Luminex ISTM Software Manual For Version 2.
© LUMINEX CORPORATION, 2001-2011. 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 IVD Luminex® ISTM Software Manual for Version 2.3 PN 89-00002-00-254 Rev.
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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 - For In Vitro Diagnostic Use xMAP Technology Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Import Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Import Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Import Template. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Insert . . . . . . . . . . . . . . . . . .
xMAP Technology Contents View Batch Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Warmup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Wash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Zoom. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Luminex IS Software Manual For Version 2.
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- For In Vitro Diagnostic Use . 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.
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- For In Vitro Diagnostic Use 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.
xMAP Technology Luminex 2.3 Software Favorites. You can use the Favorites list to create a list of oftenused commands and templates. Items appear in alphabetical order for easy locating. For more information on setting up the Favorites list, see page 40. 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 41.
xMAP Technology Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use 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 29.
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 43. The Command List displays commands associated with batches, new advanced batches or multi-batches loaded for processing on the system.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use Maintenance Tab xMAP Technology 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 83. Table 8 on page 83 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.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 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.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use • • • • Note: The Message log can be found at: 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.
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. The remaining columns display selected bead sets for the assay.
xMAP Technology Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use 1 2 3 4 5 6 7 8 9 1 Replay Batch 6 Cancel All 2 New Advanced Batch 7 Eject/Retract 3 View Batch Data 8 Pause 4 Start Plate 9 Resume 5 Cancel Command Figure 12 Acquisition Detail Toolbar The Histogram, in the lower left section of the Acquisition Detail tab, defaults to display the Doublet Discriminator (DD) on the X axis and Events on the Y axis.
xMAP Technology Luminex 2.3 Software 1 2 3 1 Gate Boundaries 2 Aggregate Beads 3 Numerical Gate Position Figure 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 29. The Dot Plot (or bead map) appears in the lower-right section of the Acquisition Detail tab. See Figure 14.
xMAP Technology Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use Figure 14 Dot Plot Display Example Four buttons appear at the top of the frame to control the display: • • • • Density/Decaying Log/Linear Zoom Maximize You can toggle between two types of dot plots using the Density/ Decaying button. The Decaying Dot Plot plots only the 100 mostrecent acquired events. The Density Dot Plot displays a constant accumulation of events.
xMAP Technology Luminex 2.3 Software 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 15 System Status Bar Table 3 describes the types of status bar messages in relation to the message color coding. Table 3.
xMAP Technology Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use Table 3.
xMAP Technology Luminex 2.3 Software Table 4. Status Bar Communication Message Details (Continued) Status Bar Color Yellow Red PN 89-00002-00-254 Rev. B Message Indicates 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.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use Secondary Windows xMAP Technology 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. In the Batch Setup window, you define information used to create batches. All of the commands are on the same page; there are no tabs. The window opens when you click New Batch and select a template.
xMAP Technology Luminex 2.3 Software • 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.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use • • • xMAP Technology 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. Samples tab—lists background samples and all samples or unknowns acquired in the batch with either a qualitative or quantitative result.
xMAP Technology Luminex 2.3 Software Figure 16 Analysis Window - Errors Tab Open Table 5. Error Categories System and Assay Errors • • • • • • • • • • • • • • • Standards Tab PN 89-00002-00-254 Rev.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology on the three tabs of the Analysis window is determined by the test selected under the Standards tab. The Standards tab displays the quantitative batch’s standard curve. It displays qualitative batches as a graph plotting the assay standard. Above the graphical information, the tab displays the formula that it used to calculate batch data.
xMAP Technology Luminex 2.3 Software competitive assays are shown in Table 6. Figure 18 shows what a standard curve for a non-competitive assay should look like. Table 6. Non-Competitive Out-Of-Range Labeling Condition Concentration Label MFI of Standard Referenced Left of Curve < min concentration standard Lowest Right of Curve > max concentration standard Highest Figure 18 Non-Competitive Assay Examples of out-of-range sample labeling for competitive assays are shown in Table 7.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 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.
xMAP Technology Luminex 2.3 Software The system does not flag results as normal or abnormal according to a defined range. Error flags only note samples that fall below or above the standard curve. The Comments column cells are editable and the information is displayed in reports. Figure 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.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology The AVG entry appears immediately after the wells being averaged or at the end of the list depending on what you select under Sort (Sequentially or Alphabetically). Follow the IVD kit package insert instructions for use regarding number of replicates to run for a particular assay.
