Lum/nex ® Luminex 100™ IS User Manual Version 2.
© LUMINEX CORPORATION, 2001-2005. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, or translated into any language or computer language, in any form or by any means without prior express, written consent of: 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 2.3 REF CN-M018-01 PN 89-00002-00-072 Rev. C October 2005 EC REP Paul. A.
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Contents Introduction 1-1 About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 The Luminex 100 IS 2.3 System . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Luminex Website . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Luminex 100 IS User Manual Version 2.3 xMAP Technology Electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 Luminex XYP Instrument General. . . . . . . . . . . . . . . . . . . . . . . . . 3-6 Luminex SD System General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 PC Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 Recommended Additional Equipment. . . . . . . . . . . . . . . . . . .
xMAP Technology Contents Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17 Secondary Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20 Batch Setup Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20 Analysis Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22 Errors Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23 Standards Tab. . . . . . . . . .
xMAP Technology Luminex 100 IS User Manual Version 2.3 Maximize/Minimize. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Next Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . New Advanced Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . New Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . New CAL Targ. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . New CON Targ. . . . . . . . . . .
xMAP Technology Contents Define Data Export Tab Information . . . . . . . . . . . . . . . . 5-41 Setting up the Favorites List . . . . . . . . . . . . . . . . . . . . . . . . . . 5-42 Startup Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43 Warm Up the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43 Prime the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43 Backflush the System . . . . . . . . . . . . . . . . . . . . . . . . . .
xMAP Technology Luminex 100 IS User Manual Version 2.3 Database Management Procedures . . . . . . . . . . . . . . . . . . . . Back Up the Database . . . . . . . . . . . . . . . . . . . . . . . . . . . Delete Database Entries . . . . . . . . . . . . . . . . . . . . . . . . . Restore Database Data. . . . . . . . . . . . . . . . . . . . . . . . . . . Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . Drain the Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
xMAP Technology Contents Pressurization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3 Fluid Leaks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4 Sample Probe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5 Calibration and Control Problems. . . . . . . . . . . . . . . . . . . . . . . . . . 7-7 Acquisition Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Luminex 100 IS User Manual Version 2.3 xMAP Technology Remove Luminex LMAT Software . . . . . . . . . . . . . . . . B-17 Remove Luminex 100 Version 1.7 Software . . . . . . . . . B-18 Install Luminex 100 IS 2.3 Software. . . . . . . . . . . . . . . . B-19 Luminex 100 IS Version 2.1/2.2 to Luminex 100 IS Version 2.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-19 Backup Luminex 100 IS 2.1 or 2.2 Database . . . . . . . . . B-19 Remove Luminex 100 IS 2.1 or 2.2 . . . . . . .
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.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Technical Support Luminex Technical Support representatives are ready to help you, particularly when the system or software cause any questions or problems. If the question or problem relates to materials from the assay kit, you should contact the kit provider directly. Luminex Technical Support is available to users in the U.S. and Canada by calling 1-877-785-BEAD (-2323) between the hours of 7:00 a.m. and 7:00 p.m.
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 2.3 system that are not specifically contained in this manual, unless you are directed to do so by Luminex Technical Support. These symbols describe warnings, cautions, and general information used in the operation of this instrument. These symbols are further defined under “Safety Precautions.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Warnings and Notes Informational notes and warnings appear in this manual. Note: A note provides general helpful information. No safety or performance issues are involved. Caution: This message is used in cases where the hazard is minor or only potential hazard is present. Failure to comply with the caution may result in potentially hazardous conditions.
xMAP Technology Safety Do not perform any maintenance or cleaning of the system’s electrical components, with the exception of replacing fuses. This label appears on the back panel of the Luminex 100 analyzer and on the back panel of the Luminex XYP instrument. Figure 2-2 CE Label The Luminex 100 analyzer and the Luminex XYP instrument comply with European Union (EU) safety requirements and, therefore, may be marketed in the Europe Single Market.
Luminex 100 IS User Manual Version 2.3 xMAP Technology The following label appears on the back of the Luminex XYP instrument. Figure 2-4 Luminex XYP Serial Number Label The Luminex XYP instrument has been tested by UL. FCC Label This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
xMAP Technology Safety You must monitor waste levels manually. Do not allow the waste container to overflow! Empty the waste container each time the sheath fluid container is filled. Do not place the waste container on top of the instrument. Warning: If biological samples have been tested with the system, use your standard laboratory safety practices when handling system waste. Luminex 100 Analyzer Laser The Luminex 100 IS system classifies per FDA 21 CFR 1040.10 and 1040.
Luminex 100 IS User Manual Version 2.3 xMAP Technology All laser apertures are located within the Luminex 100 analyzer and are contained within a protective housing. This label appears on the optics cover within the Luminex 100 analyzer. Figure 2-7 Laser Class Label Warning — Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
xMAP Technology Barcode Reader Laser Safety This label is attached to the barcode reader. Figure 2-9 Barcode Reader Laser Label Do not stare into the beam or shine it into other people’s eyes. Mechanical Warning: During operation, this system contains exposed, moving parts. Risk of personal injury is present. Observe all warnings and cautions. Warning: During operation, this system contains exposed, moving parts which could result in puncture hazard. Risk of personal injury is present.
Luminex 100 IS User Manual Version 2.3 xMAP Technology Heat Warning: The heater plate of the Luminex XYP instrument may be hot and could cause personal injury if touched. Do not touch the heater plate. Blue Indicator Light 2-8 The blue light above the Luminex 100 analyzer sample arm indicates the on/off status of the Luminex 100 analyzer, and is harmless. The blue light-emitting diode (LED) does not emit light in the UV spectrum. PN 89-00002-00-072 Rev.
xMAP Technology Decontaminating the Luminex 100 Analyzer for Return Shipment Safety Luminex Technical Support will give you a Return Material Authorization (RMA) number if they direct you to return the system. They will explain how to return the system according to Luminex procedures. The accessible surfaces and the internal fluidics system must be sanitized and decontaminated before returning the analyzer. This is particularly important when biohazardous samples have been run.
Luminex 100 IS User Manual Version 2.3 2 - 10 xMAP Technology PN 89-00002-00-072 Rev.
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 2.3 of pressurized sheath fluid. A single 20 liter sheath container provides enough fluid for 48 hours or more of normal operation. The optics assembly consists of two lasers. One laser excites the dye mixture inside the xMAP microspheres and the second laser excites the fluorosphere bound to the surface of the xMAP microspheres.
xMAP Technology xMAP Technology Reagents Required Laboratory Reagents Luminex 100 IS 2.3 Software The System • • • • • Classification calibration microspheres (CAL1) Reporter calibration microspheres (CAL2) Classification control microspheres (CON1) Reporter control microspheres (CON2) Sheath fluid • • • Household bleach 70% isopropanol or 70% ethanol Mild detergent Luminex 100 IS 2.3 software provides complete control of the system and performs data analysis. Your Luminex 100 IS 2.
xMAP Technology Luminex 100 IS User Manual Version 2.3 acquiring sample, running system calibrators, running system controls, and warming up the instrument, the system resets the four-hour internal clock. Accuracy and Precision • • • • • • Sensitivity • • Capacity Detect 1000 fluorochromes phycoerythrin (PE) per xMAP microsphere Reporter channel dynamic range: 3.
xMAP Technology The System 55°C (95°F to 131°F) when performing heated assays and using the heater block Luminex 100 Analyzer General • • • • • • • • • • • Optics • • • • • Fluidics Electronics PN 89-00002-00-072 Rev. C Indoor use only Operating temperature: 15°C to 30°C (59°F to 86°F) Humidity: 20% to 80%, noncondensing Altitude: Operation up to 2400 m (7874 ft.) above mean sea level Physical dimensions: 43 cm (17 inches) W x 50.5 cm (20 inches) D x 24.5 cm (9.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Luminex XYP Instrument General • • • • • • • • • • Luminex SD System General • • • • • • • • • PC Specifications 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 one that can provide 1050 Watts for at least 45 minutes. The UPS should be UL listed, CSA certified, and CE marked when used internationally. Surge Protector If you do not use a UPS, use a surge protector. Choose a protector that meets your needs.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Luminex XYP Instrument Ventilation Filter The XYP instrument ventilation filter cleans the air that cools the internal parts of the Luminex XYP instrument. See Figure 3-1. 1 2 3 4 5 6 7 1 1. Air intake filter access door 5. Communication Ports (DB9) 2. Power Switch 6. XYP Communication Port (DB9) 3. Power Input Module 7. Analyzer ventilation filter (on bottom of analyzer) 4.
xMAP Technology The System The alignment guide directs the sample probe into the Luminex XYP instrument. 1 2 3 4 5 1. Cheminert Fitting 2. Sample Arm 3. Luminex XYP Instrument Sample Probe 4. Shield 5. Alignment Guide Figure 3-2 Cheminert Fitting Access Doors The Luminex 100 analyzer has three access doors. Two of the access doors are on the front, and the third is on the back. The front left access door supplies access to the sheath filter.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Air Intake Filter A replaceable air intake filter cleans the air used to pressurize sheath fluid. This filter is enclosed behind an access door located on the back of the Luminex 100 analyzer. See Figure 3-4. Figure 3-4 Air Intake Filter Syringe The syringe delivers a sample from the 96-well microtiter plate to the cuvette. See Figure 3-5. 1 2 1. Syringe Seal 2. Syringe Figure 3-5 Syringe and Syringe Seal 3 - 10 PN 89-00002-00-072 Rev.
xMAP Technology Sheath Filter The System The sheath filter removes particles greater than ten microns in diameter from the sheath fluid. See Figure 3-6. Figure 3-6 Sheath Filter Air, Waste, and Sheath Fluid Connectors The air, waste, and sheath connectors, located on the left side of the analyzer, connect to the SD system and waste fluid containers using clear tubing. The air connector is green, the sheath fluid connector is blue, and the waste fluid connector is orange. See Figure 3-7. . 1 2 3 1.
