Luminex xPONENT 3.1 Rev 2 Instrukcja Użytkownika Strona 1

xPONENT® 3.1 Rev. 2Software Manual

Table of ContentsChapter 1 Introduction ...1Softw

Report Options TabUse this tab to change the look of reports generated by the system.FIGURE 52.Report Options Tab• Company - Type the company name you

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

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

5. Type the command line parameter for what parameters you want xPONENT to use withthe external analysis program. If the information is supplied with

Group SetupYou must have xPONENT administrative privileges and be using the Secure package of thesoftware to perform group setup tasks. Additionally,

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

3. In the Test Sort Order box, select the method that you want to use to sort the tests in theprotocols.4. Click Save.ArchiveUse the settings on the A

1. Click Restore. A Warning dialog box displays.CAUTION: All data and settings will be overwritten, and xPONENT willrestart once the restore task comp

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 d

Auto Maint Tab ...60L

11. Tighten the probe adjustment screw.NOTE: Use caution not to move the probe up accidently when tightening theprobe adjustment screw.12. Click Move

Run System Initialization1. On the Home page, click System Initialization. The Auto Maint page opens.2. Select the performance verification kit from t

5. Type the kit name for the exported kit into the File Name box.6. Click Save. The dialog box closes.Delete CAL and VER Kit Information1. Open the Ma

NOTE: Samples can also be added via a LIS if your software is licensed forLIS.Edit Sample Lists1. Open the Samples page.2. In the Samples Lists sectio

Create a New Batch from an existing ProtocolRead the instructions provided with the assay kit you are using.1. Open the Batches page.2. Click Create a

9. To change the Default analysis, click Change. The Analysis Settings dialog boxopens.10. Select the analysis method from the Method list. Click OK t

plate direction) as long as space remains on the plate. You can also select a well first, whichplaces the next batch in your chosen location. If space

3. Click Browse. The Select File dialog box opens.4. Navigate to the location in which you want to save the file, then click Save. Click OK inthe Expo

You can analyze an acquired batch using the analysis features of Qualitative, Quantitative,and Allele Call algorithms.Qualitative Analysis - Determine

9. On the Stds & Ctrls tab, type the appropriate information in the Standard Informationand Control Information sections. The number of Standards

Delete Batch ...104

Invalidate Standards and ControlsYour xPONENT system administrator must give you privileges to invalidate standards if youare using the Secure xPONENT

View and Print ReportsThe Luminex xPONENT software can format your batch or multi-batch results in a variety ofexport formats and provide different ty

Creating a Qualitative Assay ProtocolYou define each Qualitative assay protocol using a single kit. The kit must contain onestandard. The standard is

13. Click Next. The Plate Layout tab opens. • To add well commands, highlight the appropriate wells and mark them as unknown,standard, control, backgr

9. Check Mark as Intra-Well Normalization Bead if you want to use a normalization bead.The normalization bead is a microsphere set that is included in

18. Select a weight type in the Weight Type list (Weight Type may not display, dependingon the analysis method selected in the Method list).19. Check

27. Click Next. The Plate Layout tab opens. • To add well commands, highlight the appropriate wells and mark them as unknown,standard, control, backgr

NOTE: For more information about the commands and settings on the PlateLayout tab, see the Plate Layout Tab.Editing Quantitative Analysis SettingsTo e

9. Click the desired analyte (bead ID) in the numbered grid. Information about the analyteappears in a list on the right side of the grid. For an alle

4. Click Apply Std/Ctrl Kit to associate a kit with the protocol. If you are not using a kit,type the appropriate Standard and Controls information in

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4. Click Apply Std Lot if you wish to apply a standard lot. The Select Lot dialog box opens.Click a lot and select OK.5. Click Apply Ctrl Lot to apply

Edit Lot1. Open the Protocols page, then open the Protocols tab. Click the Stds & Ctrls tab.2. In the Installed Kits And Lots section, select a lo

