Luminex xPONENT 3.1 User Manual

xPONENT® 3.1 Rev. 2

Software User Manual

For In Vitro Diagnostic Use

©

Luminex Corporation, 2012. All rights reserved. No part of this publication may be
reproduced, transmitted, transcribed, or translated into any language or computer language,
in any form or by any means without prior express, written consent of Luminex Corporation.

For In Vitro Diagnostic Use Only.

LUMINEX CORPORATION

12212 Technology Boulevard

Austin, Texas 78727-6115

U.S.A.

Voice: [phone]

Fax: [phone]

WMDE
Bergerweg 18
6085 AT Horn

The Netherlands

xPONENT 3.1 Rev. 2 Software User Manual

PN 89-00002-00-255 Rev. C

April 2012

Luminex Corporation (Luminex) reserves the right to modify its products and services at any
time. This guide is subject to change without notice. Although prepared to ensure accuracy,
Luminex assumes no liability for errors or omissions, or for any damages resulting from the
application or use of this information.

The following are trademarks of Luminex Corporation: Luminex®, xMAP®, xTAG®,
xPONENT®, Luminex® 200™, Luminex® SD™, Luminex® XYP™, MagPix®, MAGPLEX

®

Microspheres, Microplex®.

All other trademarks, including ProClin®, Cheminert®, Windows® Pentium® and Dell® are
trademarks of their respective companies.

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

End-User License Agreement (EULA) for Luminex
xPONENT® Software

This Luminex End-User License Agreement (“EULA”) is a legal agreement between you
(either an individual or a single entity, also referred herein as “you”) the end-user and
Luminex Corporation (“Luminex”) regarding the use of the xPONENT software product
provided to you above, which includes computer SOFTWARE and online or electronic
documentation and may include associated media and printed materials (if any)
(“SOFTWARE”). The terms also apply to any updates, supplements, web content or internet­based services, such as remote access.

BY USING THE SOFTWARE, YOU ACCEPT THESE TERMS. IF YOU DO NOT ACCEPT
THEM, DO NOT USE THE SOFTWARE. INSTEAD, RETURN IT TO LUMINEX OR THE
LUMINEX AUTHORIZED THIRD PARTY FROM WHICH YOU PURCHASED THE
SOFTWARE FOR A REFUND OR CREDIT. IF YOU COMPLY WITH THESE LICENSE
TERMS, YOU HAVE THE RIGHTS TO USE THE SOFTWARE AS SPECIFICALLY SET
FORTH BELOW.

1. OVERVIEW. The SOFTWARE is protected by copyright laws and international copyright
treaties, as well as other intellectual property laws and treaties. The SOFTWARE is
licensed, not sold.

2. ADDITIONAL LICENSING REQUIREMENTS AND/OR USE RIGHTS.

a. Trial and Conversion. Some or all of the SOFTWARE may be licensed on a trial basis.

Your rights to use trial SOFTWARE are limited to the trial period. The trial SOFTWARE
and length of the trial period are set forth during the activation process. The
SOFTWARE may be used for evaluation purposes only during the trial period and not
for any commercial use, including without limitation to any diagnostic use. You may
have the option to convert your trial rights to perpetual rights. Conversion options will
be presented to you at the expiration of your trial period.

b. Activation. You can activate the SOFTWARE by obtaining a license key provided by

Luminex Technical Support at [e-mail] or 1-877-785-2323 or
1-512-381-4397.

c. Branding. You may only add additional branding or other graphics to SOFTWARE with

Luminex's express written consent.

d. Upgrades. You may only obtain updates or upgrades for the SOFTWARE from

Luminex Technical Support at [e-mail] or authorized resellers. For
more information on obtaining updates from authorized resellers, see http://
www.luminexcorp.com.

3. GRANT OF LICENSE. Subject to the terms and conditions of this EULA, Luminex hereby
grants to you a nonexclusive, nontransferable, nonassignable license (without right to
sublicense) under Luminex's copyrights and trade secrets to use the SOFTWARE on a
single computer running with a single unit of a specific model of Luminex instrument, as
such model is identified on the packaging included with the SOFTWARE. You may make
one (1) copy of the SOFTWARE for backup or archival purposes only. You may also
install the SOFTWARE on up to two (2) additional computers for purposes of performing
ancillary tasks (i.e. preparing templates/protocols, performing further analysis or re­running previous data), provided such computers are at a single location and are NOT
connected with a Luminex instrument. In addition, You may purchase the right to use the

®

iii

SOFTWARE on additional computers, as agreed to in writing with Luminex or its
authorized reseller, for purposes of performing ancillary tasks (i.e. preparing templates/
protocols, performing further analysis or re-running previous data), provided such
computers are at a single location and are NOT connected with a Luminex instrument.
Although no rights or licenses under any of Luminex's patents are granted by or shall be
implied from the license of the SOFTWARE or the sale of Luminex instrumentation to
you, the purchaser, you may obtain a license under Luminex's patents, if any, to use this
unit of Luminex instrumentation with fluorescently labeled microsphere beads authorized
by Luminex by purchasing such beads from Luminex or an authorized Luminex reseller.

