Lum/nex ® Luminex IS Software Manual For 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® ISTM Software Manual for Version 2.3 REF CN-M017-01 PN 89-00002-00-110 Rev. B October 2005 EC REP Paul. A.
Standard Terms and Conditions For Use of Product By opening the packaging containing this product ("Product") or by using such Product in any manner, you are consenting and agreeing to be bound by the following terms and conditions. You are also agreeing that the following terms and conditions constitute a legally valid and binding contract that is enforceable against you.
BUYER HEREBY GRANTS TO LUMINEX A NONEXCLUSIVE, WORLDWIDE, UNRESTRICTED, ROYALTY-FREE, FULLY PAID-UP LICENSE, WITH THE RIGHT TO GRANT AND AUTHORIZE SUBLICENSES, UNDER ANY AND ALL PATENT RIGHTS IN INVENTIONS COMPRISING MODIFICATIONS, EXTENSIONS, OR ENHANCEMENTS MADE BY BUYER TO THE PRODUCT OR TO THE MANUFACTURE OR USE OF THE PRODUCT ("IMPROVEMENT PATENTS"), TO MAKE, HAVE MADE, USE, IMPORT, OFFER FOR SALE OR SELL ANY AND ALL PRODUCT; EXPLOIT ANY AND ALL METHODS OR PROCESSES; AND OTHERWISE EXPLOIT IMPROVEMENT P
End-User License Agreement (EULA) for Luminex® Software This Luminex End-User License Agreement (“EULA”) is a legal agreement between you (either an individual or a single entity, also referred herein as “you”) the end-user and Luminex Corporation (“Luminex”) regarding the use of the Luminex software product identified above, which includes computer software and online or electronic documentation and may include associated media and printed materials (if any) (“SOFTWARE PRODUCT” or “SOFTWARE”).
5. EXPORT RESTRICTIONS. You agree that you will not export or re-export the SOFTWARE PRODUCT to any country, person, entity, or end-user subject to U.S.A. export restrictions. You hereby warrant no state or federal agency has suspended, revoked, or denied your export privileges. 6. NO WARRANTY. THE SOFTWARE PRODUCT IS LICENSED “AS IS.” ANY USE OF THE SOFTWARE PRODUCT IS AT YOUR OWN RISK. THE SOFTWARE PRODUCT IS PROVIDED FOR USE ONLY WITH LUMINEX PRODUCTS.
Contents Luminex 2.3 Software 1 Main Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Menu Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Toolbar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Tabs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Luminex IS Software Manual For Version 2.3 xMAP Technology Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Import Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Import Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Import Template. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Insert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
xMAP Technology Validate Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . View Batch Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Warmup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Wash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Zoom. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Procedures . . . . . . . . . . . . . . .
Luminex IS Software Manual For Version 2.3 iv xMAP Technology PN 89-00002-00-110 Rev.
Luminex 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 IS Software Manual for Version 2.3 . 1 2 3 4 5 1. Title bar 2. Menu bar 3. Tool bar 4. Tabs 5. Status bar Figure 1 Luminex IS 2.3 Main Window There are five major parts in the Main window: Title bar, Menu bar, Tool bar, Tabs, and Status bar. A brief description of each of these components is shown below. The Title Bar displays the name of the software. The Menu Bar contains three menus, File, Tools, and Help menu. A more thorough description of the Menu is shown on page 3.
xMAP Technology Menu Bar Luminex 2.3 Software The menu bar contains the following menus: File Menu, Tools Menu, and Help Menu.
xMAP Technology Luminex IS Software Manual for 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 12 10 11 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 Luminex 2.3 Software Favorites. You can use the Favorites list to create a customized list of often-used commands and templates. Items appear in alphabetical order for easy locating. For more information on setting up the Favorites list, see page 39. Button Groups. Button groups are grouped according to function. • The Daily Startup group contains the Warmup, Prime, Alcohol Flush, and Wash Commands. For more information on daily startup, see page 40.
xMAP Technology Luminex IS Software Manual for Version 2.3 1 2 3 1. Microtiter plate/reservoir image 2. Temperature and Pressure Gauges 3. Command List Figure 4 Run Batch Tab The command buttons on the Run Batch tab are: • 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 28. For more information on setting up batches, see See “Batch Setup Procedures” on page 48.
xMAP Technology Luminex 2.3 Software for the DD temperature both appear at the bottom of the thermometer, and the thermometer appears in red. An out-of-range temperature logs an error, but does not halt the acquisition. For information on setting the XYP instrument heater temperature, see page 42. The Command List displays commands associated with batches, new advanced batches or multi-batches loaded for processing on the system.