5. Click Save As to save the new routine. The Save Routine dialog box opens.6. Type the routine name in the Routine Name box, then click OK.Edit Routi

NOTE: If you haven’t previously saved a routine, the Export button will notdisplay.Support UtilityUse the options on the Support Utility tab to create

Technical SupportLuminex Technical Support representatives are ready to help you, particularly when thesystem or software cause any questions or probl

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Overview: Converting IS 2.3 .idt Files to xPONENT3.1 .lxt FilesWhen upgrading from the IS 2.3 system to the xPONENT® 3.1 system, the IS 2.3 (template)

Edit the IS 2.3 as .idt Files (Template)NOTE: For additional information about .idt file editing, see the Overview:Converting IS 2.3 .idt Files to xPO

Exporting Templates from IS 2.3 as .idt FilesNOTE: Before starting the export process, make note of the files that are tobe exported to the xPONENT 3.

4. Once the template has been successfully exported, make a note of the directory wherethe exported file was saved to and then click the OK button. FI

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

1. From the system taskbar, click Start, All Programs, Luminex, xCONVERT, thenLuminex xCONVERT. FIGURE 60.Launch the xCONVERT UtilityThe xCONVERT Util

3. Browse to the directory containing the exported IS 2.3 template (.idt) file and click toselect the template file to be converted. Click the Open bu

4. Click the … button to the right of the Destination Folder: field to change the directorywhere the converted file will be saved to. FIGURE 64.Change

6. Click the Convert button to begin the file conversion. FIGURE 66.Begin the Conversion Process7. Once complete, the status window confirms the file

1. From within the xPONENT 3.1 program, click the Protocols tab from the tab bar at thetop of the window, click the Protocols tab on the left side of

FIGURE 70.Import Protocol File ConfirmationOnce the import is complete, the newly converted protocol is ready to be used for batchacquisition in the x

The conventions in this document assume a basic familiarity with computers and aknowledge of Microsoft® Windows® software. Commands are often availabl

Use of unauthorized third-party software with xPONENT software may result in corruption orfailure of the xPONENT software. Use third-party software at

medical advice immediately and show the product label or container to your medical provider.A Material Safety Data Sheet is available upon request.WAR

TABLE 2.Reporter Fluorchromes WavelengthsR-Phycoerythrin Alexa 532Formula weight (Daltons) 240,000 470Absorbance max (nm) 480, 546, 565 531Extinction

Gating information may change with a new lot of xMAP beads. Each time you receive a newlot of xMAP beads, evaluate them with the current protocols. If

© Luminex Corporation, 2011. All rights reserved. No part of this publication may bereproduced, transmitted, transcribed, or translated into any langu

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

FIGURE 1.Help Icons1 System-wide Help 2 Help for Current WindowLog OffClick Log Off to log out of the software, then click OK in the Confirm Logout di

FIGURE 2.Screen Elements1 Page 3 Right-click Menu2 TabPageThe main elements at the top of the window are Pages. Click a page to go to that page in the

• Export - Opens a File Dialog dialog box. Click Browse to select a location, file name, andfile type (.txt or .csv) for the export. This exports all

• Pause - Pauses the system after the current command completes. Pause does not stopthe system in the middle of running a command. You cannot run anot

FIGURE 4.Home PageReturn to the Home page at any time by clicking Home in the Navigation toolbar. This pagecontains the following:• Click to Create a

• View - Opens the Settings tab of the Protocols page to view the selected protocol. Thistab enables viewing the settings, analytes, and plate layout

Sample Lists - Contains a list of protocols, including the version number and the number ofsamples associated with each protocol.Details - Opens the E

The following Delete, New, Edit, and Undo buttons only display depending on actions takenin the Create Sample tab.• Delete - Deletes a highlighted sam

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

Standard Terms and Conditions for Use of ProductBy opening the packaging containing this product (“Product”) or by using such Product in anymanner, yo

