Luminex xPONENT 3.1 Rev 2 (IVD) Instrukcja Użytkownika

xPONENT® 3.1 Rev. 2Software User ManualFor In Vitro Diagnostic Use

xPONENT® 3.1 Rev. 2 Software User ManualxFor In Vitro Diagnostic Use

with the Luminex analyzer operations and maintenance requirements. See the LuminexSystem Manual for more information.1. Open the Maintenance page, the

Delete RoutineYou can delete a routine that you created, but you cannot delete predefined routines.Predefined routines have (Luminex) after the routin

4. Click Run.Logging Out of the SoftwareTo log out of xPONENT, click the Log Off icon in the upper right corner of the softwarewindow. The Confirm Log

Term Definition21 CFR Part 11 21 CFR Part 11 sets the criteria under which theFood and Drug Administration (FDA) considerselectronic records, electron

Term Definitionbead map A collection of bead sets with definedclassification coordinates.bead set A set of xMAP microspheres that have a uniquelyident

Term Definitiondot plot Graphical representation of microsphere analysisclassification data displayed by frequency andintensity.doublet discriminator

Term Definitionmicroparticle A solid substance with a diameter in themicrometer range. Often used as a synonym for amicrosphere.microspheres Polystyre

Term Definitionreporter A molecule (or combination of molecules) with aspecific range of excitation and emissionwavelengths that is used to identify o

Term DefinitionVerifier microspheres, assay Used to verify standards within the kit. Tells youthat the curve or thresholds are correct.Verifier micros

The Luminex system was developed to improve workflow and efficiency in the clinicallaboratory and in research and development. End users in the labora

This guide is formatted as a PDF, and can be printed. However, the guide is best viewedonline due to the bookmarks and hypertext included in the text.

Manufacturer In-vitro Diagnostic DeviceConformitéEuropeénne(European UnionConformity)General GuidelinesModifying or deleting Luminex®xPONENT® system f

xMAP beads are hydrophobic in the aqueous medium provided and will settle if leftundisturbed. Resuspend prior to dispensing.Do not use this product wi

set. Since each bead is analyzed individually, even when the sets are mixed in a multiplexassay they can still be distinguished by their emission sign

ReagentsFormulated reagents must be free of particulates other than xMAP beads. Do not dilutexMAP calibrators or verifiers.PlatesWhen using uncovered

This chapter explores each section of the software and its functionality. For information aboutusing the software, see Using the Software.This chapter

ExitAfter you log out, click Exit, then Yes to exit the software completely.Screen ElementsThe following section details the screen elements and the c

• Tab - The elements on the left side of the window are “Tabs”. Click a tab to go to thatsection. Some tabs require you to go in order, and will not l

© Luminex Corporation, 2012. All rights reserved. No part of this publication may bereproduced, transmitted, transcribed, or translated into any langu

NOTE: A yellow Check Calibration button is visible in the command displayif the calibration or verification command has failed, when anyverification i

FIGURE 3.Home PageReturn to the Home page at any time by clicking Home in the Navigation toolbar. This pagecontains the following:• Click to Create a

• Probe and Heater - Opens the Probe and Heater tab on the Maintenance page. Formore information about this tab, see Probe and Heater Tab .• Sys Info

• Sample Lists - Contains a list of protocols, including the version number and the numberof samples associated with each protocol.• Details - Opens t

• New - Creates a new sample.• Edit - Edits a highlighted sample.• Undo - Reopens the Create Sample tab without saving any changes made using the Edit

FIGURE 6.Batch Plate Layout Report• Import - Imports a batch.• Export - Exports a batch.• Delete - Deletes a batch.• Edit - Edits a batch.• Run - Runs

FIGURE 7.Protocol TabThis tab contains the following:Batch Name/Description - Contains the protocol name, version, manufacturer, and creationdate for

FIGURE 8.Stds & Ctrls TabThis tab contains the following:Apply Std/Ctrl Kit - Opens the Select Std/Ctrl Kit dialog box. The dialog box displays th

• 1/2 Log - Creates a 1:3.16 dilution, or half of each 1:10 (Log) from each previousiteration.• Alternatively, type a number for your own dilution fac

FIGURE 9.Plate Layout TabThis tab contains the following:• Plate Image - This is a representation of the plate. Each well appears as a circle on thegr

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

entire column or row, or simply click and highlight different wells and then click a commandbelow to assign that command to all the highlighted wells.

Off Plate Area - Highlight a command and click a either a Reservoir in the Off Plate Area toselect a location for the command.Save Prtcl - Opens the S

Run Batch - Runs the batch and opens the Current Batch tab, where you can monitor thebatch as it runs.FIGURE 11.Create a New MultibatchUse this button

FIGURE 12.New Multibatch TabThis tab contains the following:Multi-Batch name - Use this field to create a name for new multi-batches you want to save.

