Luminex xPONENT 3.1 Manuale Utente

xPONENT® 3.1Software ManualLum/nex®

iiLuminex xPONENT 3.1 Software ManualSaved Batches Tab...

Luminex xPONENT 3.1 Software Manual88

89CHAPTER 3 Using the Software This chapter describes the steps needed to successfully use the xPONENT® software.Starting the SoftwareWhen you turn on

Luminex xPONENT 3.1 Software Manual90To display software information, click the blue question mark at the top of the xPONENT window, then click About

91Using 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 fo

Luminex xPONENT 3.1 Software Manual92original file. In addition, when batch, template, or protocol files are converted, the microsphere count may be c

93Using the Software3. Type the user’s name in the Name box.4. Type a password for the user in the Password box, then re-type it in the Reenter Passwo

Luminex xPONENT 3.1 Software Manual94".CSV" file will contain, and where it will be stored. For more information on this tab, see “CSV Optio

95Using the SoftwareTo restore the system using a backup file:1. Click Restore. A Warning dialog box displays.CAUTION: All data and settings will be o

Luminex xPONENT 3.1 Software Manual962. Click Import Logo and then Open after navigating to the desired file to import a graphic for the report header

97Using the SoftwareSystem InitializationxPONENT® Software contains a pre-defined startup routine to prepare the analyzer for data acquisition.This se

iiiContentsApplication Settings... 90Arrange Main Navigation

Luminex xPONENT 3.1 Software Manual984. Vortex the xMAP calibrator, verification, and fluidics containers to ensure homogeneity. Do not dilute xMAP ca

99Using the SoftwareCreate Calibration Reports1. Open the Results page, then open the Reports tab.2. In the Report list, click Calibration Summary.3.

Luminex xPONENT 3.1 Software Manual100Setting Up BatchesA batch consists of a group of samples processed under control of a protocol. Batches consist

101Using the SoftwareNOTE: If the batch spans more than one plate, the tray ejects automatically when all defined wells have been acquired. A dialog

Luminex xPONENT 3.1 Software Manual102• To add well commands, click the appropriate wells and mark them as unknown, standard, control, background, or

103Using the Software4. Navigate to the location in which you want to save the file, then click Save. Click OK in the Export Batch dialog box.NOTE:

Luminex xPONENT 3.1 Software Manual104Qualitative Analysis. Determines results as either positive or negative, reactive or non-reactive, and so on. Th

105Using the Softwarefrom the Show list, and enter the low value for each analyte. Click High Value from the Show list, and enter the high value for e

Luminex xPONENT 3.1 Software Manual106Invalidate Standards and ControlsYour xPONENT system administrator must give you privileges to invalidate standa

107Using the SoftwareView and Print ReportsThe Luminex xPONENT software can format your batch or multi-batch results in a variety of export formats an

ivLuminex xPONENT 3.1 Software ManualProtocols...

Luminex xPONENT 3.1 Software Manual108Create Qualitative Assay ProtocolYou define each Qualitative protocol using a single kit. The kit must contain o

109Using 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 3.1 Software Manual110WeightType list. Click Apply to All Analytes to apply the selection to all analytes. To edit an analysis setting

111Using the Software3. From the Method list, click No Analysis, Cubic Spline, Linear Fit, Logistic 4P, Logistic 5P, Luminex Logistic 4P, or Luminex

Luminex xPONENT 3.1 Software Manual112• To add well commands, highlight the appropriate wells and mark them as unknown, standard, control, background,

113Using 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 3.1 Software Manual1143. If the protocol uses standards, type the appropriate information for each standard in the Assay Standard Info

115Using the SoftwareWARNING: Lack of proper maintenance can lead to inaccurate test results and failure of system components. Please follow all sched

Luminex xPONENT 3.1 Software Manual116Run Routine1. Open the Maintenance page, then open the Cmds & Routines tab.2. Select a routine to run from t

117Using the SoftwareShutting Down the Analyzer1. On the Home page, click Shutdown. The Auto Maint tab opens, with System Shutdown selected.2. Refer t