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

• Dilution - Contains the following dilution options:• 1:2 - Halves the standard from each previous iteration.• 1:10 (Log) - Computes a value of one-t

FIGURE 9.Plate Layout TabCreate a New Batch From a New ProtocolClick Create a New Batch from a new Protocol to create a new batch without using aproto

FIGURE 10.Settings TabThis tab contains the following:Touring the Software21

• Name and Description boxes - Type a name and a description in the appropriate boxes.• Acquisition Settings - Use this section to set the following:•

• Analysis Settings - Use this section to set the analysis type, set the number of standardsand controls, select an external analysis program, and cho

• Min MFI Enabled - Select this box to enable a minimum MFI for the Allele Callanalysis. Type a value in this box to set the minimum MFI for analysis.

FIGURE 11.Analysis Settings Dialog BoxIf you selected Quantitative on the Settings tab, the default analysis formula is 5PWeighted. To change the defa

not enough bead events were acquired. If you select bead sets that are not present, theanalyzer continues to acquire, trying to reach the number of ev

PROFITS, FAILURE TO REALIZE SAVINGS, LOSS OF PRODUCTS OF BUYER OROTHER USE OR ANY LIABILITY OF BUYER TO A THIRD PARTY ON ACCOUNT OFSUCH LOSS, OR FOR A

• Select a method from the Method list.• If necessary, select a weight type from the Weight Type list.• Apply the analysis to all analytes in the list

Plate Layout TabUse this tab to select wells to add samples and maintenance commands to the plate. Formore information about the functionality of this

This page contains the following:Multi-Batch Name - Use this field to create a name for new multi-batches.Select Pending Batch - Contains a list of al

Plate Layout - Depicts where batches are located on the plate.Multi-Batch - Lists pending batches selected for the multi-batch. The list includes name

• LIS Results• ReportsCurrent Batch TabUse this tab to view results, statistics, and log information related to the current batch, and toperform stati

• % CV of microspheres - The measure of relative dispersion within the distribution.%CV = 100 x Std Dev / Mean• Standard Deviation - For calculating s

Both the histogram and the dot plot have buttons that enable you to change the default view:Click the maximize button to maximize the graph to fill th

Right-click inside the dot plot area to access the following options:X Axis - Changes the X axis to the following: Doublet Discriminator, Reporter 1,C

Default - Returns to the histogram and dot plot display.Saved Batches TabUse this tab to open a batch that has been run and view its details, and expo

FIGURE 18.Filter Setup Dialog BoxThis dialog box lets you choose the saved batch that you want to display in the CompletedBatches list, based on the o

and Buyer receives no rights to such intellectual property rights by virtue of its purchase ofProduct other than as expressly set forth herein. Buyer

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

Replay Batch - Uses the data stored in the run files from the initial acquisition to reprocess abatch, creating a new batch output file. A batch can b

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

• Analyze - Analyzes data that has been invalidated. This button only appears if you haveclicked Invalidate on a portion of the data, or if you have c

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 T

Print All - Click to print the information for all the analytes in the report.Save - Click to open the Save As dialog box. Select a location and click

ProtocolsThe Protocols page enables you to add standards and controls. This page contains thefollowing tabs:• Protocols• Settings• Analytes• Plate Lay

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

New Std/Ctrl - Opens the Std/Ctrl Details tab. For more information, see the “Std/CtrlDetails Tab” section.Plate Layout - Opens the Report dialog box,

FIGURE 28.Settings TabThis tab contains the following:xPONENT® 3.1 Rev. 248

• Name and Description boxes - Type a name and a description in the appropriate boxes.• Acquisition Settings - Use this section to set the following:•

• Analysis Settings - Use this section to set the analysis type, set the number of standardsand controls, select an external analysis program, and cho

• Min MFI Enabled - Select this box to enable a minimum MFI for the Allele Callanalysis. Type a value in this box to set the minimum MFI for analysis.