xMAP Technology Commands Luminex 2.3 Software This section describes the different commands used in the Luminex IS 2.3 software. They are grouped Alphabetically. Acquire Patient 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. Add Batch When creating a multibatch, adds an existing batch to a multi-batch.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology Create New Multi-Batch This command opens the Luminex Multi-Batch dialog box, in which you add or create new batches to add to a multi-batch. Delete Batch Opens the Delete Batch dialog box, which shows a listing of the unprocessed batches in the database. When you highlight a batch and click Select in this dialog box, the system deletes the selected batch.
xMAP Technology Luminex 2.3 Software Help Opens the help file. Use this command if you need instructions on using a feature in the Luminex IS 2.3 software. Import Calibration Opens a dialog box in which you select a calibration file that contains calibration lot information to import to use for calibrating the analyzer. Import Control Opens a dialog box in which you select a control file that contains control lot information to import for use when verifying calibration.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 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 Opens a dialog box in which you select a template to create a new batch in the Luminex Batch Setup window. New CAL Targ.
xMAP Technology Luminex 2.3 Software Print Batch Worklist Prints the status of each of the commands in the command list, as well as the microtiter plate graphic. Print Report Prints the data interpretation report including the standards, controls, graph of standards, and Samples data. Replay Batch Replays batch sample acquisition. All batch commands are replayed allowing for batch acquisition viewing exactly as in real-time. You cannot replay New Advanced Batches.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use • • • • • • • • xMAP Technology DSP capture test High voltage module Channel backgrounds test Pressurization test Actuator test Syringe pump test Backflush valve test Debubbler valve test Show Bead After selecting an entry from the drop-down list, sets the histogram to show events for only one beadset [bead set number], events within the gate, or events inside and outside the gate.
xMAP Technology Luminex 2.3 Software • Sequential by Region ID - the tests are sorted numerically by bead ID#. • Template Setup Order - the tests are sorted n the order set up in template, regardless of name or ID. Validate Control Opens the Validate Control dialog box. In this box, you choose to validate all control tests (click Yes), or only a single test (click No). Validate Standard Opens the Validate Standard dialog box.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use Procedures Using the Online Help xMAP Technology 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 Luminex 2.3 Software Set up and select 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.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 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.
xMAP Technology Define Data Export Tab Information Luminex 2.3 Software 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.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use Setting up the Favorites List xMAP Technology 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.
xMAP Technology Luminex 2.3 Software 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.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 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.
xMAP Technology Set Luminex XYP Instrument Heater Temperature Luminex 2.3 Software 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 heater range is 35°C to 60°C. Use the heater only with the heater block in place.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 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: • • • • Note: Schedule calibration and control frequency based on kit and laboratory recommendations. Following installation if the system is moved. if a part is replaced.
xMAP Technology Luminex 2.3 Software 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. Enter the CAL1 lot number and expiration date as printed on the bottle.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 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.
xMAP Technology Luminex 2.3 Software 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 44. 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.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 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.
xMAP Technology Luminex 2.3 Software 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.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use • • • • xMAP Technology 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.
xMAP Technology Luminex 2.3 Software 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.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 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 Exporting Batch Data Clear a Batch from the System Luminex 2.3 Software 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. Click Export to manually export the currently loaded batch to the appropriate Output.csv file. The Clear Batch command clears the entire batch from the Run Batch tab or the Message Log on the Diagnostic tab.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 2. The Open Template dialog box opens. Click on the desired template and click Select. 3. The Run Batch tab becomes the active tab. You can monitor the commands as they process. Click on the Acq. Detail tab and monitor the data, histogram, and dot plot. After replaying a batch, you can analyze the data. To analyze Replay Batch data: 1. Click Start Analysis.
