Lum/nex ® International English Version Luminex 100™ IS User Manual Version 2.
© LUMINEX CORPORATION, 2001-2003. 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: LUMINEX CORPORATION 12212 Technology Boulevard Austin, Texas 78727-6115 U.S.A. Voice: (512) 219-8020 Fax: (512) 219-5195 Luminex® 100™ IS User Manual Version 2.2 REF CN-M012-01 PN 89-00002-00-069 Rev. A December 2003 EC REP Paul. A.
End-User License Agreement (EULA) for Luminex® Software This Luminex End-User License Agreement (“EULA”) is a legal agreement between you (either an individual or a single entity, also referred herein as “you”) the end-user and Luminex Corporation (“Luminex”) regarding the use of the Luminex software product identified above, which includes computer software and online or electronic documentation and may include associated media and printed materials (if any) (“SOFTWARE PRODUCT” or “SOFTWARE”).
5. EXPORT RESTRICTIONS. You agree that you will not export or re-export the SOFTWARE PRODUCT to any country, person, entity, or end-user subject to U.S.A. export restrictions. You hereby warrant no state or federal agency has suspended, revoked, or denied your export privileges. 6. NO WARRANTY. THE SOFTWARE PRODUCT IS LICENSED “AS IS.” ANY USE OF THE SOFTWARE PRODUCT IS AT YOUR OWN RISK. THE SOFTWARE PRODUCT IS PROVIDED FOR USE ONLY WITH LUMINEX PRODUCTS.
Contents Introduction 1-1 About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 General System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 What is the Luminex 100 IS 2.2 System? . . . . . . . . . . . . . . . . . . . . 1-1 Customer Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Luminex 100 IS User Manual Version 2.2 xMAP Technology Electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 Luminex XYP Instrument General. . . . . . . . . . . . . . . . . . . . . . . . . 3-6 PC Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 Recommended Additional Equipment. . . . . . . . . . . . . . . . . . . 3-7 Uninterruptible Power Supply (UPS) . . . . . . . . . . . . . . . . 3-7 Surge Protector . . . . . . . .
Contents xMAP Technology Using Luminex 100 IS 2.2 Software 6-1 Luminex 100 IS 2.2 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 Enter Initial xMAP Calibration and Control Targets . . . . . 6-2 Luminex 100 IS Main Window. . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3 Menu Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4 Options Setup .
xMAP Technology Luminex 100 IS User Manual Version 2.2 Calibration and Verification . . . . . . . . . . . . . . . . . . . . . . . . . Set Well Locations for Calibration and Controls . . . . . . Enter System Calibration Targets . . . . . . . . . . . . . . . . . . Enter System Control Targets . . . . . . . . . . . . . . . . . . . . . Select Existing Lots for Reuse . . . . . . . . . . . . . . . . . . . . Import System Calibration or Control Lots. . . . . . . . . . . Export System Calibration or Control Lots.
Contents xMAP Technology Reprocess Samples Using Replay Batch . . . . . . . . . . . . . 6-53 Analyze Reprocessed Data with Replay Batch . . . . . . . . 6-54 Batches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-54 Batch Commands and Procedures . . . . . . . . . . . . . . . . . . . . . 6-55 Create a New Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-55 Insert Command (Batch Setup) . . . . . . . . . . . . . . . . . . . . 6-58 Open a Batch . .
Luminex 100 IS User Manual Version 2.2 xMAP Technology Samples Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-97 Replicate Averaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-98 Sample Progress Sorting . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-98 Errors Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-99 View Detailed Error Information . . . . . . . . . . . . . . . . .
Contents xMAP Technology Maintenance and Cleaning 7-1 Daily Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 Before Running Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 After Running Samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 Routine Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 Sheath and Waste Fluids. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Luminex 100 IS User Manual Version 2.2 xMAP Technology Running: Sheath Empty. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7 Sample Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7 Insufficient Bead Count. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7 Temperature Divergence from Calibration Temperature . 8-8 Failed Control in Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8 Failed Curve Fit. . . . . . . . . . . . . . . . . . . . . . . . . . .
Contents xMAP Technology Luminex Sheath Delivery System C-1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Luminex 100 IS User Manual Version 2.2 x xMAP Technology PN 89-00002-00-069 Rev.
1 Introduction About This Manual This manual provides you with information to understand and use the Luminex® 100™ IS system. It consists of multiple chapters and appendices that take you from this introduction to complete system operation. The manual’s text and figures offer examples when necessary. Procedures are presented as step-by-step instructions. Glossary and index sections assist as references. This manual instructs you through each operational stage for running the instrument.
Luminex 100 IS User Manual Version 2.2 xMAP Technology barcode reader, sheath and waste containers, and xMAP technology reagents. The Luminex software is designed to use xMAP technology with assay kits available through kit manufacturers. Customer Support Luminex Customer Support representatives are ready to help you, particularly when the instrument itself or its software causes any questions or problems.
2 Safety Symbols Please become familiar with the information in this chapter before using the equipment. Do not perform procedures on your Luminex 100 IS 2.2 system that are not specifically contained in this manual, unless you are directed to do so by Luminex Customer Support. These symbols describe warnings, cautions, and general information used in the operation of this instrument. These symbols are further defined under “Safety Precautions.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Warnings and Notes Information notes and warnings may appear in this manual. Note: A note provides general helpful information. No safety or performance issues are involved. Caution: This message is used in cases where the hazard is minor or only potential hazard is present. Failure to comply with the caution may result n potentially hazardous conditions.
xMAP Technology Safety This caution label appears on the back of Luminex 100 analyzers using Coherent lasers and on the Luminex XYP instrument. This label appears on the back of Luminex 100 analyzers using the Uniphase laser: Do not perform any maintenance or cleaning of the system electrical components except for the fuses. This label appears on the back panel of the Luminex 100 analyzer and on the back panel of the Luminex XYP instrument.
Luminex 100 IS User Manual Version 2.2 xMAP Technology The following voltage label appears on the back of the Luminex 100 analyzer using the Coherent laser. The following voltage label appears on the back of the Luminex 100 analyzer using the Uniphase laser. The Luminex 100 analyzer has been tested by Underwriter Laboratories, Inc® (UL). 2-4 PN 89-00002-00-069 Rev.
xMAP Technology Safety This label appears on the back of the Luminex XYP instrument. The Luminex XYP instrument has been tested by UL. Fluidics This system contains fluidics. In the event of a fluidic leak, turn off all power to the system and disconnect all power cords. Remember that the on/off switch is not a disconnect means, the power cord must be removed from the outlet. Contact Luminex Corporation for further information.
Luminex 100 IS User Manual Version 2.2 xMAP Technology United States and international regulations require the following warnings to appear on the instrument during operation and maintenance. This label appears on the back panel of the Luminex 100 analyzer. Under NO circumstances should the user remove the Luminex 100 analyzer cover! When routine maintenance is performed, power to the Luminex 100 analyzer must be OFF and the power cord must be disconnected.
xMAP Technology Safety Warning — Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. Attention — L’utilisation des commandes ou réglages ou l’exécution des procédures autres que celles spécifiées dans les présentes prescriptions peuvent entraîner d’une exposition à un rayonnement dangereux. This label appears above the laser apertures located inside the optics enclosure inside the Luminex 100 analyzer.
Luminex 100 IS User Manual Version 2.2 xMAP Technology Warning: During operation, this system contains exposed, moving parts which could result in pinch point hazard. Risk of personal injury is present. Keep hands and fingers away from the Luminex XYP instrument slot during operation. Note: Access doors must be closed while operating Luminex 100 analyzer; operator must be present during operation. Biological Warning: Human/animal samples may contain biohazardous infectious agents.
xMAP Technology Decontamination of the Luminex 100 Analyzer for Return Shipment Note: It is the user’s responsibility to decontaminate the analyzer before shipment. Safety Contact Customer Support to obtain a Return Material Authorization (RMA) number if they direct you to return the system to Luminex. Customer Support can then instruct in returning the system according to Luminex procedures.
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3 The System Theory of Operation Luminex 100 IS technology is based on flow cell fluorometry with Luminex-developed innovations. The fluidics, optics, robotics, temperature control, software, and xMAP microspheres work together to enable simultaneous analysis of up to 100 analytes in a single test sample. Assay analysis requiring temperature control is provided through the Luminex XYP instrument heater block. There are two fluidics paths in the Luminex 100 analyzer.
xMAP Technology Luminex 100 IS User Manual Version 2.2 intensities of the color coding classification dye mixtures inside the xMAP microspheres and a photomultiplier tube detects the excitation emission intensity of the reporter molecule bound to the surface of the xMAP microspheres. High speed digital signal processors and advanced computer algorithms provide analysis of the xMAP microspheres as they are processed through the Luminex 100 analyzer.
xMAP Technology Required Laboratory Reagents Luminex 100 IS 2.2 Software The System • • • Household bleach 70% isopropanol Mild detergent Luminex 100 IS 2.2 software provides complete control of the system and performs data analysis. Your Luminex 100 IS 2.2 system is preloaded with the Luminex software. However, we supply a software CD should you need to reinstall the software. This software requires a dedicated system.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Accuracy and Precision • • • • • • Sample uptake volume ± 5% Classification of microspheres > 80% Misclassification of microspheres < 0.5% Temperature control 0°C to + 3°C of target Internal sample carry over < 0.9% Soluble background fluorescence emission at 575 nm automatically subtracted from fluorescence intensity values Sensitivity • • Detect 1000 fluorochromes phycoerythrin (PE) per microsphere Reporter channel dynamic range: 3.
xMAP Technology Luminex 100 Analyzer General The System • • • • • • • • • • • Optics • • • • • Operating temperature: 15°C to 30°C (59°F to 86°F) Storage temperature: 0°C to 50°C (32°F to 122°F) Humidity: 20% to 80%, noncondensing Altitude: Operation up to 2400 m (7874 ft.) above mean sea level Physical dimensions: 43 cm (17 inches) W x 50.5 cm (20 inches) D x 24.5 cm (9.5 inches) H Weight: maximum of 25 kg (60 lbs.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Luminex XYP Instrument General • • • • • • • • • • PC Specifications • • • • • • Note: Contact Customer Support for additional operating system information • • • • • • • • 3-6 Ambient temperature: 15°C to 30°C (59°F to 86°F) Humidity: 20% to 80%, noncondensing Altitude: operation up to 2400 m (7874 ft) above mean sea level Physical dimensions: 44 cm (17.25 inches) W x 60 cm (23.5 inches) D x 8 cm (3 inches) H Weight: 15 kg (33 lbs.
xMAP Technology The System Recommended Additional Equipment Uninterruptible Power Supply (UPS) Luminex highly recommends using an uninterruptible power supply (UPS) to protect your system from power outages. Choose a supply that can provide 1050 Watts for at least 45 minutes. The UPS should be UL listed, CSA certified, and CE marked when used internationally. Surge Protector If you do not use a UPS, as a minimum, use a surge protector. Choose a protector that meets your needs.