xMAP Technology Luminex IS Software Manual for 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.
xMAP Technology Luminex 2.3 Software Instructions for maintenance procedures begin on page 88. Table 11 on page 88 shows a recommended use schedule for maintenance operations. 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. The Text on the Diagnostics tab turns red if the system encounters an error.
xMAP Technology Luminex IS Software Manual for Version 2.3 heater block temperature is out of range or experiencing unacceptable temperature conditions, including these items: • • • • Luminex XYP heater block temperature time-out heat circuit failure temperature out-of-range sensing temperature change since calibration, or a change in channel temperature Table 1 defines the values listed in the System Monitor.
xMAP Technology Luminex 2.3 Software The Detailed Sample Progress section displays the percentage of completion for each bead ID or test. The graph shows real-time progress, so that as each sample is analyzed, the graph adjusts to show progress. Use the zoom button to view up to 20 tests at a time. Use the toggle button to view the bead ID or test name. Use the Expand Margin (up/down and left/right) arrows to expand the chart margins and view longer test names. See Figure 9. . 1 2 3 1. Zoom button 2.
xMAP Technology Luminex IS Software Manual for Version 2.3 • • • • 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. Yellow shading indicates that a detailed description about the processes or actions is available. This color may vary depending on your tool tip color system settings.
xMAP Technology Luminex 2.3 Software 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 11 Acquisition Detail Tab 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.
xMAP Technology Luminex IS Software Manual for Version 2.3 1 2 3 4 5 6 8 7 1. Replay Batch 6. Cancel All 2. New Advanced Batch 7. Eject/Retract 3. View Batch Data 8. Pause 4. Start Plate 9. Resume 9 5. Cancel Command Figure 12 Acquisition Detail Toolbar The Histogram, in the lower left section of the Acquisition Detail tab, defaults to display the Doublet Discriminator (DD) on the X axis and Events on the Y axis.
xMAP Technology Luminex 2.3 Software The Histogram contains the Show Bead menu and four buttons: • • • • Autoscale Zoom Log/Linear Maximize For more information on these commands, see the Commands section beginning on page 28. The Dot Plot (or bead map) appears in the lower-right section of the Acquisition Detail tab. See Figure 14. The dot plot shows a graphical display of real-time data collection. Luminex recommends using the default settings to collect data.
xMAP Technology Luminex IS Software Manual for Version 2.3 accumulation of events. Increasing density is indicated by contrasting colors. See Table 2 for the density dot plot color legend. Table 2. Dot Plot Color Legend Layer 0 1 2 3 4 5 6 7 8 Color none dark blue pink dark green cyan light blue light green orange dark red The density dot plot allows visual elimination of data values determined to be insignificant to the display.
xMAP Technology Luminex 2.3 Software Table 3. Status Bar Color Coding (Continued) Category Device Status Device Activity Color Indicates Indicates the current process of or warning about the Luminex analyzer Green Running or standby Yellow Busy, pressurizing, sheath is empty, or warming up Red Not ready or disconnected Indicates the activity that the Luminex analyzer is performing. Note: The device activity has no color code.
xMAP Technology Luminex IS Software Manual for Version 2.3 status bar. Additionally, information displays as text on the Diagnostics tab. Table 4. Status Bar Communication Message Details Status Bar Color Green Yellow Red 18 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.
xMAP Technology Secondary Windows Batch Setup Window Luminex 2.3 Software In addition to the main window, there are other windows that are displayed when you select certain commands. These are the Batch Setup Window and Analysis Window. Additional windows display in the Developer’s Workbench software, if you have it installed on your system. For more information about the Developer’s Workbench, see the Luminex Developer Workbench Guide for Version 2.3.
xMAP Technology Luminex IS Software Manual for Version 2.3 • • • • • 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. The Insert command lets you insert a patient into a batch or skip a well.
xMAP Technology Analysis Window Luminex 2.3 Software When the system analyzes batches, it displays the data in a three-tab format within the Analysis window. The following three tabs present the batch information in greater detail: • • • Errors tab—lists errors that occur during batch acquisition, such as controls that failed. Standards tab—lists all tests in the batch, a regression chart for each test, and the standards or controls associated with the batch.
xMAP Technology Luminex IS Software Manual for Version 2.3 Errors Tab The Errors tab displays a list of errors that occurred during acquisition. It organizes the errors in two categories: System and assay errors (top section of tab), and Sample errors (bottom section of tab) Table 5 lists the errors in each category Figure 16 Analysis Window - Errors Tab Open Table 5.
