and the doublet 42 PN 89 00002 00 110 Rev A xMAP Technology Run System xMAP Calibrators Note When dispensing calibration and control microspheres hold the bottle upside down at a 90 degree angle to the microti
74. ent types of reports Analyte Report prints some or all of the samples grouped by the test in a batch Clinical Patient Report provides a breakdown of samples according to the test analysis with that sample Patient Summary Report prints all of the test results for a patient may include all tests or selected tests on the report Quality Control Report used to track the trends of assay standards and assay controls over a period of time Maintenance Report provides a history of all maintenance Operations performed during the date range entered by the operator Batch Summary Report prints batch information in a sample versus test grid format useful for an assay developer to quickly reference a test result for a particular sample Calibration Trend Report provides information about all instrument calibration operations that occurred during the date range entered by the operator System Control Trend Report provides information about all verification operations that were performed during the date range entered by the operator Data Analysis Report displays all the information available in the Data Analysis window You access this report through the Analysis Window For more information on printing this report see page 85 To print a report from a batch or a specific time frame Install the printer before initiating the print command 82 PN 89 00002 00 110 Rev A xMAP Technology Luminex 2 3 Software 1
75. ergy 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 00 110 Rev A xMAP Technology Luminex xMAP microsphere set laser microparticle microspheres multi analyte multi batch photobleaching PMT product Quali qualitative quantitative reporter PN 89 00002 00 110 Rev A Luminex xMAP microsphere set Luminex multi analyte microspheres containing a unique mixture of two distinctly colored fluorochromes to distinguish them from other multi 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 A group of standar
76. ers use New Advanced Batch to acquire data without having to build templates This provides the developer with a faster and more convenient tool to develop assays It does not store the results in the Luminex IS 2 3 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 PN 89 00002 00 110 Rev A xMAP Technology New Batch New CAL Targ New CON Targ New Lot Open Batch Open Help Open Incomplete Batch Open Multi Batch Pause Previous Test Prime PN 89 00002 00 110 Rev A Luminex 2 3 Software Acquisition Detail tab When you click on the New Advanced Batch button the Options dialog box opens where you enter information about the batch define bead events for the session and define commands for plate layout Opens a dialog box in which you select a template to create a new batch in the Luminex Batch Setup window Opens the Update CAL Targets dialog box in which you enter information about the calibration microspheres you are using to calibrate the system Opens the Update CON Targets dialog box in which you enter information about the control microspheres you are using to verify system calibration Opens the Open Template dialog box from which you select a template to which you want to add a lot or edit lot information 1 The Open Batch command selected from the file menu or toolbar
77. ert off plate commands establish 66 M maintenance reports 82 MFI 72 O off plate commands 65 P patient summary reports 82 Preliminary Off plate commands clear 65 processed batches analyze 79 Q Quality Control Report 82 R raw fluorescence 36 remove controls 80 standards 79 report raw fluorescence 36 reprocess batches 52 restoring the database reload database previously saved 87 PN 89 00002 00 110 Rev A Index 1 Luminex 100 IS User Manual Version 2 3 S Sample Errors 22 sample progress 11 samples tab 21 sanitize 41 91 92 remove air bubbles 41 with 70 isopropanol 41 setting 42 standards tab 21 storage raw data 36 system drain 89 errors 22 trend report 82 T tabs samples 21 standards 21 templates 48 test analysis view 79 V verification command 43 setting well location 43 updating lots 43 View detailed test analysis 79 W warnings 42 X XYP heater temperature 42 Index 2 xMAP Technology PN 89 00002 00 110 Rev A
78. erve caution when doing so Invalidating standards greatly affects the curve fit and subsequently the sample results For further instruction on assay standard curves and the appropriateness of invalidating or removing standards contact the assay kit manufacturer 79 Luminex IS Software Manual for Version 2 3 xMAP Technology 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 right mouse click procedure 1 Right click in the row containing the standard or control you want to validate or invalidate See Figure 54 Select the desired menu item to apply When invalidating the Name box turns red with an asterisk proceeding it When validating the Name box reverts to black text Invalidate Standard Invalidate Control 1 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 54 Invalidate and Validate Shortcut Menus 2 Click Recalc to recalculate the results if the Auto option was not s
79. es that it acquires using qualitative or quantitative templates It does not analyze acquisitions using Data Collection Only or Maintenance templates For an overview of the Analysis window see page 21 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 right click menu 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 Click Data Analysis 2 Double click the desired batch The Analysis window opens displaying the Standards tab 3 Double click anywhere within the graph to display the Customization dialog box See Figure 46 Notice across the dialog box are five tabs General Axis Font Color 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 xi General Axis Font Coor Style Main Tithe r Test 36 B Numenc Precision Sub Title SI Y 9 PA Viewing Style Grid Lines Color Boh C Y C X C None C Monochrome Grid in front of data C Monochrome Symbols
80. ess to the Developer Workbench DWB software features Details about these features are provided in the Luminex Developer Workbench Guide Version 2 3 documentation You must have the DWB software installed to enable these features Caution Do 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 features Batch Name and Description e Batch Data Area e Acquisition Detail Toolbar e Histogram e Dot Plot Figure 11 identifies the major features of the Acquisition Detail tab 12 PN 89 00002 00 110 Rev A xMAP Technology Batch Name Batch 4 26 2005 10 42 Batch Description Autosize Statistic Median y Luminex 2 3 Software Luminex100 Integrated System 2 3 SHA x All Loc Sample TestA 39 TebtB 56 Test C 36 ire Mstand A3 Platel B3 Platel C3 Platel E3 Platel Show Bead Acquire Lstand Acquire Lcon F3 Plate Acquire XLcon alb 8 ajtde a to ej Classification 2 100 1 7500 15000 PN 89 00002 00 110 Rev A 1 Luminex IS 2 3 Toolbar 5 Status Bar 2 Batch Name and Description 6 Histogram 3 Batch Data Area 7 Dot Plot 4 Acquisition Detail Toolbar Figure 11 Acquisition Detail Tab The Batch Name and Description section displays the name of the batch as well as its
81. for diagnostic purposes when communicating with Luminex Technical Support Table 1 System Monitor Values Property Air Pressure Value Units of Measure PSI air pressure to the sheath container from the air pump Sheath Pressure PSI sheath 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 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 Range Indicates if the XYP heater is in the set range PN 89 00002 00 110 Rev A xMAP Technology Luminex 2 3 Software The Detailed Sample Progress section 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 Expand Margin up down and left right arrows t
