Luminex xPONENT for MAGPIX 4.2 Manuel d'utilisateur

xPONENT for MAGPIX 4.2Software User Manual

Table of ContentsChapter 1 Introduction ...1Safet

• Import• Export• Exit• ViewSettings SubtabProtocols > Protocols > SettingsClick Create a New Protocol on the Protocols tab to open the Settings

• Analysis Type - Use this list to choose from the following analysis types:• None - No analysis. Select if you have your own data post-processing pro

• Fit of all Standards - The standard curve will be determined by using each individualstandard replicate when calculating the standard curve. For exa

6. If you selected Lum Qual in the Formulas list, edit the values for each range underNegative, Low Positive, or High Positive. If you selected Adv Qu

• Plate Image - This is a representation of the plate. Each well appears as a circle on thegrid. Well commands appear in the appropriate circles as yo

• Add - Opens the Commands and Routines dialog box so you can select a command orroutine.• Delete - Deletes the selected command or routine.• Post Bat

• Plate Navigation - Displays a smaller plate image for the current batch. Click and drag inthe box to select wells to display.• Off Plate Area - Desi

• 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 Man

Use this tab to select or edit analytes used in the batch or protocol.This tab contains thefollowing:This tab contains the following:Protocols Page95

• Analytes grid - A grid representing each analyte from 12 to 78. Select All selects allanalytes, and Deselect All deselects all analytes. Click a num

Create a New Batch from a New Protocol ...37Create a New Multi

• Count - Type the desired bead count for the analytes by clicking in the Count box. If eachselected bead set does not acquire this number of events,

• Selected Analytes list - Selected analytes are displayed in a list on the right side of theanalyte grid. This list includes the following informatio

• Cancel - Click Cancel to return to the Batches tab.• Back - Click Back to return to the Settings tab.• Next - Click to go to the next tab. If the An

Select All Lots in the Show selections to display the following information about eachinstalled lot:• Reagent• Lot #• Expiration• Name• Manufacturer•

Click Create New Std/Ctrl Lots on the Standards and Controls (Stds & Ctrls) tab of theProtocols page to open the Standards and Controls Details ta

• 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 Man

Use the Maintenance page to maintain and calibrate your system. This page contains thefollowing tabs:• Auto Maint• Lot Management• Cmds & Routines

This tab contains routines to initialize, verify, and maintain the analyzer.Automated Maintenance Options - Provides buttons for commonly used mainten

System InitializationxPONENT for MAGPIX contains a pre-defined routine to prepare the analyzer for dataacquisition. This section describes calibration

Running Calibration and VerificationBefore running Calibration/Verification from the Auto Maint tab, you need to import Cal andVer kit information. Pe

Auto Maintenance (Auto Maint) Tab ...103System In

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

Deleting CAL and VER Kit Information1. Open the Maintenance page, then open the Lot Management tab.2. In the Active Reagents section, select the kit y

• Routine Name - This list of pre-set routines and commands can be used for systemmaintenance. Some of these commands are also available on the Auto M

WARNING: When using multiple plates, use them in the proper order.Failure to do so can result in inaccurate data and test results.Commands - This sect

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

6. Click Save As to save the new routine. The Save Routine dialog box opens.7. Type the routine name in the Routine Name box, then click OK.Editing a

6. Click Run. The Routine Message dialog box opens when the routine is complete.7. Click OK.Importing a Routine1. Open the Maintenance page, then open

• Auto Adjust Height - Automatically adjusts the probe height using the specified location(s)in the main plate, reservoir, and strip wells.NOTE: Lumin

• Delete - Deletes the current plate from the available plates in the Plate Name list.• Save Plate - Appears when you have typed a new plate name in t

5. Click Eject to eject the plate carrier.6. Place the off plate reagent block on the plate carrier. Make sure it is well seated so that itclips into

xPONENT for MAGPIX 4.2 Software User Manualxii

FIGURE 7.Sample Probe Height AdjustmentSystem Info TabMaintenance > System InfoUse this tab to view information and diagnostics about the Luminex i

• Operating System• Licensing• Instrument Type• Serial Number• Firmware Version• XYP Heater Temp• Calibration/Verification Status• Delta Calibration T

Use this tab to view, print, and save system status log information.This tab contains the following:• Search By Log Type - Filters the type of log inf

Use this tab to view reminders for scheduled maintenance due to be performed on theanalyzer.Reminders - This section displays reminders for scheduled

Use this tab to create a support file that you can send to Luminex Technical Support. Toinclude batch information in the support file, use the Include

3. Type your name in the Name box. 4. Type your company name in the Company box.5. Type your phone number in the Phone box.6. Type your email address

You must have the appropriate license to view some of the features of in the Admin page.This page contains the following tabs:• System Setup• Group Se

Use this tab to configure system settings such as application settings, LIS settings,maintenance page options, and external analysis program settings.