xMAP Technology Standards Tab Luminex 2.3 Software The Standards tab lists all the batch tests with system comments specific to each test. The detailed test information that is displayed on the three tabs of the Analysis window is determined by the test selected under the Standards tab. The Standards tab displays the quantitative batch’s standard curve. It displays qualitative batches as a graph plotting the assay standard.
xMAP Technology Luminex IS Software Manual for Version 2.3 high or low end. Examples of out-of-range sample labeling for noncompetitive assays are shown in Table 6. Figure 18 shows what a standard curve for a non-competitive assay should look like. Table 6.
xMAP Technology Luminex 2.3 Software Figure 19 Competitive Assay The standards tab displays an Expected Concentration column for standard and control samples. The Standards Expected Concentration column allows users to edit the standard concentrations. You can edit controls; however, you must 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 IS Software Manual for Version 2.3 Samples Tab xMAP Technology The Samples tab lists tests from your batch and displays the results for each sample. Figure 20 shows a Sample tab example listing three tests. Notice that the left pane displays Test IL-4, IL-6 and IL-8 with Test IL-4 selected. The right pane shows the IL-4 sample results.
xMAP Technology Replicate Averaging Luminex 2.3 Software Standard and control replicates are predefined in the template. You define unknown sample replicates in batch setup indicated by replicate Sample ID. The data analysis function supports replicate sampling. It calculates each sample as an individual sample, which is then averaged to obtain a replicate average. • Standards tab—displays standard and control average values. • Samples tab—displays sample average values.
xMAP Technology Luminex IS Software Manual for Version 2.3 Commands Acquire Patient Add Batch Alcohol Flush Autoscale Autosize Backflush 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 Create New Multi-Batch Delete Batch Density/Decaying Display Confirmation Screens Disconnect from the Instrument Drain Eject/Retract Enable Raw Data Storage Export Batch Data Export CAL Export CON Export Data PN 89-00002-00-110 Rev. B Luminex 2.3 Software This command opens the Luminex Multi-Batch dialog box, in which you add or create new batches to add to a multi-batch. Opens the Delete Batch dialog box, which shows a listing of the unprocessed batches in the database.
Luminex IS Software Manual for Version 2.3 Help Import Calibration Import Control Import Template Insert Invalidate Control Invalidate Standard Load Patient List Log/Linear Maximize/Minimize Next Test New Advanced Batch 30 xMAP Technology Opens the help file. Use this command if you need instructions on using a feature in the Luminex IS 2.3 software. Opens a dialog box in which you select a calibration file that contains calibration lot information to import to use for calibrating the analyzer.
xMAP Technology Luminex 2.3 Software Acquisition Detail tab. When you click on the New Advanced Batch button, the Options dialog box opens, where you enter information about the batch, define bead events for the session, and define commands for plate layout. New Batch New CAL Targ. New CON Targ. New Lot Open Batch Opens a dialog box in which you select a template to create a new batch in the Luminex Batch Setup window.
xMAP Technology Luminex IS Software Manual for Version 2.3 Print Batch Worklist Print Report Recalc Replay Batch Report Raw Fluorescence Resume Sample Probe Down Sanitize Save and Load Save Only 32 Prints the status of each of the commands in the command list, as well as the microtiter plate graphic. Prints the data interpretation report including the standards, controls, graph of standards, and Samples data. Recalculates an affected test after a change is made to lot information.
xMAP Technology Self Diagnostics Luminex 2.3 Software Performs a self-diagnostics to see if the Luminex 200 analyzer and all system operations are functioning correctly. Self-Diagnostics tests these functions: • • • • • • • • • • • • Show Bead Single Step Skip [wells] Soak Start Analysis Start (Plate) Statistics PN 89-00002-00-110 Rev.