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

Luminex xPONENT 3.1 Software Manual118

119Glossary21CFRPart11 21 CFR Part 11 sets the criteria under which the Food and DrugAdministration (FDA) considers electronic records, electronicsign

Luminex xPONENT3.1 Software Manual 120two classification dyes. The unique ratio is identified by a uniquespectral address. Also sometimes called micro

121GlossaryDD temperature The current temperature of the doublet discriminator avalanche photodiode.dot plot Graphical representation of microsphere a

Luminex xPONENT3.1 Software Manual 122multi-analyte microspheres.laser Light Amplification by Stimulated Emission of Radiation. This highlypurified so

123GlossaryQual A value that determines a cutoff or threshold. This, in conjunction withranges using the Lum Qual Formula, Adv Qual Formula, or an edi

Luminex xPONENT3.1 Software Manual 124microspheres, assay. suspension Solution consisting of homogeneously dispersed microspheres in anaqueous medium.

125IndexAaccount status 93Acquisition Settings panel 24, 49AdminSystem Setup page 71adminarchive 94Archive page 84Batch Options page 79, 81, 86, 87Cre

126Luminex xPONENT 3.1 Software ManualGgate positions 5grouping 21, 56Hhelp 8, 89Histogram 36Home page 12Iinvalidate standards 106Kkitcreate 113kits 1

127Indexthird-party software 2Uuser permissions 93Vvalidate standards 105validation 77Wwarmup 97website 117

Luminex xPONENT 3.1 Software Manual2About This GuideThe conventions in this document assume a basic familiarity with computers and a knowledge of Micr

3IntroductionMultiple pipetting from the original container may affect bead concentrations. Protect the xMAP beads from light at all times. Store xMAP

Luminex xPONENT 3.1 Software Manual4each set of xMAP beads used for a particular assay will show a statistically even distribution of reporter molecul

5IntroductionSample DilutionDilute concentrated biological samples, such as plasma or serum, at least 1:5 with reagents as part of assay setup or as a

Luminex xPONENT 3.1 Software Manual6

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 3.1 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 3.1 Software Manual10• Cut - Cuts the selected data.• Copy All - Copies all data.• Copy - Copies only the selected data.• Paste - Past

11Touring the SoftwarePause. Pauses the system after the current command completes. Pause does not stop the system in the middle of running a command.

Luminex xPONENT 3.1 Software Manual12HomeThe Home page displays a welcome message, batch creation buttons, Daily Activities shortcuts, and the Install

13Touring the SoftwareView. Opens the Settings tab of the Protocols page to view the selected protocol. This tab enables viewing the settings, analyte

Luminex xPONENT 3.1 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 3.1 Software Manual16Undo. Reopens the Create Sample tab without saving any changes made using the Edit or New buttons.Save. Saves cha

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 3.1 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 9. Stds & Ctrls TabThis tab contains the followin

Luminex xPONENT 3.1 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 maintenance commands.FIGURE 10.

Luminex xPONENT 3.1 Software Manual22You can assign the following well commands. Each command is associated with a color. You can click and drag to hi

23Touring the SoftwarePlate Navigation. Displays a smaller plate image for the current batch.Single Step. Instructs the system to acquire one well and

Luminex xPONENT 3.1 Software Manual24Run Batch. Runs the batch and opens the Current Batch tab, where you can monitor the batch as it runs.Create a Ne

25Touring the Software• Timeout - Select Enabled to enable a timeout. Acquisition stops once the timeout is reached. Type a value from 1 to 250 second

Luminex xPONENT 3.1 Software Manual26^ f) and the widely used Logic 5P regression fomula is calculated as y = a + ((b-a)/(1 + ((x/c) ^ d )) ^ f).NOTE:

27Touring the SoftwareAnalytes TabUse this tab to select or edit analytes used in the batch or protocol.FIGURE 13. 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 3.1 Software Manual28FIGURE 14. Analysis Settings Dialog BoxIf you selected Quantitative on the Settings tab, the default analysis for

29Touring the Softwaresets that are not in the sample. Therefore, choose only the bead sets present in your sample.Apply All. Applies the information

Luminex xPONENT 3.1 Software Manual30• Add a range to the analysis by clicking Add Range.• Select Use Threshold Ranges to enable ranges for the analys

