Luminex xPONENT 4.0 SP1 User Manual

xPONENT® 4.0 SP1™Software ManualLum/nex®

iiLuminex xPONENT 4.0 Software ManualCurrent Batch Tab ...

Luminex xPONENT 4.0 Software Manual88• Edit Std/Ctrl Kit and Lots• Delete Std/Ctrl Kit and LotsImport and Export Data• Export Batch, Protocol, Std/Ctr

89Touring the SoftwareThis tab contains the following:Create New User. Opens the Create User Account screen.Create User Account ScreenUse this tab to

Luminex xPONENT 4.0 Software Manual90Change password after next login. Requires the user to change the password after the first login. This check box

91Touring the SoftwareBatch Options TabUse this tab to set options for acquisition and batch analysis. FIGURE 58. Batch Options TabThis tab contains t

Luminex xPONENT 4.0 Software Manual92• Calibration expiration days - Type the desired number of days a system calibration remains active before expiri

93Touring the SoftwareAlert Options TabUse this tab to set options for alerts about various system events. FIGURE 59. Alert Options TabAlert Options.

Luminex xPONENT 4.0 Software Manual94FIGURE 60. Setup Email Dialog BoxEnable or disable email notification by selecting or clearing the Email Active c

95Touring the SoftwareCSV Options TabUse this tab to set options for exporting batches to .CSV (comma separated values) files.FIGURE 61. CSV Options T

Luminex xPONENT 4.0 Software Manual96Test Sort Order - Defines a method to sort the test data. The options are By Analyte Name, By Region ID, or By Se

97Touring the SoftwareArchive TabUse this tab to set options for backing up and restoring files. FIGURE 62. Archive TabThis tab contains the following

iiiContentsSetting Administrative Options ... 102System Setup ...

Luminex xPONENT 4.0 Software Manual98• Backup - Backs up the entire system (Click View Backup Log to view information about the backup).• Restore - Re

99Touring the SoftwareStatus. Displays the status of the licensing agreements.Export. Opens the Save As dialog box to select an export name and locati

Luminex xPONENT 4.0 Software Manual100Report Options TabUse this tab to change the look of reports generated by the system.FIGURE 65. Report Options T

101CHAPTER 3 Using the Software This chapter describes the steps needed to successfully use the xPONENT® software.Starting the SoftwareWhen you turn o

Luminex xPONENT 4.O Software Manual102To display software information, click the blue question mark at the top of the xPONENT window, then click About

103Using the Software4. Click Browse to navigate to the .exe file for that program. Double-click on the file name.5. Type the command line parameter f

Luminex xPONENT 4.O Software Manual104original file. In addition, when batch, template, or protocol files are converted, the microsphere count may be

105Using the SoftwareAdding a User1. Click Create New User. The Create User Account screen opens. 2. Type the user ID in the User ID box.3. Type the u

Luminex xPONENT 4.O Software Manual106CSV OptionsYou must have xPONENT® administrative privileges to perform this task if you are using the 21 CFR Par

107Using the SoftwareNOTE: The backup file outputs by default to “C:\Documents and Settings\All Users\Documents\Backup\xPONENT.zip”To restore the sy

ivLuminex xPONENT 4.0 Software ManualTransmit a Batch ...

Luminex xPONENT 4.O Software Manual1081. Type a company name in the Company box, and any additional information in the Info: box.2. Click Import Logo

109Using the Software• Open the Maintenance page, and then the Cmds & Routines tab. Click Warmup in the Commands section at the left of the screen

Luminex xPONENT 4.O Software Manual1102. Click Import Kit at the bottom right side of the window. The Import Calibration or Performance Kit dialog box

111Using the SoftwareCreate New Sample List1. Open the Samples page.2. In the Sample Lists section, select the protocol you are using for the sample l

Luminex xPONENT 4.O Software Manual112WARNING: Human and animal samples may contain biohazardous infectious agents. Where exposure (including aerosol)

113Using the Software6. Define the settings in the Analysis Settings section. For more information about each of these settings, see “Analysis Setting

Luminex xPONENT 4.O Software Manual114Create a Multi-BatchA multi-batch is a set of batches that you want to process consecutively. You add batches to

115Using the SoftwareDelete BatchYou can only delete unprocessed batches. Batches are deleted from the Open Batch list and moved to the Open Incomplet

Luminex xPONENT 4.O Software Manual116There are two main assay types: non-competitive and competitive. In a non-competitive assay, the slope of a conc

117Using the Software• To add well commands, choose the appropriate wells and mark them as unknown, standard, control, background, or wash. You can al

1CHAPTER 1 IntroductionThe Luminex system was developed to improve workflow and efficiency in the clinical laboratory and in research and development.