82. g Box 2 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 no associated lot information a New Standard Lot or New Control Lot dialog box opens as appropriate Enter the standard and control numbers to continue Once you enter the numbers the Update Lot Information dialog box opens See Figure 42 and Figure 43 67 Luminex IS Software Manual for 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 43 That is if you are creating only standard lots then only the upper part of the screen displays 68 xMAP Technology b If the template has associated lot information the Update Lot Information dialog box opens To create a new lot when there is an existing lot click New Lot on the Standard or Control section of the dialog box A New Standard Lot or New Control Lot dialog box opens Enter the standard or control lot number See Figure 42 and Figure 43 3 Click OK New Standard Lot Number New Control Lot Number OK Cancel Figure 42 Add Lot Standard and Control Dialog Boxes Import Export 7 Cal x Lot Lot Revert Save Cancel Change the current lot by saving selected lot Test Standards 2000 Current Lot B3654QtStd Current Lot 836540t8td 7 NewLot Delete Lot Exp Date 06 05 2008 Update L
83. group contains the New Batch New Multibatch and New Lot buttons For more information on creating and running batches and multibatches see page 48 For more information about these commands see the Commands section on page 28 The Reports and Analysis group contains the Analysis and Print buttons For more information on running reports and analyses see page 82 For more information about the Analyses and Print commands see the Commands section on page 28 The Daily Shutdown group contains command buttons that you can use when shutting down the system For more information on performing a daily shutdown see page 91 For more information on the Sanitize and Soak commands see the Commands section starting on page 28 The Run Batch tab contains a microtiter plate and reservoir image XYP and DD temperature readbacks a sheath pressure gauge print button command list displaying batch commands and their status and plate and XYP command buttons See Figure 4 Luminex IS Software Manual for Version 2 3 xMAP Technology Ele Tools Help 2 nm d El zi E B 2 Ji Single Step Home Run Batch Maintenance Diagnostics Acq Detail Luminex100 Integrated System 2 3 lt No Batch Loaded gt E EE AA A A EA ETSI 2 0999099999999 1900000000000 QOOOOOOOOOOO a 0OOOOOOOOOQOO DOOOOO0O00000O gKOOOOOOOOOOQO DOOO00000000 amp OOOOOOOOOOOO CmdNo Command Plate Loc Cmd Status
84. he acquisition For information on setting the XYP instrument heater temperature see page 42 The Command List displays commands associated with batches new advanced batches or multi batches loaded for processing on the system The Command List shows the status of each command as the system processes it and whether the command completes successfully or fails Figure 5 shows that the first two commands were successful the third command is running and the rest of the commands are pending Figure 6 shows that the third command failed Esa CmdNo Command Plate Loc Cmd Status 1 XY Heater On none Plate1 Succeeded 0 sec 2 Reservoir Wash Reservoir Plate1 Succeeded 23 sec R 4 Acquire B1 Plate1 Pending 5 Acquire C1 Plate1 Pending 6 XY Heater Off none Plate Pending Figure 5 Command List Section of the Run Batch Tab CITT EE 3 CmdNo Command Plate Loc Cmd Status 1 XY Heater On lt none gt Plate1 Succeeded 0 sec 2 Reservoir Wash Reservoir Plate1 Succeeded 23 sec 3 Acquire Lstand A1 Plate1 FAILED Bt Platel R 5 Acquire C1 Plate1 Pending 6 XY Heater Off lt none gt Plate1 Pending Figure 6 Command Failure Notation in the Command List Errors are recorded in the Message Log on the Diagnostics tab See page 9 for more information about the Diagnostics tab Double click on failed commands in the Message Log for additional information You can right clic
85. ian 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 IS 2 3 software the only report affected by this selection is the Analyte Report All others are hard coded by the system Auto Start Analysis Select this feature to enable 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 36 PN 89 00002 00 110 Rev A xMAP Technology Define Company Information Tab PN 89 00002 00 110 Rev A Luminex 2 3 Software Luminex100 15 Software Options la x General Company Information Data Export Default Batch Directory CMy Batches mi Current User Analysis Display Digits 2 iv Display Confirmation Screens F Enable Raw Data Storage I Report Raw Fluorescence F Auto start Analysis E P Fares Figure 21 Options Dialog Box General Tab You can enter information about your company and a company logo into the Company Information tab This information is stored in the Registry for reference The logo will not alter any Luminex IS 2 3 report or screen Company Information name address phone and fax numbers and location of company logo Use the browse button mi to navigate to the location where the logo is stored f Luminex100 15 Software Options 154 x General C
86. igned by the party against whom enforcement is sought The waiver or failure of Luminex or you to exercise in any respect any 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 Luminex 2 3 Software 1 Main Window oooocooooococ ence eens 1 Menu Bar a NR Bates 3 Toolbar 32 A ee ales he aes 4 WA EEEE tid Otay ph OREM Ea ORE ORS EGS ER dud 4 status Bat zo Lot eL E AL E RUE PEE oes 16 Secondary Windows 0 eee eee eee eee ee 19 Batch Setup Window 0 0 02 e ee eee eee ee 19 Analysis Window 00 cee cece eee ene 21 Commands de eee ia ea Me ee aid 28 Acquire Patient ip pede Ree a ane 28 Add Batcli 23 5E e tn nS 28 Alcohol Bl sh ii RELAX 28 Autoscale i Ee te rl dai 28 AULOSIZE puc ia d bU pM diee die dus 28 Backtl sh uisi a ae ada ER D MOS RE 28 CATA 2 ume e e IGNI SERE IE 28 CALZ ido BO EM 28 Cancel Command 00 eee eee 28 Cancel AIL a te et A elas 28 Change Lotina is wale ier nee 28 CONI ai a iia 28 COND eres e dl eo Ral se RANE E som I 28 Connect to Instrument 00 eee 28 Create New Multi Batch oooooooomooom o 29 Delete Batch ec RR Ine hU es ER s pg 29 Density Decaying sees 29 Display Confirmation Screens 0 000000 29 Discon
87. ing 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 are bounded at the bottom right edges with shadows 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 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 PN 89 00002 00 110 Rev A xMAP Technology Luminex 2 3 Software Test 36 Customization E General Axis Font Color Style m Graph Attributes c Desk Background a A E a B E E LJ x mawn E Y SY L1 C Graph Foreground C Graph Background Cancel Original Export Maximize Figure 50 Customization Dialog Box Color Tab Style T
88. ining the samples in the microtiter plate Colors indicate the progress in analyzing the samples The following well colors indicate well acquisition states PN 89 00002 00 110 Rev A xMAP Technology Luminex 2 3 Software Green well with command number sample not acquired Yellow well sample currently in acquisition Red well sample failed Check the system monitor for more information Green background with check mark successfully completed Common sample errors are due to lower number of events acquired than established in the template Importing You need to import new templates to the system only once You Templates 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 the template until it is changed Templates include standards controls both standards and controls maintenance commands and acquisition commands 1 2 5 Create a New 9 Batch 1 PN 89 00002 00 110 Rev A To import a template from a diskette or CD Insert the kit s diskette or CD into the appropriate drive On the File menu click Import Template The Import Template dialog box opens 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 The kit manufacturer s template appears on the selection list
89. inishes acquiring data or after pausing the system The change is visual The data is still collected according to the gate positions set in the assay template or New Advanced Batch setup 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 also located in the lower corner of the histogram are used while collecting data are the numerical values selected in the template or the New Advanced Batch o o N Show Bead lt all gt z t tx 2 E 150 Events 100 50 1 10 100 1000 10000 7500 15000 Doublet Discriminator 1 Gate Boundaries 2 Aggregate Beads 3 Numerical Gate Position Figure 13 Set DD Gate Example 14 PN 89 00002 00 110Rev A xMAP Technology PN 89 00002 00 110 Rev A Luminex 2 3 Software The Histogram contains the Show Bead menu and four buttons Autoscale Zoom Log Linear Maximize For more information on these commands see the Commands section beginning on page 28 The Dot Plot or bead map appears in the lower right section of the Acquisition Detail tab See Figure 14 The dot plot shows a graphical display of real time data collection Luminex recommends using the default settings to collect data The default axes are Classification 1 on the X axis and Classification 2 on the Y axis To