4. RESTRICTIONS

• SOFTWARE must only be installed and operated on a single computer running with a

Luminex instrument, as set forth above.

• You may not use this SOFTWARE for any commercial purpose, including in the

performance of testing services, unless expressly agreed to in writing by Luminex or
as authorized in writing by Luminex through an authorized reseller of the SOFTWARE.

• You may only use the SOFTWARE with microspheres manufactured by Luminex or

with kits developed, manufactured and distributed by licensees authorized in writing by
Luminex.

• You must maintain all proprietary notices on all copies of the SOFTWARE.

• You may not distribute copies of the SOFTWARE to third parties.

• You may not reverse-engineer, decompile, disassemble, or otherwise attempt to derive

source code from the SOFTWARE.

• You may not copy (other than one backup or archival copy), distribute, sublicense,

rent, lease, transfer or grant any rights in or to all or any portion of the SOFTWARE.

• You must comply with all applicable laws regarding the use of the SOFTWARE.

• You may not modify or prepare derivative works of the SOFTWARE, including

modifying any branding or graphics.

• You may not use the SOFTWARE in a computer-based service business or publicly

display visual output of the SOFTWARE.

• You may not transmit the SOFTWARE over a network, by telephone, or electronically

by any means.

5. TERM AND TERMINATION. Your rights under this EULA are effective until termination.
You may terminate this EULA at any time by destroying the SOFTWARE, including all
computer programs and documentation, and erasing any copies residing on your
computer equipment. Luminex may terminate this EULA upon thirty (30) days written
notice to you. Your rights under this EULA automatically terminate without further action
on the part of Luminex if you do not comply with any of the terms or conditions of this
EULA. Upon any termination of this EULA, you agree to destroy the SOFTWARE and
erase any copies residing on your computer equipment.

6. RIGHTS IN SOFTWARE. All rights and title in and to the SOFTWARE and any copies
thereof are owned by Luminex or its suppliers. This EULA is not a sale and does not
transfer to you any title or ownership interest in or to the SOFTWARE or any patent,
copyright, trade secret, trade name, trademark or other intellectual property right therein.
You shall not remove, alter, or obscure any proprietary notices contained on or within the
SOFTWARE and shall reproduce such notices on any back-up copy of the SOFTWARE.
All title and intellectual property rights in and to the content which may be accessed
through use of the SOFTWARE is the property of the respective content owner and may

xPONENT® 3.1 Rev. 2 Software User Manual
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be protected by applicable copyright or other intellectual property laws and treaties. This
EULA grants you no rights to use such content.

7. EXPORT RESTRICTIONS. You agree that you will not export or re-export the
SOFTWARE to any country, person, entity, or end-user subject to U.S.A. export
restrictions. You hereby warrant no state or federal agency has suspended, revoked, or
denied your export privileges.

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 PRODUCTS. TO THE MAXIMUM EXTENT PERMITTED BY
APPLICABLE LAW, LUMINEX AND ITS SUPPLIERS DISCLAIM ALL WARRANTIES,
EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, IMPLIED
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
AND NONINFRINGEMENT.

9. LIMITATION OF LIABILITY. IN NO EVENT SHALL LUMINEX OR ITS SUPPLIERS BE
LIABLE FOR ANY SPECIAL, INCIDENTAL, INDIRECT, OR CONSEQUENTIAL
DAMAGES WHATSOEVER (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR
LOSS OF BUSINESS PROFITS, BUSINESS INTERRUPTION, LOSS OF BUSINESS
INFORMATION, OR ANY OTHER PECUNIARY LOSS) ARISING OUT OF THE USE OF
OR INABILITY TO USE THE SOFTWARE, EVEN IF LUMINEX HAS BEEN ADVISED
OF THE POSSIBILITY OF SUCH DAMAGES.