Luminex IS Software Manual for Version 2.3 Test Sort Orders xMAP Technology This command is in the Data Export Tab of the Options tab. You can select Alphabetical by test name, Sequential by Region ID, or by Template Setup Order • Alphabetical by Test Name - the tests are sorted by alphabetical order • Sequential by Region ID - the tests are sorted numerically by bead ID#. • Template Setup Order - the tests are sorted n the order set up in template, regardless of name or ID.
xMAP Technology Procedures Using the Online Help Luminex 2.3 Software This section explains how to perform functions in the software. Help files describe Luminex System features and capabilities. You may find these topics by searching the contents of books and topics or by searching an alphabetic listing of the topics and books. Topics provide information and details regarding software features, system capabilities, and any number of related material. Books usually contain a group of topics.
xMAP Technology Luminex IS Software Manual for Version 2.3 Setting Software Options Set up and customize the system software and enter your company information in the Options dialog box. The Software Options dialog box has three tabs: the General tab, the Company Information tab, and the Data Export tab. To configure software options: 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 2.3 Software Figure 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. This information is stored in the Registry for reference. The logo will not alter any Luminex IS 2.3 report or screen. Company Information (name, address, phone and fax numbers, and location of company logo). Use the browse button logo is stored.
Luminex IS Software Manual for Version 2.3 Define Data Export Tab Information xMAP Technology Use the Data Export tab to configure your export data. See Figure 23. The following options are available: Auto Export Batches. Select this feature to automatically export the .csv file formats when the system finishes analyzing the batch. This allows you to run your own programs on exported data without having to manually start the export. This feature also takes place after acquisition completes.
xMAP Technology Setting up the Favorites List Luminex 2.3 Software To add templates to the Favorites list: 1. On the Favorites list, click Add Template. 2. In the Open Template dialog box, double-click the template to add to your Favorites list. To add commands to the Favorites list: 1. Click Add Commands from the Favorites list. The Command List dialog box opens. Figure 24 Command List Dialog Box 2. Select the command that you want to add to your Favorites list.
xMAP Technology Luminex IS Software Manual for Version 2.3 Startup Procedures Warm Up the System Warm up the system to prepare the optics prior to sample acquisition. The system automatically begins warming up when you turn power on. This procedure takes approximately thirty minutes. Caution: Failure to properly warm up the system will effect assay results and system performance. After four hours of inactivity, the status bar appears red and indicates that the lasers are off.
xMAP Technology Luminex 2.3 Software During a backflush, the system draws sheath fluid from the sheath fluid container and sends it directly to waste. You do not need to supply solution in a plate. A backflush takes between 10 and 30 seconds. To clear obstructions from the cuvette: Click Backflush, then click OK to verify that you want to backflush the system. The status bar shows that the backflush command is processing.
Luminex IS Software Manual for Version 2.3 Set Luminex XYP Instrument Heater Temperature xMAP Technology Refer to your assay kit instructions to see if the assay needs to be analyzed at a particular temperature. If the instructions indicate that the Luminex XYP instrument heater is needed, set the heater to the specified heat setting. The user definable heater range is 35°C to 60°C. Use the heater only with the heater block in place.
xMAP Technology Luminex 2.3 Software discriminator channel. Control xMAP microspheres are used to verify calibration and optical integrity for the system. Calibrate the system at least once a month and: • • • • Following installation if the system is moved. if a part is replaced. if the delta calibration temperature shown on the system monitor (on the Diagnostics tab) is more than ±3 degrees. • if sample acquisition is problematic.
xMAP Technology Luminex IS Software Manual for Version 2.3 6. On the Maintenance tab, click Prime. Click OK and wait for the Prime to finish (about 1½ minutes). 7. Click Alcohol Flush. Click OK and wait until the alcohol flush completes. The Device Status section in the status bar changes from yellow to green and displays “Standby”. 8. Click New CAL Targ. to enter or confirm calibration lot numbers in the Update CAL Targets dialog box. See Figure 25. 9.
xMAP Technology Luminex 2.3 Software 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. The System Monitor on the Diagnostics tab displays the date and time in green if CAL1 and CAL2 are successful.
Luminex IS Software Manual for Version 2.3 xMAP Technology Figure 26 Update CON Targets Dialog Box 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 43. 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.
xMAP Technology Luminex 2.3 Software 9. Click OK and wait until the wash completes. The device status section in the status bar changes from “Running” to “Standby”. If an error occurs during system calibration or verification, an X appears in front of the Diagnostics tab title, and the title text turns red. Selecting Existing CAL or CON Lots To select an existing lot: 1. On the Maintenance tab, click New CAL Targ or New CON Targ. 2.
Luminex IS Software Manual for Version 2.3 xMAP Technology the Backup folder (directory) found in C:\Program Files\Luminex\Luminex 100 IS\Backup. 4. Enter the lot name for the exported lot into the File Name box. 5. Click Save, then click OK. The dialog box closes. After you click OK, you can use the lot target values with the next calibration or verification. The system saves the lot to the existing software as a lot accessible for the next calibration and/or verification.
xMAP Technology Luminex 2.3 Software • • • • Green well: with command number—sample not acquired. Yellow well: sample currently in acquisition Red well: sample failed. Check the system monitor for more information Green background: with check mark—successfully completed Common sample errors are due to lower number of events acquired than established in the template. Importing Templates You need to import new templates to the system only once.
