Lum/nex ® xPONENT 4.
© Luminex Corporation, 2001-2009. 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® xPONENT® Software Manual PN 89-00002-00-185 Rev. C September 2009 EC REP MDCI Ltd.
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.
ENTS" SPECIFICALLY EXCLUDES PATENT CLAIMS CONCEIVED AND REDUCED TO PRACTICE BY BUYER CONSISTING OF METHODS OF SAMPLE PREPARATION, METHODS OF CONJUGATING PRODUCT TO ANALYTES, THE COMPOSITION OF MATTER OF THE SPECIFIC CHEMISTRIES OF THE ASSAYS DEVELOPED BY BUYER AND METHODS OF PERFORMING THE ASSAYS (I.E., THE PROTOCOL FOR THE ASSAY).
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 xPONENT software product provided to you above, which includes computer SOFTWARE and online or electronic documentation and may include associated media and printed materials (if any) (“SOFTWARE”).
• You may not use this SOFTWARE for any commercial purpose, including in the performance of testing services, unless expressly agreed to in writing by Luminex or as authorized in writing by Luminex through an authorized reseller of the SOFTWARE. • You may only use the SOFTWARE with microspheres manufactured by Luminex or with kits developed, manufactured and distributed by licensees authorized in writing by Luminex. • You must maintain all proprietary notices on all copies of the SOFTWARE.
10. MISCELLANEOUS. This EULA is governed by the laws of the State of Texas, U.S.A., without reference to conflicts of laws principles. You shall not assign or sublicense or otherwise transfer the rights or license granted hereunder, by agreement or by operation of law, without the prior written consent of Luminex, and all assignments in violation of this prohibition shall be null and void.
Table of Contents Introduction .......................................................................................................................... 1 Software Packages ......................................................................................................... 1 About This Guide ............................................................................................................ 2 Warnings, Notes and Symbols...........................................................................
Luminex xPONENT 4.0 Software Manual Current Batch Tab .................................................................................................... 37 3D View............................................................................................................... 41 Saved Batches Tab .................................................................................................. 43 Results Tab ...................................................................................................
Contents Setting Administrative Options .................................................................................... System Setup ........................................................................................................ Application Settings.......................................................................................... Arrange Main Navigation Buttons..................................................................... LIS Settings ...........................................
Luminex xPONENT 4.0 Software Manual Transmit a Batch .................................................................................................... 119 Using Protocols, Lots, and Kits .................................................................................... 119 Protocols................................................................................................................. 119 Create Qualitative Assay Protocol ....................................................................
CHAPTER 1 Introduction The Luminex system was developed to improve workflow and efficiency in the clinical laboratory and in research and development. End users in the laboratory must run microtiter plates using xMAP® based assay kits developed for use with xMAP technology. Software Packages xPONENT® software has different levels of functionality: 1.
Luminex xPONENT 4.0 Software Manual About This Guide The conventions in this document assume a basic familiarity with computers and a knowledge of Microsoft® Windows® software. Commands are often available through more than one method, such as from the toolbar and from menus that appear when rightclicking an area of the screen. However, for ease of use the individual procedures in this manual describe only one method for accessing commands. This guide is formatted as a PDF, and can be printed.
Introduction General Guidelines Modifying or deleting xPONENT® system files may cause degradation to system performance. You can repair modified or deleted xPONENT system files by uninstalling and re-installing the xPONENT software. Use of unauthorized third party software with xPONENT software may result in corruption or failure of the xPONENT software. Use third party software at your own risk. If using a screen saver on the xPONENT system, be aware that xPONENT will prevent it from activating.
Luminex xPONENT 4.0 Software Manual Safety Precautions All samples should be regarded as potentially contaminated and treated as infectious. These samples should be handled at the Biosafety Level 2 as recommended for any potentially infectious human serum or blood specimen in the Center for Disease Control/ National Institutes of Health Manual, “Biosafety in Microbiological and Biomedical Laboratories” 1984.
Introduction measured and used to determine the result of each assay in a multiplex. Again, since each bead is analyzed individually, reporter signals for each bead set can be accurately quantified. The following table displays acceptable reporter fluorochromes and their excitation and emission wavelengths. TABLE 2.
Luminex xPONENT 4.0 Software Manual Reagents Formulated reagents must be free of particulates other than xMAP beads. Do not dilute xMAP calibrators or verifiers. Gating Gate positions are dependent upon buffer composition. Any changes made to the buffer composition in an assay may result in a different optimal gate location. Determine the gating on the Doublet Discriminator channel for the assay during assay development. The numeric values appear on the left side of the histogram.
CHAPTER 2 Touring the Software This chapter explores each section of the software and its functionality. For information about using the software, see “Using the Software” on page 101. This chapter describes default views. Please note that views can be changed and functionality can be disabled by the xPONENT® system administrator. Log In To log in, type your user ID at the System Login tab. If you are using the secure version of the software, type your password.
Luminex xPONENT 4.0 Software Manual Help English-language help is available for each window in the software by clicking the blue “i” button in the upper right portion of the window in which you are working. You can also access the complete system-wide help by clicking Help at the very top of the screen, and then clicking Contents and Index. Help Icons FIGURE 1.
Touring the Software Screen Elements The following section details the screen elements and the common terms used in this manual to describe them. FIGURE 2. Screen Elements 1 2 3 1 Page 2 Tab 3 Right-Click Menu Page. The main elements at the top of the window are “Pages”. Click a page to go to that section of the software. All but the Home, and in some cases the Admin, page can be moved or deleted. For more information, see “System Setup Tab” on page 82. Tab.
Luminex xPONENT 4.0 Software Manual • Export - Opens a File Dialog dialog box. Use the Browse button to select a location, file name, and file type (either a text.CSV file) for the export. This exports all data from the right-clicked item. • • • • • Cut - Cuts the selected data. Copy All - Copies all data. Copy - Copies only the selected data. Paste - Pastes previously copied text or data into the box. Delete - Erases text or data from the selection.
Touring the Software Progress. Displays a bar graph showing the progress of the current command or routine; if the command or routine is finished, it displays a full progress bar and the command status as Complete. Pause. Pauses the system after the current command completes. Pause does not stop the system in the middle of running a command. You cannot run another command while the system is paused. Stop. Stops the system, regardless of command status. Eject. Ejects the plate.
Luminex xPONENT 4.0 Software Manual Home The Home page displays a welcome message, batch creation buttons, Daily Activities shortcuts, and the Installed Protocols list. CAUTION: FIGURE 4. The sheath fluid and the solution in which beads are stored contain proclin, which may cause an allergic reaction. Use personal protective equipment, including gloves and safety glasses. Home Page Return to the Home page at any time by clicking Home in the Navigation toolbar.
