Luminex xPONENT 4.2 for FLEXMAP Manual de usuario

xPONENT® forFLEXMAP 3D®Software Version 4.2 User Guide

xPONENT® for FLEXMAP 3D®x

12. Highlight a range and click Delete Range to delete the range.13. Click OK to apply the new settings to the analyte first clicked, or Apply to All

• Replicate Count - Defines a quantity of replicate sets from one to nine.• Grouping - Selects the sequence in which the replicates are laid out in pl

• Pre Batch Routine - Opens the Commands and Routines dialog box so you can select apre-batch command or routine.• Plate Name - Specifies the plate yo

Use this tab to select or edit analytes used in the batch or protocol. This tab contains thefollowing:This tab contains the following:• Analytes grid

sets that are not in the sample. Therefore, choose only the bead sets present in yoursample.• Apply All - Applies the information in the Units and Cou

• Units - The unit of measurement you specified in the Unit box. Click this box to type avalue for the analyte.• Count - Type the desired bead count f

After you select from this box, the Std/Ctrl Details tab opens so you can create a new lotor kit.• Installed Kits And Lots - Displays information abou

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

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

Table of ContentsChapter 1 Introduction ...1Safet

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

• Verifier - If a verification reagent is selected, the Lot Details table displays targetinformation.• Sheath Fluid - Click Edit, enter the Current Lo

• Remove Air Bubbles (Luminex)• Remove Clog (Luminex)• Revive After Storage (Luminex)• Verification (Luminex)• Weekly Maintenance (Luminex)Commands -

NOTE: You should perform a Self Test as part of your scheduled weeklymaintenance.Click a command to add it to a new routine, to modify an existing rou

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

2. Click Import.3. In the Open dialog box, browse for the file you want to import, then click Open. Theroutine becomes the active routine.Exporting a

• Plate Location pin - A green pin that shows the well location used to auto adjust the probeheight for the main plate, reservoir, and/or strip wells.

8. In the Reservoir section, click in an off-plate position.9. In the Strip-Wells section, click on a well location.10. Click Auto Adjust Height. The

Use this tab to view information and diagnostics about the Luminex instrument.This tab contains the following information:• Software• Version• Operati

• System Temperature• DD Temperature• CL1 Temperature• CL2 Temperature• CL3 Temperature• CL1 Voltage• CL2 Voltage• CL3 Voltage• DD Voltage• RP1 Voltag

Importing a Batch ...49Ex

• Log Date• Message• Code• Export - Opens the Export System Log dialog box. Select a name and location for thesystem log export and click OK. Select O

Support Utility TabMaintenance > Support UtilityUse this tab to type information that will be useful in the event you need to contact LuminexTechni

• Clear - Clears all the information in the Name, Phone, Company, Email, and Commentboxes.• Browse - Opens the Browse for Folder dialog box to choose

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.

External Analysis Program SettingsThis option is for those using a program other than xPONENT® to analyze collected data.• Installed Analysis Programs

• System Initialization Procedure - Displays the available selections to use as the defaultsystem initialization procedure. After selecting an option,

NOTE: The Home page, and in some instances the Admin page, cannot bemoved.To arrange the main navigation buttons:1. Select or clear the check boxes by

2. Click System Setup. 3. Under Maintenance Options, you can select a procedure from the drop-down list. • Laser warm-up, fluidics prep, calibration,

Group Profile - The following user groups are predefined:• Administrator• Supervisor• Service• Technician2• Technician1• ReviewerThe user will belong

Commands and Routines ...97Crea

• Validate and Invalidate Results• Approve Batch• Reanalyze Results• Save Batch after changing results• Change Formula• Reacquire errored wells for pa

You must have administrative privileges and be using the Secure version of xPONENT or the21 CFR Part 11 version to perform the following tasks.• Creat

Restoring Account StatusIf users attempt to log in unsuccessfully more than the number of times allowed, they will belocked out. In the User list, cli