Luminex 100 IS User Manual Version 2.3 Luminex Sheath Delivery System Note: If you are not using the SD system, sheath fluid levels must be monitored manually. Check the sheath fluid level before starting a run or procedure. Waste Fluid Container xMAP Technology For proper operation, place the Luminex SD system at the same level as the base of the Luminex XYP instrument. Do not put it on top of the Luminex 100 analyzer.
4 Basic Concepts Background Information Fluidics Excitation PN 89-00002-00-072 Rev. C xMAP technology is a versatile system that measures soluble analytes. The Luminex 100 IS system performs simultaneous, discrete measurements of multiple microsphere-based reactions from a single specimen aliquot. For more conceptual information, refer to Practical Flow Cytometry, 3rd edition, by Howard M. Shapiro, M.D. (New York: Wiley-Liss Inc., 1995). There are two fluidic paths in the Luminex 100 analyzer.
Luminex 100 IS User Manual Version 2.3 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 or moved. You must run system controls following calibration and as often as you like to ensure that your system continues to operate optimally. The software provides you with a variety of reports.
Luminex 100 IS User Manual Version 2.3 4-4 xMAP Technology PN 89-00002-00-072 Rev.
5 Using Luminex 100 IS 2.3 Software This manual describes how to use the Luminex IS 2.3 software. It includes a glossary and information regarding the CSV file setup. The software user should have a basic familiarity with computers and Microsoft® Windows®. Commands are often available through more than one method, such as from the main menu bar, the toolbar, or on different windows. However, each procedure in this manual will describe only one method of accessing commands.
xMAP Technology Luminex 100 IS User Manual Version 2.3 . 1 2 3 4 5 1. Title bar 2. Menu bar 3. Tool bar 4. Tabs 5. Status bar Figure 5-1. Luminex IS 2.3 Main Window There are five major parts in the Main window: Title bar, Menu bar, Tool bar, Tabs, and Status bar. A brief description of each of these components is shown below. The Title Bar displays the name of the software. The Menu Bar contains three menus, File, Tools, and Help menu. A more thorough description of the Menu is shown on page 5-3.
xMAP Technology Menu Bar Using Luminex 100 IS 2.3 Software The menu bar contains the following menus: File Menu, Tools Menu, and Help Menu.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Toolbar The shortcut buttons on the toolbar can be found in other locations in the software. The Help button opens the online help. The Single Step option on the toolbar allows you to pause the system in between each command or sample acquisition within a batch. 1 2 3 4 5 6 7 8 9 10 11 12 13 1. Import Template 8. Print Report 2. New Batch 9. Connect to the Instrument 3. Open Batch 10. Disconnect from the Instrument 4.
xMAP Technology Using Luminex 100 IS 2.3 Software Favorites. You can use the Favorites list to create a customized list of often-used commands and templates. Items appear in alphabetical order for easy locating. For more information on setting up the Favorites list, see page 5-42. Button Groups. Button groups are grouped according to function. • The Daily Startup group contains the Warmup, Prime, Alcohol Flush, and Wash Commands. For more information on daily startup, see page 5-43.
xMAP Technology Luminex 100 IS User Manual Version 2.3 1 2 3 1. Microtiter plate/reservoir image 2. Temperature and Pressure Gauges 3. Command List Figure 5-4. Run Batch Tab The command buttons on the Run Batch tab are: • Print Worklist • Eject/Retract • Start Plate • Resume • Cancel Command • Pause • Cancel all For more information on these commands, see the Commands section, starting on page 5-31. For more information on setting up batches, see See “Batch Setup Procedures” on page 51..
xMAP Technology Using Luminex 100 IS 2.3 Software The DD temperature measures the doublet discriminator temperature. DD temperature shifting indicates a need for system recalibration. If you have not calibrated, the arrows showing the temperature range for the DD temperature both appear at the bottom of the thermometer, and the thermometer appears in red. An out-of-range temperature logs an error, but does not halt the acquisition.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Maintenance Tab Use the Maintenance tab to perform maintenance, XYP, daily startup, calibration, and verification commands to maintain your system and keep it in optimal working order. Figure 5-7.
xMAP Technology Using Luminex 100 IS 2.3 Software Instructions for maintenance procedures begin on page 5-93. Table 511 on page 5-93 shows a recommended use schedule for maintenance operations. Diagnostics tab Use the Diagnostics tab to monitor the progress of commands you initiate in the system. Features on this tab monitor the state of system components. This tab displays the System Monitor, Detailed Sample Progress chart, and Message Log.
xMAP Technology Luminex 100 IS User Manual Version 2.3 The system diagnoses real-time system problems related to fluidics and optics.
xMAP Technology Using Luminex 100 IS 2.3 Software Table 5-1. System Monitor Values (Continued) Property XYP Heater Temperature In Range Value Units of Measure Indicates if the XYP heater is in the set range The Detailed Sample Progress section displays the percentage of completion for each bead ID or test. The graph shows real-time progress, so that as each sample is analyzed, the graph adjusts to show progress. Use the zoom button to view up to 20 tests at a time.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Figure 5-10. Message Log The log displays actions in color-coded text and shading. Items in the Message Log appear in the following color codes: • • • • Green text represents a successful system calibration, verification command, acquisition, or maintenance functions. Red text represents failed commands, errors, or warnings. Black text represents normal processes and actions.
xMAP Technology Using Luminex 100 IS 2.3 Software Acquisition Detail tab features: • • • • • Batch Name and Description Batch Data Area Acquisition Detail Toolbar Histogram Dot Plot Figure 5-11 identifies the major features of the Acquisition Detail tab. 2 1 5 4 3 7 6 1. Luminex IS 2.3 Toolbar 5. Status Bar 2. Batch Name and Description 6. Histogram 3. Batch Data Area 7. Dot Plot 4. Acquisition Detail Toolbar Figure 5-11. Acquisition Detail Tab PN 89-00002-00-072 Rev.
xMAP Technology Luminex 100 IS User Manual Version 2.3 The Batch Name and Description section displays the name of the batch as well as its description. The Batch Data area displays sample results. The left column shows plate location and Sample ID description. The remaining columns display selected bead sets for the assay. Each row represents the data for each bead set from one well. The Acquisition Detail Toolbar shown in Figure 5-12 provides functions to acquire raw data without using templates.
xMAP Technology Using Luminex 100 IS 2.3 Software 1 2 3 1. Gate Boundaries 2. Aggregate Beads 3. Numerical Gate Position Figure 5-13. Set DD Gate Example The Histogram contains the Show Bead menu and four buttons: • • • • Autoscale Zoom Log/Linear Maximize For more information on these commands, see the Commands section beginning on page 5-31. The Dot Plot (or bead map) appears in the lower-right section of the Acquisition Detail tab. See Figure 5-14.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Figure 5-14. Dot Plot Display Example Four buttons appear at the top of the frame to control the display: • • • • Density/Decaying Log/Linear Zoom Maximize You can toggle between two types of dot plots using the Density/ Decaying button. The Decaying Dot Plot plots only the 100 mostrecent acquired events. The Density Dot Plot displays a constant accumulation of events. Increasing density is indicated by contrasting colors.
xMAP Technology Using Luminex 100 IS 2.3 Software collected events. Post acquisition does not display decaying dot plot; it’s only a real-time function. Status Bar The Status Bar displays information about the Command State, Device Status, Device Activity, Laser Status, Total Events per Second, and Region Events per Second. Color coding indicates the urgency of each item’s status. Device Activity uses no color coding. Figure 5-15.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Table 5-3.
xMAP Technology Using Luminex 100 IS 2.3 Software Table 5-4. Status Bar Communication Message Details Status Bar Color Green Yellow Red PN 89-00002-00-072 Rev. C Message Indicates Idle Waiting to process the next command. Standby The Luminex analyzer is ready and waiting to perform a command. Connecting The software is attempting to connect to the instrument. Processing The instrument is communicating with the software as it processes commands.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Secondary Windows Batch Setup Window In addition to the main window, there are other windows that are displayed when you select certain commands. These are the Batch Setup Window and Analysis Window. Additional windows display in the Developer’s Workbench software, if you have it installed on your system. For more information about the Developer’s Workbench, see the Luminex Developer Workbench Guide for Version 2.3.
xMAP Technology Using Luminex 100 IS 2.3 Software • • • • • • • Command list Microtiter Plate image Command button group box Save group box Standard Info group box Control Info group box New Lot button The Batch Info group box has text boxes in which you can input the name, description, and creator name of a new batch. The Template Info group box shows the name, description, version number, and developing company for the template that you are using in a batch.
xMAP Technology Luminex 100 IS User Manual Version 2.3 The New Lot button is visible only if the template you are using requires the use of standards or controls. The button opens the Update Lot Information dialog box, in which you can manage lot information. Analysis Window When the system analyzes batches, it displays the data in a three-tab format within the Analysis window.
xMAP Technology Using Luminex 100 IS 2.3 Software controls, and unknown samples are not always acquired in sequential wells and thus make sample viewing difficult. When viewing samples alphabetically all replicate samples are displayed together with the replicate sample’s average (AVG), then individual samples. If you view replicate batches sequentially, each sample displays in the order it was acquired, followed by a replicate average summary section.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Table 5-5.
xMAP Technology Using Luminex 100 IS 2.3 Software Figure 5-17. Analysis Window - Standards Tab Open When a median fluorescence intensity (MFI) value for an unknown sample or control lies outside the standard curve MFI range, the concentration is not calculated. The unknown sample or control result is reported as less than (<) or greater than (>) next to the corresponding standard expected concentration.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Table 5-6. Non-Competitive Out-Of-Range Labeling Condition Concentration Label MFI of Standard Referenced Left of Curve < min concentration standard Lowest Right of Curve > max concentration standard Highest Figure 5-18. Non-Competitive Assay Examples of out-of-range sample labeling for competitive assays are shown in Table 5-7. Figure 5-19 shows what a standard curve for a competitive assay should look like. Table 5-7.
xMAP Technology Using Luminex 100 IS 2.3 Software Figure 5-19. Competitive Assay The standards tab displays an Expected Concentration column for standard and control samples. The Standards Expected Concentration column allows users to edit the standard concentrations. You can edit controls; however, you must select the control name or Expected Concentration box for that control, then click Change Lot. When editing standard and control lot values the system may prompt you for a new number.