Luminex xPONENT 4.O Software Manual118Invalidate Standards and ControlsYour xPONENT system administrator must give you privileges to invalidate standa

119Using the SoftwareView and Print ReportsThe Luminex xPONENT software can format your batch or multi-batch results in a variety of export formats an

Luminex xPONENT 4.O Software Manual120Create Qualitative Assay ProtocolYou define each Qualitative protocol using a single kit. The kit must contain o

121Using the Software5. 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

Luminex xPONENT 4.O Software Manual122WeightType list. Click Apply to All Analytes to apply the selection to all analytes. To edit an analysis setting

123Using the Software3. From the Method list, click No Analysis, Cubic Spline, Linear Fit, Logistic 4P, or Logistic 5P.4. From the Weight list, click

Luminex xPONENT 4.O Software Manual124• To add well commands, highlight the appropriate wells and mark them as unknown, standard, control, background,

125Using the SoftwareEdit Protocol1. Open the Protocols page, then open the Protocols tab. 2. Select a protocol.3. Click Edit. The Settings tab opens.

Luminex xPONENT 4.O Software Manual1263. If the protocol uses standards, type the appropriate information for each standard in the Assay Standard Info

127Using the SoftwareWARNING: Lack of proper maintenance can lead to inaccurate test results and failure of system components. Please follow all sched

Luminex xPONENT 4.0 Software Manual2About This GuideThe conventions in this document assume a basic familiarity with computers and a knowledge of Mic

Luminex xPONENT 4.O Software Manual128NOTE: You can only add commands to the end of a routine. You cannot insert them before commands that are alrea

129Using the Software9. Send an email to [email protected] and attach the support file (xPONENTSupportFile.zip) to the email.Shutting Down the A

Luminex xPONENT 4.O Software Manual130

131Glossary21CFRPart11 21 CFR Part 11 sets the criteria under which the Food and DrugAdministration (FDA) considers electronic records, electronicsign

Luminex xPONENT 4.0 Software Manual 132two classification dyes. The unique ratio is identified by a uniquespectral address. Also sometimes called micr

133GlossaryDD temperature The current temperature of the doublet discriminator avalanche photodiode.dot plot Graphical representation of microsphere a

Luminex xPONENT 4.0 Software Manual 134multi-analyte microspheres.laser Light Amplification by Stimulated Emission of Radiation. This highlypurified s

135GlossaryQual A value that determines a cutoff or threshold. This, in conjunction withranges using the Lum Qual Formula, Adv Qual Formula, or an edi

Luminex xPONENT 4.0 Software Manual 136microspheres, assay. suspension Solution consisting of homogeneously dispersed microspheres in anaqueous medium

133IndexAaccount status 101Acquisition Settings panel 24, 53AdminSystem Setup page 77adminarchive 102Archive page 92Batch Options page 86, 88, 94, 95C

3IntroductionGeneral GuidelinesModifying or deleting xPONENT® system files may cause degradation to system performance. You can repair modified or del

134Luminex xPONENT 4.0 Software Manualgrouping 21, 59Hhelp 8, 97Histogram 38Home page 12Iidentificationsymbols 2invalidate standards 115Kkitcreate 122

135Indexsystem warmup 105Ttechnical support 126third-party software 3Uuser permissions 101Vvalidate standards 114validation 83Wwarmup 105warningdefini

Luminex xPONENT 4.0 Software Manual4Safety PrecautionsAll samples should be regarded as potentially contaminated and treated as infectious. These sam

5Introductionmeasured and used to determine the result of each assay in a multiplex. Again, since each bead is analyzed individually, reporter signals