xMAP Technology Luminex 2.3 Software If you need to recover a deleted batch, select Open Incomplete Batch from the File menu. Create a MultiBatch A multi-batch is a set of batches that you want to process consecutively. You can add batches to the multi-batch from existing batches in your database, or you can create new batches to add to the multi-batch. You can include as many batches as you need. The software does not limit you to a certain number of batches per multibatch.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 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. Make sure that each additional batch is in its desired location. 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 Luminex 2.3 Software 4. Load the first microtiter plate onto the plate holder. 5. Click Start Plate to retract the plate holder and begin acquiring the multi-batch data. Process Multiple Plates You can process multiple plates per batch or multi-batch. After loading a batch or multi-batch that spans more than one plate, a new plate appears to the immediate right of the existing plate image on the screen. A dark blue line separates the adjacent columns of the two plates.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 5. Click Resume. The system resumes the acquisition process. Re-Run or Recover Incomplete Batch An incomplete batch can be caused by situations such as a power failure, software failure, marking a batch for deletion, or clicking Cancel All. Use this procedure to re-run or recover an incomplete batch. To open an incomplete batch: 1. On the File Menu, click Open Incomplete Batch. The Open Run dialog box opens.
xMAP Technology Luminex 2.3 Software • • • • • • The first line of text in the file must be “LX100IS Patient List”. The second line of text in the file must be “[Accession#, Dilution Factor]”. Any following lines of text should be only in the format, “x, y”. Where x = accession ID number for the patient (patient identifier string) and y = dilution factor. The dilution factor is optional, but if entered, must be a numeric value. If the dilution factor is omitted, the system defaults to one.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology batch has an unassigned value, the system applies the first patient ID in the list to the unassigned sample acquisition command. The system appends any remaining patient IDs to the end of the command list in order as they appear in the patient list. 5. Choose whether to save the batch or multi-batch for later use. Click Save only to save the batch or multi-batch.
xMAP Technology Luminex 2.3 Software Figure 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. Only use dilution factors if instructed to do so in the IVD assay kit manufacturer instructions for use.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology Figure 34 Luminex Batch Setup for Dilution 4. To change the dilution factor, click the Dil. Factor field. The white background indicates that you can enter text. Enter each dilution factor as a decimal, not as a ratio. 5. Click Finish. The system saves the information you entered. Managing Assay Lots You can edit standard and control lot information.
xMAP Technology Luminex 2.3 Software • If you have entered lot information and have used the template to set up a batch (even if it has not been acquired), you must rename the lot. 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 35. Figure 35 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.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology Figure 37 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 37. 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 2.3 Software Figure 38 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. Double-click the template that you want to edit.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use Import Lot to an Existing Template xMAP Technology 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. The Update Lot Information dialog box opens. See Figure 39. 3. Click Import Lot.
xMAP Technology Luminex 2.3 Software To export a lot from an existing template: 1. On the Home tab, click New Lot. The Open Template dialog box opens. 2. Double-click the template containing the lot to export. The Update Lot Information dialog box opens. See Figure 39. 3. Click Export Lot. A standard or control confirmation dialog box opens verifying that you want to export the current lot for the standard or control. If you want to export the lot information for the standards, click Yes.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use Note: Luminex does not recommend performing Data Analysis while the Luminex System is performing data acquisition on another batch. xMAP Technology You may direct the system to acquire samples in replicate regardless of batch type. For qualitative batches, replicate values are averaged and the reported interpretation is determined from this replicate average.
xMAP Technology Luminex 2.3 Software Figure 40 Customization Dialog Box—General Tab Customization Dialog Box Buttons: OK: click to update the graph’s parameters with the new information and exit the Customization dialog box. Cancel: click to abort selections and exit. Apply: Apply is similar to the OK button, but does not close the Customization dialog box. It updates graph parameter with new information. Original: click this button to restore the edited information to the previous or original values.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology Customization dialog box tabs: • General Tab—Use this tab to define general parameters. See Figure 40. Main and Sub Titles: These edit-boxes allow you to add, edit, or delete these titles. If no title is present, you can enter one. Delete all characters from a title to remove it.
xMAP Technology Luminex 2.3 Software Figure 42 Customization Dialog Box—Axis Tab • Font Tab—Use the Font tab to change the appearance of the fonts that appear in the Main Title, Sub Title, and Subset/ Point/ Axis Label boxes. The bottom of the dialog box displays a sample of the font as you select it. See Figure 43. Figure 43 Customization Dialog Box—Font Tab • Color Tab—Use the Color tab to define the various color parameters on the analysis graph. See Figure 44.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology Graph Foreground: this is the color used for the bounding rectangles of the grid, the grid-lines of the graph, and lines that are used to bound some of the plotting methods (like the bounding line around bars of the Bar Plotting Method). Graph Background: this is the color that is used as the background color of the graph's grid. Table Background: This is the color used in filling the table's rectangle.