Touring the Software Installed Protocols. Displays a list of protocols. The list contains the following information about each protocol: • • • • Name Version Manufacturer Date Use the up and down arrows on the right to move through the list of protocols. View. Opens the Settings tab of the Protocols page to view the selected protocol. This tab enables viewing the settings, analytes, and plate layout for the selected protocol. Daily Activities.
Luminex xPONENT 4.0 Software Manual Samples Tab FIGURE 5. Samples Tab This tab contains the following: Create New Samples. Opens the Create Sample tab. Sample Lists. Contains a list of protocols, including the version number and the number of samples associated with each protocol. Details. Opens the Edit Samples tab to view or edit sample details for the selected protocol. Create Batch. Opens the Protocol tab to create a batch.
Touring the Software Create Sample Tab Use this tab to type and view sample information. FIGURE 6. Create Sample Tab This tab contains the following: Protocol. Displays the protocol selected in the Samples tab. If xPONENT has an LIS license enabled, any sample details provided by the LIS also appear in the Sample list. Version. Displays the protocol version number. It is not editable.
Luminex xPONENT 4.0 Software Manual Edit. Edits a highlighted sample. Undo. Reopens the Create Sample tab without saving any changes made using the Edit or New buttons. Save. Saves changes made to the Sample list. Close. Returns to the Samples tab. Batches Use the Batches page to create and run a new batch from an existing protocol, a new batch from a new protocol, or a new multi-batch.
Touring the Software Create a New Batch from an existing Protocol. Opens the Protocol tab, where you can create a new batch from an existing protocol. For more information, see “Create a New Batch from an existing Protocol” on page 18. Create a New Batch from a new Protocol. Opens the Settings tab, where you can create a new batch from a new protocol. For more information, see “Create a New Batch From a New Protocol” on page 24. Create a New Multi-Batch.
Luminex xPONENT 4.0 Software Manual Create a New Batch from an existing Protocol Creates a new batch from an existing protocol. The Protocol tab opens. Protocol Tab Use this tab to name a batch, type a description, select a protocol, and view active reagents. FIGURE 9. Protocol Tab This tab contains the following: Batch Name/Description. Used to name and describe a batch. Select a Protocol. Contains the protocol name, version, manufacturer, and creation date for each protocol. Active Reagents.
Touring the Software Stds & Ctrls Tab Use this tab to apply a kit or lot to the batch. FIGURE 10. Stds & Ctrls Tab This tab contains the following: Apply Std/Ctrl Kit. Opens the Select Std/Ctrl Kit dialog box. The dialog box displays the Std/Ctrl Kit Lot #, Std/Ctrl Kit Name, Expiration, and Manufacturer for the kit. Select a Std/Ctrl kit from the list and then click OK to close the dialog box. The kit information will display in the boxes to the right of the Apply Std/Ctrl Kit button.
Luminex xPONENT 4.0 Software Manual • 1:10 (Log) - Computes a value of one-tenth of the standard from each previous iteration. • 1/2 Log - Creates a 1:3.16 dilution, or half of each 1:10 (Log) from each previous iteration. • Alternatively, type a number for your own dilution factor. • Apply Dilution - Applies the dilution selected in the Dilution list. NOTE: Click a column header to resort the display.
Touring the Software Plate Layout Tab Use this tab to define commands that apply to one or more wells. You can define off-plate and maintenance commands. FIGURE 11. Plate Layout Tab This tab contains the following: Plate Image. This is a representation of the plate. Each well appears as a circle on the grid. Well commands appear in the appropriate circles as you assign them to wells on the plate.
Luminex xPONENT 4.0 Software Manual • 123123123. . . Lays out one of each replicate set at a time in numerical order. • 111222333. . . Lays out all the replicates in a set before moving on to the next set in numerical order. You can assign the following well commands. Each command is associated with a color.
Touring the Software Plate. Specifies the plate to display in the plate image in the list. Add Plate adds a new plate to the batch, and Delete Plate deletes the plate highlighted in the list. Direction. Specifies the direction to run the plate commands. Select either horizontally or vertically. The selected direction also dictates how wells are added to the plate when assigning multiple unknowns, standards, and controls at one time. Plate Navigation. Displays a smaller plate image for the current batch.
Luminex xPONENT 4.0 Software Manual • Expiration • Manufacturer Save. Saves the information as a pending batch. Cancel. Returns to the Batches tab. Back. Returns to the previous window. Run Batch. Runs the batch and opens the Current Batch tab, where you can monitor the batch as it runs. Create a New Batch From a New Protocol Click Create a New Batch from a new Protocol to create a new batch without using a protocol. The Settings tab opens. Raw data results write to a.CSV file.
Touring the Software Name and Description boxes. Type a name and a description in the appropriate boxes. Acquisition Settings. Use this section to set the following: • Bead Type - Select either MicroPlex (standard) or MagPlex (magnetic) beads. • Volume - This is the volume the instrument will aspirate into the system for analysis. Type the desired sample volume in microliters. Use values from 10 to 200 µl for both 96-well and 384-well plates.
Luminex xPONENT 4.0 Software Manual • Quantitative - Determines the sample concentrations from standard curves using regression methods Cubic Spline, Linear, Logistic 4P, and Logistic 5P. Type the desired values for standards and controls in the Number of Standards and Number of Controls boxes. Select either Fit of All Standards or Mean of Replicates for the calculation of the curve fit. NOTE: Luminex recommends Fit of All Standards as the most accurate calculation of the curve fit.
Touring the Software Analytes Tab Use this tab to select or edit analytes used in the batch or protocol. FIGURE 14. Analytes Tab This tab contains the following: Analyte grid. A grid representing each analyte from 1 to 500. Drag the slider box at the far left up or down, or click the blue up and down arrows to display the full range of analytes. Select All selects all analytes, and Deselect All deselects all analytes. Click a numbered analyte to select it; click the analyte again to deselect it.
Luminex xPONENT 4.0 Software Manual FIGURE 15. Analysis Settings Dialog Box If you selected Quantitative on the Settings tab, the default analysis formula is 5P weighted. To change the default, select one of the following from the Method list: • • • • • No Analysis Cubic Spline Linear Fit Logistic 4P Logistic 5P If you select Logistic 4P or Logistic 5P, select a weight type of either None or 1/Y2. If you selected Qualitative on the Settings tab, the default analysis is Luminex Qualitative.
Touring the Software Total Count. Select Stop after bead count reaches: to stop acquisition when the bead count reaches a certain number determined by the user. Type the desired value in the box. The default value is 100. You can also specify the minimum allowable bead count per well that the xPONENT® software analyzes. This excludes data from any beads carried over during acquisition. For information about this feature, see “Batch Options Tab” on page 91. Selected Analytes List.