10. MISCELLANEOUS. This EULA is governed by the laws of the State of Texas, U.S.A.,
without reference to conflicts of laws principles. You shall not assign or sublicense or
otherwise transfer the rights or license granted hereunder, by agreement or by operation
of law, without the prior written consent of Luminex, and all assignments in violation of
this prohibition shall be null and void. This EULA is the complete and exclusive
agreement of Luminex and you and supersedes all other communications, oral or written,
relating to the subject matter hereof. No change to this EULA shall be valid unless in
writing and signed by the party against whom enforcement is sought. The waiver or
failure of Luminex or you to exercise in any respect any right or rights provided for herein
shall not be deemed a waiver of any further right hereunder. If any provision of this EULA
is held unenforceable, the remainder of this EULA will continue in full force and effect.

89-30000-00-254 Rev. B

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Table of Contents

Chapter 1 Introduction ........................................................................................................1

Software Packages ......................................................................................................................................1

About this Guide ..........................................................................................................................................1

Warnings, Notes and Symbols ....................................................................................................................2

General Guidelines ......................................................................................................................................3

Biological Samples ................................................................................................................................3

Bead Handling .......................................................................................................................................3

Bead Concentration ...............................................................................................................................4

Repetitive xMAP Bead Measurements ..................................................................................................4

Classification and Reporter Fluorochromes ..........................................................................................4

Sample Volume .....................................................................................................................................5

Sample Dilution .....................................................................................................................................5

Reagents ...............................................................................................................................................6

Plates ....................................................................................................................................................6

Chapter 2 Touring the Software .........................................................................................7

Log In ...........................................................................................................................................................7

Help .............................................................................................................................................................7

Log Off .........................................................................................................................................................7

Exit ...............................................................................................................................................................8

Screen Elements .........................................................................................................................................8

System Monitor ............................................................................................................................................9

Home .........................................................................................................................................................10

Samples .....................................................................................................................................................12

Create Sample Tab .............................................................................................................................13

Batches ......................................................................................................................................................14

Batches Tab ........................................................................................................................................14

Create a New Batch from an existing Protocol ....................................................................................15

Results .......................................................................................................................................................26

Current Batch Tab ...............................................................................................................................26

Saved Batches Tab .............................................................................................................................30

LIS Results Tab ...................................................................................................................................36

Reports Tab .........................................................................................................................................37

Protocols ....................................................................................................................................................39

Protocols Tab ......................................................................................................................................39

Stds & Ctrls Tab ..................................................................................................................................41

Maintenance ..............................................................................................................................................44

Auto Maint Tab ....................................................................................................................................45

Lot Management Tab ..........................................................................................................................46

Cmds & Routines Tab .........................................................................................................................47

Probe and Heater Tab .........................................................................................................................50

System Info Tab ..................................................................................................................................51

System Status Tab ..............................................................................................................................53

Schedule Tab ......................................................................................................................................55

Support Utility Tab ...............................................................................................................................55

vii

Admin .........................................................................................................................................................56

System Setup Tab ...............................................................................................................................57

Group Setup Tab .................................................................................................................................58

User Setup Tab ...................................................................................................................................61

Alert Options Tab ................................................................................................................................63

CSV Options Tab ................................................................................................................................64

Archive Tab .........................................................................................................................................65

Licensing Tab ......................................................................................................................................66

Schedule Tab ......................................................................................................................................67

Chapter 3 Using the Software ..........................................................................................69

Starting the Software .................................................................................................................................69

Using Online Help ......................................................................................................................................69

Setting Administrative Options ...................................................................................................................70

System Setup ......................................................................................................................................70

Group Setup ........................................................................................................................................71

User Setup ..........................................................................................................................................71

Alert Options ........................................................................................................................................72

CSV Options ........................................................................................................................................72

Archive ................................................................................................................................................73

Licensing .............................................................................................................................................74

Schedule .............................................................................................................................................74

Adjusting the Sample Probe ......................................................................................................................74

System Initialization ...................................................................................................................................75

Run System Initialization .....................................................................................................................76

Add CAL or VER Kits ..........................................................................................................................76

Import CAL or VER Kits .......................................................................................................................77

Export CAL or VER Kits ......................................................................................................................77

Delete CAL and VER Kit Information ..................................................................................................77

Create Calibration Reports ..................................................................................................................77

Managing Sample Lists .............................................................................................................................78

Create New Sample List ......................................................................................................................78

Edit Sample Lists .................................................................................................................................78

Setting Up Batches ....................................................................................................................................78

Create a New Batch from an Existing Protocol ...................................................................................79

Create a New Batch from a New Protocol ...........................................................................................79

Create a Multi-Batch ............................................................................................................................81

Save Multi-batch ..................................................................................................................................81

Import Batch ........................................................................................................................................82

Export Batch ........................................................................................................................................82

Delete Batch ........................................................................................................................................82

Edit Batch ............................................................................................................................................82

Run Batch ............................................................................................................................................83