Luminex xPONENT 4.0 Software Manual6ReagentsFormulated reagents must be free of particulates other than xMAP beads. Do not dilute xMAP calibrators or

7CHAPTER 2 Touring the SoftwareThis chapter explores each section of the software and its functionality. For information about using the software, see

© Luminex Corporation, 2001-2009. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, or translated into any

Luminex xPONENT 4.0 Software Manual8HelpEnglish-language help is available for each window in the software by clicking the blue “i” button in the uppe

9Touring the SoftwareScreen ElementsThe following section details the screen elements and the common terms used in this manual to describe them.FIGURE

Luminex xPONENT 4.0 Software Manual10• Export - Opens a File Dialog dialog box. Use the Browse button to select a location, file name, and file type (

11Touring the SoftwareProgress. Displays a bar graph showing the progress of the current command or routine; if the command or routine is finished, it

Luminex xPONENT 4.0 Software Manual12HomeThe Home page displays a welcome message, batch creation buttons, Daily Activities shortcuts, and the Install

13Touring the SoftwareInstalled Protocols. Displays a list of protocols. The list contains the following information about each protocol:• Name• Versi

Luminex xPONENT 4.0 Software Manual14Samples TabFIGURE 5. Samples TabThis tab contains the following:Create New Samples. Opens the Create Sample tab.S

15Touring the SoftwareCreate Sample TabUse this tab to type and view sample information.FIGURE 6. Create Sample TabThis tab contains the following:Pro

Luminex xPONENT 4.0 Software Manual16Edit. Edits a highlighted sample.Undo. Reopens the Create Sample tab without saving any changes made using the Ed

17Touring the SoftwareCreate a New Batch from an existing Protocol. Opens the Protocol tab, where you can create a new batch from an existing protocol

Standard Terms and Conditions For Use of ProductBy opening the packaging containing this product ("Product") or by using such Product in any

Luminex xPONENT 4.0 Software Manual18Create a New Batch from an existing ProtocolCreates a new batch from an existing protocol. The Protocol tab opens

19Touring the SoftwareStds & Ctrls TabUse this tab to apply a kit or lot to the batch.FIGURE 10. Stds & Ctrls TabThis tab contains the followi

Luminex xPONENT 4.0 Software Manual20• 1:10 (Log) - Computes a value of one-tenth of the standard from each previous iteration.• 1/2 Log - Creates a 1

21Touring the SoftwarePlate Layout TabUse this tab to define commands that apply to one or more wells. You can define off-plate and maintenance comman

Luminex xPONENT 4.0 Software Manual22• 123123123. . . Lays out one of each replicate set at a time in numerical order.• 111222333. . . Lays out all th

23Touring the SoftwarePlate. Specifies the plate to display in the plate image in the list. Add Plate adds a new plate to the batch, and Delete Plate

Luminex xPONENT 4.0 Software Manual24• Expiration• ManufacturerSave. Saves the information as a pending batch.Cancel. Returns to the Batches tab.Back.

25Touring the SoftwareName and Description boxes. Type a name and a description in the appropriate boxes.Acquisition Settings. Use this section to set

Luminex xPONENT 4.0 Software Manual26• Quantitative - Determines the sample concentrations from standard curves using regression methods Cubic Spline,

27Touring the SoftwareAnalytes TabUse this tab to select or edit analytes used in the batch or protocol.FIGURE 14. Analytes TabThis tab contains the f

ENTS" SPECIFICALLY EXCLUDES PATENT CLAIMS CONCEIVED AND REDUCED TO PRACTICE BY BUYER CONSISTING OF METHODS OF SAMPLE PREPARATION, METHODS OF CONJ

Luminex xPONENT 4.0 Software Manual28FIGURE 15. Analysis Settings Dialog BoxIf you selected Quantitative on the Settings tab, the default analysis for

29Touring the SoftwareTotal Count. Select Stop after bead count reaches: to stop acquisition when the bead count reaches a certain number determined b

Luminex xPONENT 4.0 Software Manual30• Type a Range Name, a Low Value, a High Value, and select Inclusive if you wish to include the low and high valu

31Touring the SoftwareStds & Ctrls TabIf you have specified standards and controls, use this tab to apply a lot or a kit. For more information abo