Luminex 100 IS User Manual Version 2.2 System Overview xMAP Technology The system consists of three subsystems: electronic, fluidic, and optical. The following section describes the user-accessible components of each subsystem. See Figure 1. Figure 1. Luminex 100 IS 2.2 System Electronics Power Input Module P1 Communications Port (SB9-PIN) Luminex 100 Analyzer Ventilation Filter 3-8 The power input module contains the Luminex 100 analyzer on/off switch and fuses.
xMAP Technology Luminex XYP Instrument Ventilation Filter The System Located at the back of the Luminex XYP instrument, the filter cleans the air that cools the internal components of the Luminex XYP instrument. See Figure 2. 1 2 3 4 5 6 7 1. Air intake filter access door 2. Power Switch 3. Power input module 4. XYP instrument ventilation filter 5. Communications ports (DB9) 6. XYP to PC Serial cable 7. Luminex 100 analyzer ventilation filter (on bottom) Figure 2.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Luminex XYP Instrument Sample Probe A stainless steel Sample Probe acquires the sample. A shorter probe is provided for shipping and troubleshooting. Warning: During operation, this system contains exposed moving parts that can result in a puncture hazard. Risk of personal injury is present. Keep hands and fingers away from the Sample Probe. The shield should be in place.
xMAP Technology Access Doors The System Two access doors are on the face of the Luminex 100 analyzer. The center door gives you access to the syringe. The left door provides service panel access. See Figure 4. 1 2 1. Left door, access to service panel 2. Center door, access to syringe Figure 4. Luminex 100 Analyzer Access Doors Air Intake Filter A replaceable air filter cleans the air used to pressurize sheath fluid.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Syringe Located in this compartment behind the center door, the syringe delivers a sample from the 96-well microtiter plate to the cuvette. See Figure 6. 1 2 1. Syringe Seal 2. Syringe Figure 6. Syringe and Syringe Seal Sheath Filter Behind the left door, the service panel houses a sheath filter. This filter removes particles greater than ten microns in diameter from the sheath fluid. See Figure 7. Figure 7.
xMAP Technology The System connector is green, the sheath fluid connector is blue, and the waste fluid connector is orange. See Figure 8 . 1 2 3 1. Sheath fluid connector (blue) 2. Air connector (green) 3. Waste connector (orange) Figure 8. Air, Waste, and Sheath Fluid Connectors If you install the Luminex Sheath Delivery system, see the Luminex Sheath Delivery System appendix for additional information. Sheath Fluid Container (not shown) Note: Sheath fluid levels must be monitored manually.
Luminex 100 IS User Manual Version 2.2 xMAP Technology Reagents 3 - 14 xMAP Technology The xMAP technology reagent system consists of classification calibration microspheres, reporter calibration microspheres, classification control microspheres, and reporter control microspheres. PN 89-00002-00-069 Rev.
4 Basic Concepts Background Information Fluidics Excitation PN 89-00002-00-069 Rev. A xMAP technology is a versatile system that measures soluble analytes. The Luminex 100 IS performs simultaneous, discrete measurements of multiple microsphere-based reactions from a single specimen aliquot. For more conceptual information, refer to Practical Flow Cytometry, 3rd edition, by Howard M. Shapiro, M.D. (New York: Wiley-Liss Inc., 1995). There are two fluidic paths in the Luminex 100 analyzer.
Luminex 100 IS User Manual Version 2.2 xMAP Technology Photodiodes and a photomultiplier tube receive fluorescent signals from xMAP microspheres. The Luminex 100 analyzer digitizes the waveforms and delivers the signals to a digital signal processor (DSP). Proprietary algorithms function with the DSP to greatly increase sensitivity. xMAP Microspheres The xMAP microspheres are highly uniform, polystyrene particles that have been crosslinked during polymerization for physical and thermal stability.
xMAP Technology Basic Concepts System calibrators and controls are provided as part of the system. Calibrate at least once monthly, when the delta calibration (dCAL) temperature changes by ±3 degrees, or if the system is powered off. You must run system controls following calibration and as often as you like to ensure that your system continues to operate optimally.
Luminex 100 IS User Manual Version 2.2 4-4 xMAP Technology PN 89-00002-00-069 Rev.
5 System Calibration System Calibration and Verification Overview Calibrator xMAP microspheres are used to normalize the settings for the reporter channel, both classification channels, and the doublet discriminator channel for the Luminex 100 IS 2.2 system. The control xMAP microspheres are used to verify the calibration and optical integrity for the system.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Calibrate the System Run System xMAP Calibrators Note: Lasers must be in the warmed up state to calibrate. Before you calibrate or run controls you should first adjust the probe height for the appropriate plate. Refer to "Adjust the Sample Probe Vertical Height" on Page A-9. To calibrate your system with xMAP calibrators: 1. Vortex the xMAP calibrators and controls containers to ensure homogeneity. 2.
xMAP Technology System Calibration Click the Select Calendar button to display the calendar. Use the arrows at the top left and right side of the calendar to select past or future months. Alternately, select the month in header. To select the year, click the displayed year in the header. Use the up and down arrows that appear to select a past or future year. Once you select the correct month and year, click the desired expiration day on the calendar.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Note: Ensure that you enter the correct target values for each parameter before clicking OK. You can re-enter any incorrect information. 15. Enter the expiration date. 16. Enter the values, listed in the Certificate of Quality that is included with your calibrators, into the CAL2 entry fields. 17. Click OK. 18. Ensure that the analyzer is set to draw the CAL1 and CAL2 beads from the wells you loaded in step 2. 19. Click CAL1 from the Maintenance tab.
xMAP Technology System Calibration Figure 10. Update CON Targets Dialog Box 6. Enter the expiration date. 7. Enter the values, listed in the Certificate of Quality (COQ) included with your system controls, into the CON2 entry field. 8. Click OK. 9. 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 5-2. 10. Click CON1 from the Maintenance tab. A Confirmation Screen dialog box appears. 11.
Luminex 100 IS User Manual Version 2.2 xMAP Technology 13. Click OK and wait until CON2 completes. The Device Status section in the status bar changes from “Running” to “Standby”. 14. The System Monitor on the Diagnostics tab displays date and time in green if both CON1 and CON2 are successful. 15. Ensure the analyzer is set to draw the sheath fluid from the well you loaded it in step 2 of “Run System xMAP Calibrators” on page 5-2.
xMAP Technology Print or View Calibration or System Control Trend Reports System Calibration You must enter information about the date range you want to print a report about. To create a trend report for a date range: 1. Click the Print Report button on the Toolbar. A Report Selection dialog box appears. See Figure 12. Figure 12. Report Selection Dialog Box 2. Select Calibration Trend Report or System Control Trend Report and click Next.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Figure 14. Lot and Date Selection Dialog Box 4. Select the reagent lot and expiration date, and the date range (with the starting and ending date) that you want and click Finish. A Calibration Trend Report Print Preview appears with the information you entered. See Figure 15. 1 2 1. Click “X” to close screen 2. Print Button Figure 15. Report Print Preview 5. Click the Print button on the toolbar. The MS Windows Print dialog box appears.
xMAP Technology System Calibration 6. To close the Report Print Preview click the “X” in the upperright corner of the screen. Then, to close the Report Selection dialog box click the “X” in the upper-right corner or click Cancel. PN 89-00002-00-069 Rev.
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6 Using Luminex 100 IS 2.2 Software Luminex 100 IS 2.2 Software The Luminex 100 IS 2.2 software starts automatically after you log into MS Windows. When you start the Luminex 100 IS 2.2 software a splash screen appears for about ten seconds. See Figure 16. Figure 16. IS Software Splash Screen You can create your own splash screen and import it into the Luminex 100 IS 2.2 software startup process. The software can use any html file as a splash screen.
Luminex 100 IS User Manual Version 2.2 Getting Started xMAP Technology When using a new system for the first time, the system has no preexisting data in its database. After the initial splash screen disappears, the system prompts you to enter xMAP calibration and control target values. You must enter these values before the system may proceed to the main menu. Enter the calibration and control target values found on the Certificate of Quality (COQ) included in the shipment of products.
xMAP Technology Using Luminex 100 IS 2.2 Software Luminex 100 IS Main Window 1 After entering the calibration and control target values, the Luminex 100 IS Main window appears. See Figure 18. 2 3 4 5 1. Title bar 2. Menu bar 3. Tool bar 4. Tabs 5. Status bar Figure 18. Luminex 100 IS Main Window The Luminex 100 IS Main window includes menus and tools that help you to use the software and to monitor the progress of the acquisition and diagnostic processes.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Run Batch Tab—The Run Batch tab contains a command list displaying batch commands and their status, a microtiter plate image, plate command buttons, and XYP command buttons and settings. Maintenance Tab—At the Maintenance tab you perform maintenance commands, XYP commands, and calibration and verification commands during system use. Diagnostic Tab—Use the Diagnostics tab to monitor the progress of commands you initiate within the system.
xMAP Technology Options Setup General Tab Using Luminex 100 IS 2.2 Software You set up and customize the system software and enter information about your company at the Luminex 100 IS Software - Option dialog box. You can change or update this information as often as you like. The Options dialog box has four tabs: the General tab, the Company Information tab, the Splash Screen tab, and the Data Export tab. See Figure 20. You define the following options on the General tab.
xMAP Technology Luminex 100 IS User Manual Version 2.2 batches. The automatic analysis feature takes place after the system finishes acquiring data while processing batches. To configure General tab information: 1. Click Tools from the menu bar and select Options. The Options dialog box appears. See Figure 20. 2. Click the General tab. 3.
xMAP Technology Company Information Tab Note: For Luminex 100 IS 2.2 software, the logo will not alter any Luminex 100 IS report or screen. Using Luminex 100 IS 2.2 Software You can enter information about your company into the Company Information tab. This information is stored in the Registry for reference. To enter your company information into the system: 1. Click Tools from the menu bar and select Options. The Options dialog box appears. 2. Click the Company Information tab. See Figure 21. 3.
xMAP Technology Luminex 100 IS User Manual Version 2.2 To enter the path and dimensions for the graphic that you want to use as a splash screen: 1. Click Tools from the Menu Bar and select Options. The Options dialog box appears. 2. Click the Splash Screen tab. See Figure 22. Figure 22. Options Dialog Box—Splash Screen Tab 3. Enter the location of the graphic that you want for the splash screen. Use the browse button to locate the graphic within the PC.
xMAP Technology Using Luminex 100 IS 2.2 Software Copy Output.csv file to Common Output Dir. Select this feature to send a copy of the output.csv file to the My Batches/ Output folder. Additional Export Stats. Select this feature to define which sample statistics to export outside the Luminex 100 IS software to the output.csv file. Test Sort Order. Select this feature to define the sorting order. Click the radio button adjacent to the desired test sorting order. Additional Batch Information.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Figure 23. Options Dialog Box—Data Export Tab Toolbar Figure 24 shows the Luminex 100 IS Main window toolbar. 1 13 2 12 3 4 5 6 7 8 9 10 11 1. Import Templates 8. Print Report 2. New Batch 9. Connect to the Instrument 3. Open Batch 10. Disconnect from the Instrument 4. Create New Multi-Batch 11. Eject/Retract 5. Open Multi-Batch 12. Open Help Files 6. Start Analysis 13. Single Step 7. Export Batch Data Figure 24.