Luminex IS Software Manual for Version 2.3 xMAP Technology Figure 27 Luminex Batch Setup Window 4. Enter the batch name (if different from the default name), a description (optional), and the creator’s name (optional). 5. If you want to insert an Acquire Patient or Skip command, select the command from the Insert menu. In the multiplier box, enter the number of patients that you want to add to the list or the number of wells that you want to skip and click Apply.
xMAP Technology Luminex 2.3 Software 10. To add a patient file to the batch, click Load Pa List. An Open Patient List File dialog box opens. See Figure 28. If you do not want to add a patient list to the batch, skip to step 11. Note: If any of the acquire sample commands within the template of the batch has an unassigned Sample ID, the system applies the first patient ID in the list to the unassigned sample acquisition command.
xMAP Technology Luminex IS Software Manual for Version 2.3 2. Double-click on the desired batch. The system loads the batch as you created it in the Run Batch tab. 3. Click Start Plate to initiate batch acquisition. Copying and Exporting Batch Data Clear a Batch from the System To export Batch Data: Right-click in the Batch Data area of the Acquisition Detail tab. In the right-click menu, click Copy to copy the currently displayed data to the clipboard.
xMAP Technology Luminex 2.3 Software batch. If you reprocess a batch using changed parameters, the system may obtain different results. When you replay a batch it labels unknown samples as Pa1, Pa2, Pa3, and so on. If you replay a batch containing replicates, replicate averaging will not be calculated in data analysis. A number of variables can affect the final test results. You may also change the standards or controls processed with the batch or multibatch.
xMAP Technology Luminex IS Software Manual for Version 2.3 . Figure 29 Analyze Open Batch The Analysis window opens, showing the Batch info in the Standards tab. To close the Analysis window click Close. See “Analyzing Batches and Multi-Batches” on page 72. 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.
xMAP Technology Luminex 2.3 Software To create a multi-batch with new batches: 1. Click New Multi-Batch. The Luminex Multi-Batch Setup dialog box opens, shown in Figure 30. Figure 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 49. Click Save and Load instead of Save Only when you are finished setting up the New Batch. 4.
xMAP Technology Luminex IS Software Manual for Version 2.3 To create a multi-batch with existing batches: 1. Click New Multi-Batch. 2. In the Luminex Multi-Batch dialog box, click Add Batch to add an existing batch to the multi-batch. See Figure 30. 3. Select the first batch to add and click Select. The batch appears beginning in well A1 of the microtiter plate on the Luminex Multi-Batch Setup dialog box. Red lines separate this batch from subsequent batches. 4.
xMAP Technology Luminex 2.3 Software Figure 31 Processing Multiple Plates After the first microtiter plate in a multiple plate batch has been acquired, the system pauses and prompts you to insert the next plate. To process multiple plates during a batch or multi-batch: 1. Create the batch or multi-batch. See “Create a New Batch” on page 49 or “Create a Multi-Batch” on page 54. 2. Insert the first plate. 3. On the Run Batch tab, click Start Plate to begin processing the batch.
xMAP Technology Luminex IS Software Manual for Version 2.3 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. Use the Code 128 barcode label type when scanning barcode labels into the system as patient identities. Warning: Laser light. Do not stare into the beam. Class II laser product.
xMAP Technology Luminex 2.3 Software The format must be like the following example or it will not load properly. Double-check all Sample IDs before you save the newly created batch. An example of a typical patient list file: LX100IS Patient List [Accession#, Dilution Factor] a001,1 a002,2 a003,1 b001,4 b002,0.6 c917,4 cee4gf,1 To add a Patient List file while creating a batch or multi-batch: 1. On the toolbar, click Create New Batch or Create New MultiBatch. The Open Template dialog box opens. 2.
xMAP Technology Luminex IS Software Manual for Version 2.3 Edit a Patient List Use this procedure to open a previously processed batch and correct the batch’s sample names and dilution factors. You can delete a sample from a batch. If you change the patient information in a batch including those imported from a patient list, the system automatically notes the change in the comments box of the sample table within the database. While editing the database, the system marks the changes you make in red text.