Luminex 100 IS User Manual Version 2.3 xMAP Technology than one background sample, the fluorescence values of the two background samples are averaged together and subtracted from the other samples to obtain a net fluorescence intensity. Samples Tab The Samples tab lists tests from your batch and displays the results for each sample. Figure 5-20 shows a Sample tab example listing three tests. Notice that the left pane displays Test IL-4, IL-6 and IL-8 with Test IL-4 selected.
xMAP Technology Using Luminex 100 IS 2.3 Software Figure 5-20. Analysis Window - Samples Tab Open Replicate Averaging Standard and control replicates are predefined in the template. You define unknown sample replicates in batch setup indicated by replicate Sample ID. The data analysis function supports replicate sampling. It calculates each sample as an individual sample, which is then averaged to obtain a replicate average. • Standards tab—displays standard and control average values.
Luminex 100 IS User Manual Version 2.3 xMAP Technology If the system fails to determine the results for a replicate due to an excessive skew of one of the samples, you can invalidate the out of tolerance value. Use the Invalidate Standard (F4) or Invalidate Control (F6) buttons at the bottom of the Analysis window. Be aware that this fixes standards and controls, not patient sample.
xMAP Technology Commands Acquire Patient Add Batch Alcohol Flush Autoscale Autosize Backflush Using Luminex 100 IS 2.3 Software This section describes the different commands used in the Luminex IS 2.3 software. They are grouped Alphabetically This command, which is part of the Insert command/menu, adds patients to the command list. After adding the patients you define the Sample ID and Dilution Factor for each new patient. The Dilution Factor defaults to 1.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Connect to Instrument Create New Multi-Batch Delete Batch Density/Decaying Display Confirmation Screens Disconnect from the Instrument Drain Eject/Retract Enable Raw Data Storage Export Batch Data Export CAL Export CON 5 - 32 Establishes a connection between the PC and the analyzer. This command opens the Luminex Multi-Batch dialog box, in which you add or create new batches to add to a multi-batch.
xMAP Technology Export Data Help Import Calibration Import Control Import Template Insert Invalidate Control Invalidate Standard Load Patient List Log/Linear Maximize/Minimize Next Test PN 89-00002-00-072 Rev. C Using Luminex 100 IS 2.3 Software Exports data to a .csv file in the batch folder. There is no dialog box to confirm that the data was exported. Opens the help file. Use this command if you need instructions on using a feature in the Luminex IS 2.3 software.
xMAP Technology Luminex 100 IS User Manual Version 2.3 New Advanced Batch New Batch New CAL Targ. New CON Targ. New Lot Open Batch Assay developers use New Advanced Batch to acquire data without having to build templates. This provides the developer with a faster and more convenient tool to develop assays. It does not store the results in the Luminex IS 2.3 database. It writes raw data to the output.csv file if Auto Export is selected, and writes run files if Enable Raw Storage is selected.
xMAP Technology Previous Test Prime Print Batch Worklist Print Report Recalc Replay Batch Report Raw Fluorescence Resume Sample Probe Down Sanitize PN 89-00002-00-072 Rev. C Using Luminex 100 IS 2.3 Software This command is found in the Analysis window. Use this command to view the previously run test in the batch. Removes air from the system’s fluidic pathways by drawing Luminex xMAP Sheath Fluid from the sheath fluid container. You do not need to supply solution in a plate.
xMAP Technology Luminex 100 IS User Manual Version 2.3 command. However, the sanitize command uses 10% to 20% household bleach to decontaminate sample lines and the cuvette after biohazard contact. Save and Load Save Only Self Diagnostics If selected, displays the run batch tab immediately after you set up batch information and click Finish. Allows you to save the batch information. User can open the batch later to acquire data.
xMAP Technology Start Analysis Start (Plate) Statistics Test Sort Orders Using Luminex 100 IS 2.3 Software Opens the Open Batch dialog box, from which you select a batch to analyze. Once you select the batch, the Analysis window opens. This command initiates data acquisition on New Advanced Batches and New Batches using system templates. During acquisition, the system draws sample from the microtiter plate for processing. This command enables you to display selected statistics for sample data.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Procedures Using the Online Help This section explains how to perform functions in the software. Help files describe Luminex System features and capabilities. You may find these topics by searching the contents of books and topics or by searching an alphabetic listing of the topics and books. Topics provide information and details regarding software features, system capabilities, and any number of related material.
xMAP Technology Setting Software Options Using Luminex 100 IS 2.3 Software Set up and customize the system software and enter your company information in the Options dialog box. The Software Options dialog box has three tabs: the General tab, the Company Information tab, and the Data Export tab. To configure software options: 1. On the Tools menu, click Options. 2. Click on the tab in which you want to set options. A full description of each tab and its options is listed below. 3.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Auto-Start Analysis. Select this feature to enable the software to begin analyzing data immediately after processing batches. The automatic analysis feature takes place after the system finishes acquiring data while processing batches. Figure 5-21. Options Dialog Box—General Tab Define Company Information Tab You can enter information about your company and a company logo into the Company Information tab.
xMAP Technology Using Luminex 100 IS 2.3 Software Figure 5-22. Options Dialog Box—Company Information Tab Define Data Export Tab Information Use the Data Export tab to configure your export data. See Figure 523. The following options are available: Auto Export Batches. Select this feature to automatically export the .csv file formats when the system finishes analyzing the batch. This allows you to run your own programs on exported data without having to manually start the export.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Export Location Label Style. Choose one of these options to define the label data style exported to the Output.csv file. You can select sequential numbering, by plate location, or both (default). Figure 5-23. Options Dialog Box—Data Export Tab Setting up the Favorites List To add templates to the Favorites list: 1. On the Favorites list, click Add Template. 2.
xMAP Technology Using Luminex 100 IS 2.3 Software 2. Select the command that you want to add to your Favorites list. For certain commands, you will need to select the location where you want to draw or expel fluid. Use the Location drop-down menu to open the microtiter plate image. Click on the microtiter plate location on the image. Ensure that the location you select is compatible with the volume intended for that location. 3. Click OK to add the command. The command displays in the Favorites list.
xMAP Technology Luminex 100 IS User Manual Version 2.3 When priming, the system draws Luminex xMAP sheath fluid from the sheath fluid container and sends it directly out to waste, and takes approximately one minute. You do not supply solution in a plate. To prime the system: Click Prime, then click OK to confirm that you want to prime the system. The status bar indicates that the prime command is processing.
xMAP Technology Using Luminex 100 IS 2.3 Software distilled water after Sanitize. Place at least 200 µL in a microtiter well or fill the Luminex XYP reservoir with distilled water. Washing takes about 30 seconds. You should wash after calibration and verification, between batches and multi-batches, after sanitize, and before daily shutdown. To perform a Wash command: 1. On the Maintenance tab, click Eject/Retract. 2. Select Reservoir from the dropdown menu next to the Wash button, then click Wash.
xMAP Technology Luminex 100 IS User Manual Version 2.3 To set the Luminex XYP instrument heater temperature: 1. Click Eject/Retract to eject the plate holder. 2. Set the Luminex XYP heater block on the plate holder. 3. Click Eject/Retract to retract the plate holder. 4. In the Temperature and Gauges area of the Run Batch tab, click Turn ON. The light on the button turns green and the thermometer fluid turns red as it raises to reach the target temperature. 5.
xMAP Technology Using Luminex 100 IS 2.3 Software Ensure that the Luminex analyzer lasers are warmed up and the probe height is set correctly before calibrating the system. Do not move the system waste line while calibrating. You can run calibration and verification commands from the Maintenance tab. You can import and export calibration and control lots and reuse existing lot information for calibration and controls.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Figure 5-25. Update CAL Targets Dialog Box 10. Repeat step 9 for the CAL2 lot. 11. In the Maintenance tab, click CAL1, then click OK. The device status section in the status bar changes from “Running” to “Standby”. 12. Click CAL2, then click OK. Wait until CAL2 completes. The Device Status section in the status bar changes from “Running” to “Standby” and the Diagnostics tab turns red.
xMAP Technology Using Luminex 100 IS 2.3 Software You must run system controls following calibration. Continue with the following “Run System xMAP Controls” section. Run System xMAP Controls Run System xMAP controls to verify calibration. Dispense the Control microspheres into the microtiter plate at the same time that you dispense the Calibration microspheres. See “Run System xMAP Calibrators” on page 5-47. To verify system calibration with controls: 1. In the Maintenance tab, click New CON Targ.
xMAP Technology Luminex 100 IS User Manual Version 2.3 4. 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 5-47. 5. In the Maintenance tab, click CON1 then click OK. Wait until CON1 completes. The Device Status section in the status bar changes from “Running” to “Standby”. 6. Click CON2, then click OK. Wait until CON2 completes. The Device Status section in the status bar changes from “Running” to “Standby”.
xMAP Technology Using Luminex 100 IS 2.3 Software 2. Click Import CAL or Import CON as appropriate. The Open dialog box opens. 3. To select the calibration lot or control lot to import, click the drop-down arrow for the Look in box. Browse for the appropriate folder, diskette, or CD location. The file type is a .lif file. After you select the location, the available lots display in the selection list. Click the name of the lot to import and click Open. The lot name appears in the product information box.
xMAP Technology Luminex 100 IS User Manual Version 2.3 You can group batches together as a multi-batch. Multi-batches can consist of any number of batches that have been setup from different assay templates and are processed consecutively. The assay kit manufacturer may provide templates in the kits, which they distribute on diskette or CD. Templates typically include assay standards, controls, and maintenance commands (such as washes or primes to acquire along with samples).
xMAP Technology Using Luminex 100 IS 2.3 Software To import a template from a diskette or CD: 1. Insert the kit’s diskette or CD into the appropriate drive. 2. On the File menu, click Import Template. The Import Template dialog box opens. 3. Click the Look in drop-down arrow and navigate to the diskette or CD drive containing the template. The diskette drive is typically drive A and the CD drive is typically drive D. 4. The kit manufacturer’s template appears on the selection list.