xMAP Technology Luminex 2.3 Software 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 68 for details. 1. Right-click anywhere in the graph on the Standards tab. The graph menu opens. See Figure 46. 2. Select the desired menu item from the list and it is immediately applied.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology Figure 47 Options Dialog Box—Select Auto-start Analysis 2. Click the Auto-Start Analysis checkbox, then click OK. When the system completes the batch acquisition, it will automatically begin analyzing data. Analyze Processed Batch Data You can analyze only processed batches. If you acquire or process batches as a multi-batch, the system lists them separately and they must be analyzed separately.
xMAP Technology Luminex 2.3 Software tabs to observe the tests errors under the Errors tab and unknown results under the Samples tab. To view the next test in the batch click Next Test (F2). To view the previous test, click Previous Test (F3). You may also click on the test name in the left grid control. Validating or Invalidating Standards and Controls You can invalidate or validate a standard or control in either of two ways.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology To validate or invalidate a standard or control entry using the Invalidate and Validate Buttons: 1. Select the desired standard or control name in the Standards or Controls grid. 2. Click the appropriate buttons at the bottom of the Analysis window: Invalidate Standard (F4), Validate Standard (F5), Invalidate Control (F6), or Validate Control (F7). 3. The appropriate Standard or Control dialog box opens.
xMAP Technology Luminex 2.3 Software Figure 50 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 63. 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 49.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology Batch Summary Report - prints batch information in a sample versus test grid format; useful to quickly reference a test result for a particular sample. Calibration Trend Report - provides information about all instrument calibration operations that occurred during the date range entered by the operator.
xMAP Technology Luminex 2.3 Software Figure 52 Batch Selection Dialog Box 3. Enter the information (in this example, a patient report) and click Next. Another information dialog box opens. Enter specific information for the type of report the system is compiling. Figure 53 shows a Patient Selection example. Figure 53 Patient Selection Dialog Box 4. Select the desired entry or click the double arrow (>>) to select all the entries. 5. Click Finish.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology Figure 54 Open Batch Dialog Box—Select Batch 2. Select the desired batch to export. 3. Click Select. The system exports the information. The Export Batch dialog box opens showing the name and location of the exported data file. Click OK.
xMAP Technology Luminex 2.3 Software Figure 55 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.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 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 Luminex 2.3 Software 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 8 shows a recommended schedule for maintenance operations. Table 8.
xMAP Technology Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use Table 8. 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 2.3 Software 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.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology the desired files to delete and click OK. Windows deletes the files and closes the dialog box. Figure 57 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 2.3 Software 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.
Luminex IS Software Manual for Version 2.
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 - For In Vitro Diagnostic Use 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.
xMAP Technology laser laser Light Amplification by Stimulated Emission of Radiation (laser). This highly purified source of light is an efficient way to excite fluorochrome electrons. 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. microparticle A solid substance with a diameter in the micrometer range. Often used as a synonym for a microsphere.
Luminex IS Software Manual For Version 2.3 - For In Vitro Diagnostic Use 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.
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 - For In Vitro Diagnostic Use 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 - For In Vitro Diagnostic Use 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 - For In Vitro Diagnostic Use Table D-3 Statistic Column Definitions Column Name 98 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.
Luminex IS Software Manual Version 2.3 - For In Vitro Diagnostic Use xMAP Technology Luminex 100 IS Output.CSV file with all additional features enabled "Program","Luminex 100 IS" "Build","2.3 BETA" "Date","7/28/2004","2:16:30 PM" "SN","LX10001298011BE" "Session","Bead 22 Quant Batch" "Operator","" "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 - For In Vitro Diagnostic Use "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 - For In Vitro Diagnostic Use "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 view 74 Analysis window, function keys 22 assay errors 23 assigning dilution factors to samples 61 B back up the database 81 batch analyze processed batch 74 data, export 79 reprocess 53 Batch Summary Report 78 C calibration definition 89 trend report 78 verification 44 Clinical Assay Report 77 confirmation screen 37 create new session 49 D database backup 81 management 82 restore 82 decontamination 42, 87 detailed sample progress 11 dilution factor 61 draining the system 84 E enable raw da
Luminex 100 IS User Manual Version 2.