xMAP Technology Luminex 2.3 Software To assign sample dilution factors: 1. On the File menu, click New Batch. The Open Template dialog box opens. 2. Select the desired template and click Select. The Luminex Batch Setup dialog box opens. See Figure 34. 3. Select the item that uses the dilution factor that you are setting. You cannot change any item that is grayed out or locked into the command list. Figure 34 Luminex Batch Setup for Dilution 4. To change the dilution factor, click the Dil.
xMAP Technology Luminex IS Software Manual for Version 2.3 Use plates with wells that will hold at least 185 µL (the extra 25 µL from the sample, plus an extra 160 µL that is dispensed back into the well following acquisition). To create a New Advanced Batch: 1. Open the Acq. Detail tab. 2. On the Acquisition Detail toolbar, click New Advanced Batch. The Options Dialog Box opens with the General tab displayed. See Figure 35. . Figure 35 Options Dialog Box—General Tab 3.
xMAP Technology Luminex 2.3 Software • Select Total Beads to continue analyzing until the selected beads meet total beads value. Use Total Beads when you are not using all of your selected bead sets in each well. Set the total to desired high value. 6. Click the Bead Set tab. Select the checkboxes next to each desired bead set for this batch. Click Select All to select all the listed bead sets, or Deselect All to deselect all selected bead sets. Figure 36 Options Dialog Box—Bead Set Tab 7.
Luminex IS Software Manual for Version 2.3 Note: The legend at the left side of the tab (No, Cmd Name, and Symbol columns) shows available commands and their coloredcoded symbols. Symbol appears in the well when selected from the Command Menu. xMAP Technology 8. Click the Plate Layout tab. See Figure 37. On this tab you define commands for the desired wells on the plate. You can define commands that apply to one or more wells, one or more rows of wells, or one or more columns of wells.
xMAP Technology Luminex 2.3 Software Figure 38 Plate Layout Tab Command Menu 11. Establish preliminary off-plate commands. The system performs preliminary off-plate commands before the first well command. To establish a preliminary off-plate command, right-click anywhere over the plate layout and select Preliminary Off-Plate Cmd(s) from the menu.The command list dialog box appears similar to Figure 40. Click the OK button next to the Command List after you select the desired commands.
xMAP Technology Luminex IS Software Manual for Version 2.3 Figure 40 Plate Layout Tab, Off-Plate Commands 12. Insert off-plate commands. You can insert off-plate commands that run after a single well, after a range of wells, or after rows or columns of wells. The prompt sentence displayed should be appropriate for your selection. For example, if you select row B, the prompt “Establish the off-plate commands to run after wells B1 through B12” appears.
xMAP Technology Managing Assay Lots Luminex 2.3 Software You can edit standard and control lot information. Once a lot is used, changing or modifying it will prompt you for a new lot name. This includes batches that have been set up, but not yet acquired. You can modify known lot concentration values. If you change the known concentration for a used lot, the system prompts you to enter a new lot name.
xMAP Technology Luminex IS Software Manual for Version 2.3 b.) If the template has associated lot information, the Update Lot Information dialog box opens. To create a new lot when there is an existing lot, click New Lot on the Standard or Control section of the dialog box. A New Standard Lot or New Control Lot dialog box opens. Enter the standard or control lot number. See Figure 42 and Figure 43. 3. Click OK.
xMAP Technology Luminex 2.3 Software 5. Enter the standard concentration values provided in the kit manufacturer’s instructions. See Figure 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. The system applies the lot you just created to the template. Edit Lot Information on an Unused Template To edit information for an existing lot: 1.
xMAP Technology Luminex IS Software Manual for Version 2.3 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. Double-click the template that you want to edit. An Update Lot Information dialog box opens. See Figure 44. 3. Change or edit the lot concentration values. 4. Click Save.
xMAP Technology Luminex 2.3 Software Figure 45 Update Lot Information Dialog Box 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.
xMAP Technology Luminex IS Software Manual for Version 2.3 After responding to the confirmation dialog boxes, regarding standards or controls, a Save As dialog box opens. 4. Click the drop-down arrow to select the Save in: location where you want to save the lot information. 5. Enter the lot file name into the File Name: box. 6. Click Save. The system saves the lot.
xMAP Technology Note: Luminex does not recommend performing Data Analysis while the Luminex System is performing data acquisition on another batch. Customize Data Analysis Settings Luminex 2.3 Software The system can analyze only batches that it acquires using qualitative or quantitative templates. It does not analyze acquisitions using Data Collection Only or Maintenance templates. For an overview of the Analysis window, see page 21.