Luminex 100 IS User Manual Version 2.3 xMAP Technology 5. If you want to insert an Acquire Patient or Skip command, select the command from the Insert menu. In the multiplier box, enter the number of patients that you want to add to the list or the number of wells that you want to skip and click Apply. Skipped wells and patient wells added to the batch are shown as green wells on the microtiter plate image. 6. If you are running a maintenance template, add any samples (for processing).
xMAP Technology Using Luminex 100 IS 2.3 Software If all patient IDs in the batch are identified, the system appends the patient list items to the first empty location following the batch’s last command list activity. See “Add a Patient List” on page 5-62 for information regarding the patient file format. 12. Verify the dilution factor settings, and adjust as necessary. See page 5-65 for more information. 13. Select Save and Load (default) or Save Only. 14. Click Finish.
xMAP Technology Luminex 100 IS User Manual Version 2.3 2. Click Clear in the dialog box. 3. Click Yes to confirm that you want to clear the batch. Replay a Batch You can reprocess batches through the system multiple times using Replay Batch. Replay Batch uses the data stored in the run files from the initial acquisition to reprocess a batch, creating a new batch output file.
xMAP Technology Using Luminex 100 IS 2.3 Software To reprocess samples using Replay Batch: 1. On the Acq. Detail tab, click Replay Batch. The Browse for Folder dialog box opens displaying the My Batches folder. 2. Select the desired batch under the My Batches folder and click OK. 3. The Open Template dialog box opens. Click on the desired template and click Select. 4. The Run Batch tab becomes the active tab. You can monitor the commands as they process. Click on the Acq.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Delete a Batch You can only delete unprocessed batches. Batches are deleted from the Open Batch list and moved to the Open Incomplete Batch list. To delete an unprocessed batch: 1. On the File menu, click Delete Batch. A dialog box opens listing the unprocessed batches in the database. 2. Select the unprocessed batch that you want to delete. 3. Click Select to delete the batch.
xMAP Technology Using Luminex 100 IS 2.3 Software Figure 5-30. Luminex Multi-Batch Setup Dialog Box 2. In the Luminex Multi-Batch dialog box, click New Batch. 3. Create a New Batch. The procedure is shown on page 5-53. Click Save and Load instead of Save Only when you are finished setting up the New Batch. 4. To reassign the positions of the batches within the multi-batch, use the mouse to drag the highlighted well to the location on the microtiter plate where you want to begin acquiring data.
xMAP Technology Luminex 100 IS User Manual Version 2.3 3. Select the first batch to add and click Select. The batch appears beginning in well A1 of the microtiter plate on the Luminex Multi-Batch Setup dialog box. Red lines separate this batch from subsequent batches. 4. Repeat steps 2 and 3 to add additional batches. 5. Enter the Multi-Batch name and Created By, then click Finish. The Run Batch tab opens, representing the batches you selected or created on the microtiter plate. 6.
xMAP Technology Using Luminex 100 IS 2.3 Software Figure 5-31. Processing Multiple Plates After the first microtiter plate in a multiple plate batch has been acquired, the system pauses and prompts you to insert the next plate. To process multiple plates during a batch or multi-batch: 1. Create the batch or multi-batch. See “Create a New Batch” on page 5-53 or “Create a Multi-Batch” on page 5-58. 2. Insert the first plate. 3. On the Run Batch tab, click Start Plate to begin processing the batch.
xMAP Technology Luminex 100 IS User Manual Version 2.3 To open an incomplete batch: 1. On the File Menu, click Open Incomplete Batch. The Open Run dialog box opens. Select the batch you wish to recover from the list. 2. Click Start to continue where the batch left off. Note that a comment is added to the batch to indicate that the batch is being rerun. Scan in Samples With a Barcode Reader The barcode reader lets you quickly enter sample identification numbers or accession numbers.
xMAP Technology Using Luminex 100 IS 2.3 Software Where x = accession ID number for the patient (patient identifier string) and y = dilution factor. • • • The dilution factor is optional, but if entered, must be a numeric value. If the dilution factor is omitted, the system defaults to one. Patient list entries are case sensitive. This applies to entries made through the graphical user interface or in a file. The format must be like the following example or it will not load properly.
xMAP Technology Luminex 100 IS User Manual Version 2.3 system appends any remaining patient IDs to the end of the command list in order as they appear in the patient list. 5. Choose whether to save the batch or multi-batch for later use. Click Save only to save the batch or multi-batch. To run it after you finish creating it click Save and Load. 6. Click Finish. The system saves the batch or multi-batch for later use or it loads it for immediate use according to the decision you made when creating it.
xMAP Technology Using Luminex 100 IS 2.3 Software Figure 5-33. Edit Patient List Dialog Box Assign Sample Dilution Factors Indicate the sample dilution factor so the sample analysis in quantitative tests is accurate. The system multiplies the result by the dilution factor for reporting. Do not use dilution factors for qualitative testing. You define the dilution factors on a sample-by-sample, or patient-bypatient basis.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Figure 5-34. Luminex Batch Setup for Dilution 4. To change the dilution factor, click the Dil. Factor field. The white background indicates that you can enter text. Enter each dilution factor as a decimal, not as a ratio. 5. Click Finish. The system saves the information you entered. Create a New Advanced Batch Use New Advanced Batch to acquire data without creating a template. It writes raw data results to a simple csv file format.
xMAP Technology Using Luminex 100 IS 2.3 Software 2. On the Acquisition Detail toolbar, click New Advanced Batch. The Options Dialog Box opens with the General tab displayed. See Figure 5-35. . Figure 5-35. Options Dialog Box—General Tab 3. Enter the Name, Description, and Operator information. 4. Edit the following information as desired: • Sample Size - use values from 20 to 200 µL. To avoid air uptake, we recommend that your sample well contains at least 25 µL in addition to the sample size.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Figure 5-36. Options Dialog Box—Bead Set Tab 7. Edit the Events and Caption information for each bead set. Edit the Default Events box to change the default value. Click Apply to All to apply the default value to all bead sets. Table 5-8 lists selection shortcuts. Table 5-8. Bead Set Tab - Selection Shortcuts Note: The legend at the left side of the tab (No, Cmd Name, and Symbol columns) shows available commands and their colored-coded symbols.
xMAP Technology Using Luminex 100 IS 2.3 Software Figure 5-37. Plate Layout Tab Note: Wells are always read in rows (letters A to H) and columns (numbers 1 to 12) starting with A1. If partial columns are selected they are still read in the same order. 9. Select wells. To select a single well, click the well. To select multiple wells in a group, click and hold the mouse button with the cursor over the first well, then drag the cursor around the desired wells.
Luminex 100 IS User Manual Version 2.3 xMAP Technology 11. Establish preliminary off-plate commands. The system performs preliminary off-plate commands before the first well command. To establish a preliminary off-plate command, right-click anywhere over the plate layout and select Preliminary Off-Plate Cmd(s) from the menu.The command list dialog box appears similar to Figure 5-40. Click the OK button next to the Command List after you select the desired commands.
xMAP Technology Using Luminex 100 IS 2.3 Software To establish insert off-plate commands, select the desired wells, then right-click over the plate layout. Select Insert Off-Plate Cmd(s) from the menu. Select the desired commands and click OK. The background of the established wells turn green. To clear insert off-plate commands, select the wells to clear, right-click on the plate layout and select Clear Selection from the menu. 13.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Create a New Lot To create a new lot: 1. On the Home tab, click New Lot. The Open Template dialog box opens. See Figure 5-41. Figure 5-41. 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 or New Control Lot dialog box opens as appropriate.
xMAP Technology Using Luminex 100 IS 2.3 Software Figure 5-43. Update Lot Information Dialog Box 4. Enter the expiration date in the Exp. Date field. 5. Enter the standard concentration values provided in the kit manufacturer’s instructions. See Figure 5-43. 6. Enter the control reagent values. The controls are divided into 3 separate tabs: Low Limit, Expected Value, or High Limit. All information must be defined to enable the Save button. 7. Click Save.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Figure 5-44. Update Lot Information Dialog Box 3. Change or edit the expiration date and the lot concentration values. 4. Click Save. The system updates the lot changes and applies them to the template. 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. On the Home tab, click New Lot. The Open Template dialog box opens. 2.
xMAP Technology Using Luminex 100 IS 2.3 Software 5. Respond to the Create New Standard Lot or Create New Control Lot with Yes. Rename it in the New Lot Number dialog box. Import Lot to an Existing Template Use this procedure to import a lot to an existing template from another computer, from a diskette, or from a CD ROM. To import a lot to an existing template: 1. On the Home tab, click New Lot. The Open Template dialog box opens. 2. Select the template to receive the imported lot and click Select.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Export a Lot from an Existing Template Use this procedure to export a lot for use on another instrument. Depending on the template and its associated products, you may have standards, controls, or both. Standards and controls can be grouped into the same lot number. To export a lot from an existing template: 1. On the Home tab, click New Lot. The Open Template dialog box opens. 2. Double-click the template containing the lot to export.
xMAP Technology Using Luminex 100 IS 2.3 Software There are two main assay types: non-competitive (such as a “capture sandwich”) and competitive. In a non-competitive assay, the slope of a concentration versus Mean Fluorescent Intensity (MFI) standard curve is a positive number. That is, low concentrations result in low MFIs and high concentrations result in high MFIs.
xMAP Technology Luminex 100 IS User Manual Version 2.3 3. Double-click anywhere within the graph to display the Customization dialog box. See Figure 5-46. Notice across the dialog box are five tabs: General, Axis, Font, Color, and Style. Also notice that there are six buttons along the bottom of the dialog box. They are the OK, Cancel, Apply, Original, Export, and Maximize buttons. Figure 5-46.