• Browse - Opens another dialog box to select the file location for the third-party analysisprogram. The selected location appears in the Path box, an

1. If the program is on an external media such as a CD or flash drive, insert the media.2. Click Add New to open the New External Analysis Program dia

Safety PrecautionsDANGER: Samples and waste fluid can contain biohazardous infectiousagents. Handle them at Biosafety level 2, as recommended forany p

NOTE: See "Daily Activities" on the Home page for daily maintenanceroutines.Luminex recommends that you verify daily and calibrate weekly. Y

3. Under Maintenance Options, select Fluidics prep, performance verification from thedrop-down list. FIGURE 8.Setting System Initialization Routine4.

Users are assigned to groups and permissions are granted to each group. Do not assignpermissions directly to individual users. Use this tab to unlock

• System Administration• Manage Users (add, edit, or delete users)• Manage System Configuration• Perform Calibration and Verification• Manage Alerts•

When you perform an action that requires an electronic signature, the Electronic Signaturedialog box opens. The user ID autopopulates. Type your passw

• Create New User - Opens the Create User Account screen.• Global User Settings - This section contains the following:• Password Expiration - Type a l

Use this tab to set the options for a new user. Admin users can assign rights to any and allgroups. Either the 21 CFR Part 11 or the Secure package is

On this page, users can modify the information of the user who was selected from the UserSetup tab.The Edit User page contains the following:• User ID

Editing User Permissions1. In the Users list, click the user ID, then click Edit User.2. In the Edit User Account window, edit the desired information

Use this tab to set options for analysis and acquisition of batches.This tab contains the following:xPONENT for MAGPIX 4.2 Software User Manual136

The Home page displays a welcome message, batch creation buttons, Daily Activitiesshortcuts, and the Installed Protocols list.Return to the Home page

• Batch Options - This section displays the following options:• Allow running or saving a batch with expired reagents and fluids - Allows batchesto ru

This cannot be deleted or modified and runs by default. However, you can turn off thisroutine or use a different routine. Luminex recommends cleaning

This tab contains the following:Alert Options - Offers three check boxes for each alert - Dialog, Email, and Sound. Thissection displays the following

The Test button tests the email settings. Select Apply to initiate the settings you’ve selected,or click OK to use the settings and exit the dialog bo

You must have administrative privileges to perform this task if you are using the 21 CFR Part11 or Secure package. Use this tab to define what the CSV

Archive Options TabAdmin > ArchiveUse this tab to archive all file types - batches, protocols, kits, lots, and LIS records. When youclick the Launc

The Archive Utility can be used within xPONENT to set up frequency and type of files toback up. Statistics about disk space and archive space used, as

• System Backup - Click this to back up your system. It requires a log in and then instructsyou to shutdown the xPONENT software and launch the Archiv

Setting Up Automatic ArchivingClick Edit in the Schedule Overview box to enable the fields to accept your edits and toenable the Browse button. The la

1. In the Archive Utility, click Manual Archive to open the Manual Archive window. 2. Using the tabs on the left side of the window, select the type o

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

Contact Luminex Technical Support to upgrade xPONENT for MAGPIX or to obtain a newlicense.NOTE: You must restart the computer for the new license to t

Use the Schedule tab to enable or change the recurrence of scheduled maintenancereminders.• Select the time of day that you want to receive alerts in

1. Access the Admin page, then the Schedule tab.2. On the Schedule tab, use the dropdown menus to edit the following items for anyscheduled activity:

1. Type a company name in the Company box, and any additional information in the Info:box. NOTE: The logo file should be 920 x 125 pixels. If you want

LUMINEX CORPORATION12212 Technology BoulevardAustin, Texas 78727-6115U.S.A.Voice: (512) 219-8020Fax: (512) 219-5195 151

Navigation Elements1. Page - Across the window, above the content pane, are pages. Click a page to go to thatpart of xPONENT.2. Tab - On the left side

9. Delta Cal Temperature 10. XY Status11. Power Off buttonSystem Status Button - This button has two functions: When clicked, it opens the systemlog.

To display quick start information, click the blue question mark at the top of the xPONENTwindow, then click Quick Start. This displays information ab

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

• Instrument Type• Serial Number• Firmware Version• XYP Heater Temp• Calibration/Verification Status• Delta Calibration Temp• System Temperature• Last

Adding a New License KeyContact Luminex Technical Support if you have any difficulty saving or adding a new licensekey.1. Access the Admin page, then

CAUTION: Use of this software by untrained personnel can result ininaccurate data and test results. Users of xPONENT must readthe documentation thorou

1. Adjusting the Sample Probe Height2. Revive After Storage (Luminex) Routine3. Calibration/VerificationAdjusting the Sample Probe HeightAdjust the sa

NOTE: When you adjust and save the probe height settings for all threeareas under a plate name, all areas retain the adjustment.WARNING: Correct sampl

3. Add 70% isopropanol or ethanol to reservoir RB1 on the off-plate reagent block asindicated on the Cmds & Routines tab. NOTE: The rinse reservoi

Running the System Initialization Routine1. On the Home page, click System Initialization under Daily Activities. The Auto Mainttab opens. On the Auto

1. On the Home page, click Shutdown. The Auto Maint tab opens, with SystemShutdown selected.2. Click Eject.3. Fill reservoir RA1 with 3/4 of DI water.