90. is 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 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 ca
91. ish to accept your edits and close the dialog box E Edit Patient List Batch 4 5 02 12 09 ID 6 Ljolx Location Sample ID Dil Factor C1 al 1 Y pi D Finish El 1 F1 i f 1 X Cancel LJ Load Pa List Figure 33 Edit Patient List Dialog Box Assign Sample Indicate the sample dilution factor so the sample analysis in Dilution Factors quantitative tests is accurate The system multiplies the result by the dilution factor for reporting 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 60 PN 89 00002 00 110 Rev A xMAP Technology Create a New Advanced Batch PN 89 00002 00 110 Rev A Luminex 2 3 Software To assign sample dilution factors 1 On the 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 34 3 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 patien
92. isk View Files Cancel Figure 63 Disk Cleanup for Selected Drive To delete the Message Log directory In the Cleanup Utility dialog box click Delete MsgLog In the Cleanup Utility confirmation dialog box click Yes To delete the batch folders In the Cleanup Utility dialog box click Delete Batch In the Cleanup Utility confirmation box click Yes to delete all the batch folders All the folders under C My Batches are deleted The C My Batches folder remains Sanitize the system with 10 to 20 household bleach to decontaminate the sample lines and the cuvette after biohazard contact You should sanitize 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 91 Luminex IS Software Manual for Version 2 3 xMAP Technology To sanitize the fluidics in the analyzer 1 On the Maintenance tab click Eject Retract 2 Put the bleach solution in the reservoir 3 Click OK The plate holder retracts and the system performs the Sanitize command 4 Runtwo Wash commands Run a Wash Use the wash command as part of shutdown procedure and as Command needed especially after calibration and after sanitizing Place at least 200 mL in a microtiter well or fill the Luminex XYP reservoir with distilled water To perform a Wash command Onthe
93. ists tests from your batch and displays the results for each sample Figure 20 shows a Sample tab example listing three tests Notice that the left pane displays Test IL 4 IL 6 and IL 8 with Test IL 4 selected The right pane 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 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 The Comments column cells are editable and the information is displayed in reports Open Batch Export Data Close Protein Batch IL 4 Sample ID R 2 0 9995 Sample High Low Background R 2 0 9999 Sample High Low Background Sys Sample High Low Sys Sample High Low Sys Sample High Low Sys Sample High Low Unknown 1 569 61 Unknown 2 N A 0 Unknown 3 N A 0 Unknown 4 4508 602 40 9 Next Test F2 invatidate Standard F4 Invalidate Control F6 Change Formula F8 Es any OR order RETO recae IV auto Previous Test F3 Validate Stand
94. it 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 PN 89 00002 00 110 Rev A xMAP Technology Luminex 2 3 Software 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 occasion 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 Numeric 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 gr
95. k Select The Update Lot Information dialog box opens See Figure 45 3 Click Import Lot The Open dialog box 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 70 PN 89 00002 00 110 Rev A xMAP Technology Export a Lot from an Existing Template PN 89 00002 00 110 Rev A Luminex 2 3 Software Update Lot Information Import Export 13 la x i uer Revert Save Cancel Change the current lot by saving selected lot r Test Standards 2000 Current Lot B3654QtStd Current Lot EREE gt NewLot Delete Lot Exp Date 06 05 2003 7 r Test Controls 2000 Current Lot B3654QtCon Current Lot B36540Con y NewLot DeleteLot Exp Datefo3 07 2003 LowLimit Expected Values High Limit Test 54 mg dL 405 Figure 45 Update Lot Information Dialog Box Use this procedure to export a lot for use on another instrument Depending on the template and its associated products you may have standards controls or both Standards and controls can be grouped into the same lot number 0 To export a lot from an existing template 1 On the Home tab click New Lot The Open Template dialog box opens 2 Double click the template containing the lot to export The Update Lot Information dialog box opens See Figure 45 3 Click Export Lot A standard or control confirmation dia
96. k a highlighted row to copy data to the clipboard or clear the batch from the screen Luminex IS Software Manual for Version 2 3 xMAP Technology Maintenance Tab Use the Maintenance tab to perform maintenance XYP daily startup calibration and verification commands to maintain your system and keep it in optimal working order tn Luminex100 IS Software Luminex100 Integrated System 2 3 A ash y J Reservoir vi ain y r Figure 7 Maintenance Tab See the Commands section starting on page 28 for detailed information about these commands Warmup Prime Backflush Alcohol Flush Sanitize Wash Drain Soak Self Diagnostics Calibration Commands CAL 1 CAL2 CON 1 CON2 New CAL target and New CON target Sample Probe Down Eject Retract PN 89 00002 00 110 Rev A xMAP Technology Diagnostics tab h Luminex100 IS Software File Tools Help EL Luminex 2 3 Software Instructions for maintenance procedures begin on page 88 Table 11 on page 88 shows a recommended use schedule for maintenance operations Use the Diagnostics tab to monitor the progress of commands you initiate in the system Features on this tab monitor the state of system components This tab displays the System Monitor Detailed Sample Progress chart and Message Log The 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 ME
97. labeling for non competitive assays are shown in Table 6 Figure 18 shows what a standard curve for a non competitive assay should look like Table 6 Non Competitive Out Of Range Labeling Condition Concentration Label MFI of Standard Referenced Left of Curve min concentration standard Lowest Right of Curve max concentration standard Highest a STDS Median Unknown B Fluorescent Unknown A Concentration Intensity Concentration gt STDS MFI lt STD1 Concentration Figure 18 Non Competitive Assay Examples of out of range sample labeling for competitive assays are shown in Table 7 Figure 19 shows what a standard curve for a competitive assay should look like Table 7 Competitive Out Of Range Labeling Condition Concentration Label MFI of Standard Referenced Left of Curve min concentration standard Highest Right of Curve max concentration standard Lowest 24 PN 89 00002 00 110 Rev A xMAP Technology PN 89 00002 00 110 Rev A Luminex 2 3 Software Unknown C STD 1 Median Fluorescent Concentration STO 3 Unknown D Intensity STD 1 Concentration MFI gt STOS Concentration Figure 19 Competitive Assay 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
98. late Cmd s Figure 38 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 The command list dialog box appears similar to Figure 40 Click the OK button next to the Command List 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 p Preliminary Off Plate Cmd s P Clear Off Plate Cmd s MMC N N Figure 39 Preliminary Off Plate Command Corner Marker To clear preliminary off plate commands right click on the corner marker or plate layout and select Clear Off Plate Cmd s See Figure 39 65 Luminex IS Software Manual for Version 2 3 xMAP Technology General Bead Set Plate Layout Right click the grid to display the popup command menu Establish the offplate commands to run before the plate begins Acquire Data Cmd Name Warmup 1 Reservoir Wash Prime Backflush Sanitize Reservoir Drain Cancel Clear All Self Test OK Cancel Figure 40 Plate Layout Tab Off Plate Commands 12 Insert off plate commands You c