FIGURE 13.Select Pending Batch dialog boxPlate layout - Depicts where batches are located on the plate.FIGURE 14.New Multibatch tab with plate layout

Plate Layout - Opens the Multibatch Report dialog box that contains:• Page - Use these arrows to scroll through the report pages.• Zoom - Select from

NOTE: When a batch is saved to a multibatch, you cannot edit or delete itunless it is removed from the multibatch.Run - Runs the batch.ResultsOnce dat

FIGURE 16.Current Batch TabStatistic - To view a particular statistic for analytes in a batch, select one of the following:• Median - The point in a d

Trimmed%CV of microspheres - The measure of relative dispersion within the trimmeddistribution.• Trimmed %CV = 100 x Trimmed Std Dev / Trimmed Mean• T

Click the maximize button to maximize the graph to fill the whole window. In themaximized view, use the sliders to zoom in or zoom out. To return to t

SOFTWARE on additional computers, as agreed to in writing with Luminex or itsauthorized reseller, for purposes of performing ancillary tasks (i.e. pre

Progress - Click to display real-time progress of the well acquisition. Analyte counts aredisplayed in a dynamic bar graph as they are acquired. The s

Filter - Opens the Filter Setup dialog box.FIGURE 18.Filter Setup Dialog BoxThis dialog box lets you choose the saved batches you want to display in t

FIGURE 19.Batch Plate Layout ReportApprove - Opens the Batch Approval Confirmation dialog box to approve the selectedbatch. Only approved batches can

Results TabFIGURE 20.Results TabThe Results tab has the same Save Image, Progress, and Well Report buttons as theCurrent Batch tab. For more informati

Settings TabUse this tab to view the acquisition parameters of the selected saved batch and print thebatch settings report.FIGURE 21.Settings TabPage

FIGURE 22.Log TabThis tab displays the following information about each activity:• Date• Message• CodeLog entries display yellow if a well was acquire

FIGURE 23.Sample Details TabArrows - Scrolls through the sample details.Transmit - For systems configured for LIS transmission, select a single analyt

FIGURE 24.LIS Results TabFilter - Opens the Filter Setup dialog box.Clear - Click to turn off the filter.Completed Samples - Displays Name, Protocol,

FIGURE 25.Reports TabReport and Type lists. Choose a report from one of the following categories:• Batch Reports - A list of batches appears below the

System Log Reports - Displays a list of system log reports. Choose from the followingselections:• All• Maintenance• Security• Warning and ErrorsSelect

be protected by applicable copyright or other intellectual property laws and treaties. ThisEULA grants you no rights to use such content.7. EXPORT RES

FIGURE 26.Protocols TabThis tab contains the following:• Installed Protocols - Displays installed protocols. The list includes Name, Version,Manufactu

FIGURE 27.Protocols Plate Layout ReportDelete - Opens the Delete Protocol dialog box to delete a protocol selected in the InstalledProtocol list. Clic

FIGURE 28.Stds & Ctrls TabThis tab contains the following:Create New Std/Ctrl Lots - Opens the Std/Ctrl Details tab to create a new lot or kit. Fo

Select Std/Ctrl Kits Only in the Show selections to display the following information aboutthe installed Std/Ctrl Kits:• Std/Ctrl Kit #• Std/Ctrl Kit

Apply Std/Ctrl Kit - Opens the Select Std/Ctrl Kit dialog box. The dialog box displays theStd/Ctrl Kit Lot #, Std/Ctrl Kit Name, Expiration, and Manuf

• Auto Maint• Lot Management• Cmds & Routines• Probe & Heater• System Info• System Status• Schedule• Support UtilityAuto Maint TabThis tab con

The commands for these routines display in the command list below the buttons.Command - This list is used to view the name of the current command, its

• Performance Verification Kit - Select a performance verification kit from this list. Detailsof the selected kit display in the Lot Type, Active Lot

FIGURE 32.Maintenance Commands and Routines TabRoutine Name - This list of pre-set routines and commands can be used for systemmaintenance. Some of th

• Soak - Prevents salt crystals from forming in the probe due to air exposure. Soaking theprobe replaces sheath fluid in the probe with water. You sho

xPONENT® 3.1 Rev. 2 Software User ManualviFor In Vitro Diagnostic Use

Command Sequence - When you select a routine, the individual commands in the routineappear in order in the Command Sequence list. The list includes th

FIGURE 33.Probe and Heater TabMove Probe Down - Moves the probe down in the specified well(s).Plate Type - Defines the selection of either a 96-well p

FIGURE 34.System Info TabThis tab contains the following information:• Software• Version• Operating System• Licensing• Instrument Type• Serial Number•

• Last CON2 Verification• Delta Calibration Temp• System Temperature• DD Temperature• CL1 Temperature• CL2 Temperature• CL1 Voltage• CL2 Voltage• DD V