xMAP Technology Using Luminex 100 IS 2.3 Software Figure 5-47. Exporting Dialog Box Maximize: Click to maximize the graph to full screen. Restore to original size by pressing Escape on the keyboard or by clicking in the title bar. Customization dialog box tabs: • PN 89-00002-00-072 Rev. C General Tab—Use this tab to define general parameters. See Figure 5-46. 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.
xMAP Technology Luminex 100 IS User Manual Version 2.3 • • Grid in front of data: Check this option to place the grid in front of the data graphics. Otherwise, the data graphics are drawn on top of the grid. Axis Tab—Use the Axis tab to change your X axis and Y axis values and specify whether to display them as linear or log. If you select Log, use “Auto” or ensure that the “Min” value is greater than zero. See Figure 5-48. Figure 5-48.
xMAP Technology Using Luminex 100 IS 2.3 Software Desk Background: this is the color that surrounds the bounding rectangle of the graph's grid. That is, the color of the border that appears behind the text labeling. Shadow Color: the rectangles that make up the graph's grid and table are bounded at the bottom/right edges with shadows. To remove the shadows, choose the same color as the Desk Background.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Figure 5-51. Customization Dialog Box—Style Tab To modify features using the Graph Menu: Most of these menu items provide a shortcut for many of the features provided in the Customization dialog box. Refer to page 5-77 for details. 1. Right-click anywhere in the graph on the Standards tab. The graph menu opens. See Figure 5-52. 2. Select the desired menu item from the list and it is immediately applied. Figure 5-52.
xMAP Technology Using Luminex 100 IS 2.3 Software To ensure that calculated data is exported to the output.csv file, you should not select both Auto-Start Analysis and the Auto Export Batches checkbox on the Data Export tab of the Options dialog box. Also note that Analysis and data reduction are synonymous terms. To enable automatic analysis: 1. On the Tools menu, click Options, then click on the General tab. See Figure 5-53. Figure 5-53. Options Dialog Box—Select Auto-start Analysis 2.
xMAP Technology Luminex 100 IS User Manual Version 2.3 View Detailed Test Analysis To view detailed test analysis: 1. On the Home tab, click Analysis. The Open Batch dialog box opens. 2. Click on the desired batch to analyze and click Select. The Analysis window opens showing the progress as the system opens the batch and analyzes the data. Each test displays “Analyzing” as the system calculates. 3. On the Standards tab, select the test or analyte you want to view.
xMAP Technology Using Luminex 100 IS 2.3 Software 1 2 1. Menu for multiple tests 2. Menu for single test Figure 5-54. Invalidate and Validate Shortcut Menus 2. Click Recalc to recalculate the results if the Auto option was not selected. To validate or invalidate a standard or control entry using the Invalidate and Validate Buttons: 1. Select the desired standard or control name in the Standards or Controls grid. 2.
xMAP Technology Luminex 100 IS User Manual Version 2.3 analysis. Figure 5-55 shows standard and control. Figure 5-56 shows standard only. Figure 5-55. Choose Lot Dialog Box—Standard and Control Figure 5-56. Choose Lot Dialog Box—Standard Only 3. To create a new lot from this dialog box as an alternate method, click New Lot and follow the steps in the Create New Lot procedure on “Create a New Lot” on page 5-72. To create a new lot for use within a batch: 1. Click New Lot. 2.
xMAP Technology Running Reports and Analyses Report Types Using Luminex 100 IS 2.3 Software You can output data by printing reports and exporting batch data. The Luminex IS 2.3 software can format your batch or multibatch results in a variety of export formats and provide different types of information in different types of reports. Analyte Report - prints some or all of the samples grouped by the test in a batch.
Luminex 100 IS User Manual Version 2.3 xMAP Technology Figure 5-57. Report Selection Dialog Box 2. Select the type of report that you want to print and click Next. For the Analyte, Clinical Patient, and Batch Summary Reports, the Batch Selection dialog box opens. Select the batch to print. See Figure 5-58. For the Quality Control, Maintenance, Calibration Trend, and System Control Trend Reports, a dialog box related to the specific report opens.
xMAP Technology Using Luminex 100 IS 2.3 Software Figure 5-59. Patient Selection Dialog Box 4. Select the desired entry or click the double arrow (>>) to select all the entries. 5. Click Finish. A report print preview appears using the information you entered. You may have more than one dialog box in which to enter information. 6. Click Print Report to print the report. 7. The Print dialog box opens. Select the desired parameters and click Print. Export Batch Data To export batch data: 1.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Print Data Analysis Report A printed batch report includes the following criteria that is applied to the batch during analysis: • • • • • • • batch name and test name formula used curve fit standards controls samples graph (this is the only way to print a graph of standards) To print data analysis reports: 1. On the Home tab, click Analysis. 2. In the Open Batch dialog box, select the desired batch to analyze. 3.
xMAP Technology Using Luminex 100 IS 2.3 Software Figure 5-61. Data Interpretation Report (Print Preview) Database Management Procedures Back Up the Database To manage the system database, back up and delete saved data and files. The system stores data results for instrument calibrators, instrument controls, assay calibrators, and assay controls. It records acquisition and maintenance data in real-time to minimize data loss in case of system failure.
xMAP Technology Luminex 100 IS User Manual Version 2.3 To back up the database: 1. On the Tools menu, click Database Backup. The Backup Database To dialog box opens. 2. Choose the file name and location of the database that you want to back up. The default name is LX100IS(month-date-year). 3. Click Save. The LX100 IS Database Backup dialog box opens informing you the backup is in progress to the specified location. Delete Database Entries You can erase sample information from the database at any time.
xMAP Technology Using Luminex 100 IS 2.3 Software 3. From the Restore Database From dialog box, select a database backup file to restore and click Open. The system restores the previously saved database. Notice that the files are organized by date (month-day-year). 4. A Database Restored dialog box opens the next time you start up the system. The dialog box prompts you to verify that the lot information for CAL 1, CAL2, CON1, and CON2 reagents are correct. 5.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Table 5-11.
xMAP Technology Using Luminex 100 IS 2.3 Software To drain the system: 1. On the Maintenance tab, click Eject/Retract. Ensure that the reservoir is empty, or insert a plate onto the plate holder. 2. Make sure that the correct location is selected next to the Drain button. Click Drain. A confirmation dialog box opens. 3. Click OK. The Device Activity box on the Status Bar indicates that the system is draining. Run SelfDiagnostics To run self diagnostics: 1. On the Maintenance tab, click Self-Diag. 2.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Figure 5-62. Cleanup Utility Dialog Box To perform a disk cleanup: 1. In the Cleanup Utility dialog box, click Disk Cleanup. 2. In the Select Drive dialog box, select the desired drive and click OK. The Disk Cleanup dialog box opens showing it is calculating progress. This can take several minutes. 3. When Windows finishes calculating the cleanup it displays the Disk Cleanup for dialog box. See Figure 5-63.
xMAP Technology Using Luminex 100 IS 2.3 Software To delete the batch folders: 1. In the Cleanup Utility dialog box, click Delete Batch Directory. 2. In the Cleanup Utility confirmation box click Yes to delete all the batch folders. All the folders under C:\My Batches are deleted. The C:\My Batches folder remains. Daily Shutdown Procedures Sanitize the System Sanitize the system with 10% to 20% household bleach to decontaminate the sample lines and the cuvette after biohazard contact.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Perform a Soak Command Soak the sample probe to prevent the sheath fluid crystals from forming in the sample probe. To perform a soak command: 1. On the Maintenance tab, click Eject/Retract. 2. Select Reservoir from the dropdown menu next to the Soak button, then click Soak. A confirmation dialog box opens telling you to place solution in the reservoir. 3. Put distilled water in the reservoir. 4. Click OK.
6 Maintenance and Cleaning To ensure accurate test results, properly clean and maintain the Luminex 100 IS system. Read and follow all instructions in this section. For your convenience, a maintenance log form is included at the end of this chapter. Warning: When analyzing potentially infectious biological samples on the Luminex 100 analyzer, follow standard laboratory safety practices. These safety precautions should also be taken when cleaning or maintaining the analyzer.
xMAP Technology Luminex 100 IS User Manual Version 2.3 5. Click Wash. In the confirmation dialog box, click on the dropdown arrow located to the right of the Eject/Retract button to choose the desired location. Click Eject/Retract. The Luminex XYP instrument tray ejects. Place sheath fluid in the selected well or reservoir on the plate. Click OK. Perform this step twice. 6. Check that the Luminex XYP instrument sample probe has been vertically aligned for the plate used in the kit.
xMAP Technology Refill the Sheath Fluid Container Maintenance and Cleaning 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 To empty the waste container: 1. Disconnect the waste container from the Luminex 100 analyzer. Note: There is NO warning of a high waste volume.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Flush the System Run 3 backflushes, 3 drains, 2 alcohol flushes and 3 washes with distilled water. Monthly Clean the Sample Probe Danger: Be sure that the system is not performing an operation when you remove the sample probe. Caution: The Luminex XYP instrument sample probe should slide up easily while removing it from the sample arm. If you feel resistance, do not force the probe up. Contact Luminex Technical Support.
xMAP Technology Maintenance and Cleaning 3. Open both doors of the analyzer and clean all accessible surfaces with detergent followed by a 10% to 20% bleach solution and then plain distilled water. 4. Dry the sheet metal surfaces to prevent corrosion. 5. Plug in and power on the Luminex 100 analyzer, the Luminex XYP instrument, and the Luminex SD system. 6. Calibrate the system as outline in “Calibration Procedures” on page 5-46.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Figure 6-2 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 XYP instrument air intake filter: 1.
xMAP Technology Maintenance and Cleaning Figure 6-3 Removing the Screen 3. Replace the filter and replace the screen. See Figure 6-4. Figure 6-4 Removing and Replacing the Filter 4. Plug in and turn on Luminex XYP instrument power. PN 89-00002-00-072 Rev.
xMAP Technology Luminex 100 IS User Manual Version 2.3 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 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 To clean the Luminex 100 analyzer ventilation filter: 1.
xMAP Technology Luminex 100 IS User Manual Version 2.3 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. 3. Open the left door on the Luminex 100 analyzer. Disconnect the filter by pushing down on the metal clamps on each connection.