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 3.1 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 3.1 Software Manual34ResultsOnce data is collected in a batch, observation and analysis take place in the Results page. This page cont

35Touring the SoftwareStatistic. To view a particular statistic for analytes in a batch, select one of the following:• Median - The point in a data se

Luminex xPONENT 3.1 Software Manual36Plate. A list of the available plates (if more than one).WARNING: If using multiple plates, be careful to ensure

37Touring the SoftwareNOTE: Gate positions are dependent upon buffer composition. Any changes made to your assay buffer composition may result in a

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 3.1 Software Manual38• Yellow - Well acquired, but the system detects a possible problem (select the Log tab for more information).• G

39Touring the SoftwareFIGURE 21. Filter Setup Dialog BoxThis dialog box lets you choose the saved batches you want to display in the Completed Batches

Luminex xPONENT 3.1 Software Manual40Exp Results. Opens the Save As dialog box to choose an export destination for the .CSV file containing your resul

41Touring the Softwareprotocol. The functionality of the tabs you see while configuring the replay batch is the same as described in “Batches Tab” on

Luminex xPONENT 3.1 Software Manual42• Analyze - Analyzes data that has been invalidated. This button only appears if you have clicked Invalidate on a

43Touring the SoftwareLog TabThis tab displays a log of the activity which occurred during the acquisition of the selected batch. FIGURE 25. Log TabTh

Luminex xPONENT 3.1 Software Manual44Sample Details TabUse this tab to view sample results.FIGURE 26. Sample Details TabArrows. Scrolls through the sa

45Touring the SoftwareReports TabUse this tab to view, generate, and print reports.FIGURE 27. Reports TabReport and Type lists. Choose a report from o

Luminex xPONENT 3.1 Software Manual46• New Report - Click to return to the main Reports window.NOTE: If running a data interpretation of an allele c

47Touring the SoftwareLIS Results TabThis tab displays saved batches containing LIS samples.FIGURE 28. LIS Results TabFilter. Opens the Filter Setup d

purchaser, you may obtain a license under Luminex’s patents, if any, to use this unit of Luminex instrumentation with fluorescently labeled microspher

Luminex xPONENT 3.1 Software Manual48Protocols TabUse this tab to create, import, export, edit, or delete a protocol. You can also add new assay stand

49Touring the Softwaretabs to return to the main Protocols tab, or Back to return to a preceding tab. The View option does not allow any changing of t

Luminex xPONENT 3.1 Software Manual50box, type the maximum value. The default minimum and maximum values are 7500 and 13500 respectively.• Reporter Ga

51Touring the Software• Number of Standards - Click to type the number of standards for the protocol.• Number of Controls - Click to type the number o

Luminex xPONENT 3.1 Software Manual52click the analyte again to deselect it. You can also click and drag to select groups of analytes. Selected analyt

53Touring the SoftwareClick Apply to All Analytes to apply your selection to all selected analytes. Click OK to change the default analysis to the ana

Luminex xPONENT 3.1 Software Manual54FIGURE 33. Analysis Settings Dialog Box• Select a method from the Method list.• If necessary, select a weight typ

55Touring the SoftwareCancel. Click to return to the Protocols tab.Back. Click to return to the Settings tab.Next. Click to go to the next tab. Plate

Luminex xPONENT 3.1 Software Manual56Grouping. Selects the sequence in which the replicates are laid out in plate wells. The options are:• 123123123.

57Touring the Software• Clear Command - Select a well and click Clear Commands to remove all maintenance commands from the well.Plate. Specifies the p

8. NO WARRANTY. THE SOFTWARE IS LICENSED “AS IS.” ANY USE OF THE SOFTWARE IS AT YOUR OWN RISK. THE SOFTWARE IS PROVIDED FOR USE ONLY WITH LUMINEX PROD

Luminex xPONENT 3.1 Software Manual58This tab contains the following:Create New Std/Ctrl Lots. Opens the Std/Ctrl Details tab to create a new lot or k

59Touring 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 3.1 Software Manual60• 1:10 (Log) - Computes a value of one-tenth of the standard from each previous iteration.• 1/2 Log - Creates a 1