99. lates PN 89 00002 00 110 Rev A xMAP Technology PN 89 00002 00 110 Rev A Luminex 2 3 Software To create a multi batch with new batches Click New Multi Batch The Luminex Multi Batch Setup dialog box opens shown in Figure 30 1 Luminex Multi Batch Setup Please enter 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 PARAE Add Batch New Batch Finish Cancel pum Name mu By OOOOODODOD0O OOOOO000000O QQOOOOOO0000 OOOOO0000000O QQQOOOOOO0O00O QQOQOOOOOO00O QQOOOOOO0000 le 7 mienne OQOOOOOOOO0O0QO00 NoIID Batch Name Batch Description No Omds 7 Figure 30 Luminex Multi Batch Setup Dialog Box In the Luminex Multi Batch dialog box click New Batch Create a New Batch The procedure is shown on page 49 Click Save and Load instead of Save Only when you are finished setting up the New Batch To reassign the positions of the batches within the multi batch use the mouse to drag the highlighted well to the location on the microtiter plate where you want to begin acquiring data Make sure that each additional batch is in its desired location Enter the Multi Batch name and Created By then click Finish The Run Batch tab opens representing the batches you selected or created on the microtiter plate Click Eject and load the first plate of the multi batch
100. lculated because it fell outside the valid range of the curve fit gt 10000 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 The number of gated events that fell within the test s specified region Mean 100 Optional The sum of the data points in the distribution divided by the number of data points Mean Ex N PN 89 00002 00 110 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 NEx x N N 1 12 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 N Trimmed C
101. liability for errors or omissions or for damages resulting from the application or use of this information This chapter refers to the Luminex 100 analyzer but it can also be used for performing tasks in the Luminex IS 2 3 software installed for a Luminex 200 analyzer The Output CS V 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 with 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 Sample 97 Luminex IS Software 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 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
102. log box opens verifying that you want to export the current lot for the standard or control 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 control lot or current lot for a control Luminex IS Software Manual for Version 2 3 Analyzing Batches and Multi Batches 12 xMAP Technology 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 File Name box 6 Click Save The system saves the lot 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 creation A Qualitative analysis determines results as either positive or negative reactive or non reactive and so on The system is flexible in defining custom result ranges such as negative low positive high positive and so on Refer to the Luminex Developer Workbench Guide Version 2 3 for additional information All determinations are based on a single standard A Quantitative analysis determines the sample concentrations from standard curves using regression methods such as 4P or 5P logistic curve fitting Ther
103. n 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 PN 89 00002 00 110Rev A xMAP Technology Delete Database Entries Restore Database PN 89 00002 00 110 Rev A Data Luminex 2 3 Software 2 Choose the file name and location of the database that you want to back up The default name is LX100IS month date year 3 Click Save The LX100 IS Database Backup dialog box opens informing you the backup is in progress to the specified location 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 affect
104. nect from the Instrument oo oooooooooo o 29 Dr eon b ee bee bi eas 29 BjecURetract oo be pe llc gel ees RE ESSI 29 Enable Raw Data Storage lees 29 Export Batch Data llle 29 Export CA Lents wee dr ua 29 Export CON cuidada is es iS UR e 29 Export Dala is 29 PN 89 00002 00 110 Rev A Luminex IS Software Manual For Version 2 3 xMAP Technology H lp ke aa A edam dedere her E Seer Sees 30 Import Calibration 0 0 0 0 eee eee ee eee 30 Import Control 2 0 eee eee ee eee 30 Import Template 00 0 aa ee eee eee 30 INSEL io etu e REO 30 Invalidate Control nias osipa ei ea cece 30 Invalidate Standard 0 0 eee cee oo 30 Load Patient List 0 0 0 00 eee 30 Log Eamear i ico ocean cb Se V ea UO 30 Maximize Minimize 0 0 cece eee eee eee 30 Next Destaca nep Ia ath anne sah shyt I ane seen eens 30 New Advanced Batch 0 0 0 cece eee eee 30 New Batch 2 2i As 31 New CAL Tarna a Panis ee Pals 31 New CON Tare wen sn ca nh ER AER S EE AED SEDE e 31 Nr e OR breve ead 31 Open Batch etes re eer btts 31 Open Help vir a eee ed eae EEE E a 31 Open Incomplete Batch 0 0 0 0 eee eee eee 31 Open Multi Batch 0 0 eee eee ee 31 PAUSE ide eedem p Ie qe md ale Re Pho date bate teal 31 Previous Testa senno pirata ete aes REG dt aa 31 PM PE HE Xe Ra ere aate 31 Print Batch Worklist ecceri einen oana a aea 32 Print Report 00
105. ng 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 CL 1 Volts CL2Volts RP1Volts DDRVal CL1RVal CL2RVal Passed MachineSerialNo Classification Calibrator L100 CAL1 A4206 06 07 2006 12 00 00 AM 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 A4110 02 18 2006 12 00 00 AM 07 28 2004 09 43 01 AM 26 7795138888889 1 4 6 3 1 te 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
106. ng 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 Table 4 shows the typical messages that appear in the PN 89 00002 00 110 Rev A Luminex IS Software Manual for Version 2 3 xMAP Technology status bar Additionally information displays as text on the Diagnostics tab Table 4 Status Bar Communication Message Details Status Bar Message Indicates Color Green Idle Waiting to process the next command Standby The Luminex analyzer is ready and waiting to perform a command Yellow Connecting The software is attempting to connect to the instrument Processing The instrument is communicating with the software as it processes commands Pausing The instrument has stopped processing the list of commands but finishing the active command Paused The software stopped processing the list of commands A resume func
107. nt 2 Patient 3 Patient 4 ES Previous Finish Cancel a Figure 59 Patient Selection Dialog Box 4 Select the desired entry or click the double arrow gt gt to select all the entries 5 Click Finish A report print preview appears using the information you entered You may have more than one dialog box in which to enter information 6 Click Print Report to print the report 7 The Print dialog box opens Select the desired parameters and click Print Export Batch Data 4 To export batch data Onthe File menu click Export Batch Data The Open Batch dialog box opens See Figure 60 ID Batch Name Description Multi Batch ID Name E 2 B3654 Quant Testing Mean SD Trimmed Mean 4 3654 Rep Quant Batch Mean SD Trimmed Mean 5 Batch 5 1 02 16 10 FILEMODE None 6 Batch amp 1 02 16 11 FILEMODE None 7 Batch 6 302 13 49_FILEMODE None B Batch 6 3 02 13 51_FILEMODE None 9 Batch 6 302 13 52 FILEMODE None 10 Batch 6 302 13 53_FILEMODE None 11 Batch 6 3 02 13 54 FILEMODE None 12 Batch 6 3 02 14 13 FILEMODE None 13 Batch 6 342 14 17 FILEMODE None 14 Batch 6 3 02 14 17_FILEMODE None 16 Ratch RAM 14 10 ElL EMODE Mones Figure 60 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
108. ntrol lot to import click the drop down arrow for the Look in box Browse for the appropriate folder diskette or CD location The file type is a lif file 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 in 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 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 47 Luminex IS Software Manual for Version 2 3 Batch Setup Procedures 48 xMAP Technology the Backup folder directory found in CAProgram Files Luminex Luminex 100 IS Backup 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 t
109. o expand the chart margins and view longer test names See Figure 9 1 2 Detailed Sample Progress 2 123 Complete tsi Tests Bead ID 1 Zoom button 2 Toggle button 3 Expand Margin arrows Figure 9 Detailed Sample Progress The Message Log is the lower pane on the Diagnostic tab It displays a list of completed commands errors and warnings It also displays command progress time and date and results See Figure 10 55 Da y me 01 11 10 06 AM Batch data exported SN atchesiDNA Batch_ID2A0uB 54 Commands Finished 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 Carmmand Ctartad Tima RISRISANA ALASAN AM Paramandhlarao Neanira Datiant 1 Camrmandadtla 19 af 1 al