Luminex xPONENT 4.0 Software Manual • Type a Range Name, a Low Value, a High Value, and select Inclusive if you wish to include the low and high values in the range. Click OK to exit the dialog box. • Units - The unit of measurement you specified in the Unit box. Click this box to type a value for the analyte. • Count - The total desired bead count for an analyte. Click this box to type a value.
Touring the Software Stds & Ctrls Tab If you have specified standards and controls, use this tab to apply a lot or a kit. For more information about the functionality of this tab, see “Stds & Ctrls Tab” on page 19. FIGURE 17.
Luminex xPONENT 4.0 Software Manual Plate Layout Tab Use this tab to select wells to add samples and maintenance commands to the plate. For more information about the functionality of this tab, see “Plate Layout Tab” on page 21. FIGURE 18.
Touring the Software Create a New MultiBatch Use this button to add or remove pending batches to the multi-batch set up and to run a multi-batch. A multi-batch is composed of one or more pending batches which, together, will fit on one plate. Use the multi-batch feature to conserve plates. NOTE: FIGURE 19. You cannot add a batch that forces multiple plates to a multi-batch operation. When creating or adding batches, ensure your batches fit on one plate.
Luminex xPONENT 4.0 Software Manual FIGURE 20. This tab contains the following: Select Pending Batch. Contains a list of all pending batches. The list includes name, protocol, protocol version, date, and status information for each pending batch. Select the batch you want to add to the plate. Click OK. A plate layout diagram automatically populates the wells for the batch. Click Add to open this box again and add additional batches. FIGURE 21. Select Pending Batch dialog box Plate layout.
Touring the Software FIGURE 22. New Multibatch tab with plate layout displayed Multi-Batch. Lists pending batches selected for the multi-batch. The list includes name and “Start at” well. Plate Layout. Opens the Multibatch Report dialog box that contains: • • • • • Page. Use these arrows to scroll through the report pages. Zoom. Select from the list to change the report magnification. Print. Prints report. Save. Saves report. Close. Closes report dialog box.
Luminex xPONENT 4.0 Software Manual FIGURE 23. Multibatch Report dialog box New Batch. Opens the Create New Batch tab. Create your new batch. Click Save to return to the New Multibatch tab. Add. Opens the Select Pending Batch box.Add a batch from the available options, including batches newly created.The selected batch then appears on the plate layout. If the batches selected do not fit on the plate, a Multi-Batch error dialog box opens, indicating you must edit one or more of the selected batches.
Touring the Software Results Once data is collected in a batch, observation and analysis take place in the Results page. This page contains the following tabs: • • • • • • • • Current Batch Saved Batches Results Settings Log Sample Details LIS Results Reports Current Batch Tab Use this tab to view results, statistics, and log information related to the current batch, and to perform statistical analysis on batch results.
Luminex xPONENT 4.0 Software Manual • Median - The point in a data set where there are as many values occurring above it as there are below it. • Test Result - The calculated analysis value for quantitative or qualitative assays derived from standards with known values. • Range - A sem-quantitative result for a particular numerical result falling between a predefined set of values such as “Normal” or “Negative”. • • • • Count - Gated events, if gates are set.
Touring the Software Results. Displays statistics related to the batch. Use the up, down, left, and right arrow buttons to move through the table, or use the scroll bars. The maximize/minimize toggle button expands the batch table and returns it to the standard size. Plate. A list of the available plates (if more than one). WARNING: If using multiple plates, be careful to ensure that plates are used in the proper order. Failure to do so can result in inaccurate data and test results. Histogram/Dot Plot.
Luminex xPONENT 4.0 Software Manual NOTE: You can change the X axis of the histogram for troubleshooting purposes. Use only the default settings in all other instances. • Gate - Show, create, delete, or move the gate. You can also move the gates by clicking and dragging the red lines on the histogram. • Autoscale - Click to automatically adjust the maximum number of events shown on the Y axis. Click during acquisition to readjust the Y axis scale. • Set Scale - The Set Scale dialog box displays.
Touring the Software Details. Opens the Results tab, enabling more analysis and results. For more information, see “Results Tab” on page 48. Progress. Click to display real-time progress of the well acquisition. Analyte counts are displayed in a dynamic bar graph as they are acquired. The scroll bar at the bottom of the Progress display scrolls through the analyte list. • • • • Maximize - Maximizes the Progress display to fill the window. Zoom - Enable a closer look at the analyte progress.
Luminex xPONENT 4.0 Software Manual FIGURE 25. 3D View 3D BeadMap. The main display is the 3D BeadMap. The display shows the CL1, CL2, and CL3 axes. Left-click and drag your mouse to move the display for better viewing of a particular section. Right-click anywhere in the display to select from the following viewing options: • Display Mode - Select either Logarithmic or Linear. The default is logarithmic. • Display Position - Select from 3D View, CL1/CL3 View, CL1/CL2 View, or CL2/CL3 View.
Touring the Software Sample Lists. Contains a list of protocols, including the version number and the number of samples associated with each protocol. Settings. Opens the 3D Settings dialog box.
Luminex xPONENT 4.0 Software Manual Completed Batches. Displays a list of completed batches which includes the Name, Protocol, Protocol Version, Date, Status, and User information for each batch. This list does not include batches which have not been run. FIGURE 26. Saved Batches Tab Filter. Opens the Filter Setup dialog box. FIGURE 27.
Touring the Software This dialog box lets you choose the saved batches you want to display in the Completed Batches list based on options you select or clear in the following check boxes: • • • • • • • • • • • Batch Name Protocol Batch Status Lot ID Kit ID Analyte Sample ID First Name Last Name User ID Date Reset - Clears all check boxes. OK - Closes the dialog box and applies any changes you made. Cancel - Closes the dialog box and cancels any changes you made. Save Prtcl.
Luminex xPONENT 4.0 Software Manual Import. Opens the Open dialog box to choose a batch file (.mdf) to import. Select Include Raw Files (LXB) to import the raw data file as well. Export. Opens the Export Batch dialog box to choose a destination for the batch file (.mdf). Select Include Raw Files (LXB) to include the raw file in the export. Select Overwrite to overwrite pre-existing files. Replay. Opens the Select Replay Mode dialog box. FIGURE 29.
Touring the Software Open. Opens the Results tab. Use this tab to view the saved batch results for the selected batch.
Luminex xPONENT 4.0 Software Manual Results Tab FIGURE 30. Results Tab The Results tab has the same Save Image, Progress, Well Report, and 3-D buttons as the Current Batch tab. For more information about these buttons, see “Current Batch Tab” on page 37. The following buttons are added to the Results tab: • Formula - Opens the Change Analysis dialog box with a list of analytes used in the batch.