Luminex xPONENT 4.0 Software Manual32Plate Layout TabUse this tab to select wells to add samples and maintenance commands to the plate. For more infor

33Touring the SoftwareCreate a New MultiBatchUse this button to add or remove pending batches to the multi-batch set up and to run a multi-batch. A mu

Luminex xPONENT 4.0 Software Manual34FIGURE 20.This tab contains the following:Select Pending Batch. Contains a list of all pending batches. The list

35Touring the SoftwareFIGURE 22. New Multibatch tab with plate layout displayedMulti-Batch. Lists pending batches selected for the multi-batch. The li

Luminex xPONENT 4.0 Software Manual36FIGURE 23. Multibatch Report dialog boxNew Batch. Opens the Create New Batch tab. Create your new batch. Click S

37Touring the SoftwareResultsOnce data is collected in a batch, observation and analysis take place in the Results page. This page contains the follow

End-User License Agreement (EULA) for Luminex® SoftwareThis Luminex End-User License Agreement (“EULA”) is a legal agreement between you (either an in

Luminex xPONENT 4.0 Software Manual38• Median - The point in a data set where there are as many values occurring above it as there are below it.• Test

39Touring the SoftwareResults. Displays statistics related to the batch. Use the up, down, left, and right arrow buttons to move through the table, or

Luminex xPONENT 4.0 Software Manual40NOTE: You can change the X axis of the histogram for troubleshooting purposes. Use only the default settings in

41Touring the SoftwareDetails. Opens the Results tab, enabling more analysis and results. For more information, see “Results Tab” on page 48.Progress.

Luminex xPONENT 4.0 Software Manual42FIGURE 25. 3D View3D BeadMap. The main display is the 3D BeadMap. The display shows the CL1, CL2, and CL3 axes. L

43Touring the SoftwareSample Lists. Contains a list of protocols, including the version number and the number of samples associated with each protocol

Luminex xPONENT 4.0 Software Manual44Completed Batches. Displays a list of completed batches which includes the Name, Protocol, Protocol Version, Date

45Touring the SoftwareThis dialog box lets you choose the saved batches you want to display in the Completed Batches list based on options you select

Luminex xPONENT 4.0 Software Manual46Import. Opens the Open dialog box to choose a batch file (.mdf) to import. Select Include Raw Files (LXB) to impo

47Touring the SoftwareOpen. Opens the Results tab. Use this tab to view the saved batch results for the selected batch.

• 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 xPONENT 4.0 Software Manual48Results TabFIGURE 30. Results TabThe Results tab has the same Save Image, Progress, Well Report, and 3-D buttons

49Touring the SoftwareSettings TabUse this tab to view the acquisition parameters of the selected saved batch and print the batch settings report.FIGU

Luminex xPONENT 4.0 Software Manual50Log TabThis tab displays a log of the activity which occurred during the acquisition of the selected batch. FIGUR

51Touring the SoftwareSample Details TabUse this tab to view sample results.FIGURE 33. Sample Details TabArrows. Scrolls through the sample details.Tr

Luminex xPONENT 4.0 Software Manual52LIS Results TabThis tab displays saved batches containing LIS samples.FIGURE 34. LIS Results TabFilter. Opens the

53Touring the SoftwareFIGURE 35. Reports TabReport and Type lists. Choose a report from one of the following categories:• Batch Reports - A list of ba

Luminex xPONENT 4.0 Software Manual54• Print - Click to print the analyte information currently being viewed.• New Report - Click to return to the mai

55Touring the SoftwareProtocolsThe Protocols page enables you to create and edit the settings for protocols, in addition to adding standards and verif

Luminex xPONENT 4.0 Software Manual56Plate Layout. Opens the Report dialog box, which includes the Plate Layout Report. See Figure 37 on page 56.FIGUR

57Touring the SoftwareFIGURE 38. Settings TabThis tab contains the following:Name and Description boxes. Type a name and a description in the appropri

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 a

Luminex xPONENT 4.0 Software Manual58Analysis Settings. Use this section to set the analysis type, set the number of standards and controls, select an

59Touring the Software• Use External Analysis Program - Select this check-box to use a third-party program to analyze the data. The Analysis Program l