110. o import to another computer 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 You can group batches together as a multi batch 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 Templates typically include assay standards controls and maintenance commands such as 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 conta
111. og box from which you select a batch to analyze Once you select the batch the Analysis window opens This command initiates data acquisition on New Advanced Batches and New Batches using system templates During acquisition the system draws sample from the microtiter plate for processing This command enables you to display selected statistics for sample data There are eleven different statistics CV Trimmed 96C V Count Trimmed Count Mean Trimmed Mean Median Trimmed Peak Peak Trimmed Std Dev and StdDev 33 Luminex IS Software Manual for Version 2 3 xMAP Technology Test Sort Orders This command is in the Data Export Tab of the Options tab You can select Alphabetical by test name Sequential by Region ID or by Template Setup Order Alphabetical by Test Name the tests are sorted by alphabetical order Sequential by Region ID the tests are sorted numerically by bead ID Template Setup Order the tests are sorted n the order set up in template regardless of name or ID Validate Control Opens the Validate Control dialog box In this box you choose to validate all control tests click Yes or only a single test click No Validate Standard Opens the Validate Standard dialog box In this box you choose to validate all control tests click Yes or only a single test click No View Batch Data Click to open a previously acquired batch that is stored in the database You cannot view New Advanced Batches
112. ompany Information Data Export Name l uminex Corporation I Address 12212 Technology Boulevard Austin TX 78727 6115 Phone 51233198020 51233198020 FAX 612 219 5195 Logo EN a Figure 22 Options Dialog Box Company Information Tab 37 Luminex IS Software Manual for Version 2 3 38 Define Data Export Tab Information xMAP Technology Use the Data Export tab to configure your export data See Figure 23 The following options 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 after acquisition completes If this is not selected while running a New Advanced Batch you must right click on the data grid to get your output csv file 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 IS 2 3 software to the Output csv file Test Sort Order Choose an option to define the so
113. opens the Open Batch Dialog box from which you choose an existing batch to use for acquisition 2 The Open Batch command on the Analysis window allows you to view data from a different batch Opens the online help file Opens the Open Run dialog box in which you select a batch to recover Opens the Open Multi Batch dialog box in which you select a multi batch to use for acquisition Pauses the command that the system is currently processing This command is found in the Analysis window Use this command to view the previously run test in the batch Removes air from the system s fluidic pathways by drawing Luminex xMAP Sheath Fluid from the sheath fluid container You do not need to supply solution in a plate Priming takes approximately one minute This command should also be used as part of the daily startup routine 31 Luminex IS Software Manual for Version 2 3 Print Batch Worklist Print Report Recalc Replay Batch Report Raw Fluorescence Resume Sample Probe Down Sanitize Save and Load Save Only 32 xMAP Technology Prints the status of each of the commands in the command list as well as the microtiter plate graphic Prints the data interpretation report including the standards controls graph of standards and Samples data Recalculates an affected test after a change is made to lot information There are two options Manual recalculate and auto If the auto checkbox is selected the R
114. ot Information Test Controls 2000 Current Lot B3654QtCon Current Lot B36540tCon NewLot DeleteLot Exp Datejos o7 2003 Low Limit Expected Values High Limit Test 36 Test 54 imgidL mg dL Con Normal 150 405 Figure 43 Update Lot Information Dialog Box 4 Enter the expiration date in the Exp Date field PN 89 00002 00 110 Rev A xMAP Technology Edit Lot Information on an Unused Template PN 89 00002 00 110 Rev A 5 1 Luminex 2 3 Software Enter the standard concentration values provided in the kit manufacturer s instructions See Figure 43 Enter the control reagent values The controls are divided into 3 separate tabs Low Limit Expected Value or 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 Highlight the template that you want to edit and click Select The Update Lot Information dialog box opens See Figure 44 Import Export x mr x ES La Revert Save Cancel Change the current lot by saving selected lot r Test Standards 2000 Current Lot B3654QtStd Current Lot EEEEISISISE gt NewLot_ Delete Lot Exp Date 06 05 2003 gt Test 36 Test 54 mg dL mg dL 15 Update Lot Information 150
115. ously entered lot select it from the drop down menu in the Current CALI group box or click Import to import the information See page 47 for more details on importing a Calibration lot S Update CAL Targets CAL 1 Product Information Lot Information Number Title Value L100 CAL1 Lot Number A2501 Name Expiration Date 05 02 2002 Classification Calibrator Manufacturer Target Information Luminex Target Channel Value i DD Target 9800 CL 1 Target Current CAL1 Lot A2501 A2501 3911 Import CAL 1 Export CAL 1 NewLot rCAL 2 Product Information Lot Information Number Title Value L100 CAL2 Lot Number A3735 Name Expiration Date 05 19 2002 z Reporter Calibrator Manufacturer r Target Information Luminex Target Channel Value Current CAL2 Lot A3735 A3735 Import CAL 2 Export CAL 2 New Lot Change the current lot by saving selected lot om Figure 25 Update CAL Targets Dialog Box 10 Repeat step 9 for the CAL2 lot 11 In the Maintenance tab click CAL1 then click OK The device 44 status section in the status bar changes from Running to Standby PN 89 00002 00 110Rev A xMAP Technology Run System xMAP Controls PN 89 00002 00 110 Rev A Luminex 2 3 Software 12 Click CAL2 then click OK Wait until CAL2 completes The Device Status s
116. oves obstructions from the fluidics pathways by drawing sheath fluid from the sheath fluid container You do not need to supply solution in a plate A backflush command takes about seven seconds Runs the Classification portion of the Luminex System calibration Runs the Reporter portion of the Luminex System calibration Cancels the process for the last command initiated Cancels all the commands in progress Opens the Change Lot dialog box from which you select a lot to apply to a batch Runs the verification for the Classification calibration Runs the verification for the Reporter calibration Establishes a connection between the PC and the analyzer PN 89 00002 00 110 Rev A xMAP Technology Create New Multi Batch Delete Batch Density Decaying Display Confirmation Screens Disconnect from the Instrument Drain Eject Retract Enable Raw Data Storage Export Batch Data Export CAL Export CON Export Data PN 89 00002 00 110 Rev A Luminex 2 3 Software This command opens the Luminex Multi Batch dialog box in which you add or create new batches to add to a multi batch Opens the Delete Batch dialog box which shows a listing of the unprocessed batches in the database When you highlight a batch and click Select in this dialog box the system deletes the selected batch Toggles between the default density dot plot and the decaying dot plot views Enables confirmation dialog boxes to display when yo
117. pt you for a new lot name This includes batches that have been set up 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 concentration values in an unused lot the system updates the lot with the new concentration values For assay reagents specified in templates you can create new lots edit lot information select pre existing lots for reuse import lots 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 set up a batch you can edit the lot value If you have entered lot information and have used the template to set up a batch even if 1t has not been acquired you must rename the lot To create a new lot 1 On the Home tab click New Lot The Open Template dialog box opens See Figure 41 Open Template Version 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 15 42 2 2 100 8 Template 2 5 02 10 04 2 2 101 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 2 2 101 12 Template 2 5 02 11 01 2 2 101 13 Template 2 5 02 11 02 Select Cancel Figure 41 Open Template Dialo