Touring the Software Settings Tab Use this tab to view the acquisition parameters of the selected saved batch and print the batch settings report. FIGURE 31. Settings Tab Page. Scrolls through the Batch Settings report. Save. Opens the Save As dialog box to save the Batch Settings report. Select a location and click OK to save the file. The default save type is a .pdf file. Print. Prints the report. Close. Returns to the Saved Batches tab.
Luminex xPONENT 4.0 Software Manual Log Tab This tab displays a log of the activity which occurred during the acquisition of the selected batch. FIGURE 32. Log Tab This tab displays the following information about each activity: • Date • Message • Code Log entries display yellow if a well was acquired but there was a possible problem. They display red if a problem occurred during the acquisition. Print. Prints the log. Export. Opens the Save As dialog box to save the batch log file.
Touring the Software Sample Details Tab Use this tab to view sample results. FIGURE 33. Sample Details Tab Arrows. Scrolls through the sample details. Transmit. For systems configured for LIS transmission, select a single analyte or the entire sample and click Transmit to send the results. Close. Reopens the Saved Batches tab.
Luminex xPONENT 4.0 Software Manual LIS Results Tab This tab displays saved batches containing LIS samples. FIGURE 34. LIS Results Tab Filter. Opens the Filter Setup dialog box. For more information, see Figure 27 on page 44. Clear. Click to turn off the filter. Completed Samples. Displays Name, Protocol, Sample Count, Date, Status, and User information for each batch displayed in this list. Transmit. Transmits a batch to an LIS if xPONENT is connected to one. Details.
Touring the Software FIGURE 35. Reports Tab Report and Type lists. Choose a report from one of the following categories: • Batch Reports - A list of batches appears below the Type list. The list includes Name, Protocol, Protocol Version, Date, Status, and User information.
Luminex xPONENT 4.0 Software Manual • Print - Click to print the analyte information currently being viewed. • New Report - Click to return to the main Reports window. NOTE: If running a data interpretation of an allele call batch report, be aware that when choosing analytes from the Select Analytes list, selecting one analyte will select all analytes in that group. • Protocol Reports - A list of protocols displays.
Touring the Software Protocols The Protocols page enables you to create and edit the settings for protocols, in addition to adding standards and verifiers. This page contains the following tabs: • • • • • Protocols Settings Analytes Plate Layout Stds & Ctrls Protocols Tab Use this tab to create, import, export, edit, or delete a protocol. You can also add new assay standard and or control information using one of the installed protocols. FIGURE 36.
Luminex xPONENT 4.0 Software Manual Plate Layout. Opens the Report dialog box, which includes the Plate Layout Report. See Figure 37 on page 56. FIGURE 37. Protocols Plate Layout Report Delete. Opens the Delete Protocol dialog box to delete a protocol selected in the Installed Protocol list. Click Yes to delete the selected protocol. Import. Opens the Open dialog box to select a protocol (.lxt file) to import. Navigate to the protocol file you wish to import and click Open. Export.
Touring the Software FIGURE 38. Settings Tab This tab contains the following: Name and Description boxes. Type a name and a description in the appropriate boxes. Acquisition Settings. Use this section to set the following: • Bead Type - Select either MicroPlex (standard) or MagPlex (magnetic) beads. • Volume - This is the volume the instrument will aspirate into the system for analysis. Type the desired sample volume in microliters. Use values from 10 to 200 µl for both 96-well and 384-well plates.
Luminex xPONENT 4.0 Software Manual Analysis Settings. Use this section to set the analysis type, set the number of standards and controls, select an external analysis program, and choose whether to analyze results while acquiring samples. • Analysis Type - Use this list to choose from the following analysis types: • None - No analysis. Select if you have your own data post-processing program and want to obtain only fluorescent intensity results. You cannot apply standards or controls when you select None.
Touring the Software • Use External Analysis Program - Select this check-box to use a third-party program to analyze the data. The Analysis Program list becomes active when this is selected. • Analysis Program - Use this list to select which program to use for data analysis. Cancel. Click to return to the main Protocol tab. Next:. Click to advance to the Analytes tab. Analytes Tab Use this tab to select or edit analytes used in the batch or protocol. FIGURE 39.
Luminex xPONENT 4.0 Software Manual FIGURE 40. Analysis Settings Dialog Box If you selected Quantitative on the Settings tab, the default analysis formula is 5P weighted. To change the default, select one of the following from the Method list: • • • • No Analysis Cubic Spline Linear Fit Logistic 4P • Logistic 5P If you select Luminex Logistic 4P or Luminex Logistic 5P, select a weight type of either None or 1/Y2.
Touring the Software Total Count. Select Stop after bead count reaches: to stop acquisition when the bead count reaches a certain number determined by the user. Type the desired value in the box. The default value is 100. You can also specify the minimum allowable bead count per well that the xPONENT® software analyzes. This excludes data from any beads carried over during acquisition. For information about this feature, see “Batch Options Tab” on page 91. Selected Analytes List.
Luminex xPONENT 4.0 Software Manual • Units - The unit of measurement you specified in the Unit box. Click this box to type a value for the analyte. • Count - The total desired bead count for an analyte. Click this box to type a value. The system continues analyzing until each bead set has met the minimum events as determined in the Count box above. If you select the Stop after total bead count reaches: check box and type a total count in the corresponding box, this column does not appear.
Touring the Software Command Sequence. Contains the command sequence for the active plate. The list includes all active wells, the type of command (Unknown, Standard, Control, Background, or assigned maintenance command), ID, and dilution factor. Double click the ID field to type an ID. Double click the Dilution field to type a dilution factor. A command’s ID and Dilution fields have a blue border around them if they can be double clicked to type information. Move Command.
Luminex xPONENT 4.0 Software Manual • Soak • Wash For information on what these commands do, see “Cmds & Routines Tab” on page 71. After selecting a maintenance command, click one of the following buttons: • Before Well - The system performs the command before acquiring the well. An open dot appears in the upper left corner of the selected well on the plate image. The command appears in the command sequence list before the selected well.
Touring the Software Stds & Ctrls Tab Use this tab to delete, edit, export, import, and create standards and controls. FIGURE 43. Stds & Ctrls Tab This tab contains the following: Create New Std/Ctrl Lots. Opens the Std/Ctrl Details tab to create a new lot or kit. For more information, see “Std/Ctrl Details Tab” on page 67. Installed Kits And Lots. Displays information about the kits and lots currently installed on the system.
Luminex xPONENT 4.0 Software Manual • Std/Ctrl Kit Name Select Std/Ctrl Kits Only in the Show selections to display the following information about the installed Std/Ctrl Kits: • • • • • • Std/Ctrl Kit # Std/Ctrl Kit Name Expiration Manufacturer Created with Protocol Version Delete. Deletes a selected lot. The Delete Lot(s) Confirmation dialog box opens. Click Yes to delete the lot. Edit. Opens the Std/Ctrl Details tab to edit the lot information. Export.