Add a Patient List ................................................................................................................................83

Performing Analysis ...................................................................................................................................84

Analyze Current Batch ........................................................................................................................84

Manage Saved Batches ......................................................................................................................84

View and Print Reports ........................................................................................................................86

Transmit Batch ....................................................................................................................................86

Using Protocols, Lots, and Kits ..................................................................................................................86

Protocols .............................................................................................................................................86

Lots and Kits ........................................................................................................................................87

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Performing System Maintenance ...............................................................................................................89

Performing Individual Maintenance Commands ..................................................................................89

Perform System Calibration ................................................................................................................89

Manage Maintenance Routines ...........................................................................................................89

Support Utility ......................................................................................................................................91

Shutting Down the Analyzer ......................................................................................................................91

Logging Out of the Software ......................................................................................................................92

Exiting the Software ...................................................................................................................................92

Technical Support ......................................................................................................................................92

Luminex Website .......................................................................................................................................92

Appendix A Glossary ........................................................................................................93

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Table of Contents

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Chapter 1: Introduction

The Luminex system was developed to improve workflow and efficiency in the clinical
laboratory and in research and development. End users in the laboratory must run microtiter
plates using xMAP®-based assay kits developed for use with xMAP technology.

Software Packages

xPONENT® software has different levels of functionality:

• Allows you to perform analysis from IVD protocols and batches, review and print reports,
and perform Luminex system maintenance.

• Instrument Control - Allows the application to connect to and communicate with an
instrument identified by a specific serial number.

• Secure - Includes all of the Basic functionality, as well as administrator-controlled user
permission levels.

• 21 CFR Part 11 - Includes all of the Secure functionality as well as requiring electronic
signatures to perform certain tasks. Electronic signatures are listed in the system log.
Electronic signatures for batch functions are also listed in the batch audit log.

• Remote Web Monitoring - Allows you to view alerts and system status using a webpage.

• LIS - Includes the ability to communicate with an external Laboratory Information System
(LIS) database. The LIS edition allows the export of patient result data in ASTM file format
and the import of patient sample information in ASTM format

You will need an instrument control license to operate the instrument.

For more information on purchasing upgraded packages or to obtain specific package
documentation, contact your vendor.

About this Guide

The conventions in this document assume a basic familiarity with computers and a
knowledge of Microsoft® Windows® software. Commands are often available through more
than one method, such as from the toolbar and from menus that appear when right-clicking
an area of the screen. However, for ease of use the individual procedures in this manual
describe only one method for accessing commands.

1

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

This guide may be updated periodically. To ensure that you have a current version, access
http://www.luminexcorp.com/Downloads/index.htm. The most recent version of this guide, as
well as all translations of this guide, are available for download at that URL.

Warnings, Notes and Symbols

The following informational notes and warning appear as necessary in this manual.

TABLE 1.

Type of Note Meaning

NOTE This message is used to provide general helpful

CAUTION This message is used in cases where the hazard

WARNING This message is used in cases when danger to

Definitions

information. No safety or performance issues are
involved.

is minor or only a potential hazard is present.
Failure to comply with the caution may result in
hazardous conditions.

the operator or to the performance of the
instrument is present. Failure to comply with the
warning may result in incorrect performance,
instrument failure, invalid results, or hazard to the
operator.

You may encounter these symbols during the use of xPONENT software. They represent
warnings, conditions, identifications, instructions, and regulatory notations as follows.

TABLE 2.

Symbols

Warning,
Biological Hazard

General Warning,
Caution, or Risk of
Danger

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Heat/Hot Surface Warning

Authorized Representative in
the European Community

For In Vitro Diagnostic Use

TABLE 2.

Symbols Continued

General Guidelines

Modifying or deleting Luminex®xPONENT® system files may cause degradation to system
performance. You can repair modified or deleted xPONENT system files by uninstalling and
re-installing the xPONENT software.

Use of unauthorized third-party software with xPONENT software may result in corruption or
failure of the xPONENT software. Use third-party software at your own risk.

If using a screen saver on the xPONENT system, be aware that xPONENT will prevent it
from activating. A dialog box will display each time xPONENT is launched, recommending
that the screen saver and any power management settings are turned off.

This system contains electrical, mechanical, and laser components that, if handled
improperly, are potentially harmful. In addition, biological hazards may be present during
system operation. Therefore, we recommend that all system users adhere to standard
laboratory safety practices. The protection provided by the equipment may be impaired or the
warranty voided if the Luminex FLEXMAP 3D is used in a manner not specified by the
instructions or by Luminex Corporation.