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.
Luminex 100 IS User Manual Version 2.3 6 - 12 xMAP Technology PN 89-00002-00-072 Rev.
Luminex 100 IS Maintenance Log Month(s): ________________________________________Year:_______________ Maintenance Log Procedure: Use this form to record information over a four-week period. Fill in the month(s) and year above. Fill in the dates in the first line of the table. For each item listed at the left, enter your initials under each date that you perform the item. Note: Follow your standard laboratory safety practices when cleaning or maintaining the system.
7 Troubleshooting Troubleshooting the Luminex 100 IS System Troubleshooting procedures help users isolate, identify, and remedy problems with the Luminex 100 analyzer and Luminex XYP. This chapter does not troubleshoot problems with the PC. For help with PC problems, please call Dell Technical Support at 800-624-9896. To troubleshoot a problem, select a general symptom. Next, identify the possible problem and remedy it with one of the solutions listed.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Friday. Inquiries may also be sent by email to support@luminexcorp.com. Users in Europe can call us at +31-162408333 between 8:30 and 5:30, Central European Time, Monday through Friday. Email inquiries in Europe can be sent to supporteurope@luminexcorp.com Power Supply Problems Power supply problems often involve a blown fuse, faulty electronic component, or even something as simple as a disconnected cable. Use extreme care when you replace a fuse.
xMAP Technology Troubleshooting The XYP or the LX 100 power is not turned on. Pressurization Symptom Pressurization fails or pressure is too low. PN 89-00002-00-072 Rev. C Turn off the PC and then turn on the LX100, XYP, and then the PC. Normal air and sheath pressure readings vary between 6-9 psi while the compressor runs. If the system pressure is out of range, your sample acquisition will fail or return poor results. Possible problem Solution The sheath and waste lines are not fully connected.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Pressure too High Fluid Leaks Symptom Pressure too low Problem internal to the instrument. Determine if the problem is with the analyzer or the SD or bottles by disconnecting the sheath line from the analyzer and running a prime. Check the air pressure on the Diagnostic tab. If air pressure builds, the problem is with the SD or sheath fluid bottle. The sheath bottle is overfilled. Ensure that the sheath bottle is not filled above the fill line.
xMAP Technology Troubleshooting The syringe valve leaks. Sample Probe Symptom Hand-tighten the syringe connection. (silver knob) to the white syringe valve. Run a Prime. If leaks continue, contact Technical Support. Problems with the sample probe can lead to fluid leaks and pressurization problems, as well as inhibit sample acquisition. Possible problem Solution Sample probe leak The sample probe is clogged. Clean the sample probe. See page 6-4. Sample arm is stuck in the up position.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Sample arm stuck in the down position. The sample probe height is too low, or the path to the well is blocked. DO NOT turn off the Luminex XYP instrument. 1. Remove the blue light housing from the Luminex 100. 2. Unscrew the tubing connector that connects the sample tube to the top of the sample arm. The system monitor changes from “Busy” to “Running” and sample acquisition continues.
xMAP Technology Troubleshooting The analyzer is misaligned with the XYP instrument. Reposition the Luminex 100 analyzer on top of the Luminex XYP instrument so that the holes match up correctly. The alignment guide should tighten and loosen fairly easily if the instruments are aligned correctly. Continue to square the instruments until the guide loosens and tightens easily. The sample probe is bent. Remove the sample probe from the Luminex 100 analyzer. Roll it on a flat surface.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Zero events collected during calibration. Analyzer fails Controls. 7-8 There is a partial clog in the system. Clean the sample probe. See page 6-4. Run 3 backflushes, 3 drains, 2 alcohol flushes, and 3 washes with distilled water. There is air in the system. Run a prime and alcohol flush. Possible problem with the laser. View the calibration trend report. Check for dramatic changes in temperature, sheath pressure, or voltages.
xMAP Technology Troubleshooting Not enough control microspheres added to the well. Make sure that you use at least four or five drops of control microspheres to the well. Control lot is expired. Use a new bottle of control microspheres. The sample probe height is incorrect. Adjust the sample probe height. See page 6-8. The sample probe is clogged. Clean the sample probe. See page 6-4. There is air in the system. Run a prime and alcohol flush. Possible problem with the lasers.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Slow or unsuccessful sample acquisition Bead Detail Irregularities The calibration lot number selected in setup is incorrect. Enter the correct calibration lot number in the Update CAL Targets dialog box. Target values for chosen calibration lot number are incorrect. Enter correct target values in the Update CAL Targets dialog box. The wrong wells are selected in the Setup XY tab. Ensure that the correct wells are selected in the Run Batch tab.
xMAP Technology Troubleshooting Review reports routinely to detect trends. Use system xMAP control microspheres to check the success of the system calibration and for troubleshooting purposes. If there is a problem with your kit results, xMAP controls can help determine if the problem is analyzer related. If Calibration and Controls are successful, contact the kit manufacturer. A normal bead detail display is shown below. It depicts a tight bead population within a white region.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Symptom Possible problem Solution Calibration microspheres classify too high. You may be using photobleached calibration microspheres. Replace the microspheres with a fresh batch. To avoid photobleaching, protect your microspheres from light. xMAP microspheres hit the lower right of the region. You may be using photobleached xMAP microspheres. Replace microspheres with a fresh batch.
xMAP Technology Troubleshooting You are using incompatible sheath fluid. Error States Error Message Disconnected Use only Luminex sheath fluid in the Luminex 100 analyzer. Other fluids may damage your analyzer. The following error states display on the Status Bar on the Run Batch tab when an error occurs during system operation. Possible problem Solution The software hasn’t made initial connection. On the toolbar, click Connect; wait for the status to change.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Error Message Possible problem Solution Unknown Diagnostic Error Unknown/varied XYP Instrument Heater Stability Range Exceeded The heater block temperature is not hitting the target value. Low Voltage Detected Possible laser failure. Turn off the analyzer, XYP, and PC, then turn them back on. Calibrate and verify the system. If the error message occurs again, contact Luminex Technical Support.
xMAP Technology Troubleshooting Command Encountered Time Out Error The current command failed. Check the system to verify that it is warmed up and that there are no pressurization problems. Repeat the command. If the command continues to time out, contact Technical Support. Instrument Not Calibrated The instrument is out of calibration. Calibrate the instrument. Sample Error Messages Message Sample error messages occur when there is a problem with sample acquisition.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Verify that the system is functioning properly by running the system controls. If the system controls pass, contact the kit manufacturer. Failed Curve Fit The calculation could not occur for the assay standards for data interpretation. Verify that you selected the correct template. Verify that the correct control lot number and target values were selected and entered correctly.
xMAP Technology Troubleshooting Sample probe height is set incorrectly. Adjust the sample probe height. There is a clog in the sample line. Run the following commands: Backflush, Drain, Alcohol Flush, and Wash. Verify that the delta cal temperature is within ± 3.0. If the system is not within these limits, recalibrate, then retry Sample Empty Detected The system completely acquired the entire sample volume. Verify that you properly mixed the samples before dispensing into the wells.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Cannot calculate inverse function Luminex SD Problems Filter Malfunction Draining the Reservoir 7 - 18 This error message encompasses a range of mathematical errors often indicating that the sample result was negative or invalid. This is according to the parameters defined by the formula used to analyze the sample results. Standards, assay controls, and unknowns may all be flagged with Unknown Formula Failure.
xMAP Technology Verification Troubleshooting 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. Fill the Luminex XYP reservoir with a solution of 70% isopropanol or 70% ethanol. 6. Click Eject/Retract. The plate holder retracts. 7.
xMAP Technology Luminex 100 IS User Manual Version 2.3 15. Click OK and wait until the Wash completes. The Device Status section on the Status Bar changes to standby when the Wash cycle is complete. The Run Batch tab indicates if the command succeeded or failed upon completion. 16. Run four WASH commands. 7 - 20 PN 89-00002-00-072 Rev.
8 Product Numbers Hardware Note: These part numbers are subject to change without notice. Note: Common description of product is enclosed in brackets. PN 89-00002-00-072 Rev.
xMAP Technology Luminex 100 IS User Manual Version 2.3 8-2 Luminex 100 IS Documentation, Version 2.3 (Manuals on CD) Luminex 100 IS User Manual, Version 2.3 (North American) Luminex 100 IS User Manual, Version 2.3 (International English) Luminex 100 IS User Manual, Version 2.3 (Danish) Luminex 100 IS User Manual, Version 2.3 (French) Luminex 100 IS User Manual, Version 2.3 (German) Luminex 100 IS User Manual, Version 2.3 (Greek) Luminex 100 IS User Manual, Version 2.
xMAP Technology Product Numbers Syringe Seal (Qty 4) CN-0014-01 Cable, USB CN-0018-01 Waste Bottle CN-0012-01 Luminex SD [Luminex Sheath Delivery System] CN-S001-01 Product Description Customer Number Luminex 100 IS Version 2.
Luminex 100 IS User Manual Version 2.3 8-4 xMAP Technology PN 89-00002-00-072 Rev.
A Glossary agglutination The coalescing of small particles that are suspended in solution; these larger masses are then (usually) precipitated. 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.
xMAP Technology Luminex 100 IS User Manual Version 2.3 CL1 Refers to dyes embedded in the microsphere. Also see classification channel. CL2 Refers to dyes embedded in the microsphere. Also see classification channel. 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.
xMAP Technology Luminex xMAP microsphere set Luminex xMAP microsphere set Luminex multi-analyte microspheres containing a unique mixture of two distinctly colored fluorochromes to distinguish them from other multi-analyte microspheres. 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.
xMAP Technology Luminex 100 IS User Manual Version 2.3 sample The mixture of assay components (microspheres, reporter, patient diluent) that are analyzed. sample reaction The reaction that occurs between your reagents and the beads. signal Detectable measurement unit of the reporter molecule.