Touring the Software Std/Ctrl Details Tab The Std/Ctrl Details tab lets you create or edit a standard and control lot. You can also group a lot as a kit. FIGURE 44. Std/Ctrl Details Tab This tab contains the following: Apply Std/Ctrl Kit. Opens the Select Std/Ctrl Kit dialog box. The dialog box displays the Std/Ctrl Kit Lot #, Std/Ctrl Kit Name, Expiration, and Manufacturer for the kit. Select a Std/Ctrl kit from the list and then click OK to close the dialog box.
Luminex xPONENT 4.0 Software Manual • 1:2 - Halves the standard from each previous iteration. • 1:10 (Log) - Computes a value of one-tenth of the standard from each previous iteration. • 1/2 Log - Creates a 1:3.16 dilution, or half of each 1:10 (Log) from each previous iteration. • Alternatively, type a number for your own dilution factor. • Apply Dilution - Applies the dilution selected in the Dilution list. NOTE: Click a column header to resort the display.
Touring the Software Auto Maint Tab This tab contains routines to initialize, verify, and maintain the analyzer. FIGURE 45. Auto Maintenance Tab Automated Maintenance Options. Provides buttons for commonly used maintenance routines for the machine. Select from the following: • System Initialization - Select this routine to use with the System Initialization kit. • Performance Verification - Select this routine to use with the Performance Verification kit.
Luminex xPONENT 4.0 Software Manual Import Kit. Opens the Import Calibration or Performance Kit dialog box. Select a kit and click Open to import a kit. Run. Initiates the selected routine. Lot Management Tab Use this tab to manage calibration and verification kits. FIGURE 46. Lot Management Tab Active Reagents. Use this section to change calibration or performance verification kits, lot numbers, and expiration dates, or to delete a kit. • Calibration Kit - Select a calibration kit from this list.
Touring the Software • Calibrator - If a calibration reagent is selected, the Lot Details table displays Channel and Target information. • Verifier - If a verification reagent is selected, the Lot Details table displays target information. Import Kit. Opens the Import Calibration or Performance Kit dialog box to import a kit. Import. Opens the Import Calibrator or Verification Lot dialog box to import a lot. Export. Opens the Export Calibrator or Verification Lot dialog box.
Luminex xPONENT 4.0 Software Manual This tab contains the following: Routine Name. This list of pre-set routines and commands can be used for system maintenance. Some of these commands are also available on the Auto Maint tab. Additionally, you can create custom routines on this tab, which display in the Routine Name list once you save the routine. To create a custom routine, startwith None and add the desired commands. You can also modify a Luminex routine and save it as a new routine.
Touring the Software cuvette after biohazard contact. Sanitize as part of your daily shutdown routine after biohazard contact. • Prime - Removes air from the system’s fluidic pathways by drawing sheath fluid from the sheath fluid container. You do not need to supply solution in a plate. • F3DCAL2 - Calibrates xMAP reporters. • F3DVER2 - Verifies RP1 at normal and high PMT and extended ranges for all xMAP Bead types. • Drain - Helps remove debris from the bottom of the cuvette during troubleshooting.
Luminex xPONENT 4.0 Software Manual Save As. Opens the Save Routine dialog box. Choose a routine name to save the routine under. After saving, the new routine will then appear in the Routine Name list. This button only appears if a routine has been customized or if a new routine has been made. Cancel. Cancels changes made to the default location of one of the commands in the Command Sequence. Click it to cancel those changes. This button only appears if changes have been made to the command sequence.
Touring the Software Probe and Heater Tab Use this tab to adjust the probe height and plate heater settings. FIGURE 48. Probe and Heater Tab Auto Adjust Height. Automatically adjusts the probe height using the specified location(s) in the main plate, reservoir, and strip wells. NOTE: It is recommended to calibrate the probe height using row A. Plate Location. Defines the location used to auto adjust the probe height. Select the check box for either the main plate, reservoir, and/or strip wells.
Luminex xPONENT 4.0 Software Manual Plate Heater. Sets the temperature of the plate to the number typed in the Set Temperature box. Up and down arrows allow half-degree adjustments of the temperature, and Apply activates the adjustment. Current and Target temperatures display at the bottom of this section. NOTE: The temperature range is 35 to 60° Celsius. WARNING: Be advised that the plate heater can become hot enough to cause injury. Use caution when handling after heating. Delete.
Touring the Software System Info Tab Use this tab to view information and diagnostics about the Luminex instrument. FIGURE 49.
Luminex xPONENT 4.0 Software Manual • • • • • • • • • • • System Temperature DD Temperature CL1 Temperature CL2 Temperature CL3Temperature CL1 Voltage CL2 Voltage CL3 Voltage DD Voltage RP1 Voltage Number of Syringes Items in this list relating to CAL/VER calibration and verification have one of the following states: • Passed - Indicates that the process completed successfully. • Failed - Indicates that the process was not completed successfully. Failed items appear in red.
Touring the Software System Status Tab Use this tab to view, print, and save system status log information. You can also access this information by clicking the System Status button on the System Monitor. For more information, see “System Status” on page 10. FIGURE 50. System Status Tab This tab contains the following: Search By Log Type. Filters the type of log information. Select All, Maintenance, Security, or Warnings and Errors. Search By Log Date.
Luminex xPONENT 4.0 Software Manual Save. Click to open the Save As dialog box. This saves the file as a .pdf. Pick a file name and location to save the file, and click Save. Schedule Tab Use this tab to view reminders for scheduled maintenance due to be performed on the analyzer. FIGURE 51. Schedule Tab The Reminders section displays Subject, Reminder, Next Alert Date, Alert Time, and Notes. This schedule can be changed using the Schedule tab of the Admin page.
Touring the Software FIGURE 52. Support Utility Tab This tab contains the following: Name, Phone, Company, and Email. Type your information in these boxes so that Luminex Technical Support can contact you. Clear. Clears all information in the Name, Phone, Company, Email, and Comment boxes. Comment. Type any comments in this box. Include Batch info. Includes batch information from a selected batch in the Support Utility.zip export folder. Select Batch. Displays a list of all batches.
Luminex xPONENT 4.0 Software Manual Admin You must have the appropriate license to view some of the windows in the Admin section. This page contains the following tabs: • • • • • • • • • • System Setup Group Setup User Setup Batch Options Alert Options CSV Options Archive Licensing Schedule Report Options System Setup Tab Use this tab to configure system settings. FIGURE 53.
Touring the Software Allow the application to be minimized. Enables minimization of the xPONENT® software so that the computer’s desktop can be accessed. If this check box is clear, the application’s minimize button will not function. Ignore user permission when attempting to exit software. Enables the user to exit the xPONENT software, regardless if permission has been granted in the User Setup tab. Add header when exporting data from grids. Adds a header row when exporting the data. Allow 3D View.