xMAP Technology Using Luminex 100 IS 2.2 Software between every command or acquisition until you disable (or deselect) the single step option. Status Bar The status bar appears along the bottom of the 100 IS Main window and displays the system status. Check the status bar periodically while running a batch to ensure that the system is performing accurately. See Figure 25. Figure 25.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Table 1.
xMAP Technology Status Communication Messages Using Luminex 100 IS 2.2 Software Table 2 shows the details of typical messages that appear in the status bar. Table 2. Status Bar Communication Message Details Status Bar Color Green Yellow PN 89-00002-00-069 Rev. A Message Indicates Idle This Command State term appears when the software is waiting to process the next command. For example, idle between commands.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Table 2. Status Bar Communication Message Details (Continued) Status Bar Color Red Tabs Home Tab 6 - 14 Message Indicates Disconnected This term appears when the software has not yet attempted to connect or fails to connect to the instrument. To connect the instrument, power on the Luminex 100 analyzer, then the XY Platform and click Connect on the toolbar.
xMAP Technology Using Luminex 100 IS 2.2 Software acquisition phases, including daily startup, instrument calibration, batch setup, reports and analysis, and daily shutdown. See Figure 26. 1 2 1. Home Tab button 2. Favorites Section Figure 26. Home Tab Favorites List PN 89-00002-00-069 Rev. A The Favorites list contains a list where you can add frequently-used templates and commands for easy access. You can tailor the favorites list to your specific needs.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Figure 27. Favorites List Add Templates to Favorites To add templates to the Favorites list: 1. Click Add Template from the Favorites list. An Open Template dialog box appears. 2. Select the template that you want to add to your Favorites list. 3. Click Select. The template name that you selected appears on the Favorites list. Add Commands to Favorites 6 - 16 To add commands to the Favorites list: 1. Click Add Command from the Favorites list.
xMAP Technology Using Luminex 100 IS 2.2 Software Figure 28. Command List Dialog Box 2. Select the command that you want to add to your Favorites list. Note: Ensure that the location you select is compatible with the volume intended for that location. The location’s capacity may vary depending on the microtiter plate sizes used. Refer to the specifications in Chapter 3 for additional information. 3. For certain commands, select the location where you want to draw or expel fluid.
Luminex 100 IS User Manual Version 2.2 Data Acquisition Categories xMAP Technology The Home tab contains categories representing different phases of data acquisition. Each category consists of a group of command buttons associated with typical phases of data acquisition. At the click of a button, the system performs or initiates the process to perform the function for the button you click. See Figure 26.
xMAP Technology Using Luminex 100 IS 2.2 Software Run Batch Tab The Run Batch tab contains a command list displaying batch commands and their status, a microtiter plate image, plate command buttons, and XYP command buttons and settings. See Figure 30. 1 2 3 4 5 6 1. Microtiter Plate Image 4. Progress (when running) 2. XYP Reservoir 5. Print Button 3. Pressure Range 6. Command List Figure 30.
Luminex 100 IS User Manual Version 2.2 Microtiter Plate xMAP Technology The Run Batch tab shows an image representing the microtiter plate where you place the samples. The system analyzes microtiter plate samples in the following order. Vertically, from top-to-bottom within the column and left-to-right after each column. See Figure 31. Figure 31.
xMAP Technology Using Luminex 100 IS 2.2 Software 1 4 Note: While warming the Luminex XYP instrument heater block, the temperature can fluctuate prior to reaching the target temperature. Wait for the temperature to stabilize before acquiring sample 2 3 1. XYP Target Temperature 3. DD Current Temperature 2. XYP Current Temperature 4. Current Sheath Pressure Figure 32.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Prior to being turned on or set, the Turn ON button appears gray and disabled. To set the Luminex XYP instrument heater temperature: Warning: The heater plate of the Luminex XYP instrument is hot when in use and may cause personal injury. Do not touch the heater plate. 1. Click Eject to eject the Luminex XYP instrument plate holder. 2. Insert the Luminex XYP instrument heater block into the plate holder. 3. Click Retract. 4.
xMAP Technology Using Luminex 100 IS 2.2 Software Figure 33. Command List Section on the Run Batch Tab Figure 34 shows an example of a failed command in the command list on the Run Batch tab. Figure 34. Command Failure Notation In Command List If an error occurs during the batch, it is recorded in the Message Log. See “Error Messages” on page 6-44 for details. Double-click the failure row for additional information if it is highlighted in yellow.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Maintenance Tab At the Maintenance tab you perform maintenance commands, XYP commands, and calibration and verification commands during system use. See Figure 35. Figure 35. Maintenance Tab Maintenance Commands Perform these commands to maintain your system and to keep it in optimal working condition. Follow the step-by-step instructions for each command (found after this section) when using as-needed maintenance operations.
xMAP Technology Using Luminex 100 IS 2.2 Software the command process in yellow text below the graphic. For example, Figure 36 shows the Warmup command graphic. Figure 36. Processing Device Activity Commands Table 3 shows a recommended schedule for maintenance operations. Table 3. Maintenance Operations: Recommended Use Schedule Operation PN 89-00002-00-069 Rev.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Table 3.
xMAP Technology Using Luminex 100 IS 2.2 Software Caution: Failure to properly warm up the system will effect assay results and system performance. After four hours of inactivity, the status bar appears red and indicates that the lasers are off. You need to warm up the system again by manually initiating warmup procedures. To warm up the system: 1. Click Warmup on the Maintenance tab or Home tab. A confirmation dialog box appears to verify that you want to warm up the system. 2. Click OK to continue.
xMAP Technology Luminex 100 IS User Manual Version 2.2 2. Click OK to continue. The command list on the Run Batch tab indicates that the system is running. The Device Activity field on the Status Bar indicates that the system is priming. Upon completion, the command list indicates whether the command succeeded with green text or the command failed with red text.
xMAP Technology Using Luminex 100 IS 2.2 Software 4. Click OK to continue. The command list on the Run Batch tab indicates that the system is running. The Device Activity field on the Status Bar indicates that the system is sanitizing. Upon completion, the command list indicates whether the command succeeded with green text or the command failed with red text. Sanitize Command Sanitize the system with 10% to 20% household bleach to decontaminate the sample lines and the cuvette after biohazard contact.
Luminex 100 IS User Manual Version 2.2 xMAP Technology 2. If a different location is desired, click the drop-down arrow located in the lower right-corner. The Microtiter plate and XYP reservoir image appears. The reservoir image appears as a rectangle in the upper right corner. See Figure 37. Figure 37. Microtiter Plate and Reservoir Image 3. Select the location for the wash solution and click Eject/Retract. The plate holder ejects. 4.
xMAP Technology Using Luminex 100 IS 2.2 Software To drain the system: 1. Click Drain on the Maintenance tab. A confirmation dialog box appears. 2. If a different location is desired, click the drop-down arrow to the right of the Eject/Retract button within the confirmation dialog box. An image of the microtiter plate and Luminex XYP reservoir appears. 3. Select a location on the image of the microtiter plate and reservoir to receive the drain fluid and then click Eject/Retract. The plate holder ejects.
xMAP Technology Luminex 100 IS User Manual Version 2.2 2. Click the drop-down arrow to the right of the Eject/Retract button. An image of the microtiter plate and Luminex XYP reservoir appear. See Figure 39. Figure 39. Microtiter Plate and XYP Reservoir Image Note: The system may show a default location. In this case, the microtiter plate shows a well with a yellow line inside the well. 3.
xMAP Technology Using Luminex 100 IS 2.2 Software • • • • Actuator test Syringe pump test Backflush valve test Debubbler Valve test To run self diagnostics: 1. Click Self-Diagnostics on the Maintenance tab. A confirmation dialog box appears. 2. Click OK. The system begins processing the various self diagnostic tests. As it completes the tests, 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. 3.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Set Well Locations for Calibration and Controls To set the locations on the microtiter plate for calibration and control solutions: 1. Click the drop-down arrow next to the entry cell for the desired calibration (CAL1 or CAL2) or verification (CON1 or CON2). A list of well locations appears below the arrow. 2. Click the well location on the microtiter plate image.
xMAP Technology Using Luminex 100 IS 2.2 Software 2. Enter the CAL1 lot number in the Lot Number field. 3. Enter the expiration date. Click the Expiration Date field. A Select Calendar button appears on the right side of the field. Click the button to display the calendar. Use the arrows at the top left and right side of the calendar to select past or future months. Alternately, select the month in header. To select the year, click the displayed year in the header.
xMAP Technology Luminex 100 IS User Manual Version 2.2 2. Enter CON1 lot number. 3. Enter the expiration date. Click the “Expiration Date” field. A “Select Calendar” button appears on the right side of the field. Click the button to display the calendar. Use the arrows at the top left and right side of the calendar to select past or future months. Alternately, select the month in header. To select the year, click the displayed year in the header.
xMAP Technology Using Luminex 100 IS 2.2 Software 4. Enter the values listed in the Certificates of Quality included with your controls into the CON1entry fields. You can also find the target value information on the Luminex website at http:// luminexcorp.custhelp.com. 5. Enter CON2 lot number. Note: Ensure that the correct target values are added for each parameter before you click OK. If necessary, reenter the information to correct any incorrect information. 6. Enter the expiration date. 7.
xMAP Technology Luminex 100 IS User Manual Version 2.2 4. Click OK to complete the operation. Export System Calibration or Control Lots To export system CAL or CON lots: 1. Click New CAL Targets or New CON Targets on the Maintenance tab. An Update CAL Targets or an Update CON Targets dialog box appears as appropriate. Ensure you have the desired lot to export displayed or selected. 2. Click Export CAL or Export CON as appropriate. A Save As dialog box appears. 3.
xMAP Technology Lower and Raise Sample Probe Using Luminex 100 IS 2.2 Software You manually raise or lower the Sample Probe when you are adjusting the probe height. This adjustment is recommended when using different microtiter plates or when changing Sample Probes. See “Adjust the Sample Probe Vertical Height” on page A-10 for the adjusting procedure. To lower the Sample Probe: 1. Select a well location (or use the default well). 2. Click Sample Probe Down on the Maintenance tab.