To display system-level help, click the blue question mark at the top of the xPONENTwindow, then click Contents and Index. The online help opens, wher

• Remote Web Monitoring - Enables you to view alerts and system status using awebpage.• LIS - Enables the system to communicate with an external Labor

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

FIGURE 2.LED Image-Based Analysis1 Beads in chamber2 Red LED (635 nm)3 CCD Imager4 Green LED (525 nm)Running Assays with MAGPIXGeneral GuidelinesWARNI

CAUTION: This system contains electrical and mechanical components that,if handled improperly, are potentially harmful. Adhere to standardlaboratory s

Classification and Reporter FluorochromesMagPix beads in the calibration kit are used to autofocus the camera and calibrate the CL1,CL2, and RP1 chann

when the analyzer flushes the sample lines after sample acquisition and expelsapproximately 75 µL of sample back into the well.Examples• If you use a

See the recommended consumables list on the Luminex website at http://www.luminexcorp.com/Support/index.htm and click Recommended Materials from theSu

xPONENT for MAGPIX 4.2 Software User Manual22

Samples Page FunctionalitySamples > SamplesUse this tab for the following:• Click Create New Samples to display the Create Samples subtab, on which

• Click Details to display the Edit Samples subtab, on which you can view or edit sampledetails for the selected protocol.• Click Create Batch to name

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

1. Open the Samples page. 2. In the Sample Lists section, select the protocol you are using for the sample list, thenclick Create New Samples. The Cre

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

8. To add more samples, click New. Repeat Steps 3-7 until you have added all of thesamples you want in your samples list.9. Once you have added all th

3. Click a sample, then use the Move arrows to move it up or down in the sample list,changing the order in which they will be acquired.4. To add a new

Batches Page FunctionalityBatches > BatchesOptions on the Batches tab on the Batches page are:• Create a New Batch from an existing Protocol• Creat

• Analytes - Displays when Create a New Batch from a new Protocol is clicked.• Plate Layout - Displays when Create a New Batch from an existing Protoc

1. Open the Batches page.2. Click one of the following:• Create a New Batch from an Existing Protocol• Create a New Batch from a new Protocol - if you

Use this tab to name a batch, type a batch description, select a protocol, and view activereagents. This tab contains the following:• Batch Name/Descr

Use this tab to apply a kit or lot to the batch. This tab contains the following:Batches Page33

• 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 Man

• Assay Control Information - Lists the selected control reagents. The list displays theReagent, Name, Lot Number, Expiration, and Manufacturer. Exist

• Import List - Opens the Open dialog box to import an existing command sequence list.• Replicate Count - Defines a quantity of replicate sets from on

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

Clicking either Pre Batch Routine or Post Batch Routine opens the Commands andRoutines dialog box, where you can select the command or routine you wan

5. Define the settings in the Acquisition Settings section. These are Volume, XY Heater(enable/disable and set temperature), Plate Name, and enable/di

16. Click Single Step to acquire the first well, then pause acquisition.17. Click Run Batch to start acquisition, or Save to save the batch for a late

• Name box and box for description - Type a name and a description in the appropriateboxes.• Acquisition Settings - Use this section to set the follow

• Analysis Settings - Displays the analysis type to be used for the batch. Use this section toset the analysis type, set the number of standards and c

• Use External Analysis Program - Select this check box to use a third-party programto analyze the data. The Analysis Program list becomes active when

• Analytes grid - A grid representing each analyte from 12 to 78. Select All selects allanalytes, and Deselect All deselects all analytes. Click a num

• Count - Type the desired bead count for the analytes by clicking in the Count box. If eachselected bead set does not acquire this number of events,

• Selected Analytes list - Selected analytes are displayed in a list on the right side of theanalyte grid. This list includes the following informatio

• Cancel - Click Cancel to return to the Batches tab.• Back - Click Back to return to the Settings tab.• Next - Click to go to the next tab. If the An

Standard Terms and Conditions for Use of InstrumentProductBy opening the packaging containing this product ("Product") or by using such Prod

• 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 Man

• Assay Control Information - Lists the selected control reagents. The list displays theReagent, Name, Lot Number, Expiration, and Manufacturer. Exist