• Technician2• Technician1• Reviewer• Password - Type a unique password for the user in this box.• Reenter Password - This becomes active when you typ

• Group Profile - The user's group or category.• Change Password After Next Login - A box that, when checked, indicates that the userwill change

• Allow running a batch if the instrument is not warmed up - Allows batches to run if theinstrument is not warmed up.• Allow running or saving a batch

• Error (Stop) - Stops the batch.• Warning ( Pause) - Pauses the batch.• Warning (Log) - Logs a warning if the number of successive wells in the Well

• Scheduled Maintenance - A scheduled maintenance routine is now due.• Low Bead Count Detected - A bead count below the accepted range is encountered.

4. If you choose to send an email notification for a specific event, and the email address isnot already set up, click Setup Email to open the Setup E

CSV and Batch Export OptionsThis tab contains the following:• Automatically export results CSV file when batch is complete - Automatically exportthe r

xPONENT® for FLEXMAP 3D®xiv

• Automatically convert the raw run files to CSV format for each well in the batch -Click the check box if you want the automatic conversion.• Cancel

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 Restore - Click this to restore your system. It requires a log in and then refers youto the Start menu to restore your system.• Manual 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

Contact Luminex Technical Support to upgrade xPONENT® for FLEXMAP 3D® or to obtain anew license.NOTE: You must restart the computer for the new licens

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

2. On the Schedule tab, use the drop-down menus to edit the following items for anyscheduled activity: • Alert Time - the time of day that you want to

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

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

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

• System Initialization - Opens the routine specified in the Maintenance Options on theAdmin page.• Shutdown - Opens the System Shutdown command in th

Right-Click MenuCertain sections of the software such as tables, lists, and text boxes have right-click optionmenus. Menus are different depending upo

Command Display - Displays the following:• The command currently running.• The system state (i.e. running, idle, etc.).• Date and time.Progress - Disp

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

To Go to Expanded HelpAdjust the sample probe height Home > Probe and Heater Adjusting the Sample ProbeInitialize the system Home > System Initi

• Serial Number• Firmware Version• XYP Heater Temperature• Sheath Pressure• Calibration/Verification Status• Last F3DCAL1 Calibration• Last F3DeCAL1 C

Basic ProceduresStartingxPONENT®• On the PC desktop, click the Luminex® xPONENT® icon, or click Start > All Programs >Luminex > xPONENT >

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

4. From the Maintenance options drop-down menu you can define the daily startup routine.Select the check box if you want to Allow running the calibrat

NOTE: If using a strip-well plate, ensure that a strip is present in theselected well location, prior to calibration.5. Place the plate on the plate h

WARNING: Correct sample probe height is critical to successful sampleacquisition and calibration. Problems with the sample probe canlead to fluid leak

NOTE: See the Defining the System Initialization section for moreinformation.Calibrator xMAP beads are used to normalize the settings for the reporter

3. Click Exit to exit the application.Using Online HelpEnglish-language help is available at all times while you are using xPONENT®. To displayonline

Luminex® SupportViewing the Luminex® WebsiteAdditional information is available on the Luminex® website. FAQs are available at http://www.luminexcorp.

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

xPONENT® for FLEXMAP 3D®16

General GuidelinesWARNING: Modifying or deleting xPONENT® system files can causedegradation of system performance. Repair modified or deletedxPONENT®

Biological SamplesCAUTION: Human and animal samples may contain biohazardousinfectious agents. Where exposure to potentially biohazardousmaterial—incl

• Maximum well volume plate = The maximum volume capacity of the wells in a selected 96and 384-well microtiter plate.NOTE: This sample volume informat

xPONENT® for FLEXMAP 3D®20

Samples Page OverviewSamples > SamplesUse this tab for the following:Create New Samples - Click to create a new sample.Protocol - Displays the prot