Luminex xPONENT 4.0 Software Manual with the external analysis program documentation, use that information. Otherwise, you can type the following parameters built into xPONENT, in any order: • • • • #c - Output.csv, full file path #p - Protocol name #b - Batch name #u - Logged in user name To keep the default command line settings, leave Command Line Parameters blank. Set Default. Sets the chosen analysis program as the default analysis program for xPONENT. OK.
Touring the Software Maintenance Options This section displays procedures to use when initializing the system. System Initialization Procedure. Displays the available selections to use as the default system initialization procedure. After selecting an option, click Save at the bottom right portion of the window to save the selection as the default procedure. Data Conversion This section contains options to use when converting data from an earlier version of xPONENT. Open.
Luminex xPONENT 4.0 Software Manual FIGURE 55. Group Setup Tab Users are assigned to groups. These users then have permissions granted to their group. Do not assign permissions directly to an individual user. On this tab, you can reinstate users who lock themselves out of the system at the System Login tab. This tab contains the following: Group Profile .
Touring the Software The Allowed check box next to the desired permission in the Features section enables the selected group to perform that task. The Signature Required check box next to the desired permission requires a digital signature whenever a user in the selected group performs that task. Clear Allow and select Signature Required to require the electronic signature of another user whose account is configured to allow the action.
Luminex xPONENT 4.0 Software Manual • Edit Std/Ctrl Kit and Lots • Delete Std/Ctrl Kit and Lots Import and Export Data • Export Batch, Protocol, Std/Ctrl Kit/Lot Files • Import Batch, Protocol, Std/Ctrl Kit/Lot Files Archiving • Backup/Restore • Import/Archive When you perform an action that requires an electronic signature, the Electronic Signature dialog box opens. The user ID autopopulates. Type your password and any comments.
Touring the Software This tab contains the following: Create New User. Opens the Create User Account screen. Create User Account Screen Use this tab to set the options for a new user. Any user with access to this tab can assign rights to any and all groups. FIGURE 57. Create User Account Screen This tab contains the following: User ID. Type a user ID in this box. The user ID is not case-sensitive. You can change the required number of characters on the User Setup tab.
Luminex xPONENT 4.0 Software Manual Change password after next login. Requires the user to change the password after the first login. This check box is enabled by default. Save. Saves and returns to User Setup. Cancel. Returns to User Setup without saving. Global User Settings. This section contains the following: • Password Expiration - Type a length of time in days. The default is 180 days. • Unsuccessful Login Attempts - The default number of allowed unsuccessful logins is three attempts.
Touring the Software Batch Options Tab Use this tab to set options for acquisition and batch analysis. FIGURE 58. Batch Options Tab This tab contains the following: Batch Options. This section displays the following options: • Allow running a batch if the instrument is not warmed up - Allows batches to run if the instrument is not warmed up. • Allow running a calibration if the instrument is not warmed up - Allows calibration to run if the instrument is not warmed up.
Luminex xPONENT 4.0 Software Manual • Calibration expiration days - Type the desired number of days a system calibration remains active before expiring. The default number of days is seven. • Analysis display decimal places - Type the number of digits the system displays. The default number of digits is three. • Minimum bead count for obtaining results - Type any whole number from 0 to 1000000.
Touring the Software Alert Options Tab Use this tab to set options for alerts about various system events. FIGURE 59. Alert Options Tab Alert Options. Offers three check boxes for each alert - Dialog, Email, and Sound. This section displays the following events: • • • • • • • • • • Locked User - The user is locked out of the login. Batch Complete - The batch is finished. Warmup Complete - The laser is warmed up. Heater In Range - The plate heater is warmed to the designated range.
Luminex xPONENT 4.0 Software Manual FIGURE 60. Setup Email Dialog Box Enable or disable email notification by selecting or clearing the Email Active check box. Contact your network administrator to determine the information needed in the Mail Server Host, From Email Address, From Email Password, and Mail Server Port boxes, and if you need to select the Enable SSL (Secure Sockets Layer) check box. The Test button tests the email settings.
Touring the Software CSV Options Tab Use this tab to set options for exporting batches to .CSV (comma separated values) files. FIGURE 61. CSV Options Tab This tab contains the following: CSV and Batch Export Options Automatically export results CSV file when batch is complete - Automatically exports the .CSV file when the system finishes analyzing the batch. This allows running programs on exported data without having to manually start the export.
Luminex xPONENT 4.0 Software Manual Test Sort Order - Defines a method to sort the test data. The options are By Analyte Name, By Region ID, or By Setup Order. Cancel - Cancels changes. Save - Saves changes.
Touring the Software Archive Tab Use this tab to set options for backing up and restoring files. FIGURE 62. Archive Tab This tab contains the following: Archive. Use this section to choose file types to archive destinations for the archive file. This section contains the following: • File Type - Choose from Protocols, Batches, Std/Ctrl Kits, Lots, Patient Samples, or Log. The selected information appears in the list below the Archive Folder path.
Luminex xPONENT 4.0 Software Manual • Backup - Backs up the entire system (Click View Backup Log to view information about the backup). • Restore - Restores all information in the archive file to the system. This will overwrite all information. Import. Select a file type to import in the File Type list and click Import to import all files of that type from the archive. The imported files will then display in the list below the Archive Folder path. Archive.
Touring the Software Status. Displays the status of the licensing agreements. Export. Opens the Save As dialog box to select an export name and location. License. Opens the Change License dialog box. • Type the file path for the license file in the License File box, or use the Browse button to display the Open License dialog box and navigate to the file. You can also update the xPONENT® license status by manually typing the license code in the License Code box.
Luminex xPONENT 4.0 Software Manual Report Options Tab Use this tab to change the look of reports generated by the system. FIGURE 65. Report Options Tab • Company - Type the company name you wish to display on reports. • Info - Type any information you wish to display below the company name. • Import Logo - Displays the Open dialog box and selects the file you wish to use for the logo at the top of reports. • Clear Logo - Returns to the default logo. Cancel. Cancels changes. Save. Saves changes.
CHAPTER 3 Using the Software This chapter describes the steps needed to successfully use the xPONENT® software. Starting the Software When you turn on the computer for your Luminex system, xPONENT should launch automatically. If it does not, click the Luminex xPONENT icon on the PC desktop, or click Start>Programs>Luminex>xPONENT>Luminex xPONENT. If you have a trial license, a dialog box opens. Click OK to close the dialog box.