118. quantitative acquisition only or maintenance To reprocess samples using Replay Batch On the Acq Detail tab click Replay Batch The Browse for Folder dialog box opens displaying the My Batches folder Select the desired batch under the My Batches folder and click OK The Open Template dialog box opens Click on the desired template and click Select 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 After replaying a batch you can analyze the data 1 2 To analyze Replay Batch data Click Start Analysis In the Open Batch 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 29 53 Luminex IS Software Manual for Version 2 3 54 Delete a Batch Create a Multi Batch xMAP Technology ID Batch Name Description Open Batch Multi Batch ID Name 2 B3654 Quant Testing Mean SD Tammed Mean 4 3654 Rep Quant Batch Mean SD Timmed Mean 5 Batch 5 142 16 10 FILEMODE None 6 Batch 5 1 02 16 11 FILEMODE None 7 Batch 6 302 13 49 FILEMODE None B Batch 5 342 13 51 FILEMODE None 9 Batch 5 3 12 1352 FILEMODE None 10 Batch 6 3 02 13 53 FILEMODE None 11 Batch 8 342 13 54 FILEMODE None 12 Batch 6 302 14 13_FILEMODE None 13 B
119. r samples gates regions events on plate and off plate commands This feature does not store the results in the Luminex System database or allow you to perform data analysis on acquired batches The Luminex analyzer uses only the 100 region bead map However in the Acquisition Detail tab you can view the data for 25 50 64 and 100 regions and save the data to a csv file 61 Luminex IS Software Manual for Version 2 3 xMAP Technology 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 Tocreate a New Advanced Batch 1 Open the Acq Detail tab 2 On the Acquisition Detail toolbar click New Advanced Batch The Options Dialog Box opens with the General tab displayed See Figure 35 General Bead Set Plate Layout Name Description Operator Sample size 5o uL DD Gate Timeout 95 sec 7500 to 15000 Bead Events 1 100 regions PerBead Total Beads 100 OK Cancel Figure 35 Options Dialog Box General Tab 3 Enter the Name Description and Operator information 4 Edit the following information as desired 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 O to 400 where
120. re are the property of Luminex and are copyrighted Except as specified in the End User License Agreement any reproduction in whole or in part is strictly prohibited End User License Agreement EULA for Luminex amp 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 instrumenta
121. red during acquisition It organizes the errors in two categories System and assay errors top section of tab and Sample errors bottom section of tab Table 5 lists the errors in each category Quantitative Batch Test 1 Open Batch Export Data Errors F9 Standards F11 Samples F12 System Errors Failed Control in Batch Test 3 Failed Control in Batch Test 4 Sample Errors A2 Sample HighiLow H1 Sample High Low Next Test F2 Invalidate Standard F4 Invalidate Control F6 Change Formula F8 B ERATES Previous Test F3 Validate Standard F5 Validate Control F7 Change Lot Alt F8 22 E M Auto Alphabetically by Sample ID Figure 16 Analysis Window Errors Tab Open Table 5 Error Categories System and Assay Errors Instrument Not Calibrated Failed Verification system lists each failed control Failed Control verifier failed Temperature Divergence from Calibration Temperature Failed Curve Fit Analysis Error 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 Sample Errors Insufficient Bead Count Sample High Low Analyzer Error High Sheath Pressure Low Sheath Pressure Sample Timeout Sample Empty Cannot Calculate Inverse Function Different Qualita
122. rocess multiple plates during a batch or multi batch 1 Create the batch or multi batch See Create a New Batch on page 49 or Create a Multi Batch on page 54 Insert the first plate On the 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 underneath the sheath pressure gauge Click Eject then remove the acquired plate and load the next plate for processing Click Resume The system resumes the acquisition process 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 JE On the File Menu click Open Incomplete Batch The Open Run dialog box opens Select the batch you wish to recover from the list 57 Luminex IS Software Manual for Version 2 3 xMAP Technology 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 Scan in Samples The barcode reader lets you quickly enter sample identification With a Barcode numbers or accession numbers Use the Code 128 barcode label type Reader when scanning barcode labels into the system as patient identities Warning Laser light Do not stare into the beam Class II laser product
123. rting order For more information on the options see the Command section beginning on page 28 Additional Batch Information Select one or more options to add additional information to the exported batch file output csv 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 General Company Information Data Export Iv Auto Export Batches iv Copy Output csv to Common Output Dir T Promptfor Batch Comment I Write Sample Comments Additional Export Stats Additional Batch Information Template ID Template Name O Template Version O Template Desc o M Mean I Trimmed CV E C CV Trimmed Peak Template Dev Co O T Peak T Trimmed Std Dey Template Author d F Std Dev T Avg Results Sample Volume a I Trimmed Count DD Gate H Trimmed Mean Sample Timeout o zl r Export Location Label Style r Test Sort Order Sequential 1 2 3 Alphabetical by Test Name C Sequential by Region ID _ Template Setup Order C Plate Location A1 B1 C1 Both 1 A1 2 B1 301 P OK i Cancel a F a Figure 23 Options Dialog Box Data Export Tab PN 89 00002 00 110 Rev A xMAP Technology Setting up the Favorites List PN 89 00002 00 110 Rev A Luminex 2 3 Software To ad
124. s and Multi Batches 72 Running Reports and Analyses 000000005 82 Database Management Procedures 4 86 Maintenance Procedures 0 0 0 0 ce ee ee eee eee 88 Daily Shutdown Procedures 0 0 00 e eee eee 91 Glossary 93 Output CSV 97 OVerview iue cw AP EP eO Doreen 97 Overall Desi O rice ege d e t sheds Pe dia 97 Blank Lines in AAA AA tS 98 Field Definitions 2 0 0 0 0 0 eee eee ee eee 98 Statistics Definitions 0 0 0 0 cece eee ee ee ee 100 Statistics Column Definitions 000 101 Luminex 100 IS Output CSV file with no additional features enabled 0 eee eee eee eee 103 Luminex 100 IS Output CSV file with all additional features enabled wf e LLL Sa ea 104 PN 89 00002 00 110 Rev A 111 Luminex IS Software Manual For Version 2 3 xMAP Technology PN 89 00002 00 110 Rev A Luminex 2 3 Software Main Window PN 89 00002 00 110 Rev A This manual describes how to use the Luminex IS 2 3 software It includes a glossary and information regarding the CSV file setup The software user should have a basic familiarity with computers and Microsoft Windows Commands are often available through more than one method such as from the main menu bar the toolbar or on different windows However each procedure in this manual will describe only one method of accessing commands This chapter has the following sections Main
125. s of wells or one or more columns of wells You can define on plate or off plate commands Right click the grid to display the popup command menu 1 2 3 4 5 6 7 8 9 10 44 12 OOOOOOOOD000O COOOQOOO0OQOO0Q0C00 OOOOOOQO0O0000 C OOOOCOOO0O0O0Q00 0 QOQ000000000 COOOOO0O0Q0QO0O0000 C OOOOOOQOO0000 OOOOOOO0O0O0O0O00 z o 7 m 9 o s OK Cancel 9 10 Figure 37 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 38 Select the desired command The associated command symbol appears in the designated plate well To make a correction select the wells selected wells are outlined in blue right click over the selected wells to display the Command menu and then click Clear Selection from the list Table 10 following lists Plate Layout selection shortcuts PN 89 00002 00 110 Rev A xMAP Technology PN 89 00002 00 110 Rev A Luminex 2 3 Software Acquire Data CAL1 CAL2 CON1 CON2 Wash JA Drain Soak JA J4 Clear Selection JA Add Command Label s Clear Command Label s Insert Off Plate Cmd s Clear Off Plate Cmd s Preliminary Off P