B Luminex 100 IS System Installation Overview This appendix provides hardware, firmware, and software installation procedures as required for new or system updates. On new systems, the factory preinstalls the latest versions of the firmware and software; you perform only the hardware installation. Upgrades become available for enhancements or to repair a corrupted file.
xMAP Technology Luminex 100 IS User Manual Version 2.3 The following sections describe how to connect the Luminex 100 IS system components. An Installation Drawing (page B-27) provides clearances and other related information. Figure B-1 shows the components of the system and how they should be placed. Perform the following procedures to set up the system. Each of these steps can be found on the page number shown in parentheses: 1. Connect the Luminex 100 analyzer and Luminex XYP to the PC (page B-3) 2.
xMAP Technology Connect the Luminex 100 analyzer and Luminex XYP to the PC Luminex 100 IS System Setup You must set up and calibrate the Luminex 100 analyzer and Luminex XYP instrument before you can install the Luminex SD system. To connect and power on the system: Caution: Due to the weight of the analyzer, use two people for lifting. Note: Do not place the PC or monitor on top of the Luminex 100 analyzer or XYP instrument. 1.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Note: The cable that connects the analyzer to the PC is 5 feet long; the cable that connects the SD to the analyzer is 2.5 feet long. ( Figure B-3 Install Alignment Guide 7. Ensure that the power switches on the analyzer and XYP instrument are in the off position. 8. Attach the power cord to the power input module of the Luminex XYP instrument and attach the serial cable to the Luminex XYP instrument.
xMAP Technology 8 Luminex 100 IS System Setup 1 9 10 7 6 2 5 15 4 14 13 11 12 3 1. USB Communication Cable (P1) 9. Y-Cable Port 2. Luminex XYP Instrument 10. Mouse Cable port 3. Luminex XYP Instrument to PC Serial Cable 11.PC Power Cable 4. Power Cords 12. Luminex 100 port (USB) 5. Luminex XYP Instrument Power Switch 13. Monitor cable port 6. Luminex 100 Analyzer Power Switch 14. Luminex XYP port 7. Luminex 100 analyzer 15. Printer cable port 8.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Note: The sheath and waste containers must be placed on the same surface as the Luminex XYP instrument. Do not place the containers on top of the Luminex 100 analyzer. 12. Connect the color-coded tubing connectors to the Luminex 100 analyzer. Blue = sheath, green = air, orange = waste. 13. Fill the sheath bottle with sheath fluid to just below the air intake fitting. Place the sheath and waste containers to the left side of the analyzer.
xMAP Technology Luminex 100 IS System Setup 3. Unscrew the cap from the Cheminert fitting. 4. Insert the sample probe into the sample probe holder. Insert the Cheminert fitting into the sample probe holder, turning it clockwise. Be careful that the threads are correctly aligned. Hand tighten only. See Figure B-7. 1 2 3 1. Cheminert Fitting 3. Sample Probe 2. Sample Probe Holder Figure B-7 Insert Sample Probe and Cheminert Fitting 5. Push the light housing back into place. 6.
xMAP Technology Luminex 100 IS User Manual Version 2.3 7. Plug the Luminex XYP instrument and the Luminex 100 analyzer into an approved outlet. Power On System Components Power on the system components: • • • The Luminex 100 analyzer (switch on back) The Luminex XYP instrument (switch on back) The PC and monitor (switches on front) After you power on the PC, Windows automatically starts up and then the Luminex 100 IS software automatically starts up. Continue with “Configure the Luminex 100 IS 2.
xMAP Technology Luminex 100 IS System Setup 2. In a 96-well microtiter plate where overall height is no more than 0.75 inches (19 mm), place the appropriate alignment tool in the plate: For a standard plate with flat-bottom wells—stack two of the larger (5.08 mm diameter) alignment discs together and place them into the selected well. Note: Alignment discs can be placed in any well as long as the well is designated in the software. For a filter bottom plate—stack three of the larger (5.
xMAP Technology Luminex 100 IS User Manual Version 2.3 To install the Luminex XYP instrument reservoir: 1. On the Maintenance tab, click Eject/Retract to eject the plate holder. 2. Insert the reservoir in the upper-right corner of the plate holder. See Figure B-10. Figure B-10 The XYP Instrument Reservoir 3. Click Eject/Retract to retract the plate holder. Calibrate and Verify the System Install the SD System Run system calibration.
xMAP Technology Note: Do not place the Luminex SD on top of the Luminex 100 Analyzer. Luminex 100 IS System Setup 3. Place the Luminex SD system near the sheath fluid connection on the left side of the Luminex 100 analyzer. Make the following connections; refer to Figure B-11 as needed. • Connect the sheath fluid line (blue fitting) to the Sheath Out connector on the front of the Luminex SD system. • Connect the air line (green fitting) to the Air In connector on the front of the Luminex SD system.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Note: Ensure that the sheath fluid box is at least three feet below the system, otherwise the Luminex SD system will overfill. • Lower the stainless steel filter end of the sheath fluid line to the bottom of a full 20 liter box of sheath fluid. Secure the cap on the sheath fluid box. Place the sheath fluid container so that the cap is on the top. • Attach the power cord to the input module on the back of the Luminex SD system.
xMAP Technology Luminex 100 IS System Setup Figure B-13 Luminex 100 Analyzer Regulator Adjustment 6. From the Home or Maintenance tab, select Prime. During this prime cycle, use a screwdriver to adjust the regulator on the front of the Luminex SD system. See Figure B-13. Adjust it until the sheath pressure displayed on the Diagnostic tab, System Monitor section, reads the same as the sheath pressure you recorded in step 4. The system should stabilize at this sheath pressure.
xMAP Technology Luminex 100 IS User Manual Version 2.3 To install the Luminex XYP instrument heater block: 1. On the Maintenance tab, click Eject/Retract to eject the plate holder. 2. Insert the Luminex XYP instrument heater block on the plate holder. See Figure B-14. Figure B-14 The Luminex XYP Instrument Heater Block 3. Click Eject/Retract to retract the plate holder. 4. Turn the heater on and set the temperature. Refer to Set Luminex XYP Instrument Heater Temperature (page 5-45).
xMAP Technology Luminex 100 Version 1.7 with Windows 98 to Luminex 100 IS Version 2.3 Install New PC Luminex 100 IS 2.3 Software Installation Overview of upgrade to Luminex IS 2.3 software procedure: • • • Install new PC Install Luminex IS 2.3 software Verify successful upgrade. To install the new PC: 1. Close all applications. Perform a complete system shutdown. Turn the power off and unplug the Luminex 100 analyzer, Luminex XYP, and PC. 2. Remove all connections from the old PC.
Luminex 100 IS User Manual Version 2.3 xMAP Technology Figure B-15 Luminex 100 IS 2.3 Startup Splash Screen 4. At the Luminex 100 IS Setup—Welcome dialog box, click Next to continue. 5. At the Luminex 100 IS Setup—License Agreement dialog box, read the End-User License Agreement (EULA). Use the scroll bar to display all the text. Click Yes to continue. 6. At the Luminex 100 IS Setup—InstallShield Complete dialog box, remove any floppy disks from their drives and click Finish.
xMAP Technology Luminex 100 IS 2.3 Software Installation Figure B-16 Software Information Window 3. Run system calibration. See Calibration Procedures (page 5-46) to complete the verification process by running the system calibrators and controls. Luminex 100 Version 1.7 with Windows 2000 to Luminex 100 IS Version 2.3 Archive “My Sessions” folder Remove Luminex LMAT Software To upgrade to Luminex IS 2.
Luminex 100 IS User Manual Version 2.3 xMAP Technology 4. The InstallShield Wizard—Welcome dialog box opens. See Figure B-17. Figure B-17 InstallShield Wizard Dialog Box—Remove Select Remove and click Next. The Confirmation File Deletion dialog box opens. Click OK. 5. If the Shared File Detected dialog box opens, select Don’t display this message again, then click Yes. 6. If the Registry Editor dialog box opens, click OK. 7.
xMAP Technology Luminex 100 IS 2.3 Software Installation 5. Click OK in the Confirmation File Deletion dialog box. If a Shared File Detected dialog box opens, select the Don’t display this message again checkbox, then click Yes. If a Self-registration error dialog box opens, Click OK. 6. When the InstallShield Wizard—Maintenance Complete dialog box opens, click Finish. 7. Click Close on the Add/Remove Programs dialog box. Click the X on the Control Panel to close. 8.