• Import List - Opens the Open dialog box to import an existing command sequence list.• Replicate Count - Defines a quantity of replicate sets from on

Clicking either Pre Batch Routine or Post Batch Routine opens the Commands andRoutines dialog box, where you can select the command or routine you wan

your plate orientation) as long as space is available on the plate. You can also select a wellfirst, which places the next batch in your chosen locati

• New Batch - Opens the Create New Batch tab. Create your new batch. Click Save toreturn to the New Multibatch tab.• Add - Opens the Select Pending Ba

1. Open the Batches page.2. Click Import. The Import Batch dialog box opens. Batch files are MDF files. 3. Click Browse to open the Select File dialog

3. Edit the information as needed on the Protocol, Std & Ctrls, and Plate Layout tabs. Forthe tab, confirm that the plate layout conforms to your

Results Page FunctionalityResults > Current BatchOnce data is collected in a batch, observation and analysis take place in the Results page.This pa

• Current Batch - View statistics for the current run and progress per well.• Saved Batches - View information about already processed batches and, if

hardware not provided by Luminex. If Product is purchased from a Luminex authorizedreseller, any warranty obligations shall be provided in writing dir

You can direct the system to acquire samples in replicate regardless of batch type. Forqualitative batches, qualitative results for replicates are ave

plot data. The statistics available on this tab are intrawell bead statistics. They do notdescribe replicate well assay results.There are four maximiz

• Statistic - To view a particular statistic for analytes in a batch, select one of the options onthe drop-down list. The statistical options displaye

• Control Range - High - The highest value for an assay control used to determine pass/fail criteria for an assay.• Normalized Net Median - For each a

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

• Filter - Click Filter to open the Filter Setup dialog box.This dialog box lets you choose the saved batches you want to display in the CompletedBatc

• Save Prtcl - Opens the Save Protocol dialog box, displaying the kit information for theselected batch.• Plate Layout - Opens the Report dialog box,

• Replay - Opens the Select Replay Mode dialog box. This box enables you to use the datastored in the run files from the initial acquisition to reproc

Click an analyte to open the Analysis Settings dialog box from which you can select anew analysis setting for the analyte.• Progress - Click to displa

Replaying or recalculating a large batch can take 1 hour or more to complete. Batch replaycannot be stopped while in progress. Allow adequate time for

indicated on the Product label, the Product has not received approval from the United StatesFood and Drug Administration or other federal, state or lo

This subtab displays the following features:There are three maximize buttons in this window, one for each major pane. Click theappropriate one to maxi

• Statistic - To view a particular statistic for analytes in a batch, select one of the options onthe drop-down list. The statistical options displaye

• Control Range - High - The highest value for an assay control used to determine pass/fail criteria for an assay.• Normalized Net Median - For each a

• Invalidate - Invalidates an entire selected row or cell in the Results table. The selection willturn red when invalidated. Select the same item and

When you click the Settings subtab on the Saved Batches page, a report opens. This reportdisplays:• A date and time stamp at the top of the report• &l

This tab displays a log of the activity which occurred during the acquisition of the selectedbatch; you can print the log.The following information is

• < and > Arrows - Scroll left to right through the sample details.• ^ and v Arrows - Scroll up and down through the sample details.• Transmit -

• Filter - Opens the Filter Setup dialog box.Batch-Specific Details• Batch Name• Protocol• Batch Status• Lot ID• Kit ID• AnalyteSample Details• Sample

Reports TabResults > ReportsUse this tab to view, generate, and print reports.• Report and Type lists - Report lists the categories of reports. The

• Select Analyte arrows - This feature is directly below the Report list. Use the left and rightarrows to display information for individual analytes

contract or any other theory of law or equity arising out of, directly or indirectly, the use of theProduct or by reason of Buyer's failure to pe

Protocols Page FunctionalityProtocols > ProtocolsThe Protocols page enables you to create or import a new protocol, or select an existingprotocol f

There are action buttons at the bottom of the page. Most of these buttons are not displayedunless you are working with a saved protocol. While you are

13. To set a bead count and the units for a single analyte, click in the Units and Countcolumns directly to the right of the analyte grid, and type a

13. To set a bead count and the units for a single analyte, click in the Units and Countcolumns directly to the right of the analyte grid, and type a

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

default Post Batch routine can be changed in the Batch Optionstab of the Admin page.Creating a Qualitative Assay ProtocolYou define each Qualitative a

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

6. Define the plate layout.7. Click Save.Exporting a Protocol1. Open the Protocols page, then open the Protocols tab.2. Select a protocol.3. Click Exp

3. If the protocol uses standards, type the appropriate information for each standard in theAssay Standard Information section. In each analyte column

3. Type the name of the kit in the Name box, the lot number in the Std/Ctrl Kit Lot# box,the expiration date using MM/DD/YY format in the Expiration b