Manufacturer In-vitro Diagnostic Device

Conformité
Europeénne
(European Union
Conformity)

Biological Samples

Human and animal samples may contain biohazardous infectious agents. Where exposure to
potentially biohazardous material, including aerosol, exists, follow appropriate biosafety
procedures and use personal protective equipment - gloves, gowns, laboratory coats, face
shields, or mask and eye protection - and ventilation devices. Observe all local, state, and
federal biohazard handling regulations when disposing of biohazardous waste material.

Bead Handling

Avoid excessive agitation of the product to reduce foaming and surface precipitation. The
xMAP beads will settle if left undisturbed. Always ensure that the xMAP beads are
homogeneously resuspended prior to dispensing. The uncoupled xMAP beads are not
monodispersed and tend to aggregate until coated. Multiple pipetting from the original
container may affect bead concentrations. Protect the xMAP beads from light at all times.
Store xMAP beads at 2 to 8°C.

NOTE: Refer to the product information sheet that accompanies your xMAP

beads or assay for additional information.

Limitations

xMAP beads are susceptible to photobleaching; photobleaching effects are cumulative.
Minimize exposure of xMAP beads to light to maintain product integrity.

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Introduction

3

xMAP beads are hydrophobic in the aqueous medium provided and will settle if left
undisturbed. Resuspend prior to dispensing.

Do not use this product with strong organic solvents. For information on specific compatibility,
visit the Luminex Technical Support website at Luminex Technical Support.

Safety Precautions

All samples should be regarded as potentially contaminated and treated as infectious. These
samples should be handled at the Biosafety Level 2 as recommended for any potentially
infectious human serum or blood specimen in the Center for Disease Control/National
Institutes of Health Manual, “Biosafety in Microbiological and Biomedical Laboratories” 1984.

Although beads do not contain hazardous or carcinogenic components at toxic levels, they
may be toxic if swallowed. Contact with acids liberates toxic gases. If product comes in
contact with skin, wash immediately with copious amounts of water. In case of accident, seek
medical advice immediately and show the product label or container to your medical provider.
A Material Safety Data Sheet is available upon request.

WARNING: Reagents may contain sodium azide as a preservative. Sodium

azide may react with lead and copper plumbing to form highly
explosive metal azides. It is also highly toxic and rates a
material safety data sheet (MSDS) health hazard 4. On
disposal, flush drains with a generous amount of cold water to
prevent azide build-up. Consult the manual guideline “Safety

Management No. CDC-22, Decontamination of Laboratory Sink
Drains to remove Azide salts” (Centers for Disease Control,

Atlanta, Georgia, April 30, 1976).

CAUTION: The sheath fluid and the solution in which beads are stored

contain ProClin®, which may cause an allergic reaction. Use
personal protective equipment, including gloves and safety
glasses.

Bead Concentration

The concentration of beads in an assay is a factor in system speed. If running an xMAP­based kit, follow the instruction found on the kit’s product insert and use the provided
software protocol.

Repetitive xMAP Bead Measurements

In an xMAP assay, the reporter signal is the result of the assay. Due to small bead size,
xMAP bead suspension exhibits near solution phase reaction kinetics. This means that each
set of xMAP beads used for a particular assay will show a statistically even distribution of
reporter molecules bound to the surface of each bead. During data acquisition, numerous
beads of each set are analyzed and the median statistic is computed for that set by the
software. The more beads of a set measured, the more confidence that can be given for that
particular measurement. If running an xMAP IVD kit, follow the kit’s product insert and use
the provided software protocol.

Classification and Reporter Fluorochromes

Each xMAP bead set is internally dyed with two classification dyes, or three dyes for beads
above 100-plex. The fluorescence signal of these dyes allows for classification of each bead

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For In Vitro Diagnostic Use

set. Since each bead is analyzed individually, even when the sets are mixed in a multiplex
assay they can still be distinguished by their emission signals. The fluorescence signal of
reporter molecules bound to the surface of each bead set is measured and used to determine
the result of each assay in a multiplex. Again, since each bead is analyzed individually,
reporter signals for each bead set can be accurately quantified.

The following table displays acceptable reporter fluorochromes and their excitation and
emission wavelengths.

TABLE 3.

Formula weight (Daltons) 240,000 470

Absorbance max (nm) 480, 546, 565 531

Extinction max (M-1cm-1) 1,960,000 83,800

Emission max (nm) 578 554

Quantum yield 0.82 0.8

Reporter Fluorchromes Wavelengths

Sample Volume

Sample volumes or sample sizes range from 10 to 200 µL. Ensure that some sample remains
in the well after aspiration; about 25 µL greater than the sample volume. This amount may
vary depending on the type of plate used. After acquisition, the Luminex analyzer washes the
sample lines resulting in ejection of approximately 150165 µL of sheath fluid back into the
well for a 96-well plate. Ensure that there is room to add this amount to the well without
overflowing and contaminating other wells. Follow the IVD kit package insert instructions for
use.