Luminex xPONENT 4.O Software Manual To display software information, click the blue question mark at the top of the xPONENT window, then click About Luminex xPONENT. The xPONENT information dialog box opens, displaying the software version information. Setting Administrative Options Click Admin on the toolbar to display the tabs used to set administrative options. System Setup You must have xPONENT administrative privileges to perform System Setup tasks.
Using the Software 4. Click Browse to navigate to the .exe file for that program. Double-click on the file name. 5. Type the command line parameter for what parameters you want xPONENT® to use with the external analysis program. If the information is supplied with the external analysis program documentation, use that information. Otherwise, you can type the following parameters built into xPONENT, in any order: • • • • #c - Output.csv, full file path. #p - Protocol name. #b - Batch name.
Luminex xPONENT 4.O Software Manual original file. In addition, when batch, template, or protocol files are converted, the microsphere count may be converted automatically to 100. NOTE: xPONENT 4.0 will not convert any raw bead data files (from LX100/200) since the raw bead data files are not compatible with xPONENT 4.0. To convert an earlier version of data: 1. Click Open to open the xCONVERT Utility dialog box. 2. Click ... in the Source File box to navigate to the source file you wish to convert. 3.
Using the Software Adding a User 1. 2. 3. 4. Click Create New User. The Create User Account screen opens. Type the user ID in the User ID box. Type the user’s name in the Name box. Type a password for the user in the Password box, then re-type it in the Reenter Password box. If you want the user to change the password on first login, select Change password after first login. 5. In the Group Profile list, select the role for the user you are creating. 6. Click Save.
Luminex xPONENT 4.O Software Manual CSV Options You must have xPONENT® administrative privileges to perform this task if you are using the 21 CFR Part 11 or Secure package. Use the commands on this tab to define what the ".CSV" file will contain, and where it will be stored. For more information on this tab, see “CSV Options Tab” on page 95. To set CSV Options: 1. In the CSV and Batch Export Options section, select the CSV Options you want to apply to the CSV file.
Using the Software NOTE: The backup file outputs by default to “C:\Documents and Settings\All Users\Documents\Backup\xPONENT.zip” To restore the system using a backup file: 1. Click Restore. A Warning dialog box displays. CAUTION: All data and settings will be overwritten, and xPONENT® will restart once the restore task completes. 2. Click OK to continue restoring the system. The File Dialog box opens. The most recent backup file displays in the File Name box.
Luminex xPONENT 4.O Software Manual 1. Type a company name in the Company box, and any additional information in the Info: box. 2. Click Import Logo and then Open after navigating to the desired file to import a graphic for the report header. 3. Click Clear Logo to remove the logo. 4. Click Save. Adjusting the Sample Probe Adjust the sample probe to ensure that it drops far enough into the well to acquire sample. NOTE: Ensure that there is no liquid in the wells or reservoirs. 1.
Using the Software • Open the Maintenance page, and then the Cmds & Routines tab. Click Warmup in the Commands section at the left of the screen, and then click the Run button at the bottom right to begin the procedure. The warmup process takes 30 minutes to complete. Calibrator xMAP beads are used to normalize the settings for the reporter channel, both classification channels, and the doublet discriminator channel.
Luminex xPONENT 4.O Software Manual 2. Click Import Kit at the bottom right side of the window. The Import Calibration or Performance Kit dialog box opens. 3. Locate the xMAP calibrator or verification kit information file, and click Open. Import CAL or VER Kits 1. Open the Maintenance page, then open the Lot Management tab. 2. Click Import Kit. The Import Calibration or Performance Kit dialog box opens. 3. Select the kit you wish to import, then click Open. Export CAL or VER Kits 1.
Using the Software Create New Sample List 1. Open the Samples page. 2. In the Sample Lists section, select the protocol you are using for the sample list, then click Create New Samples. The Create Sample tab opens. 3. In the ID box, type the sample ID. 4. Type a patient first name in the First name box if desired. 5. Type a patient last name in the Last name box if desired. 6. To add a comment about the sample, type it in the Comment box; this is optional. 7.
Luminex xPONENT 4.O Software Manual WARNING: Human and animal samples may contain biohazardous infectious agents. Where exposure (including aerosol) to potentially biohazardous material exists, follow appropriate biosafety procedures and use personal protective equipment, such as gloves, gowns, laboratory coats, face shields, or mask and eye protection, and ventilation devices. Observe all local, state, and federal biohazard handling regulations when disposing of biohazardous waste material.
Using the Software 6. Define the settings in the Analysis Settings section. For more information about each of these settings, see “Analysis Settings” on page 25. If you select Quantitative, Allele Call or Qualitative from the Analysis Type list, you can select Analyze results while acquiring samples to view real-time analysis. The xPONENT® analysis package can only analyze batches that it acquires using qualitative, quantitative, or allele call protocols. 7. Click Next. The Analytes tab opens. 8.
Luminex xPONENT 4.O Software Manual Create a Multi-Batch A multi-batch is a set of batches that you want to process consecutively. You add batches to the multi-batch from pending batches in your database. You can also create a new batch to add to the database for the multi-batch. You can include as many batches as you need. The software does not limit you to a certain number of batches per multi-batch. You must ensure the batches fit on one plate.
Using the Software Delete Batch You can only delete unprocessed batches. Batches are deleted from the Open Batch list and moved to the Open Incomplete Batch list. 1. Open the Batches page. 2. In the Pending Batches section, click the batch you want to delete, then click Delete. The Delete Pending Batch dialog box opens. 3. Click Yes. Edit Batch 1. 2. 3. 4. Open the Batches page. Click the batch you want to edit, then click Edit. The Protocol tab opens.
Luminex xPONENT 4.O Software Manual There are two main assay types: non-competitive and competitive. In a non-competitive assay, the slope of a concentration versus Median Fluorescent Intensity (MFI) standard curve is a positive number. That is, low concentrations result in low MFIs and high concentrations result in high MFIs.
Using the Software • To add well commands, choose the appropriate wells and mark them as unknown, standard, control, background, or wash. You can also delete commands that you’ve added, and change the starting location on the plate. If you wish to run in replicate mode, change the Replicate Count to the appropriate number and the Grouping to your preferred grouping method. • To add maintenance commands, choose the desired command from the list.
Luminex xPONENT 4.O Software Manual Invalidate Standards and Controls Your xPONENT system administrator must give you privileges to invalidate standards if you are using the Secure xPONENT package. You can invalidate or remove a standard if doing so improves the curve fit. CAUTION: Observe caution when invalidating standards. Doing so greatly affects the curve fit and subsequent sample results.
Using the Software View and Print Reports The Luminex xPONENT software can format your batch or multi-batch results in a variety of export formats and provide different types of information in different types of reports. Three types of reports are available. See “Reports Tab” on page 52 for a description of available reports. NOTE: Install the printer before initiating the Print command. 1. 2. 3. 4. Open the Results page, then open the Reports tab. In the Report list, click the report you want to view.