126. s remain intact and unchanged You reprocess a batch using Replay Batch to e Runas 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 The number of beads for collection must be less than or equal to the number of previously collected in the original sample If you reprocess a batch with the same template parameters in a different template the system obtains results identical to the original 52 PN 89 00002 00 110 Rev A xMAP Technology Note The Open Batch dialog box does not list or show the templates associated to the batches PN 89 00002 00 110 Rev A Luminex 2 3 Software 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 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 standards or controls validation or invalidation type of analysis qualitative
127. scence 94 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 200 analyzer Principal fluid pathway within the optics component of the system 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 en
128. select the control name or Expected Concentration box for that control then click Change Lot When editing standard and control lot values the system may prompt you for a new 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 Background samples are commonly used in the assay process Although recommended the discretion on whether to use or not is left to the assay or kit developer If background samples are included they are 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 report net MFI 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 25 Luminex IS Software Manual for Version 2 3 xMAP Technology Samples Tab The Samples tab l
129. t a plate onto the plate holder 2 Make sure that the correct location is selected next to the Drain button Click Drain A confirmation dialog box opens 3 Click OK The Device Activity box on the Status Bar indicates that the system is draining To run self diagnostics 1 On the Maintenance tab click Self Diag 89 Luminex IS Software Manual for Version 2 3 xMAP Technology 2 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 minute to complete 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 If a diagnostics test failed an error message displays 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 Using the Cleanup Use the Cleanup Utility to Utility Perform a disk cleanup e Delete the Message Log Directory e Delete the Batch Directory To display the Cleanup Utility dialog box On the Tools menu click Cle
130. t information Note indicates a required field Insert Acquire Patient X fi Apply Batch mo No Location Command Sample ID Dil Factor Name A 1 A1 Plate1 Acquire Standard Standard Conc 1 1 Y Batch 6 3 02 10 36 5 2B1 Plate1 Acquire Standard 1 S e 8 3 C1 Plal Acquir ard 1 Finish Description 8 4 D1 Plate1 Acquire Standard 1 None z 8 5 E1 Plate1_ Acquire Standard Standard Conc 5 il 8 6 F1 Plate1 Acquire Control Control Reagent 1 c i ul T G1 Plate1 Acquire Patient 3 nes 8 H1 Plate1 Acquire Patient 3 Created By 9 A2 Plate1 Acquire Patient 3 Ld Nams B2 Plate1 Acquire Patient d toad eect r Template Info e Name Help Quantitative 1 Description al Quantitative 5 Stadards 1 seni Leal New Lot Control Pera r Standard Info Expired E Product No 1 Product Name Product Version No Lot Name A123456 pai Expiration Date 05 30 2002 r Control Info Expired Developing Co Product No 1 Product Name Product uminex Lot Name A123457 Expiration Date 05 30 2002 Figure 34 Luminex Batch Setup for Dilution 4 To change the dilution factor click the Dil Factor field 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 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 fo
131. tart Analysis feature is disabled when processing a multi batch To ensure that calculated data is exported to the output csv file you should not select both Auto Start Analysis and the Auto Export Batches checkbox on the Data Export tab of the Options dialog box Also note that Analysis and data reduction are synonymous terms To enable automatic analysis 1 On the Tools menu click Options then click on the General tab See Figure 53 Luminex100 IS Software Options 151xi General Company Information Data Export Default Batch Directory c My Batches E Current User p gt Analysis Display Digits 2 Iv Display Confirmation Screens F Enable Raw Data Storage F Report Raw Fluorescence m Auto start Analysis 9 OK E 1 A Figure 53 Options Dialog Box Select Auto start Analysis 2 Click the Auto Start Analysis checkbox then click OK When the system completes the batch acquisition 1t will automatically begin analyzing data PN 89 00002 00 110Rev A xMAP Technology Analyze Processed Batch Data View Detailed Test Analysis Validating or Invalidating Standards and Controls PN 89 00002 00 110 Rev A Luminex 2 3 Software 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 All batches within a multi batch have the multi batch name listed under the multi batch ID
132. ter Plate image 19 Luminex IS Software Manual for Version 2 3 20 xMAP Technology Command button group box Save group box e Standard Info group box Control Info group box New Lot button The Batch Info group box has text boxes in which you can input the name description and creator name of a new batch The Template Info group box shows the name description version number and developing company for the template that you are using in a batch The Insert command lets you insert a patient into a batch or skip a well The Command list displays the commands that were imported from the template plus commands added using the Insert command or manually entered The lock in the far left column indicates that the command was imported from the template and cannot be changed in the Batch Setup window The Microtiter Plate image reflects the command information for each well as defined in the template The Command button group contains the Finish Cancel Load Pa List and Help command buttons For more information on these commands see the Commands section beginning on page 28 The Save group box contains the Save and Load and Save only option buttons For more information on these commands see the Commands section beginning on page 28 The Standard Info group box is visible only if the template you are using requires the use of standards If standards are used in the template the Standard Info group box reflec
133. ter plate to ensure that you are getting accurate drop volume PN 89 00002 00 110 Rev A Luminex 2 3 Software discriminator channel Control xMAP microspheres are used to verify calibration and optical integrity for the system Calibrate the system at least once a month and Following installation e if the 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 if sample acquisition is problematic 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 If you need target value information for Calibration or Control microspheres you can find the information on the Luminex website at http www luminexcorp com Click on the Support link then navigate to the FAQ page on the Support page Ensure that the Luminex analyzer lasers are warmed up and the probe height is set correctly before calibrating the system Do not move the system waste line while calibrating You can run calibration and verification commands from the Maintenance tab You can import and export calibration and control lots and reuse existing lot information for calibration and controls
134. the lot that you wish to apply Standard Lots for Product Control Lots for Product B3638 Qt Kit B3638 Qt Kit 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 55 Choose Lot Dialog Box Standard and Control 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 B21LQStd ID 5 Note indicates the lot that is set as the current lot for new batches Cancel New Lot Figure 56 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 67 PN 89 00002 00 110 Rev A 81 Luminex IS Software Manual for Version 2 3 xMAP Technology 4 To create a new lot for use within a batch 1 Click New Lot 2 In the 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 55 Running Reports and You can output data by printing reports and exporting batch data Analyses Report Types The Luminex IS 2 3 software can format your batch or multibatch results in a variety of export formats and provide different types of information in differ