Luminex 100 IS User Manual Version 2.2 xMAP Technology Figure 42. 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. System Monitor The System Monitor provides information about the physical state of the 100 IS instruments, lasers, and system calibration status.
xMAP Technology Using Luminex 100 IS 2.2 Software Figure 43. The System Monitor The system can diagnose real-time system problems related to fluid input and output.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Table 4.
xMAP Technology Message Log Using Luminex 100 IS 2.2 Software The Message Log shows a list of completed commands, errors, and warnings. It is located on the lower part of the Diagnostics tab. It also displays each operation’s progress, time and date, and results. See Figure 45. Figure 45. Message Log The log also displays actions in color-coded text and shading.
xMAP Technology Luminex 100 IS User Manual Version 2.2 To clear the Message Log: 1. Right-click in the Message Log. From the menu select Clear. A Clear Message Log confirmation dialog box opens. See Figure 46. Figure 46. Clear Message Log Dialog Box 2. Click Yes. The Message Log clears from the screen. Error Messages If an error occurs during system operation the Diagnostic tab turns red. Click on the Diagnostics tab. The Message Log displays errors as a row with red text.
xMAP Technology Using Luminex 100 IS 2.2 Software Acquisition Detail tab Main features: • • • • • New Advanced Batch View Batch Data Replay Histogram Dot Plot This section provides an overview and basic descriptions of the Acquisition Detail. Refer to the Luminex 100 IS Developer Guide for xMAP Technology for detailed operation. Figure 47 displays the Acquisition Details tab and identifies the major components. 2 1 5 3 4 7 6 1. IS Toolbar 5. Status bar 2. Batch name and description 6.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Acquisition Detail Toolbar Acquisition detail toolbar provides batch and advanced functions to acquire raw data “on the fly” without using templates. Use the Replay Batch function to utilize batch acquisition simulation. The toolbar provides a variety of commands to use during a batch, including: Start Plate, Cancel Command, Pause, and Resume. 1 2 3 4 5 7 6 1. Replay batch 6. Cancel All 2. New advanced batch 7. Eject 3.
xMAP Technology Using Luminex 100 IS 2.2 Software Start Cancel Select to initiate data acquisition on the new advanced or selected batch. Select to cancel the process for the last command initiated in the system. The system then processes the next command. Cancel All Select to cancel all the commands in process. It essentially performs an abort operation. Eject (Retract) If retracted, select to direct the Luminex XYP to eject the microtiter plate.
xMAP Technology Luminex 100 IS User Manual Version 2.2 statistics to export through the Data Export tab on the Options dialog box (select Tools Menu, then Options). • %CV—Coefficient of Variation = Standard Deviation/Mean x 100% • Count—Gated events, if gates are set • Peak—Histogram bar with the highest value • Std. Deviation—Standard deviation from the mean.
xMAP Technology Using Luminex 100 IS 2.2 Software Note: The gate in effect when the system collects data determines which values to use to obtain the result. Applying a gate or changing a gate for existing data does not change your calculated values. The gate positions used while collecting data are the numerical values selected in the template or the New Advanced Batch (also located in the lower corner of the histogram). 1 2 3 1. Gate Boundaries 2. Aggregate Beads 3.
Luminex 100 IS User Manual Version 2.2 Dot Plot xMAP Technology This section provides an overview of the Dot Plot. Details are provided in the Luminex 100 IS Developer Guide for xMAP Technology Version 2.2. The Dot Plot (or bead map) appears in the lower-right section of the Acquisition Detail tab. See Figure 50. The dot plot shows a graphical display of real-time data collection as a dot plot. You may define the X axis and Y axis scales from within the dot plot.
xMAP Technology Using Luminex 100 IS 2.2 Software The Density Dot Plot displays a constant accumulation of events. Increasing density is indicated by contrasting colors. See Table 5 for the density dot plot color legend. Table 5. Dot Plot Color Legend Layer 0 1 2 3 4 5 6 7 8 Color none dark blue pink dark green cyan light blue light green orange dark red To change density plot options: 1. Right-click within the dot plot to display the drop-down menu. 2.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Display above level: Use this option to set the density level at which events are displayed in the dot plot. Events below this level are ignored. This number is the exponent of the level multiplier and may be set between 1 and 8. Level Multiplier: Use to establish the necessary number of events that must fall within an area before being displayed.
xMAP Technology Using Luminex 100 IS 2.2 Software • Note: The number of beads for collection must be less than or equal to the number previously collected in the original sample. Test a batch using different parameters, such as setting a different number of events to be collected or using a different bead map or new formula for analysis, also using a different template. If you reprocess a batch with the same template parameters, the system should obtain results similar to the original batch.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Analyze Reprocessed Data with Replay Batch After running Replay Batch, you can analyze the data. To analyze Replay Batch data: 1. Select Start Analysis on the toolbar. Note: The Open Batch dialog box does not list or show the templates associated to the batches. 2. At the Open Batch dialog box select the batch you want to analyze and click Select. The most recent Replay Batch is the last or has the highest ID number. See Figure 52. Figure 52.
xMAP Technology Using Luminex 100 IS 2.2 Software The assay kit manufacturer may provide templates in the kits which they distribute on floppy disk or CD ROM. Templates typically include assay standards, controls, and maintenance commands (such as washes or primes to acquire along with samples). OEM manufacturers may provide templates preinstalled with your system. The kit manufacturer includes assay reagents in the assay kit.
Luminex 100 IS User Manual Version 2.2 xMAP Technology 2. Click New Batch from the Batch Setup section of the Home tab. An Open Template dialog box appears. See Figure 53. Figure 53. Open Template Dialog Box 3. Select the template you want to apply to the new batch and click Select. The template loads, and a Luminex Batch Setup dialog box appears. See Figure 54. Figure 54. Luminex Batch Setup Dialog Box 4.
xMAP Technology Using Luminex 100 IS 2.2 Software 6. Click the Sample ID field on the last row for the empty well on the microtiter plate. See Figure 55. Figure 55. Entering Additional Samples Note: Batches may span more than one plate. When the first plate is full, a blue line appears separating the columns of the first plate with those of a second plate. 7. Enter the sample ID for the sample to add to the batch. Repeat this step to add all of the additional samples to the batch.
Luminex 100 IS User Manual Version 2.2 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. xMAP Technology Figure 56. Open Patient List File Dialog Box 9. Select a patient file to append to the batch and click Open.
xMAP Technology Using Luminex 100 IS 2.2 Software defined number of wells on the microtiter plate. The skipped wells are displayed on the plate graphic on the Run Batch tab as empty wells colored solid white. The Insert Command section contains a list box, multiplier field, and Apply button. See Figure 57. In the list box you select Acquire Patient or Skip well command. Note: When you use the Load Patient List feature all the Sample IDs and Dilution Factors are predefined.
xMAP Technology Luminex 100 IS User Manual Version 2.2 The yellow wells indicate sample commands, performed from a well that were locked into the batch from template commands. Figure 58. Luminex Batch Setup Screen Open a Batch Note: You can open “Saved Only” batches using Open Batch Use this procedure to open a batch that you created earlier (save only). To verify that you opened the correct batch, the batch name and batch description appear on the Run Batch tab when you load the batch.
xMAP Technology Delete a Batch Note: Make sure that the batch that you want to delete is the batch that you selected. Once you delete a batch, you cannot recover it. Using Luminex 100 IS 2.2 Software You can delete unprocessed batches (Save Only). To delete an unprocessed batch: 1. Click File. The file menu appears. 2. Click Delete Batch. A dialog box appears listing only the unprocessed batches in the database. 3. Select the unprocessed batch that you want to delete. 4. Click Select.
Luminex 100 IS User Manual Version 2.2 xMAP Technology Figure 59. Luminex Multi-Batch Setup Dialog Box 3. Select the batch that you want to process first in the multi-batch and click Select. The batch appears beginning in well A1 of the microtiter plate on the Luminex Multi-Batch Setup dialog box. A thick red line appears above well A1 and another thick red line below the last well in the batch. These lines separate this batch from subsequent batches that you add to the multi-batch.
xMAP Technology Note: Batches may span more than one plate. When the first plate is full, a blue line appears to separate the columns of the first plate and those of the second plate. Note: If any of the acquire sample commands within the template of the batch has an unassigned Sample ID, the system applies the first patient ID in the list to the unassigned sample acquisition command. The system appends any remaining patient IDs to the end of the command list in order as they appear in the patient list.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Open a MultiBatch Use this procedure to open a multi-batch that you created earlier for acquisition. To load a multi-batch for acquisition: Note: Each batch within a multi-batch appears on the list of available multi-batches. The software differentiates them according to the batch ID, name, and description. However, the software gives all batches comprising a multibatch the same multi-batch ID number and name. 1.
xMAP Technology Note: You may need to scroll to the right of the screen to see the additional plate(s). Using Luminex 100 IS 2.2 Software During acquisition for multiple plate batches, after the first microtiter plate has been acquired, the system pauses and prompts you to insert the next plate. To process multiple plates during a batch or multi-batch: 1. Create the batch or multi-batch. See “Create a New Batch” on page 6-55 or “Create a Multi-Batch” on page 6-61 for more information. 2.
xMAP Technology Luminex 100 IS User Manual Version 2.2 To scan samples into the system using the barcode reader: Warning: Laser light. Do not stare into the beam. Class II laser product. Note: The barcode reader beam must encompass the entire set of bars in the barcode. Shaded area of Figure 62 1. Aim the barcode reader’s beam to read the middle of the barcode series, horizontally. See Figure 62. Figure 62. Barcode Reader Beam Aimed Across Code 2. Click the barcode reader’s trigger.
xMAP Technology Using Luminex 100 IS 2.2 Software An example of a typical patient list file follows below: LX100IS Patient List [Accession#, Dilution Factor] a001,1 a002,2 a003,1 b001,4 b002,0.6 c917,4 cee4gf,1 To add a Patient List text file while creating a batch or multibatch: 1. Click Create New Batch or Create New Multi-Batch on the toolbar. An Open Template dialog box appears. 2. Select a template to create a new batch and click Select.
Luminex 100 IS User Manual Version 2.2 xMAP Technology 3. Click Load Patient List. An Open Patient List File dialog box appears. See Figure 64. Figure 64. Open Patient List File Dialog Box Note: If any of the acquire sample commands within the template of the batch has an unassigned value, the system applies the first patient ID in the list to the unassigned sample acquisition command.
xMAP Technology Using Luminex 100 IS 2.2 Software To edit a patient list: 1. From the File menu, select Edit Patient List. The Open Batch dialog box appears. 2. Select the desired unprocessed batch containing the patient list that you want to edit and click Select. The Edit Patient List dialog box appears similar to Figure 65. 3. Edit the desired patient and associated dilution factor information. Click Finish to accept your edits and close the dialog box. Figure 65.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Change Start Acquiring Data Location in MultiBatches You can change the location for multi-batches to begin acquiring data. To change the locations for beginning acquisition for batches in a multi-batch: 1. Click Create New Batch or Create New Multi-Batch on the toolbar. The Luminex Multi-Batch Setup dialog box appears. Refer to “Create a New Batch” on page 6-55 or “Create a MultiBatch” on page 6-61 for more information. 2.
xMAP Technology Using Luminex 100 IS 2.2 Software empty wells in front of the new starting well now appear red in the Batch Setup box or white in the Multi-batch Setup box. When you process this batch, the system begins acquiring data from the well indicated. You do not need to run batches in consecutive wells within a multi-batch. There can be empty wells between batches.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Figure 67. Luminex Batch Setup for Dilution 4. Click the Dilution Factor field. The white indicates that you can enter text into the field. 5. Enter the dilution factor used if the factor is other than one. Enter each dilution factor as a decimal, not as a ratio. 6. Click Finish. The system saves the information you entered.
xMAP Technology Using Luminex 100 IS 2.2 Software plate image or Command List areas on the Run Batch Tab the Command Information dialog box does not appear. Paste Batch Information to a Document To paste information from the current batch into a document: 1. Open the document where you want to paste the information. Click the cursor at the insertion point in the document. 2. Press the Ctrl+V keys on the keyboard or right-click in the document and select Paste from the drop-down command list.