Number of Samples - Displays the number of samples are in the protocol.NOTE: If a protocol is created using the same name and version as apreviously d

2. In the Sample Lists section, select the protocol you are using for the sample list, thenclick Create New Samples. The Create Sample tab opens. 3. I

Editing a Sample List1. Open the Samples page.xPONENT® for FLEXMAP 3D®24

2. In the Samples list section, choose the protocol you want to edit, then click Details. TheEdit Samples subtab opens.3. Click a sample, then use the

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

xPONENT® for FLEXMAP 3D®26

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

NOTE: These tabs (except New MultiBatch) are sequential. You mustcomplete each screen in a specific order.The Pending Batches list displays the name o

Using the Batches Page1. Open the Batches page.2. Click one of the following:• Create a New Batch from an Existing Protocol• Create a New Batch from a

NOTE: If the batch spans more than one plate, the tray ejects automaticallywhen all defined wells have been acquired. A dialog box opens,prompting you

Use this tab to apply a kit or lot to the batch. This tab contains the following:Apply Std/Ctrl Kit - Opens the Select Std/Ctrl Kit dialog box. The d

Apply Std Lot - Opens the Select Lot dialog box.Select a lot from the list and then click OK to apply the lot.Apply Values - Applies a value across or

Cancel - Returns to the Batches tab.Back - Returns to the previous tab.Next - Continues to the Plate Layout tab.Plate Layout SubtabBatches > Batche

Replicate Count - Defines a quantity of replicate sets from one to nine.NOTE: Replicate count selection must be made before adding a wellcommand.Grou

an error when attempting to run a batch on a system where theroutine does not exist.Clicking either Pre Batch Routine or Post Batch Routine opens the

Luminex's laser based fluorescent analytical test instrumentation. Buyer furtheracknowledges that the Product has not received approval from the

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

CAUTION: Acquiring data before the heater has reached the propertemperature can compromise test results.• Timeout - Check the Enabled box to enable th

• Number of Standards - Click to type the number of standards for the protocol.• Number of Controls - Click to type the number of controls for the pro

Default Analysis - The default analysis changes based on the Analysis Type selected in theSettings tab. You can change the analysis settings for all a

Selected Analytes List - Selected analytes appear in a list on the right side of the analytegrid. This list includes the following information:• Name

Use this tab to apply a kit or lot to the batch. This tab contains the following:• Apply Std/Ctrl Kit - Opens the Select Std/Ctrl Kit dialog box. The

• 1:2 - Halves the standard from each previous iteration.• 1:10 (Log) - Computes a value of one-tenth of the standard from each previousiteration.• 1/

Use this tab to define commands that apply to one or more wells. You can also define off-plate and maintenance commands. This tab contains the followi

• 123123123. . . Lays out one of each replicate set at a time in numerical order.• 111222333. . . Lays out all the replicates in a set before moving o

consulting fees) that any of the Released Parties may sustain or incur as a result of any claimagainst such Released Party based upon negligence, brea

• Plate Navigation - Displays a smaller plate image for the current batch.• Single Step - Instructs the system to acquire one well and then stop. Use

Multi-Batch - Lists pending batches selected for the multi-batch. The list includes name and“Start at” well.Plate Layout - Opens the Multi-batch Repor

2. Once you've selected a batch click Ok.3. On the next screen, select a well location for the next batch and click Add.xPONENT® for FLEXMAP 3D®4

4. Once the batches are created, click Run.After creating a multi-batch, you can save it to the Select Pending Batch list. When saved tothis list, the

4. Navigate to the location to which you want to save the file, then click Save.5. Click OK in the Export Batch dialog box. NOTE: When exporting a lar

Results PageOnce data is collected in a batch, observation and analysis take place in the Results page.This page contains the following tabs:Current B

• Batch Audit• Patient Report• Protocol Reports• Protocol Settings• Plate Layout• Protocol Audit• Calibration and Verification ReportsNOTE: Calibratio