135. tion becomes available to change the state back to processing Busy The instrument is processing a maintenance command Red Disconnected The software has not yet attempted to connect or fails to connect to the instrument Locked Out 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 18 PN 89 00002 00 110 Rev A xMAP Technology Secondary Windows Batch Info Batch Setup Window Luminex Batch Setup Luminex 2 3 Software In addition to the main window there are other windows that are displayed when you select certain commands These are the Batch Setup Window and Analysis Window Additional windows display in the Developer s Workbench software if you have it installed on your system For more information about the Developer s Workbench see the Luminex Developer Workbench Guide for Version 2 3 In the Batch Setup window you define information used to create batches All of the commands are on the same page there are no tabs The window opens when you click New Batch and select a template Please establish the starting location for the batch and enter the appropriate patient information Note indicates a required field Name Batch 6 3 02 16 38 Description None l Created By
136. tion to you the purchaser you may obtain a license under Luminex s patents if any to use this unit of Luminex instrumentation 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 e 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
137. tive Results PN 89 00002 00 110 Rev A xMAP Technology Standards Tab Ee analysis Protein Batch Luminex 2 3 Software 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 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 the tab displays the Standards and Controls values for the selected test 0 xl Open Batch Export Data Close IL 4 Errors F9 Standards F11 Samples F12 Test llame System Comments y 1 48E 02 2 85E 04 1 X 4 85E 03 1 26E 00 6 69E 01 ILA EIL 6 R 2 0 9999 Sample High Low Logiti p y a tol c c PAYE EIL 8 R 2 0 9994 Sample High Low Lt TT f E o d pk el o 1000 2000 3000 4000 5000 5000 7000 8000 9000 10000 pgm Loc Standard Expected Conc MFI TestResult CV Unit n e 10 10 8 amp 2 1456 pgimL D1 10 10 68 1541 pgimL E1 315 se 212 2770 pg mL F1 316 316 208 27 30 pgimL 61 100 100 853 93 05 pgimL H1 100 100 833 90 84 pgimL A2 316 316 28
138. to save the batch information User can open the batch later to acquire data PN 89 00002 00 110 Rev A xMAP Technology Self Diagnostics Show Bead Single Step Skip wells Soak Start Analysis Start Plate Statistics PN 89 00002 00 110 Rev A Luminex 2 3 Software Performs a self diagnostics to see if the Luminex 200 analyzer and all system operations are functioning correctly Self Diagnostics tests these functions 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 After selecting an entry from the drop down list sets the histogram to show events for only one beadset bead set number all gated events within the gate or all events inside and outside the gate Select all default before setting the gate Selecting this option on the toolbar pauses the system in between each command or sample acquisition within a batch Enables you to deliberately bypass specific wells during batch acquisition Prevents 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 Opens the Open Batch dial
139. ts the Standard information as defined in the template product The Control Info group box is visible only if the template you are using requires the use of controls If controls are used in the template the Control Info group box reflects the Control information as defined in the template products The New Lot button is visible only if the template you are using requires the use of standards or controls The button opens the Update Lot Information dialog box in which you can manage lot information PN 89 00002 00 110 Rev A xMAP Technology Analysis Window PN 89 00002 00 110 Rev A Luminex 2 3 Software When the system analyzes batches it displays the data in a three tab format within the Analysis window The following three tabs present the batch information in greater detail e Errors tab lists errors that occur during batch acquisition such as controls that failed 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 Nine 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 e Previous Test F3
140. u initiate many of the maintenance commands Disconnects communication between the PC and the analyzer Used during troubleshooting to help remove debris from the bottom of 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 If the XYP plate is retracted this command ejects the microtiter plate If the XYP plate is already ejected this command retracts the plate Saves bead event data to the database Opens the Open Batch dialog box from which you choose a batch to export to an output csv file Opens a dialog box in which you choose the calibration file to export to an output file Opens a dialog box in which you choose a control validation file to export to an output file Exports data to a csv file in the batch folder There is no dialog box to confirm that the data was exported 29 Luminex IS Software Manual for Version 2 3 Help Import Calibration Import Control Import Template Insert Invalidate Control Invalidate Standard Load Patient List Log Linear Maximize Minimize Next Test New Advanced Batch 30 xMAP Technology Opens the h
141. uid on the plate 40 PN 89 00002 00 110 Rev A xMAP Technology Run an Alcohol Flush Run a Wash Cycle PN 89 00002 00 110 Rev A Luminex 2 3 Software During a backflush the system draws sheath fluid from the sheath fluid container and sends it directly to waste You do not need to supply solution in a plate A backflush takes between 10 and 30 seconds To clear obstructions from the cuvette Click Backflush then click OK to verify that you want to backflush the system The status bar shows that the backflush command is processing 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 To remove air bubbles from the sample tubing and cuvette 1 On the Maintenance tab click Eject Retract 2 Aconfirmation dialog box opens telling you to place solution in the reservoir 3 Put 7096 isopropanol or 7046 ethanol in the reservoir 4 Click OK The plate holder retracts and the system performs the Wash command Use the wash cycle after an alcohol flush or as needed For example wash four times with distilled water after calibration and twice with distilled water after Sanitize Place at least 200 uL in a microtiter well or fill the Luminex XYP reservoir with distilled water Washing takes about 30 seconds You should wash
142. ult value Click Apply to All to apply the default value to all bead sets Table 8 lists selection shortcuts Table 8 Bead Set Tab Selection Shortcuts Selected Column Select by clicking in the box Events Column Select desired field and right click The value displayed in the Default Events box updates the selected field when you click Apply Default 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 00 110 Rev A 63 Luminex IS Software Manual for 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 9 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 64 xMAP Technology Click the Plate Layout tab See Figure 37 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 row
143. us bar appears red and indicates that the lasers are off You need to warm up the system again by manually initiating warmup 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 Activity 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 Prime the System Prime your system as part of the daily startup routine and as necessary to remove air from the system s fluidic pathways after e refilling the sheath container removing and replacing the sheath container e observing air in the tubing changing the sheath fluid filter changing the syringe seal When priming the system draws Luminex xMAP sheath fluid from the sheath fluid container and sends it directly out to waste and takes approximately one minute You do not supply solution in a plate To prime the system Click Prime then click OK to confirm that you want to prime the system The status bar indicates that the prime command is processing Backflush the Backflush the system System 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 fl

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