Luminex 100 IS User Manual Version 2.3 xMAP Technology 2. Choose the file name and location of the database that you want to back up and click Save. The database is backed up and the Backup Database To... dialog box closes. Close the IS Software. Remove Luminex 100 IS 2.1 or 2.2 You remove the Luminex 100 IS Version 2.1 or 2.2 software through the Windows Control Panel. 1. On the PC desktop select: StartÖSettingsÖControl Panel. The Control Panel dialog box opens on the desktop.
xMAP Technology Luminex 100 IS 2.3 Firmware Installation Firmware Upgrade Cable Configurations PN 89-00002-00-072 Rev. C Luminex 100 IS 2.3 Firmware Installation The Luminex 100 analyzer, the Luminex XYP instrument, and the Luminex SD system use firmware to perform internal control functions. Although seldom required, firmware updates may become available to enhance functionality.
xMAP Technology Luminex 100 IS User Manual Version 2.3 • Luminex XYP instrument—Continue to use the serial interface cable between the PC and Luminex XYP. Luminex 100 Analyzer Firmware Upgrade Follow the steps in this section to update and verify the Luminex 100 analyzer firmware. Perform the Luminex 100 IS Version 2.3 software update before installing firmware upgrade tools and firmware files. See Luminex 100 IS 2.3 Software Installation (page B-14) for the procedure.
xMAP Technology Note: If you are directed by Technical Support or by upgrade kit instructions to upgrade to a specific firmware version, then click the Browse button and select the desired firmware version from the Open dialog box. Luminex 100 IS 2.3 Firmware Installation 1 2 5 3 4 1. LXR Runtime Version 4. Status of Upgrade 2. Luminex 100 analyzer firmware version 5. Movement Device/SD Device selection button 3.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Update Interface Cable • • Luminex XYP Instrument Firmware Update Update Firmware If you are upgrading from Luminex 100 Version 1.7 replace the serial interface cable with USB cable supplied in the upgrade. If you are upgrading from Luminex 100 IS Version 2.1 or 2.2 continue to use the USB cable. Follow the steps in this section to update and verify the Luminex XYP instrument firmware. To update the Luminex XYP instrument firmware: 1.
xMAP Technology Luminex 100 IS 2.3 Firmware Installation version listed in the upgrade document. Your upgrade kit instructions list the correct version number. Luminex SD System Firmware Update Update Firmware If you are upgrading the firmware for more than one component (for instance, the SD and the XYP), you must upgrade the SD system first.Follow the steps in this section to update and verify the Luminex SD system firmware. To update the Luminex SD system firmware: 1. Close any open applications. 2.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Verify Successful Firmware Upgrade 1. On the PC desktop click StartÖProgramsÖLuminexÖLXRÖLX Firmware. The LX Firmware Update Tool dialog box opens. See Figure B-19. 2. An entry in the Movement Device text box should read: Firmware up-to-date. 3. Turn the power off to the SD, XYP, and LX100. 4. Reconnect the serial cable to the XYP. 5. Connect the SD interface cable to the SD and LX100. 6. Turn on the power to the SD, The XYP, and the LX100.
Clearance for cooling and intake/exhaust, and cable clearance for power switch access . PN 89-00002-00-072 Rev. C Back View Cooling Air Intake Cooling Air Exhaust Possible Aerosol Exhaust 7.50 (190.50mm) Cooling Air Intake 2.0 (50.8mm) 6 4.0 3.0 (101.6mm) 7 (76.2mm) Cooling Air Exhaust 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.
Luminex 100 IS User Manual Version 2.3 B - 28 xMAP Technology PN 89-00002-00-072 Rev.
C Output.CSV Overview This chapter describes the file specification for the Luminex 100 IS 2.3 OUTPUT.CSV file. Although this document may refer to older versions of Luminex software for historical purposes, it is intended only to describe the OUTPUT.CSV file for the Luminex 100 IS 2.3 system. Although this chapter was prepared to ensure accuracy, Luminex assumes no liability for errors or omissions or for damages resulting from the application or use of this information. The OUTPUT.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Sample2 .... SampleM StatN StatN Header: Sample Location, Sample Name, Test1, Test2, ..., TestN, Total Count, Notes Sample1 Sample2 .... SampleM Blank Lines • • • • • There is one blank line between the Date and SN fields. There are four blank lines between the Operator field (or last optional field) and Samples field. There is one blank line between the Samples and Results fields.
xMAP Technology Table D-1 Field Definitions (Continued) Field Name Field Value Description TemplateName, "value” (Optional) The name of the template used to create the batch. Limited to 30 characters. TemplateVersion, "value” (Optional) The version of the template used to create the batch. Limited to 10 characters. TemplateDescription, "value” (Optional) The description of the template used to create the batch. Limited to 200 characters.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Table D-1 Field Definitions (Continued) Field Name Field Value Description Results This field has no associated value. It is used to indicate the beginning of the statistical results section of the OUTPUT.CSV file. DataType:,"type” This field is the name of the statistic represented in the Sample (versus the Test data block immediately below this field).
xMAP Technology Table D-2 Statistics Definitions Statistic Description %CV (Optional) The measure of relative dispersion within the distribution. %CV = 100 x Std Dev / Mean Peak (Optional) The value that is equal to the largest number of data points within the distribution. For example in data set {1,2,2,3,3,3,4,5}, 3 is the peak because it occurs the most number of times in the distribution list. Std Dev (Optional) The measure of dispersion within the distribution.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Table D-3 Statistic Column Definitions Column Name C-6 Description Total Events The number of events that fell with in the defined DD gate and into one of the defined regions for a test in the batch.
xMAP Technology Luminex 100 IS OUTPUT.CSV file with no additional features enabled "Program","Luminex 100 IS",409 "Build","2.
xMAP Technology Luminex 100 IS User Manual Version 2.3 Luminex 100 IS OUTPUT.CSV file with all additional features enabled "Program","Luminex 100 IS" "Build","2.3 BETA" "Date","7/28/2004","2:16:30 PM" "SN","LX10001298011BE" "Session","Bead 22 Quant Batch" "Operator","" "TemplateID","4" "TemplateName","Quant Batch" "TemplateVersion","2.3c" "TemplateDescription","IS 2.3.
xMAP Technology "Samples","8","Min Events","0" "Results" "DataType:","Median" "Location","Sample","Test 22","Total Events","Notes" "1","Std s","57","75","" "2","Std m","525","75","" "3","Std l","4341","75","" "4","Std xl","14316","75","" "5","Std xxl","25694","75","" "6","Low Control","58","75","" "7","Patient 1","532","75","Sample Comment for Patient 1." "8","Patient 2","14567","75","Sample Comment for Patient 2." "DataType:","Result" "Location","Sample","Test 22","Total Events","Notes" "1","Std s","2.
Luminex 100 IS User Manual Version 2.3 xMAP Technology "3","Std l","4450.92","75","" "4","Std xl","13478.6666666667","75","" "5","Std xxl","24817.8933333333","75","" "6","Low Control","60","75","" "7","Patient 1","561.12","75","Sample Comment for Patient 1." "8","Patient 2","14402.3466666667","75","Sample Comment for Patient 2." "DataType:","%CV" "Location","Sample","Test 22","Total Events","Notes" "1","Std s","662.071761559013","75","" "2","Std m","42.0677216044823","75","" "3","Std l","28.
xMAP Technology "1","Std s","69","75","" "2","Std m","69","75","" "3","Std l","69","75","" "4","Std xl","69","75","" "5","Std xxl","69","75","" "6","Low Control","69","75","" "7","Patient 1","69","75","Sample Comment for Patient 1." "8","Patient 2","69","75","Sample Comment for Patient 2." "DataType:","Trimmed Mean" "Location","Sample","Test 22","Total Events","Notes" "1","Std s","56.9855072463768","75","" "2","Std m","494.463768115942","75","" "3","Std l","4466.08695652174","75","" "4","Std xl","13634.
Luminex 100 IS User Manual Version 2.3 xMAP Technology "DataType:","Trimmed StdDev" "Location","Sample","Test 22","Total Events","Notes" "1","Std s","13.6634901596136","75","" "2","Std m","130.732391650918","75","" "3","Std l","925.292874765645","75","" "4","Std xl","3467.39037575852","75","" "5","Std xxl","3533.78728678387","75","" "6","Low Control","12.9976389750536","75","" "7","Patient 1","117.063202011273","75","Sample Comment for Patient 1." "8","Patient 2","2992.
Index A access doors 2-7, 3-10 accessories see accessory instructions 6-11 accuracy/precision specifications 3-4 acquisition area 5-2 Acquisition Detail New Advanced Batch 5-43 Replay Batch 5-43 Acquisition Detail tab 5-41 Acquisition Detail toolbar 5-42 add sheath fluid 6-2 additional equipment barcode labels 3-7 bath sonicator 3-7 printer 3-7 surge protector 3-7 vortex 3-7 additional software 3-3 adjust sample probe vertical height B-8 adjust sample probe B-8 adjust sample probe height B-8 after running s
xMAP Technology Luminex 100 IS User Manual Version 2.
xMAP Technology reports 5-108 database backup 5-112 compressed patient reports 4-3 management 5-112, 5-113 restore 5-114 DD temperature 5-15 decaying dot plot 5-46 decontamination 2-2, 2-9, 5-24 density dot plot 5-46 detailed sample progress 5-39 Diagnostics tab 5-37, 5-41 digital signal processor 4-1 dilution factor 5-65 discard waste 6-2 disconnect from AC power 6-5 disconnected status 5-10 dot plot 5-46 decaying 5-46 density 5-46 draining the system 5-25 during operation 2-2 E edit menu 5-3 efficiency
xMAP Technology Luminex 100 IS User Manual Version 2.
xMAP Technology semi-annual 6-6 weekly 6-4 manual adjustment 3-12 Manual recalculate 5-94 marketing 2-3 Maximize/Minimize 5-46 Mean of Replicates 5-82 mechanical 2-2, 2-7 menu analyze 5-3 edit 5-3 file 5-3 help 5-3 tools 5-3 view 5-3 message log 4-2, 5-2, 5-40 Microsoft 5-67 microsphere 4-1, 4-2 microtiter plate 4-1, 5-49 microtiter well 5-24 monitor the system 4-2 monitor waste fluid refill sheath container 6-2 multi-analyte 4-1 multi-batch analyze 5-85 load 5-58 multiple batches start location 5-64 multi
xMAP Technology Luminex 100 IS User Manual Version 2.
xMAP Technology filter 6-10 levels 6-1 product number 8-3 sheath fluid container 3-12 show bead 5-45 Shut Down the Instrument 5-120 single step 5-8 soak 5-26 software 3-3, 8-3 software overview Luminex 100 IS software 4-2 software specifications 3-3 dedicated system 3-3 soluble analytes 4-1 sorting methods 5-99 specifications Index raw data 5-4 subsystems 3-8 successful acquisition 5-83 surge protector 3-7 surge protector specifications 3-7 symbols 2-1 syringe 3-10, 4-1 syringe seal 6-8, 8-2 system backf
xMAP Technology Luminex 100 IS User Manual Version 2.