The volume can be expounded by the following formula:

Total well volume (µL) – Sample uptake volume (µL) + 150165 (µL) <Maximum Well Volume
(µL)

R-Phycoerythrin Alexa 532

• Total well volume = Starting sample volume of a well before the unit samples for
acquisition. Well volume is determined by the consistency of the bead set.

• Sample uptake volume = Uptake volume for acquisition (program this in the protocol as
sample volume).

• 165 (µL) = Volume expelled back as stated in the above paragraph.

• Maximum well volume plate = The maximum volume capacity of the wells in a selected 96­well microtiter plate.

Sample Dilution

Dilute concentrated biological samples such as plasma or serum following the IVD kit
package insert instructions for use. If running an xMAP-based kit, follow the dilution
instructions in the kit’s product insert.

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Introduction

5

Reagents

Formulated reagents must be free of particulates other than xMAP beads. Do not dilute
xMAP calibrators or verifiers.

Plates

When using uncovered plates, use black opaque plates, if possible, to reduce
photobleaching.

For heated assays, use CoStar® Thermowell® 96-well, thin-wall polycarbonate, model P
plates.

For non-heated assays, select a 96-well plate with an overall height no greater than 0.75
inches (19 mm). Follow the xMAP based IVD kit instructions for use. See the Bead
Concentration section.

See the recommended consumables list on the Luminex website at http://
www.luminexcorp.com/Support/SupportResources/index.htm#tabs-4 for more information.

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Chapter 2: Touring the Software

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

This chapter describes default views. Please note that views can be changed and
functionality can be disabled by the xPONENT system administrator.

Log In

Help

Log Off

To log in, type your user ID at the System Login tab. If you are using the secure version of
the software, type your password. Once you have logged in, the Home page opens. The
xPONENT system administrator must set up the User ID and initial logon passwords. Contact
your xPONENT system administrator if you have not been assigned a user ID and password.

NOTE: If a user is locked out of the application, each time the Admin user

logs in, a dialog box opens to notify the Admin user that a user is
locked out.

WARNING: Use of this software by untrained personnel can result in

inaccurate data and test results. It is highly advised that users
read this manual thoroughly before operating the software.

English-language help is available for each window in the software by clicking the blue “i”
button in the upper-right portion of the window in which you are working. You can also access
the complete system-wide help by clicking Help at the very top of the screen, and then
clicking Contents and Index.

Click Log Off to log out of the software, then click OK in the Confirm Logout dialog box.

7

Exit

After you log out, click Exit, then Yes to exit the software completely.

Screen Elements

The following section details the screen elements and the common terms used in this manual
to describe them.

FIGURE 1.

Screen Elements

• Page - The main elements at the top of the window are “Pages”. Click a page to go to that
section of the software. All but the Home, and in some cases the Admin, page can be
moved or deleted. For more information, see Arrange Main Navigation buttons.

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3 Right-click Menu

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• Tab - The elements on the left side of the window are “Tabs”. Click a tab to go to that
section. Some tabs require you to go in order, and will not let you click a tab further down
without performing a task on the current tab.

• Right-Click Menu - Certain sections of the software such as tables, lists, and text boxes
have right-click option menus. Menus are different depending upon the item you right­clicked.

• Print All - Prints all sections or cells of the item.

• Print Selection - Prints only the selected section or cell.

• Import - Imports a file.

• Export - Opens a File dialog box. Use the Browse button to select a location, and type

a file name. The export is in .CSV format. This exports all data from the right-clicked
item.

• Cut - Cuts the selected data.

• Copy All - Copies all data.

• Copy - Copies only the selected data.

• Paste - Pastes previously copied text or data into the box.

• Delete - Erases text or data from the selection.

System Monitor

The System Monitor remains at the bottom of all xPONENT windows. It displays the physical
state of the Luminex analyzer. The values displayed are reported directly from the Luminex
system.

FIGURE 2.

• System Status - This button has two functions: When clicked, it opens the system log (see
System Status Tab). It also displays the current status of the system. If there are no
warnings or errors, the System Status button is green with a check mark. If there is a
warning, error, or other important user-notification, the button turns yello with an
exclamation point.

• Command - Displays the command currently running on the system.