xMAP Technology Luminex 100 IS User Manual Version 2.2 together and subtracted from the other samples to obtain a net flourescence intensity (MFI). Templates When creating batches or multi-batches, you must select a template to associate to the batch. Templates are predefined command sequences set by assay kit manufacturers to use during batch acquisition. Refer to the Luminex 100 IS Developer Guide for xMAP Technology Version 2.2 for template details. Caution: Do not alter predefined templates.
xMAP Technology Using Luminex 100 IS 2.2 Software 4. The kit manufacturer’s template appears on the selection list. Click the name of the template. 5. Click Open. The template is now loaded and available for use. Assay Lot Management You can edit standard and control lot information. Once a lot is used, changing or modifying it will prompt you for a new lot name. This includes batches that have been setup, but not yet acquired. Lot number information is not entered until it is used.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Create a New Lot To create a new lot: 1. Click New Lot on the Home tab. An Open Template dialog box appears. See Figure 69. Figure 69. Open Template Dialog 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 and New Control Lot dialog box appears as appropriate.
xMAP Technology Using Luminex 100 IS 2.2 Software Figure 71. Update Lot Information Dialog Box 4. Select the Exp. Date arrow and select the date from the calendar. 5. Enter the standard concentration values provided in the kit manufacturer’s instructions. See Figure 71. 6. Enter the control reagent values in the appropriate field. The controls are divided into 3 separate tabs: Low Limit, Expected Value, or Mean and High Limit. All fields must be defined to enable the Save button. 7. Click Save.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Edit Lot Information on an Unused Template To edit information for an existing lot: 1. Click New Lot on the Home tab. An Open Template dialog box appears. See Figure 72. Figure 72. Open Template To Update New Lots 2. Highlight the template that you want to edit and click Select. An Update Lot Information dialog box appears. See Figure 73. 3. Change or edit the expiration date and the lot concentration values.
xMAP Technology Using Luminex 100 IS 2.2 Software Figure 73. Update Lot Information Dialog Box Edit Lot Information on a Used Template To edit lots on a used template (may have new lot number of reagents, but are using same template): 1. Click New Lot on the Home tab. An Open Template dialog box appears. See Figure 74. Figure 74. Open Template To Update New Lots 2. Highlight the template that you want to edit and click Select. An Update Lot Information dialog box appears. See Figure 73.
xMAP Technology Luminex 100 IS User Manual Version 2.2 3. Change or edit the lot concentration values. Upon entering the information in the entry fields, the Save button activates. 4. Click Save. The system alerts you that this lot has been used to setup a batch and that you must create a new lot to continue. See Figure 75. Figure 75. Updating Used Template Notification Dialog Boxes 5.
xMAP Technology Using Luminex 100 IS 2.2 Software Figure 76. Update Lot Information Dialog Box Export a Lot from an Existing Template Use this feature to export a lot for use on another instrument. To export a lot from an existing template: 1. Click New Lot from the Home tab. An Open Template dialog box appears. See Figure 72. 2. Select the template containing the lot to export and click Select. An Update Lot Information dialog box appears. See Figure 76. 3. Click Export Lot.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Figure 77. Export Confirmation Dialog Box Note: Depending on the template and its associated products, you may have standards and controls or only standards. Standards and controls can be grouped into the same lot number. 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 appears to verify if you want to export the current lot as a control.
xMAP Technology Using Luminex 100 IS 2.2 Software • • Fit of All Standards (default) Mean of Replicates The assay developer defines the curve fit generation method while creating the assay template. The system default is to generate the curve fit according to the fit of all standards method. When generating a curve fit according to the fit of all standards, the system plots all standards to define the curve.
Luminex 100 IS User Manual Version 2.2 Start Plate xMAP Technology The Start Plate command begins the acquisition process. During acquisition, the system draws sample from the microtiter plate for processing. As the system processes data, the system analyzes whether the sample passes predetermined criteria or not. If a sample fails, the system flags that sample and acquisition continues on to the next sample. To start acquiring sample from a microtiter plate: 1.
xMAP Technology Using Luminex 100 IS 2.2 Software Once you start processing a batch, you cannot reacquire data. If you have used a batch for acquisition before, the system will not display it in the open batch list. Pause The Pause command temporarily interrupts the acquisition process.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Eject/Retract The Eject/Retract command ejects or retracts the microtiter plate from its current position. To eject or retract the microtiter plate: Click Eject/Retract on the Run Batch tab or the Acquisition Detail tab. The command toggles between Eject and Retract depending on the current status. That is, if the plate is retracted, click Eject/Retract to eject the plate. If the plate is ejected, click Eject/Retract to retract the plate.
xMAP Technology Using Luminex 100 IS 2.2 Software When the system analyzes batches, it displays the data in a three-tab format within the Analysis window. See Figure 78. The following three tabs present the batch information in greater detail: • • • Standards tab—lists all tests in the batch, a regression chart for each test, and the standards or controls associated with the batch.
xMAP Technology Luminex 100 IS User Manual Version 2.2 To automatically begin analysis upon completing sample acquisition: 1. Click Tools from the menu bar and select Options. The Options dialog box appears. See Figure 79. Figure 79. Options Dialog Box—Select Auto-start Analysis 2. At the General tab, click the Auto-Start Analysis checkbox. Click OK to complete the operation. When the system completes the batch acquisition, it will automatically begin analyzing data.
xMAP Technology Using Luminex 100 IS 2.2 Software 2. Select a batch to analyze and click Select. The system loads the batch and the Analysis window displays the Standards tab. See Figure 80. Figure 80. Analysis Window—Standards Tab (Data Reduction) Four buttons appear in the upper-right corner of the Analysis window: Open Batch. Opens an existing batch that you want to analyze. Export Data. Exports the data to the output csv file in the batch folder.
xMAP Technology Luminex 100 IS User Manual Version 2.2 • • samples graph (this is the only way to print a graph of standards) To print data analysis reports: 1. Click Analysis from the Home Tab. 2. At the Open Batch dialog box, select the desired batch to analyze. 3. On the Analysis dialog box, select Print Report. The Data Interpretation Report displays a print preview. See Figure 81. 4. Select any print options along the title bar and then click the print button (printer icon). 5.
xMAP Technology Using Luminex 100 IS 2.2 Software 2. Select the desired batch to analyze and click Select. The Analysis window appears showing the progress as the system opens the batch and analyzes the data. See Figure 80. Each test displays “Analyzing” as the system calculates. 3. Select the desired test or analyte to view from the Standards tab. 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.
xMAP Technology Luminex 100 IS User Manual Version 2.2 1405 Figure 82. Analysis Window—Standards Tab Function Keys On the lower portion of the Analysis window the system lists nine function keys. These keys perform tasks or functions that are relevant to the Standards tab although they appear on all three tabs of the Analysis window.
xMAP Technology Recalculation Using Luminex 100 IS 2.2 Software When you make a change, such as invalidating a standard or editing lot information, you must recalculate the affected test. The system provides two options, Automatic recalculate and manual recalculate. The Auto checkbox (under Recalc button) at the bottom of the Standards tab determines the option. Figure 83. Recalc Button Note: The Recalc button is greyed out unless you make changes that require recalculation.
xMAP Technology Luminex 100 IS User Manual Version 2.2 1. Select the desired standard or control name in the Standards or Controls grid. 2. Right-click to display the related menu. See Figure 84. Select the desired menu item to apply. When invalidating, the Name field turns red with an asterisk proceeding it. When validating, the red returns to the normal color. 1 2 1. Menu for multiple tests 2. Menu for single test Figure 84. Invalidate and Validate Shortcut Menus 3.
xMAP Technology Using Luminex 100 IS 2.2 Software Figure 85. Invalidate Data Analysis Example Expected Concentrations 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 in that field. You can edit controls, however, you must select the control name or Expected Concentration field for that control, then select the Change Lot (Alt+F8) button.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Figure 86. Choose Lot Dialog Box—Standard and Control Figure 87. 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 6-76. To have a lot selected as the current lot for use with future batches: 1. Select New Lot. 2. Select Standard lot or Control lot from the Update Lot Info screen.
xMAP Technology Samples Tab Using Luminex 100 IS 2.2 Software The Samples Tab lists tests from your batch and displays the results for each sample. Figure 88 shows a Sample tab example listing two tests. Notice that the left column displays Test 36 and 54 with Test 36 selected. The Sample column on the right side shows the Test 36 sample results.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Replicate Averaging Note: You predefine standard and control replicates in the template. You define unknown sample replicates in batch setup indicated by replicate Sample ID. The data analysis function supports replicate sampling. The function calculates each sample as an individual sample, then averaged to obtain a replicate average. • • Standards tab—displays standards and controls average values. Samples tab—displays samples average values.
xMAP Technology Using Luminex 100 IS 2.2 Software Choose from two sorting methods: Sequentially (by order acquired). This feature arranges sample data progress beginning with data acquired from the first sample in your batch and continues chronologically until the last sample with the AVG section at end. Alphabetical (by sample ID). This feature arranges sample data progress alphabetically according to the sample, beginning with A to Z, then one through nine.
xMAP Technology Luminex 100 IS User Manual Version 2.2 View Detailed Error Information To view error details during acquisition: 1. At the Analysis window, click the Errors tab. 2. The top half of the screen displays system and assay related error. The name of the error and a detailed description is displayed. See Figure 90 and Table 6. 3. The bottom half of the screen displays sample related errors. The error is displayed as Test Name, Sample ID, and Errors. See Figure 90 and Table 6. Figure 90.
xMAP Technology Customization Dialog Box Using Luminex 100 IS 2.2 Software To modify the general features of the Standards tab graph: 1. Click Analysis from the main toolbar. 2. Select the desired batch. The Analysis window appears displaying the Standards tab. See Figure 82. 3. Double-click anywhere within the graph to display the Customization Dialog Box. See Figure 91. Notice across the dialog box are five tabs: General, Axis, Font, Color, and Style.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Figure 92. Exporting Dialog Box Maximize: click to maximize the graph to full screen. Restore to original size by pressing Escape or by clicking in the title bar. Customization Dialog Box Tabs: • General Tab—Use this tab to define general parameters. See Figure 91. Main and Sub Titles: These edit-boxes allow you to add, edit, or delete these titles. If no title is present, you can enter one. Delete all characters from a title to remove it.
xMAP Technology Using Luminex 100 IS 2.2 Software Grid Lines: The Graph can contain vertical grid lines, horizontal grid lines, both vertical and horizontal grid lines, or no grid lines. Select the appropriate radio button. Grid in front of data: Check this option to place the grid in front of the data graphics. Otherwise, the data graphics are drawn on top of the grid. Note: If you select Log, use “Auto” or ensure that the “Min” value is greater that zero.