xMAP Technology Luminex IS Software Manual for Version 2.3 Cancel: click to abort selections and exit. Apply: Apply is similar to the OK button, but does not close the Customization dialog box. It updates graph parameter with new information. Original: click this button to restore the edited information to the previous or original values. Export: click this button to export data from a Metafile or BMP graphic to a .csv output file in the batch folder file, or to the clipboard.
xMAP Technology Luminex 2.3 Software Font Size: The Graph supports three font sizes, Large, Medium, and Small. When printing the graph, a font size of Medium or Small is suggested. On occasion the graph may automatically reduce the size of the font to produce a higher quality image. Show Annotations: Currently, this feature is not used. This check box allows you to remove or add the annotations from the image.
xMAP Technology Luminex IS Software Manual for Version 2.3 Figure 49 Customization Dialog Box—Font Tab • Color Tab—Use the Color tab to define the various color parameters on the analysis graph. See Figure 50. Desk Foreground: this is the color that is used when placing text onto the Desk Background. It includes the main title, sub title, subset/point labels, grid numbers. Desk Background: this is the color that surrounds the bounding rectangle of the graph's grid.
xMAP Technology Luminex 2.3 Software Figure 50 Customization Dialog Box—Color Tab • Style Tab—use the Style tab for control of subset color, subset line type, and subset point type. Subset 1 = line type, and Subset 2 = data point. See Figure 51. Figure 51 Customization Dialog Box—Style Tab To modify features using the Graph Menu: Most of these menu items provide a shortcut for many of the features provided in the Customization dialog box. Refer to page 73 for details. 1.
xMAP Technology Luminex IS Software Manual for Version 2.3 Figure 52 Graph Menu Items Enable Automatic Analysis You can configure the system to automatically start analysis (data reduction) immediately following batch acquisition. If you disable the Auto-start Analysis feature, you must select Analysis from the Home tab or toolbar to analyze a batch. Note that the Auto-start Analysis feature is disabled when processing a multi-batch. To ensure that calculated data is exported to the output.
xMAP Technology Analyze Processed Batch Data Luminex 2.3 Software You can analyze only processed batches. If you acquire or process batches as a multi-batch, the system lists them separately and they must be analyzed separately. All batches within a multi-batch have the multi-batch name listed under the multi-batch ID name column. This allows you to see the batches that have been processed as a multi-batch. To analyze data from processed batches and multi-batches: 1. On the Home tab, click Analysis.
xMAP Technology Luminex IS Software Manual for Version 2.3 Invalidating controls—You can invalidate or remove a control in data analysis. However, Luminex does not recommend invalidating controls. For further instruction on assay controls and guidelines regarding accepting or rejecting control values, contact the assay kit manufacturer. To validate or invalidate a standard or control entry using the right mouse-click procedure: 1.
xMAP Technology Change Lot Luminex 2.3 Software Use the Change Lot command to edit the lot that is applied to the batch currently opened in data analysis. To change the lot to another available lot: 1. Click Change Lot (Alt + F8), located at the bottom of Analysis window, to display the Choose Lot dialog box. See Figure 55. 2. The dialog box displays a list of available standard and control lots that you can apply to a batch.
xMAP Technology Luminex IS Software Manual for Version 2.3 To create a new lot for use within a batch: 1. Click New Lot. 2. In the Update Lot Info dialog box, select Standard lot or Control lot, then click Save to display the Choose Lot dialog box. An asterisk identifies the selected lot. See Figure 55. Running Reports and Analyses Report Types You can output data by printing reports and exporting batch data. The Luminex IS 2.
xMAP Technology Luminex 2.3 Software 1. Click Print Report. The Report Selection dialog box opens. Figure 57 Report Selection Dialog Box 2. Select the type of report that you want to print and click Next. For the Analyte, Clinical Patient, and Batch Summary Reports, the Batch Selection dialog box opens. Select the batch to print. See Figure 58. For the Quality Control, Maintenance, Calibration Trend, and System Control Trend Reports, a dialog box related to the specific report opens.
xMAP Technology Luminex IS Software Manual for Version 2.3 Figure 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 Print Data Analysis Report Luminex 2.3 Software A printed batch report includes the following criteria that is applied to the batch during analysis: • • • • • • • batch name and test name formula used curve fit standards controls samples graph (this is the only way to print a graph of standards) To print data analysis reports: 1. On the Home tab, click Analysis. 2. In the Open Batch dialog box, select the desired batch to analyze. 3. In the Analysis window, click Print Report.