61Touring the SoftwareAuto Maint TabThis tab contains routines to initialize, verify, and maintain the analyzer.FIGURE 37. Auto Maintenance TabAutomat

Luminex xPONENT 3.1 Software Manual62Import Kit. Opens the Import Calibration or Performance Kit dialog box. Select a kit and click Open to import a k

63Touring the Software• Calibrator - If a calibration reagent is selected, the Lot Details table displays Channel and Target information.• Verifier -

Luminex xPONENT 3.1 Software Manual64• Daily Instrument Shutdown (Luminex)• Daily Instrument Startup (Luminex)• Fluidics Maintenance (Luminex)• None•

65Touring the Software• Flash memory• Microcontroller RAM• Nonvolatile memory• DSP CRC• DSP run• High voltage• Background• Pressurization• Actuator• S

Luminex xPONENT 3.1 Software Manual66Probe and Heater TabUse this tab to adjust the probe height and plate heater settings.FIGURE 40. Probe and Heater

67Touring the SoftwareSystem Info TabUse this tab to view information and diagnostics about the Luminex instrument.FIGURE 41. System Info TabThis tab

Luminex xPONENT 3.1 Software Manual68• Delta Calibration Temp• System Temperature• DD Temperature• CL1 Temperature• CL2 Temperature• CL1 Voltage• CL2

69Touring 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 3.1 Software Manual70Schedule TabUse this tab to view reminders for scheduled maintenance due to be performed on the analyzer.FIGURE 4

71Touring the SoftwareFIGURE 44. Support Utility TabThis tab contains the following:Name, Phone, Company, and Email. Type your information in these bo

Luminex xPONENT 3.1 Software Manual72• Batch Options• Alert Options• CSV Options• Archive• Licensing• Schedule• Report OptionsSystem Setup TabUse this

73Touring the SoftwareAdd header when exporting data from grids. Adds a header row when exporting the data. LIS SettingsThis setting is only for those

Luminex xPONENT 3.1 Software Manual74Set Default. Sets the chosen analysis program as the default analysis program for xPONENT.OK. Saves the chosen se

75Touring the SoftwareGroup Setup TabThis tab is accessible only in the Security or 21 CFR Part 11 packages. Use this tab to assign permissions to dif

Luminex xPONENT 3.1 Software Manual76• System Administration• Batch Management• Protocol Management• Lot and Std/Ctrl Kit management• Import and expor

77Touring the SoftwareLot and Std/Ctrl Kit Management• Create Std/Ctrl Kit and Lots• Edit Std/Ctrl Kit and Lots• Delete Std/Ctrl Kit and LotsImport an

iTable of ContentsIntroduction...

Luminex xPONENT 3.1 Software Manual78This tab contains the following:Create New User. Opens the Create User Account screen.Create User Account ScreenU

79Touring the SoftwareSave. Saves and returns to User Setup.Cancel. Returns to User Setup without saving.Global User Settings. This section contains t

Luminex xPONENT 3.1 Software Manual80This tab contains the following:Batch Options. This section displays the following options:• Allow canceling the

81Touring the SoftwareAlert Options TabUse this tab to set options for alerts about various system events. FIGURE 51. Alert Options TabAlert Options.

Luminex xPONENT 3.1 Software Manual82FIGURE 52. Setup Email Dialog BoxEnable or disable email notification by selecting or clearing the Email Active c

83Touring the SoftwareCSV Options TabUse this tab to set options for exporting batches to .CSV (comma separated values) files.FIGURE 53. CSV Options T

Luminex xPONENT 3.1 Software Manual84Archive TabUse this tab to set options for backing up and restoring files. FIGURE 54. Archive TabThis tab contain

85Touring the SoftwareImport. Select a file type to import in the File Type list and click Import to import all files of that type from the archive. T

Luminex xPONENT 3.1 Software Manual86Export. Opens the Save As dialog box to select an export name and location.License. Opens the Change License dial

87Touring the SoftwareReport Options TabUse this tab to change the look of reports generated by the system.FIGURE 57. Report Options Tab• Company - Ty