Luminex 100 IS User Manual Version 2.2 xMAP Technology • Color Tab—Use the Color tab to define the various color parameters on the analysis graph. See Figure 95. Desk Foreground: this is the color that is used when placing text onto the Desk Background. It includes the main title, sub title, subset/point labels, grid numbers. Desk Background: this is the color that surrounds the bounding rectangle of the graph's grid. That is, the color of the border that appears behind the text labeling.
xMAP Technology Using Luminex 100 IS 2.2 Software 1. Select the desired subset in the Subsets list box. The corresponding color and possible line and point types are then highlighted in their respective controls. 2. To change the color, use the mouse to click an alternate color or use the keyboard arrow keys to move to adjacent colors. Adjust the subset line and point types as desired. 3. Click OK to update the graph’s image. Figure 96.
xMAP Technology Luminex 100 IS User Manual Version 2.2 2. Select the desired menu item from the list and it is immediately applied. Figure 97. Graph Menu Items Analyze Data Outside the IS Software There are two ways to access the data interpretation feature from outside the Luminex 100 IS software application: • • Through the desktop Start menu Through Microsoft Explorer To access the Standards tab from Analysis using the desktop Start menu: 1. Click Start at the bottom left corner of the desktop.
xMAP Technology Using Luminex 100 IS 2.2 Software To access the Standards tab from Analysis using Microsoft Explorer: 1. Right-click on the desktop Start button to display the menu. Select Explore to open Microsoft Explorer. 2. Browse through Explorer to access the following location: C:\Program Files\Luminex\Luminex100IS\DataInterpApp.exe 3. Double-click the DataInterpApp executable file. The Analysis window appears. 4. Click Open Batch to open a file for analysis. 5.
Luminex 100 IS User Manual Version 2.2 xMAP Technology Patient Summary Report This report prints all the test results for a patient. It may include all tests or selected tests on the report. Quality Control Report This report is used to track the trends of assay standards and assay controls over a period of time. Maintenance Report Batch Summary Report Calibration Trend Report System Control Trend Report Print Reports Print from within Luminex 100 IS 2.
xMAP Technology Note: The system information may vary depending on the type of report that you select. Using Luminex 100 IS 2.2 Software Maintenance Report, Calibration Trend Report, and System Control Trend Report a dialog box related to the specific report appears. Figure 99. Batch Selection Dialog Box 3. Enter the information (in this example, a patient report) and click Next. Another information dialog box appears. Enter specific information for the type of report the system is compiling.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Figure 101. Report Print Preview Dialog Box 6. Click Print Report from the toolbar to print the report. 7. The MS Windows Print dialog box appears. Select the desired parameters and click Print. Print Using External Program There are two ways to print reports from outside of the Luminex 100 IS 2.2 software. To print a report using the desktop Start menu or Explore: 1. Click Start at the bottom left corner of the desktop. 2.
xMAP Technology Export Batch Data Using Luminex 100 IS 2.2 Software To export batch data: 1. Click Export Batch Data from the toolbar Batch dialog box appears. See Figure 102. . The Open Figure 102. 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 appears showing the name and location of the exported data file. See Figure 103. Figure 103. Batch Data Exported Dialog Box 4.
xMAP Technology Luminex 100 IS User Manual Version 2.2 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. Click Tools from the menu bar. 2. From the Tools menu, select Database Backup. The Backup Database To dialog box appears. Figure 104. Backup Database To Dialog Box 3.
xMAP Technology Using Luminex 100 IS 2.2 Software When the database is 98% full, sample acquisition is prevented. System calibration and control information is not affected when you erase sample information. The system also does not affect standard and control information while erasing data from the database. To erase information from the database: 1. Click Tools on the menu bar. 2. From the Tools menu, select Erase Database. The Choose Date calendar appears. See Figure 106. 3.
xMAP Technology Luminex 100 IS User Manual Version 2.2 To restore information to the database: 1. Click Tools on the menu bar. 2. From the menu, select Database Restore. The Restore Database dialog box warns you that the Luminex 100 IS software will shut down after restoring the database. See Figure 108. Figure 108. Restore Database Dialog Box 3. Click Yes to continue to restore a database. 4. From the Restore Database From dialog box, select a database backup file to restore and click Open.
xMAP Technology Using Luminex 100 IS 2.2 Software information for CAL 1, CAL2, CON1, and CON2 reagents are correct. See Figure 110. Figure 110. Database Restored Dialog Box 5. Click OK to verify that the lot information is accurate. Cleanup Utility Use the Cleanup Utility to: • • • Perform a disk cleanup Delete the Message Log directory Delete the Batch Directory To display the Cleanup Utility dialog box: 1. Click Cleanup on the Menu Bar's Tools Menu. The Cleanup Utility dialog box appears. 2.
Luminex 100 IS User Manual Version 2.2 xMAP Technology 2. At the Select Drive dialog box, select the desired drive and click OK. See Figure 112. The Disk Cleanup dialog box appears showing it is calculating progress. This can take several minutes. See Figure 113. Figure 112. Select Drive Dialog Box Figure 113. Disk Cleanup Dialog Box 3. When MS Windows finishes calculating the cleanup it displays the Disk Cleanup dialog box. See Figure 114. Check or uncheck 6 - 116 PN 89-00002-00-069 Rev.
xMAP Technology Using Luminex 100 IS 2.2 Software the desired files to delete and click OK. Windows deletes the files and closes the dialog box. Figure 114. Disk Cleanup for (Selected Drive) Delete MsgLog Directory To delete the Message Log directory: 1. Click Delete MsgLog Directory on the Cleanup Utility dialog box. See Figure 111. 2. At the Cleanup Utility confirmation dialog box, if you are sure that you want to delete the Message Log, click Yes. The Message Log is deleted. See Figure 115.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Delete Batch Directory 1. To delete the batch folders: 1. Click Delete Batch Directory on the Cleanup Utility dialog box. See Figure 111. 2. At the Cleanup Utility confirmation dialog box, if you are sure that you want to delete all the batch folders (directories), click Yes. See Figure 116. All the folders under C:\My Batches are deleted. The C:\My Batches folder remains. Figure 116.
xMAP Technology Using Luminex 100 IS 2.2 Software 3. Scroll through the contents and select the desired topic. Also, consider the index to locate information. 4. Double-click the help topic that you want to view. A topical dialog box appears with information on that topic. About the Device To display device information about the Luminex 100 analyzer, Luminex XYP instrument, and the Luminex LXR SDK: 1. Click Help from the menu bar. 2. Click About the Device.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Figure 118. About Luminex 100 IS Software Dialog Box 3. Click OK. System Information To display system information: 1. Click Help from the menu bar. 2. Click About the Software. The About Luminex 100 IS Software dialog box appears that lists software information. 3. Click System Info. The System Information dialog box appears. See Figure 119. 4. Click X in the top-right corner to close the dialog box. 5.
xMAP Technology Shutdown the Instrument Using Luminex 100 IS 2.2 Software Luminex recommends sanitizing with 10% household bleach as part of your daily shutdown routine after biohazard contact. Sanitizing uses the Luminex XYP reservoir to accommodate the amount of fluid necessary to sanitize the Luminex 100 analyzer. After sanitizing, perform a soak command to soak the probe in distilled water to prevent crystal formation in the Luminex XYP Sample Probe. To shutdown the Luminex 100 analyzer: 1.
xMAP Technology Luminex 100 IS User Manual Version 2.2 6. Click the drop-down arrow to the right of the Eject/Retract button. An image of the microtiter plate and reservoir appears in the plate holder. See Figure 121. Figure 121. Microtiter Plate Image For Location Selection Note: The system may show a default location from which to draw fluid. In this case, the microtiter plate shows that well with a yellow line outlining the well. 7.
7 Maintenance and Cleaning Proper maintenance and cleaning of the Luminex 100 IS system is required. Read and follow all instructions in this section. For your convenience, a maintenance log form is included at the end of this chapter. Warning: When analyzing potentially infectious biological samples on the Luminex 100 analyzer, follow standard laboratory safety practices. These safety precautions should also be taken when cleaning or maintaining the analyzer.
xMAP Technology Luminex 100 IS User Manual Version 2.2 5. Click Wash. A confirmation dialog box appears. To choose the desired location, click on the drop-down arrow located to the right of the Eject/Retract button. Click Eject/Retract. The Luminex XYP instrument tray ejects. Place sheath fluid in the selected well or reservoir on the plate. Click OK. Perform this step twice. Refer to “Maintenance Commands” on page 6-24 for detailed command operation. 6.
xMAP Technology Maintenance and Cleaning Figure 123. Refill Sheath Fluid Warning (Circled in Photo) Refill the Sheath Fluid Container To refill the sheath fluid container: 1. Release system pressure by removing the lid from the sheath fluid container. 2. Replace the sheath fluid box with a new box or refill the sheath fluid container. Empty the Waste Container Note: There is NO warning of a high waste volume. Empty the waste container each time you fill the sheath container.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Weekly Visual Inspection Open all of the Luminex 100 analyzer doors and visually inspect for leaks, corrosion, and other signs of improper function. Check all visible tubing connections. Check the Luminex XYP instrument air intake filter for buildup of dust. Monthly Cleaning the Sample Probe Danger: Be sure that the system is not performing an operation when you remove the Sample Probe.
xMAP Technology Clean Exterior Surfaces Maintenance and Cleaning To clean exterior surfaces, follow these steps: 1. Disconnect the system from ac power by turning off the power switches and unplugging the Luminex 100 analyzer and the Luminex XYP instrument. 2. Wipe all exterior surfaces with mild detergent, followed by a 10% bleach solution. 3. Open both doors of the system and clean all accessible surfaces with detergent followed by a 10% bleach solution. 4.
xMAP Technology Luminex 100 IS User Manual Version 2.2 3. Grasp the tubing and pull the filter 3 to 4 inches from the unit. See Figure 124. Figure 124. Grasping the Tubing 4. Remove the filter with one hand, and hold the tubing with the other hand. 5. Connect a new filter to the tubing and position the filter inside the panel. 6. Reattach the panel door to the unit. 7. Plug in and power on the Luminex 100 analyzer. Luminex XYP Instrument Air Intake Filter To replace the air intake filter: 1.
xMAP Technology Maintenance and Cleaning Figure 125. Removing the Screen 3. Replace the filter and replace the screen. See Figure 126. Figure 126. Removing and Replacing the Filter 4. Plug in and turn on Luminex XYP instrument power. PN 89-00002-00-069 Rev.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Syringe Seal To replace the syringe plunger seal: Danger: The syringe arm does not deactivate when changing the plunger; injury could result if the system is not unplugged. 1. Disconnect the Luminex 100 analyzer from ac power by turning off the power switch on the rear of the analyzer, then unplugging the power cord from the wall source. 2. Open the center-most door on the front of the Luminex 100 analyzer. 3.
xMAP Technology Maintenance and Cleaning 9. Screw the syringe back into its housing. 10. Return the syringe arm to its original position. 11. Hand-tighten the screw on the syringe arm. 12. Plug in the power cord and turn the Luminex 100 analyzer power on. 13. Prime the system twice, watching for any leaks in the syringe area. 14. When the prime finishes, close the center door. Luminex 100 Analyzer Ventilation Filter Clean the ventilation filter.
xMAP Technology Luminex 100 IS User Manual Version 2.2 5. Re-install it with the arrows facing up. The filter should click into place. 6. Plug in and turn on the Luminex 100 analyzer power. Annually Sheath Filter To change the Luminex 100 analyzer sheath filter: 1. Disconnect the Luminex 100 analyzer from ac power by turning off the power switch on the rear of the analyzer, then unplugging the analyzer power cord from the wall source. 2. Disconnect the sheath fluid tubing before changing the filter.
xMAP Technology Maintenance and Cleaning As required Fuses Danger: To avoid serious injury or death by electric shock, you must turn off the system and unplug it from the wall outlet. To replace the fuses in either the Luminex 100 analyzer or the Luminex XYP instrument: 1. Turn off the power switch on the rear of the analyzer or instrument, then unplug the instrument power cord from the wall source. Remove the power cord from the analyzer or instrument. 2.
xMAP Technology Luminex 100 IS User Manual Version 2.2 6. Replace the module door. 7. Plug in and power on the analyzer or instrument. 7 - 12 PN 89-00002-00-069 Rev.