xMAP Technology Luminex IS Software Manual for Version 2.3 Figure 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 2.3 Software 2. Choose the file name and location of the database that you want to back up. The default name is LX100IS(month-date-year). 3. Click Save. The LX100 IS Database Backup dialog box opens informing you the backup is in progress to the specified location. Delete Database Entries You can erase sample information from the database at any time. You will see a warning when the database is 80% full (approximately 200 MB free of a two GB hard drive limit).
xMAP Technology Luminex IS Software Manual for Version 2.3 information for CAL 1, CAL2, CON1, and CON2 reagents are correct. 5. Click OK to verify that the lot information is accurate. Maintenance Procedures Table 11 shows a recommended schedule for maintenance operations. Table 11.
xMAP Technology Luminex 2.3 Software Table 11. Maintenance Operations: Recommended Use Schedule (Continued) Operation Drain the Analyzer Recommended Use Schedule Drain • For troubleshooting and preventative maintenance purposes only: – drain the cuvette and refill in preparation for running. Draining the system removes debris from the bottom of the cuvette. – when draining, you do not supply solution.
xMAP Technology Luminex IS Software Manual for Version 2.3 2. Click OK. The system processes the various self- diagnostic tests. When tests are complete, the Status Bar changes from a “Processing” command state to an “Idle” command state. The self-diagnostic tests should take less than one minute to complete. If the self diagnosis fails, you can obtain detailed information regarding the results of the self-diagnostic test. See the following “View Self-Diagnostic Details” section.
xMAP Technology Luminex 2.3 Software the desired files to delete and click OK. Windows deletes the files and closes the dialog box. Figure 63 Disk Cleanup for (Selected Drive) To delete the Message Log directory: 1. In the Cleanup Utility dialog box, click Delete MsgLog Directory. 2. In the Cleanup Utility confirmation dialog box, click Yes. To delete the batch folders: 1. In the Cleanup Utility dialog box, click Delete Batch Directory. 2.
xMAP Technology Luminex IS Software Manual for Version 2.3 To sanitize the fluidics in the analyzer: 1. On the Maintenance tab, click Eject/Retract. 2. Put the bleach solution in the reservoir. 3. Click OK. The plate holder retracts, and the system performs the Sanitize command. 4. Run two Wash commands. Run a Wash Command Use the wash command as part of shutdown procedure, and as needed, especially after calibration and after sanitizing.
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 200 analyzer.
Luminex IS Software Manual For Version 2.3 xMAP Technology 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.
Luminex IS Software Manual For Version 2.3 xMAP Technology quantify an analyte. Examples of acceptable reporters are Phycoerythrin and Alexa 532. reporter channel (RP or RP1) A specific range of wavelengths that includes the emission wavelength of a designated reporter molecule. RP1 Refers to the dyes bound to the surface of the xMAP microsphere. Also see reporter channel. RP See reporter channel. sample The mixture of assay components (microspheres, reporter, patient diluent) that are analyzed.
Output.CSV Overview This chapter describes the file specification for the Luminex IS 2.3 Output.CSV file. Although this document may refer to older versions of Luminex software for historical purposes, it is intended only to describe the Output.CSV file for the Luminex IS 2.3 software. 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.
xMAP Technology Luminex IS Software 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 IS Software 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 IS Software Manual Version 2.3 Table D-3 Statistic Column Definitions Column Name 102 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 IS Software 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 IS Software 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","662.110761559013","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 IS Software 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 analysis 36 view 79 Analysis window, function keys 21 assay errors 22 assigning dilution factors to samples 60 auto-start analysis 36 B back up the database 86 batch analyze processed batch 79 data, export 84 reprocess 52 Batch Summary Report 82 C calibration definition 93 trend report 82 verification 43 Clear Preliminary Off-plate commands 65 Clinical Assay Report 82 commands, off-plate 65 confirmation screen 36 create new session 48 D database backup 86 management 87 restore 87 decontamination 41
Luminex 100 IS User Manual Version 2.3 xMAP Technology S Sample Errors 22 sample progress 11 samples tab 21 sanitize 41, 91, 92 remove air bubbles 41 with 70% isopropanol 41 setting 42 standards tab 21 storage raw data 36 system drain 89 errors 22 trend report 82 T tabs samples 21 standards 21 templates 48 test analysis,view 79 V verification command 43 setting well location 43 updating lots 43 View detailed test analysis 79 W warnings 42 X XYP heater temperature 42 Index-2 PN 89-00002-00-110 Rev.