Luminex xPONENT 4.O Software Manual Create Qualitative Assay Protocol You define each Qualitative protocol using a single kit. The kit must contain one standard. The standard is assigned a “Quali” value for each test. Controls are optional, but are recommended for judging the acceptability of batch results. 1. Open the Protocols page, then open the Protocols tab. Click Create New Protocol. The Settings tab opens. 2. In the Name box, type the name of the protocol. 3.
Using the Software 5. Type a new name for the edited formula in the Formula Name box. 6. Edit the values for each range in the Negative, Low Positive, or High Positive if you selected Lum Qual in the Formulas list, or Negative, Low Positive, Moderate Positive, or Strong Positive if you selected Adv Qual in the Formulas list. Select the check box in the Inclusive column to include the value in the range.
Luminex xPONENT 4.O Software Manual WeightType list. Click Apply to All Analytes to apply the selection to all analytes. To edit an analysis setting, see “Edit Quantitative Analysis Settings” on page 122. 15.To change the analysis for a single analyte, click the Analysis field for the analyte you wish to modify. The Analysis Settings dialog box opens. 16.Select an analysis method in the Method list. 17.
Using the Software 3. From the Method list, click No Analysis, Cubic Spline, Linear Fit, Logistic 4P, or Logistic 5P. 4. From the Weight list, click None or 1/Y^2. NOTE: The Weight options are only available if the chosen Method is Logistic 4P or Logistic 5P. 5. Check Mark as Intra-Well Normalization Bead if you wish to use a normalization bead. The normalization bead is a microsphere set that is included in the assay as an internal control.
Luminex xPONENT 4.O Software Manual • To add well commands, highlight the appropriate wells and mark them as unknown, standard, control, background, or wash. You can also delete commands that you’ve added, and change the starting location on the plate. If you wish to run in replicate, change the Replicate Count to the appropriate number and the Grouping to your preferred grouping method. • To add maintenance commands, choose the desired command from the Command list.
Using the Software Edit Protocol 1. 2. 3. 4. 5. 6. 7. Open the Protocols page, then open the Protocols tab. Select a protocol. Click Edit. The Settings tab opens. Define settings and click Next. The Analytes tab opens. Define analytes and click Next. The Plate Layout tab opens. Define the plate layout. Click Save. Lots and Kits 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.
Luminex xPONENT 4.O Software Manual 3. If the protocol uses standards, type the appropriate information for each standard in the Assay Standard Information section. In each analyte column, type the expected concentration for the analyte. 4. Alternatively, click Apply Std/Ctrl Kit and select a lot from the Select Lot dialog box. Click OK to apply the lot. 5. If your batch uses controls, select Expected, Low, or High from the Show Value options.
Using the Software WARNING: Lack of proper maintenance can lead to inaccurate test results and failure of system components. Please follow all scheduled maintenance routines to ensure proper functioning of equipment. Perform System Calibration Perform system calibration weekly. In addition, recalibrate the system if the delta cal temperature exceeds +/-5ºC. For further information, see “System Initialization” on page 108.
Luminex xPONENT 4.O Software Manual NOTE: You can only add commands to the end of a routine. You cannot insert them before commands that are already part of a routine. Run Routine 1. 2. 3. 4. Open the Maintenance page, then open the Cmds & Routines tab. Select a routine to run from the Routine Name list. Click Eject on the status bar. Add the appropriate reagents to the plate, reservoirs, and well strips as indicated in the plate image and set the plate on the plate holder. 5. Click Retract. 6.
Using the Software 9. Send an email to support@luminexcorp.com and attach the support file (xPONENTSupportFile.zip) to the email. Shutting Down the Analyzer 1. On the Home page, click Shutdown. The Auto Maint tab opens, with System Shutdown selected. 2. Fill the off-plate reagent areaRB2 with a 10% to 20% household bleach and water solution. 3. Add deionized water to RA1. 4. Click Run.
Luminex xPONENT 4.
Glossary 21CFRPart11 21 CFR Part 11 sets the criteria under which the Food and Drug Administration (FDA) considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. agglutination The coalescing of small particles that are suspended in solution; these larger masses are then (usually) precipitated.
Luminex xPONENT 4.0 Software Manual two classification dyes. The unique ratio is identified by a unique spectral address. Also sometimes called microsphere set, microsphere region, or test by the software during acquisition. calibration A process used to normalize the settings for the reporter channel, both classification channels, and the doublet discriminator channel for the Luminex System. Calibration ensures optimal and consistent microsphere classifications and reporter readings.
Glossary DD temperature The current temperature of the doublet discriminator avalanche photo diode. dot plot Graphical representation of microsphere analysis classification data displayed by frequency and intensity. doublet discriminator (DD) A classification channel measuring side scatter; used to filter for single bead events based on size. emission spectrum Wavelength range that an excited fluorochrome emits when its electrons fall from a higher to a lower energy state.
Luminex xPONENT 4.0 Software Manual multi-analyte microspheres. laser Light Amplification by Stimulated Emission of Radiation. This highly purified source of light is an efficient way to excite fluorochrome electrons. LIS Laboratory Information System; A system for storing sample records and test requests. lot A reagent with specific target values used for analysis or calibration.
Glossary Qual A value that determines a cutoff or threshold. This, in conjunction with ranges using the Lum Qual Formula, Adv Qual Formula, or an edited range specific for your assay, helps to determine qualitative results for unknown samples. qualitative Pertaining to calculations that determine the absence or presence of an analyte. quantitative Pertaining to calculations that determine the precise numerical measurement of an analyte. reagent A substance used to detect or measure other substances.
Luminex xPONENT 4.0 Software Manual microspheres, assay. suspension Solution consisting of homogeneously dispersed microspheres in an aqueous medium. system controls Include the xMAP reporter and classification control microspheres. They are used to verify the calibration of the Luminex analyzer. template This is now called a protocol. test Each test represents an analyte and corresponds to a bead set. Each bead set falls into a particular location on the bead map.
Index A account status 101 Acquisition Settings panel 24, 53 Admin System Setup page 77 admin archive 102 Archive page 92 Batch Options page 86, 88, 94, 95 Create New User Account page 84 CSV Options page 90 group setup 100 Group Setup page 80 licensing 103 Licensing page 93 support utility 125 user groups 81 user setup 100 User Setup page 83 Analyte Settings 28, 56 analytes select 27, 55 statistics 37 Application Settings 98 B batch run 24 single step 23, 60 transmit 116 view and print reports 116 view lo
Luminex xPONENT 4.
Index system warmup 105 T technical support 126 third-party software 3 U user permissions 101 V validate standards 114 validation 83 W warmup 105 warning definition 2 website 126 135