Month(s): ________________________________________Year:_______________ Date/Initials: Date/Initials: Calibrate and verify Date/Initials: Date/Initials: Replace syringe plunger seal, or syringe Check analyzer ventilation filter Comments: Replace fuses As required Replace sheath filter Date/Initials: Date/Initials: Date/Initials: Replace air intake filter, XYP Yearly Date/Initials: Replace air intake filter, analyzer Every six months Date/Initials: Wipe exterior surfaces Date/Initials:
8 Troubleshooting Troubleshooting the Luminex 100 IS System Luminex Customer Support is available to users in the U.S. and Canada by calling 1-877-785-BEAD (-2323) between the hours of 7:00 a.m. and 7:00 p.m. Central Time, Monday through Friday. Users outside of the U.S. and Canada can call us at +1-512-381-4397 between the hours of 7:00 a.m. and 7:00 p.m. Central Time, Monday through Friday. Inquiries may also be sent by email to support@luminexcorp.com.
xMAP Technology Luminex 100 IS User Manual Version 2.2 problem with your kit results, xMAP controls can help determine if the problem is analyzer related. Verify the System with System Controls To verify your system from the Maintenance Tab: 1. Vortex xMAP reagent containers to ensure homogeneity. 2. Load a microtiter plate with CON1, CON2, and four wells with sheath fluid in the six desired wells. 3. Click Eject/Retract. The plate holder ejects. 4. Place the plate on the plate holder. 5.
xMAP Technology Troubleshooting 14. Click on the Maintenance Tab. Select the well where sheath fluid is located from Step 2 using the drop-down arrow located to the right of the Wash button. Click Wash. A confirmation dialog box appears. 15. Click OK and wait until the Wash completes. The Device Status section on the Status Bar changes to standby upon completion. The Run Batch tab will indicate if the command succeeded or failed upon completion. 16.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Luminex 100 Analyzer Fails Controls Perform the following items in order until you find your problem. 1. View the system control trend report. 2. Verify that the system control microspheres were properly mixed before they were dispensed into the wells. 3. Check the lot numbers and target values entered into Update CON Targets dialog box. 4. Verify that you added the system xMAP control microspheres to the correct wells on the plate. 5.
xMAP Technology Troubleshooting • • Channel backgrounds test Syringe pump test Call Luminex Customer Support if the functions fail again: Pressurization test—if the pressurization test fails, ensure that the sheath fluid container lines are attached to the appropriate connectors on the Luminex 100 analyzer. Check for air or sheath fluid leaks at all connections. Repeat the self diagnostics test.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Low Voltage Detected • • • Runtime Sheath Pressure Out of Limits (Too High) • • • Runtime Sheath Pressure Out of Limits (Too Low) • • • • Low Laser Power Detected • • • • Command Encountered Time Out Error System Error States Disconnected • Verify that the sheath fluid container is at the same level as the analyzer.
xMAP Technology Troubleshooting If you power the off, you must calibrate and verify the system when the system properly connects. Locked Out • Close all software applications other than the Luminex 100 IS 2.2 software. Note: Do not install unapproved software applications on the Luminex 100 IS 2.2 system. Refill Sheath Running: Sheath Empty Sample Error Messages Insufficient Bead Count A warning displays in red under the temperature and pressure gauges on the Run Batch tab.
xMAP Technology Luminex 100 IS User Manual Version 2.2 • • Temperature Divergence from Calibration Temperature • • Verify that the delta cal temperature is within ± 3.0 degrees. Recalibrate if outside the limits and retry. If the system controls pass, contact the kit manufacturer. Calibrate and verify the system. If this message still appears following calibration, contact Luminex Customer Support. Note: We recommend that you install the system in a temperature-controlled environment.
xMAP Technology Sample Timed Out Troubleshooting • • • • • • • • • Sample Empty Detected • • • • • • • • PN 89-00002-00-069 Rev. A Verify that the delta cal temperature is ± 3.0 degrees. Recalibrate if outside these limits and retry. Run the system controls. If the system controls pass, contact the kit manufacturer. This error message occurs when the system completely acquires the entire sample volume.
xMAP Technology Luminex 100 IS User Manual Version 2.2 • • • • Verify that you selected the correct template. Verify that lot information is entered correctly. Verify that the system is functioning properly by running system controls. If the system controls pass, contact the kit manufacturer. Power On Indicator Light Is Not On • • • • • Verify that the Luminex 100 analyzer is powered on. Verify that the system is plugged into an outlet with current.
xMAP Technology Troubleshooting • • • • • • Remove and sonicate or flush the Luminex XYP instrument Sample Probe to remove possible clogs. Verify that the Sample Probe is properly aligned. Complete the following analyzer functions from the Maintenance Tab: Backflush, Drain, Alcohol Flush and Water Wash. Verify that the delta cal temperature is ± 3.0 degrees. Recalibrate if outside these limits and retry. Run controls if calibrating.
Luminex 100 IS User Manual Version 2.2 8 - 12 xMAP Technology PN 89-00002-00-069 Rev.
9 Product Numbers Hardware Note: These part numbers are subject to change without notice. Note: Common description of product is enclosed in brackets. PN 89-00002-00-069 Rev.
xMAP Technology Luminex 100 IS User Manual Version 2.2 9-2 Luminex 100 IS User Manual, Version 2.2 (International English) Luminex 100 IS User Manual, Version 2.2 (French) Luminex 100 IS User Manual, Version 2.2 (German) Luminex 100 IS User Manual, Version 2.2 (Italian) Luminex 100 IS User Manual, Version 2.2 (Spanish) CN-M012-01 Luminex 100 IS Developer Guide to xMAP Technology Version 2.
xMAP Technology Product Numbers Syringe Seal (Qty 4) CN-0014-01 Cable, USB CN-0018-01 Assy, Bottle, Waste [Container] CN-0012-01 Assy, Sample Needle Height Alignment Kit CN-0015-01 Luminex SD [Luminex Sheath Delivery System] CN-S001-01 Product Description Customer Number Luminex 100 IS with Assay Developer’s Workbench, Version 2.2.
Luminex 100 IS User Manual Version 2.2 9-4 xMAP Technology PN 89-00002-00-069 Rev.
A Installation Assemble and Power up System Hardware Setup Connect the Luminex XYP Instrument and the Luminex 100 Analyzer to the PC Note: Due to the weight of the analyzer, use two people for lifting. Before installing the system, ensure that the facility complies with all system and safety requirements. Read the safety information that begins in “Warnings and Notes” on page 2-2. Position the instrument to minimize temperature fluctuations.
xMAP Technology Luminex 100 IS User Manual Version 2.2 4. Attach the power cord to the power input module of the Luminex XYP instrument and attach the communication cable to the Luminex XYP instrument. Do not plug the Luminex XYP instrument into the power outlet. 5. Place the Luminex 100 analyzer onto the Luminex XYP instrument. 6. Attach the power cord to the input module of the Luminex 100 analyzer and attach the USB cable to port 1 on the analyzer. Do not plug into the power outlet.
xMAP Technology Installation Refer to the documentation that came with your PC to determine if changing the voltage selection switch is required, and for instructions on changing the switch setting. Note: Do not place the PC or monitor on top of the Luminex 100 analyzer. 9. Place the PC to the right of the Luminex 100 analyzer and the Luminex XYP instrument. 10. Place the monitor on top of the PC and connect the monitor cable to the PC. See Figure 133. 1 2 3 4 5 1. Monitor 4. Computer 2.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Connect the Luminex 100 analyzer and the Luminex XYP instrument communications cables to the PC. See Figure 134 10 8 1 11 9 7 6 2 5 4 14 16 3 15 13 12 1. USB Communication Cable 9. Instrument USB Cables 2. Luminex XYP Instrument 10. Network Connection 3. Luminex XYP Instrument to PC Serial Cable 11. Monitor Cable 4. Power Cords 12. Y-Cable (to keyboard port) 5. Luminex XYP Instrument Power Switch 13. Mouse Cable (top port) 6.
xMAP Technology Installation 11. Connect the barcode reader, mouse, and keyboard. See Figure 135. 4 1 2 3 1. Keyboard 3. Y-Cable 2. Barcode Reader 4. Mouse Figure 135. Connecting the PC, Mouse, Barcode Reader, and Keyboard 12. Fill the sheath bottle with sheath fluid to just below the air intake fitting.
xMAP Technology Luminex 100 IS User Manual Version 2.2 2. Remove the light housing directly above the sample arm by grasping and firmly pulling out. The housing remains attached by a wire. Place the housing on top of the Luminex 100 analyzer. See Figure 136. Figure 136. Light Housing A-6 PN 89-00002-00-069 Rev.
xMAP Technology Installation 3. Remove the Cheminert fitting by turning the connector counterclockwise. If the tubing is difficult to remove, push up gently on the Sample Probe. See Figure 137. 1 2 1. Cheminert Fitting 2. Sample Probe Figure 137. Cheminert Fitting 4. Remove the Sample Probe by grasping the probe and gently pushing up. Read the Caution to the left. Caution: The Luminex XYP instrument Sample Probe should slide up easily while removing it from the Sample Arm.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Figure 138. The Luminex XYP Instrument Sample Probe 6. Reinstall the light housing by pushing until it snaps into place. 7. Install the clear plastic shield to cover the Sample Probe area. Remove this shield only to adjust the Sample Probe height. See Figure 139. Figure 139. The Shield A-8 PN 89-00002-00-069 Rev.
xMAP Technology Installation 8. Plug in the Luminex XYP instrument and the Luminex 100 analyzer. Configure the Luminex 100 IS 2.2 Software If the Luminex 100 IS 2.2 software initializes successfully, the software launches automatically. After configuring the system devices, the system prompts you to enter target values for calibration xMAP microspheres and control xMAP microspheres. See “Calibrate the System” on page 5-2 for more information.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Enter Target Values When using a new system for the first time, the system has no preexisting data in its database, so the system prompts you to enter xMAP calibration and control targets. You must enter these values before the system may proceed to the main menu. Enter the calibration and control target values found on the Certificate of Quality (COQ) included in the shipment of products.
xMAP Technology Installation 2. Remove the clear plastic shield that covers the Sample Probe area. 3. In a 96-well microtiter plate where overall height is no more than 0.75 inches, place the appropriate alignment tool in the plate. Note: Alignment discs can be placed in any well as long as the well is designated in the software. For a standard plate with flat-bottom wells, stack two of the larger (5.08 mm diameter) alignment discs together and place them into well A1.