FIGURE 29.Analysis Settings Dialog BoxIf you selected Quantitative on the Settings tab, the default analysis formula is 5PWeighted. To change the defa

not enough bead events were acquired. If you select bead sets that are not present, theanalyzer continues to acquire, trying to reach the number of ev

• Select a method from the Method list.• If necessary, select a weight type from the Weight Type list.• Apply the analysis to all analytes in the list

Grouping - Selects the sequence in which the replicates are laid out in plate wells. Theoptions are:• 123123123. . . Lays out one of each replicate se

Off Plate Area - Designates an alternate location for maintenance commands in theCommands: list. Highlight a command, and then click the reservoir in

3. GRANT OF LICENSE. Subject to the terms and conditions of this EULA, Luminex herebygrants to you a nonexclusive, nontransferable, nonassignable lice

• Reagent• Lot #• Expiration• Name• Manufacturer• Protocol• Version• Std/Ctrl Kit#• Std/Ctrl Kit NameSelect Std/Ctrl Kits Only in the Show selections

FIGURE 32.Std/Ctrl Details TabThis tab contains the following:Apply Std/Ctrl Kit - Opens the Select Std/Ctrl Kit dialog box. The dialog box displays t

Assay Standard Information - Displays the selected standard reagents in a list. The listdisplays the Reagent, Name, Lot #, Expiration, Manufacturer, a

• System Status• Schedule• Support UtilityAuto Maint TabThis tab contains routines to initialize, verify, and maintain the analyzer.FIGURE 33.Auto Mai

Reagents - Displays the reagents and well locations necessary for the selected routine. Youcan select kits for the routines from the Calibration Kit a

Active Reagents - Use this section to change calibration or performance verification kits, lotnumbers, and expiration dates, or to delete a kit.• Cali

FIGURE 35.Maintenance Commands and Routines TabThis tab contains the following:Routine Name - This list of pre-set routines and commands can be used f

Commands - This section contains the following commands:• Wash - Sends distilled water through the fluidics lines in the system. It pulls the fluid fr

NOTE: When you modify an existing routine, by adding or clearing acommand, the routine name defaults to None in the Routine Namedropdown menu and the

FIGURE 36.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

5. TERM AND TERMINATION. Your rights under this EULA are effective until termination.You may terminate this EULA at any time by destroying the SOFTWAR

FIGURE 37.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 38.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 39.The Schedule TabThe Reminders sectio

FIGURE 40.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 - Ope

Disable Automatic launching of External Third Party Analysis when batches completefor all protocols - Disables the automatic launch of the third-party

FIGURE 43.Group Setup TabUsers are assigned to groups. These users then have permissions granted to their group. Donot assign permissions directly to

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

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Lot and Std/Ctrl Kit Management - • Create Std/Ctrl Kit and Lots• Edit Std/Ctrl Kit and Lots• Delete Std/Ctrl Kit and LotsImport and Export Data - • E

Create User Account ScreenUse this tab to set the options for a new user. Any user with access to this tab can assignrights to any and all groups.FIGU

Global User Settings - This section contains the following:• Password Expiration - Type a length of time in days. The default is 180 days.• Unsuccessf

• Allow running a batch with expired reagents - Allows batches to run with expiredreagents.• Allow running a batch if XY temperature is not in range -

FIGURE 47.Alert Options TabAlert Options - Offers three check boxes for each alert - Dialog, Email, and Sound. Thissection displays the following even

Enable or disable email notification by selecting or clearing the Email Active check box.Contact your network administrator to determine the informati

CSV and Batch Export OptionsAutomatically export results CSV file when batch is complete - Automatically exportsthe .CSV file when the system finishes

FIGURE 49.Archive TabThis tab contains the following:Archive - Use this section to define archive locations for specific file types.• File Type - Choo

Import - Select a file type to import in the File Type list and click Import to import all files ofthat type from the archive. The imported files will

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 todisplay th