Current Batch TabResults > Current BatchUse this tab to view results, statistics, and log information related to the current batch, and toperform s

The Current Batch tab has the following features:• Statistic - To view a particular statistic for analytes in a batch, select one of the options onthe

• Analyte - Contains a list of analytes run in the batch. Select an analyte to view all statisticsfor that analyte.• Well(s) to View• Current Well - D

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

changed to visually inspect the effect. Only the visual display of the dot plot and histogramis affected for saved batches, not the acquired data.NOTE

• Date• Message• CodeLog entries indicating warnings are highlighted ion yellow. Errors are highlighted in red. Otherlog entries are not highlighted.

• 3D BeadMap - The main display is the 3D BeadMap. The display shows the CL1, CL2,and CL3 axes. Left-click and drag your mouse to move the display for

• Linear• Display Position• 3D View• CL1/CL3 Plane• CL2/CL3 Plane• CL1/CL2 Plane• View• All Events• Gated Events• Show Cursors• Show Region Labels• Sh

Use this tab to open a batch that has been run and view its details, and to export, approve, orreplay a batch.Select a Completed Batch and click Open

This dialog box lets you choose the saved batches you want to display in the CompletedBatches list, based on options you select or clear in these chec

• Plate Layout - Opens the Report dialog box, which contains the Batch Plate LayoutReport.• Approve - Opens the Batch Approval Confirmation dialog box

• Recalculate data - Reanalyze the batch results using only the batch MFI values. Thebatch MFI values are recalculated using the analysis settings and

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

• Trimmed%CV of microspheres• Trimmed Standard Deviation• Trimmed Peak• %CV of Replicates• % Recovery• Expected Result - The known or expected test re

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

• Close - Closes the batch and reopens the Saved Batches tab.• Save - Saves the batch. This button only appears if a change has been made to the batch

Viewing Batch Settings1. Open the Results page, then open the Saved Batches tab.2. Click Saved Batches, then click the batch for which you want to vie

• Export - Opens the Save As dialog box to save the batch log file. Select a location andclick Save.• Close - Reopens the Saved Batches tab.Viewing Ba

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

Others• User ID• Date• Reset• OK / Cancel• Clear - Click to turn off the filter.• Completed Samples - Displays Name, Protocol, Sample Count, Date, Sta

• Data Interpretation• Batch Settings• Plate Layout• Batch Audit• Patient ReportIf you choose Data Interpretation, a Select Analysis section appears o

Perfomance Verification Reports - Displays two report types. Choose either of thefollowing:• Condensed• DetailedSelect a report type, a date range fro

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

• Name• Version• Manufacturer• DateClick the Create New Protocol button or click Stds/Ctrls to move to those pages.There are action buttons at the bot

8. Click Next. The Analytes tab opens.9. Click the desired analyte (bead ID) in the numbered grid. Information about the analytesis displayed in a lis

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

NOTE: The protocol for a quantitative assay must have at least two or morestandards. The number of controls are optional.8. Click Next. The Analytes t

• Check Mark as Intra-Well Normalization Bead if you want to use the analyte as anormalization bead.NOTE: The normalization bead is a microsphere set

6. Define settings in the Analysis Settings section, selecting Qualitative as the analysistype. NOTE: The protocol for a qualitative assay contains a

Exporting a Protocol1. Open the Protocols page, then open the Protocols tab.2. Select a protocol.3. Click Export. The Save as dialog box opens.4. Sele

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/YYYY format in the Expiration

Installed Protocols - Displays installed protocols. The list includes Name, Version,Manufacturer, and Date information for each protocol.New Std/Ctrl

add at least 25 µl to the sample well in addition to the sample size. The default value is 45µl.• XY heater - Select Enabled to enable the XY heater.

NOTE: Luminex recommends Fit of All Standards as the most accuratecalculation of the curve fit.Based on a range of quantitative, numerical results, a

7. 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