Luminex 100 IS User Manual Version 2.2 xMAP Technology To install the Luminex XYP instrument reservoir: 1. Turn on the Luminex XYP instrument, Luminex 100 analyzer, and PC. Wait for the Luminex 100 IS software to start. 2. Click Eject/Retract to eject the plate holder. 3. Insert the reservoir in the upper-right corner of the plate holder. See Figure 142. Figure 142. The XYP Instrument Reservoir (circled) 4. Click Eject/Retract to retract the plate holder. 5. Turn heater on and set temperature.
xMAP Technology Installation 2. Insert the Luminex XYP instrument heater block on the plate holder. See Figure 143. Figure 143. The Luminex XYP Instrument Heater Block 3. Click Eject/Retract to retract the plate holder. 4. Turn heater on and set temperature. Refer to “Set Luminex XYP Instrument Heater Temperature” on page 6-21. Luminex 100 IS 2.2 Software Installation The Luminex 100 IS 2.2 system arrives with the Luminex 100 IS 2.2 software installed.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Note: Removing the software does not remove the database. Do not remove the database unless you want to permanently delete all your data. To remove the database navigate to the folder: C:\Program Files\Luminex\Luminex 100 IS and select DropLX100ISDb.exe To install or reinstall the 100 IS 2.2 software: 1. Insert the Luminex 100 IS 2.2 software CD into the CDRW drive. 2.
xMAP Technology Installation Figure 146. Modify, Repair, or Remove Dialog Box Network Installation Advisory This section is intended for your network IT representative. If you are installing your system on a network be advised not to change the computer name or the Luminex 100 IS 2.2 database will fail. If you must change the name, then perform these steps: To change the computer name on Luminex 100 IS 2.2 systems: 1. Change the computer name following the MS Windows process. 2.
A - 16 8 Cooling Air Intake Back View 6 Cooling Air Exhaust Possible Aerosol Exhaust Cooling Air Exhaust Possible Aerosol Exhaust 7.50 (190.50mm) Cable clearance. 7 2.0 (50.8mm) 4.0 3.0 (101.6mm) 7 (76.2mm) 6 Supporting Surface Luminex XYP Tray Clearance Cooling Air Intake 8 2.0 (50.8mm) Right Side View Isometric View Luminex 100 53.92 lb. (24.46 kg.) When Using Short Probe (For Installation and Diagnostics) Probable Aerosol Exhaust Point 0° +.5° -.0° Luminex SD 19.55 lb. (8.89 kg.
B Glossary ambient temperature The temperature of the surrounding environment. analyte A substance that is detected through assay analysis. Each test or bead set will test for a specific analyte. analyzer This term is used to refer to the Luminex 100 analyzer. APD 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.
xMAP Technology Luminex 100 IS User Manual Version 2.2 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. control microspheres, assay Used to verify standards within the kit. Tells you that the curve or thresholds are correct.
xMAP Technology laser laser Light Amplification by Stimulated Emission of Radiation (laser). This highly purified source of light is an efficient way to excite fluorochrome electrons. microparticle A solid substance with a diameter in the micrometer range. Often used as a synonym for a microsphere. microspheres Polystyrene spheres with a diameter in the micrometer range. Also called beads. multi-analyte Several assays or tests performed simultaneously in the same reaction container.
xMAP Technology Luminex 100 IS User Manual Version 2.2 signal Detectable measurement unit of the reporter molecule. standards microspheres, assay 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. suspension Solution consisting of homogeneously dispersed microspheres in an aqueous medium.
C Luminex Sheath Delivery System Overview Use this appendix to install, use, and maintain the Luminex Sheath Delivery System (Luminex SD™). Specifications General • • • • • • • Power Intended Use PN 89-00002-00-069 Rev. A • • Ambient temperature: 15°C to 30°C (59° to 86°F) Humidity: 20% to 80%, noncondensing Altitude: designed to operate at up to 2400m (7874 feet) above mean sea level Physical dimensions: 20 cm (8 inches) W x 30 cm (11.75 inches) D x 24.75 cm (9.
xMAP Technology Luminex 100 IS User Manual Version 2.2 Hardware The Luminex SD system includes: • • • • • • • Luminex Sheath Delivery device Waste line tubing (orange fitting) Sheath fluid line (blue fitting) Air line (green fitting) Sheath fluid intake line (white fitting) Power cord Screwdriver 1. 2. 3. 4. 5. 6. 7. 1. Power and Fault indicators 2. Prime button 3. Regulator adjust 4. Air In connector (green) 5. Sheath Out connector (blue) 6. Sheath In connector (white) 7.
xMAP Technology Installation Luminex Sheath Delivery System To install the Luminex SD system: 1. Locate the sheath fluid and waste bottles that are connected to the Luminex 100 analyzer. Check that the sheath fluid bottle is filled to just below the air intake valve. 2. Verify that the Luminex 100 analyzer is turned on and start the Luminex 100 IS 2.2 software. Perform the following tasks. 3. Calibrate the system. Refer to Chapter 5, "System Calibration". 4.
xMAP Technology Luminex 100 IS User Manual Version 2.2 receptacle is level with the Luminex 100 analyzer or no more than three feet below it. Note: Ensure that the sheath fluid box is at least three feet below the system, otherwise the Luminex SD system will overfill. • Connect the sheath fluid intake line (white fitting) to the Sheath In connector on the front of the Luminex SD system. • Connect the power cord to the back of the Luminex SD system and plug the other end into an approved outlet. 7.
xMAP Technology Luminex Sheath Delivery System sheath pressure displayed on the Diagnostic tab, System Monitor section, reads the same as the sheath pressure you recorded in step 4. The system should stabilize at this sheath pressure. The air pressure should be the same as you recorded in step 4, within 0.1 psi. If the Prime cycle ends before you have completed the adjustment, select Prime again and continue to adjust the regulator. 11. Calibrate the system again.
Luminex 100 IS User Manual Version 2.2 xMAP Technology Regularly, as required. Replace the sheath fluid as required. Weekly. Visually inspect the Luminex SD system and its connections for leaks. If you see a leak, turn off the power to the Luminex SD system and contact Luminex Corporation. Monthly. Turn off the power to the Luminex SD system. Clean the exterior surfaces by wiping with mild germicidal detergent, followed by a 10% bleach solution.
xMAP Technology Labels PN 89-00002-00-069 Rev. A Luminex Sheath Delivery System These labels appear on the back of the Luminex SD.
xMAP Technology PN 89-00002-00-069 Rev.
Index Symbols 7-6 %CV 6-48 A about device 6-119 about Luminex 100 IS 6-119 software 6-119 access doors 2-7, 3-11 accessories see accessory instructions 7-11 accuracy/precision specifications 3-4 Acquiring data location, starting location multiple batches 6-70 acquisition area 6-3 Acquisition Detail New Advanced Batch 6-46 Replay Batch 6-46 Acquisition Detail tab 6-44 main features 6-45 Acquisition Detail Toolbar 6-46 add sheath fluid 7-2 additional equipment bar code labels 3-7 printer 3-7 surge protector
xMAP Technology Luminex 100 IS User Manual Version 2.
xMAP Technology cautions 2-1, 2-6 CD supplied 3-3 CE mark 2-3 Change Lot 6-95 Change Lot (Alt+F8) 6-92 changing fuses 7-11 check analyzer ventilation filter 7-5 checklist 2-9 cheminert fitting A-7 Cheminert fitting illustration 3-10 classification 4-1 classification laser 4-1 classification laser, specification 3-5 clean accessible surfaces 7-5 clean exterior surfaces 7-5 clean sample probe needle 7-4 with bath sonicator 7-4 cleaning general 7-1 cleaning the sample probe monthly 7-4 cleaning, Luminex SD C-
xMAP Technology Luminex 100 IS User Manual Version 2.
xMAP Technology file menu 6-4 File Mode, analyze data 6-54 filter 3-9 remove screen 7-6 replacing air intake 7-6 sheath fluid 7-10 Fit of All Standards 6-83 flow 4-1 flow rate 3-5 fluidic leak 2-5 fluidic leaks 2-5 fluidic path 4-1 fluidics 2-2, 2-4, 2-5, 3-5, 4-1 components 3-9 illustration 3-9 warning 3-9 fluidics specifications 3-5 fluorescence 4-2 fluorescent signal 4-2 Function Keys 6-92 fuses product number 9-1 replacing 7-11 G gate settings 6-48 general Luminex 100 analyzer specifications 3-5 XYP
xMAP Technology Luminex 100 IS User Manual Version 2.
xMAP Technology maintenance reports 4-3 Maintenance tab, commands 6-24 Maintenance tab, Single Step 6-10 manual adjustment 3-13 manual product number 9-2 Manual recalculate 6-93 marketing 2-3 Maximize/Minimize 6-49 Mean 6-48 Mean of Replicates 6-83 mechanical 2-2, 2-7 mechanical warnings 2-7 Median 6-48 menu analyze 6-4 edit 6-4 file 6-4 help 6-4 tools 6-4 view 6-4 message log 4-2, 6-3 message log, clear 6-43 Microsoft Excel 6-73 Microsoft Word 6-73 microsphere 4-2 microsphere types 4-2 microspheres 4-1 mi
xMAP Technology Luminex 100 IS User Manual Version 2.2 temporary 6-85 PC 2-2 PC specifications 3-6 Peak 6-48 performance specifications 3-3 photodiode 4-1 photomultiplier 4-1 picture 2-1 pictures 2-7, 2-8 plate 4-1, 6-54 plate commands starting a plate 6-82 plate holder 6-38 ejecting A-12 ejecting, tray A-12 retracting A-12 polystyrene 4-2 power cord product number 9-2 power down 7-5 practical flow cytometry 4-1 Practical Flow Cytometry, 3rd edition, by Howard M. Shapiro, M.D. (New York Wiley-Liss Inc.
xMAP Technology Replicate averaging 6-98 Replicate samples 6-82 Replicates 6-82 Report Raw Fluorescence 6-5 report, create 6-108 reporter 4-1 reporter channel 3-5 reporter laser 4-1 reporter laser, specifications 3-5 Reports 6-107 reports 4-3 reports and analysis 6-18 reprocess batches 6-52 reprocess samples 6-53 reprocess samples using File Mode 6-53 reservoir 6-3, 6-20 reservoir, use A-11 responsibility 2-9 restore database 6-114 restoring the database reload database previously saved 6-113 results repor
xMAP Technology Luminex 100 IS User Manual Version 2.
xMAP Technology successful acquisition 6-84 support 1-2, 8-1 surge protector specifications 3-7 symbols 2-1 syringe 3-12, 4-1 syringe cylinder, product number 9-3 syringe seal 7-8 maintenance 7-8 syringe seal, product number 9-3 System and Assay Errors 6-99 system component 2-2 System control targets, enter 6-35 System Control Trend Report 6-108 system controls 8-1 System error APD Temperature Range Exceeded 8-5 Unknown Diagnostic Error 8-5 XYP Heater Stability Range Exceeded 8-5 system error disconnected
xMAP Technology Luminex 100 IS User Manual Version 2.