System Monitor

1 System Status button 2 Command display

3 Progress bar and buttons 4 Delta Cal Temp status button

5 Sheath Pressure status 6 XY status

7 Laser status 8 Region Events status

9 Total Events status

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Touring the Software

9

NOTE: A yellow Check Calibration button is visible in the command display

if the calibration or verification command has failed, when any
verification is not current, or when the calibration or verification was
performed prior to the calibration expiration setting.

• Progress - Displays a bar graph showing the progress of the current command or routine;
if the command or routine is finished, it displays a full progress bar and the command
status as Complete.

• Pause - Pauses the system after the current command completes. Pause does not stop
the system in the middle of running a command. You cannot run another command while
the system is paused.

• Stop - Stops the system, regardless of command status.

• Eject - Ejects the plate. Once the plate is ejected, the Eject button changes to Retract.
Retract retracts the plate, and the Retract button changes back to Eject.

• Temp - Displays the difference in temperature between the current reading and the
reading when it was calibrated, in degrees Celsius. If the temperature is out of tolerance, it
shows a high or low arrow. When clicked, it opens the Auto Maint tab.

• Sheath Pressure - Displays the sheath pressure in psi. A high or low arrow is displayed if
the pressure is trending up or down versus the calibration pressure and it turns yellow.
When clicked, it opens the System Info tab.

• XY Status - Displays the current location of the command, and the temperature of the
plate heating block in degrees Celsius. When clicked, it opens the Probe and Heater tab.

• Laser - Displays the laser status, including the time remaining until you must warm up the
laser again. The Laser status button is blue. The button turns yellow when the lasers are
turned off and about ten minutes before they turn off. When clicked, it restarts the active
clock for the laser.

• Region Events - Displays the number of bead events detected per second that are
classified in a region.

• Total Events - Displays the number of total events detected per second.

Home

The Home page displays a welcome message, batch creation buttons, Daily Activities
shortcuts, and the Installed Protocols list.

CAUTION: The sheath fluid and the solution in which beads are stored

contain ProClin®, which may cause an allergic reaction. Use
personal protective equipment, including gloves and safety
glasses.

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FIGURE 3.

Home Page

Return to the Home page at any time by clicking Home in the Navigation toolbar. This page
contains the following:

• Click to Create a new Batch using the highlighted Protocol below - Creates a new
batch using a selected protocol from the Installed Protocols list. For more information
about creating a batch from an existing protocol, see Create a New Batch from an Existing

Protocol.

• Installed Protocols - Displays a list of protocols. The list contains the following information
about each protocol:

• Name

• Version

• Manufacturer

• Date

Use the up and down arrows on the right to move through the list of protocols.

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

• Daily Activities - Contains shortcut buttons to common commands in the xPONENT
software:

• System Initialization - Opens the System Initialization command in the Auto Maint

tab on the Maintenance page. For more information about this tab, see Auto Maint Tab.

• Shutdown - Opens the System Shutdown command in the Auto Maint tab on the

Maintenance page. For more information about this tab, see Auto Maint Tab.

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Samples

• Probe and Heater - Opens the Probe and Heater tab on the Maintenance page. For

more information about this tab, see Probe and Heater Tab .

• Sys Info - Opens the System Info tab of the Maintenance page. For more information,
see System Info Tab.

• Reports - Opens the Reports tab of the Results page. For more information, see Reports

Tab.

Use this page to create new samples, view the details of a sample list, or to create a new
batch. Samples can also be added via a Lab Information System (LIS), if your software is
licensed for a LIS.

This page contains the following tabs:

• Create Sample - Displays when the Create New Samples button is clicked.

• Edit Samples - Displays when the Details button is clicked.

• Protocol - Displays when the Create Batch button is clicked.

• Stds & Ctrls - Displays when the Create Batch button is clicked.

• Plate Layout - Displays when the Create Batch button is clicked.

FIGURE 4.

Samples Tab

This tab contains the following:

• Create New Samples - Opens the Create Sample tab.

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

• Details - Opens the Edit Samples tab to view or edit sample details for the selected
protocol.

• Create Batch - Opens the Protocol tab to create a batch.

Create Sample Tab

Use this tab to type and view sample information.

FIGURE 5.

Create Sample Tab

This tab contains the following:

• Protocol - Displays the protocol selected in the Samples tab. If xPONENT has an LIS
license enabled, any sample details provided by the LIS also appear in the Sample list.

• Version - Displays the protocol version number. It is not editable.

• Sample - If you have the LIS-enabled version of the software and are currently connected
to the LIS, the sample list autopopulates when the LIS provides samples orders. You can
only view or run a sample list created in the LIS; you cannot edit it. Otherwise, use Create
New Samples to create a new sample. Once you have typed and saved the sample
information, it appears in the list to the left. This list displays the samples you have already
created. To reorder the sample’s acquisition location, use the move arrows.