FIGURE 35.System Status TabThis tab contains the following:Search By Log Type - Filters the type of log information. Select All, Maintenance,Security,

Schedule TabUse this tab to view reminders for scheduled maintenance due to be performed on theanalyzer.FIGURE 36.The Schedule TabThe Reminders sectio

FIGURE 37.Support Utility TabThis tab contains the following:Name, Phone, Company, and Email - Type your information in these boxes so that LuminexTec

• User Setup• Batch Options• Alert Options• CSV Options• Archive• Licensing• Schedule• Report OptionsSystem Setup TabUse this tab to configure system

LIS SettingsThis setting is only for those using xPONENT with a Lab Information System (LIS).Connect to LIS - Enables connection the LIS.Browse - Open

FIGURE 39.Group Setup TabUsers are assigned to groups. These users then have permissions granted to their group. Donot assign permissions directly to

Table of ContentsChapter 1 Introduction ...1Softw

The Allowed check box next to the desired permission in the Features section enables theselected group to perform that task. The Signature Required ch

Archiving• Backup/Restore• Import/ArchiveWhen you perform an action that requires an electronic signature, the Electronic Signaturedialog box opens. T

FIGURE 41.Create User Account ScreenThis tab contains the following:User ID - Type a user ID in this box. The user ID is not case-sensitive. You can c

• Minimum User ID Length - The default minimum User ID length is six characters.• Minimum Password Length - The default minimum password length is six

• Delta Cal Temp Exceeded Tolerance During Batch - The delta cal temperature felloutside the designated range during the running of the batch.Select t

Use US regionalization format only - Exports data only in US regionalization format.Include Advanced Statistics - Exports advanced statistics in the C

• Exclude Raw Data Files - Select this option if you have selected Batches in the File Typelist to exclude files that contain only raw data.• Browse -

FIGURE 45.Licensing TabThis tab contains the following:License Code - The current license code being used on the system.Current License Agreements - Y

FIGURE 46.Schedule TabReminders - This section displays reminders for scheduled maintenance.• Alert Time - Select a time from this list to display mai

This chapter describes the steps needed to successfully use the xPONENT software.Starting the SoftwareWhen you turn on the computer for your Luminex s

Admin ...

Setting Administrative OptionsClick Admin on the toolbar to display the tabs used to set administrative options.System SetupYou must have xPONENT admi

The data conversion utility is xCONVERT. For additional information about using thexCONVERT utility, see the Appendix A: Converting IS 2.3 .idt Files

Editing User PermissionsIn the Users list, click the user ID, then click Edit User. In the Edit User Account screen,edit the desired information, then

ArchiveUse the settings on the Archive tab to set options for backing up, exporting and restoringfiles.To archive a file:1. In the File Type list, cli

3. Click OK to start the restore. A progress bar displays, followed by a Warning dialog boxstating that xPONENT needs to be restarted.4. Click OK to r

2. Review the adjustment location for the well that you will use for alignment. Click a well onthe plate image if you want to use a different well. A

• Open the Maintenance page, and then the Cmds & Routines tab. Click Warmup in theCommands section at the left of the screen, and then click the R

WARNING: Inaccurate data entry can invalidate the results of theseprocedures. Careful entry of data in each field is necessary toensure accurate resul

8. Click Print to print the report, or Save to save the report.9. Click New Report to generate another report.Managing Sample ListsUse the Samples pag

You can group batches together as a multi-batch. Multi-batches can consist of any number ofbatches that have been set up from different protocols and

Performing System Maintenance ...89Perform

1. Open the Batches page.2. Click Create a New Batch from a new Protocol to open the Settings tab.3. Type a name in the Name box.4. Type a description

well command. If you are working with more than one plate, choose the Plate list.Here, you can add a plate, change the order of the plates, and scroll

Import BatchYou need to import batches to the system only once. You must type lot information for thestandard and control reagents as specified in the

NOTE: You cannot delete or edit a batch included in a saved multi-batch.Remove the batch from the multibatch to make changes.Run BatchOpen the Batches

Performing AnalysisYou may direct the system to acquire samples in replicate regardless of batch type. Forqualitative batches, qualitative results for

are working with more than one plate, choose the Add & Change Plate drop down list.Here, you can add a plate, change the order of the plates, and

View Sample Details1. Open the Results page and then open the Saved Batches tab.2. Click Saved Batches, then click the batch for which you want to vie

Import Protocol1. Open the Protocols page, then open the Protocols tab. Click Import.2. In the Open dialog box, navigate to the protocol file you want

For assay reagents specified in protocols, you can create new lots, edit lot information, selectpre-existing lots for reuse, import lots, and export l

Delete Lot1. Open the Protocols page, then open the Protocols tab. Click the Stds & Ctrls tab.2. In the Installed Kits And Lots section, click the