Luminex xPONENT 4.0 Software Manual60FIGURE 40. Analysis Settings Dialog BoxIf you selected Quantitative on the Settings tab, the default analysis for

61Touring the SoftwareTotal Count. Select Stop after bead count reaches: to stop acquisition when the bead count reaches a certain number determined b

Luminex xPONENT 4.0 Software Manual62• Units - The unit of measurement you specified in the Unit box. Click this box to type a value for the analyte.•

63Touring the SoftwareCommand Sequence. Contains the command sequence for the active plate. The list includes all active wells, the type of command (U

Luminex xPONENT 4.0 Software Manual64• Soak• WashFor information on what these commands do, see “Cmds & Routines Tab” on page 71.After selecting a

65Touring the SoftwareStds & Ctrls TabUse this tab to delete, edit, export, import, and create standards and controls.FIGURE 43. Stds & Ctrls

Luminex xPONENT 4.0 Software Manual66• Std/Ctrl Kit NameSelect Std/Ctrl Kits Only in the Show selections to display the following information about th

67Touring the SoftwareStd/Ctrl Details TabThe Std/Ctrl Details tab lets you create or edit a standard and control lot. You can also group a lot as a k

Luminex xPONENT 4.0 Software Manual68• 1:2 - Halves the standard from each previous iteration.• 1:10 (Log) - Computes a value of one-tenth of the stan

69Touring the SoftwareAuto Maint TabThis tab contains routines to initialize, verify, and maintain the analyzer.FIGURE 45. Auto Maintenance TabAutomat

Luminex xPONENT 4.0 Software Manual70Import Kit. Opens the Import Calibration or Performance Kit dialog box. Select a kit and click Open to import a k

71Touring the Software• Calibrator - If a calibration reagent is selected, the Lot Details table displays Channel and Target information.• Verifier -

Luminex xPONENT 4.0 Software Manual72This tab contains the following:Routine Name. This list of pre-set routines and commands can be used for system m

73Touring the Softwarecuvette after biohazard contact. Sanitize as part of your daily shutdown routine after biohazard contact.• Prime - Removes air f

Luminex xPONENT 4.0 Software Manual74Save As. Opens the Save Routine dialog box. Choose a routine name to save the routine under. After saving, the ne

75Touring the SoftwareProbe and Heater TabUse this tab to adjust the probe height and plate heater settings.FIGURE 48. Probe and Heater TabAuto Adjust

Luminex xPONENT 4.0 Software Manual76Plate Heater. Sets the temperature of the plate to the number typed in the Set Temperature box. Up and down arrow

77Touring the SoftwareSystem Info TabUse this tab to view information and diagnostics about the Luminex instrument.FIGURE 49. System Info TabThis tab

iTable of ContentsIntroduction ...

Luminex xPONENT 4.0 Software Manual78• System Temperature• DD Temperature• CL1 Temperature• CL2 Temperature• CL3Temperature• CL1 Voltage• CL2 Voltage•

79Touring the SoftwareSystem Status TabUse this tab to view, print, and save system status log information. You can also access this information by cl

Luminex xPONENT 4.0 Software Manual80Save. Click to open the Save As dialog box. This saves the file as a .pdf. Pick a file name and location to save

81Touring the SoftwareFIGURE 52. Support Utility TabThis tab contains the following:Name, Phone, Company, and Email. Type your information in these bo

Luminex xPONENT 4.0 Software Manual82AdminYou must have the appropriate license to view some of the windows in the Admin section. This page contains t

83Touring the SoftwareAllow the application to be minimized. Enables minimization of the xPONENT® software so that the computer’s desktop can be acces

Luminex xPONENT 4.0 Software Manual84with the external analysis program documentation, use that information. Otherwise, you can type the following par

85Touring the SoftwareMaintenance OptionsThis section displays procedures to use when initializing the system.System Initialization Procedure. Display

Luminex xPONENT 4.0 Software Manual86FIGURE 55. Group Setup TabUsers are assigned to groups. These users then have permissions granted to their group.

87Touring the SoftwareThe Allowed check box next to the desired permission in the Features section enables the selected group to perform that task. Th