The following Delete, New, Edit, and Undo buttons only display depending on actions taken
in the Create Sample tab.

• Delete - Deletes a highlighted sample.

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Batches

• New - Creates a new sample.

• Edit - Edits a highlighted sample.

• Undo - Reopens the Create Sample tab without saving any changes made using the Edit
or New buttons.

• Save - Saves changes made to the Sample list.

• Close - Returns to the Samples tab.

Use the Batches page to create and run a new batch from an existing protocol or a new
multi-batch. This page contains the following tabs:

• Protocol - Displays when the Create a New Batch from an existing Protocol button is
clicked.

• Stds & Ctrls - Displays when the Create a New Batch from an existing Protocol button
is clicked.

• Plate Layout - Displays when the Create a New Batch from an existing Protocol button
is clicked.

• New MultiBatch - Displays when the Create a New Multi-Batch button is clicked.

Batches Tab

The Batches tab displays the following:

• Create a New Batch from an existing Protocol - Opens the Protocol tab, where you can
create a new batch from an existing protocol. For more information, see Create a New

Batch from an Existing Protocol.

• Create a New Multi-Batch - Simultaneously opens the New Multibatch tab and the
Select Pending Batch dialog box, where you can create a multi-batch from pending

batches. For more information, see Create a Multi-Batch.

• Pending Batches - Displays a list of pending batches. It includes the batch name,
protocol, protocol version, date, and status for each pending batch. If there is no data in the
list of pending batches, the following buttons do not appear on the screen.

• Single Step - Instructs the system to acquire a two wells and then pause. This ensures the
system is working correctly before running an entire batch.

• Save Prtcl - Saves a protocol and or assay standard/control information.

• Plate Layout - Opens the Report dialog box, which includes the Batch Plate Layout
Report. See

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FIGURE 6.

Batch Plate Layout Report

• Import - Imports a batch.

• Export - Exports a batch.

• Delete - Deletes a batch.

• Edit - Edits a batch.

• Run - Runs a batch.

Create a New Batch from an existing Protocol

Creates a New Batch from an existing protocol. The Protocol tab opens.

Protocol Tab

Use this tab to name a batch, type a description, select a protocol, and view active reagents.

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FIGURE 7.

Protocol Tab

This tab contains the following:

Batch Name/Description - Contains the protocol name, version, manufacturer, and creation
date for each protocol.

Select a Protocol - Contains the protocol name, version, manufacturer, and creation date for
each protocol.

Active Reagents - Displays assay and control lots/kits associated with the selected protocol.
The Standard/Ctrls Kit Name - Lot# field displays the assay standard/control kit/lot name
and lot number currently associated with the selected protocol. The Standard Lots and
Controls Lots fields display any standard or control lots associated with the selected
protocol.

Cancel - Returns to the main Batches tab.

Next - If you have selected a protocol with no standards or controls (Displayed as None in

the Active Reagents section), clicking Next continues to the Plate Layout tab. If you have
selected a protocol with standards and controls, clicking Next continues to the Stds & Ctrls
tab.

Stds & Ctrls Tab

Use this tab to apply a kit or lot to the batch.

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FIGURE 8.

Stds & Ctrls Tab

This tab contains the following:

Apply Std/Ctrl Kit - Opens the Select Std/Ctrl Kit dialog box. The dialog box displays the
Std/Ctrl Kit Lot #, Std/Ctrl Kit Name, Expiration, and Manufacturer for the kit. Select a

Std/Ctrl kit from the list and then clickOK to close the dialog box. The kit information will
display in the boxes to the right of the Apply Std/Ctrl Kit button. The selected kit must be
associated with the same analyte names.

Manually type information by clicking in the Name, Std/Ctrl Kit Lot #, Expiration, and

Manufacturer boxes and typing the information.

Assay Standard Information - Displays the selected standard reagents in a list. The list

displays the Reagent, Name, Lot #, Expiration, Manufacturer, and expected concentration
value of each analyte.

• 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 down the Reagent, Name, Lot #, Expiration,
and Analyte fields. Type a value in these fields by double-clicking on them and then using
one of the two Apply Values arrows to apply that value down or across the list of analytes.

NOTE: The Dilution list and Apply Dilution button only appear if a

quantitative analysis has been selected.

• Dilution - Contains the following dilution options:

• 1:2 - Halves the standard from each previous iteration.

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

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• 1/2 Log - Creates a 1:3.16 dilution, or half of each 1:10 (Log) from each previous

iteration.

• Alternatively, type a number for your own dilution factor.

• Apply Dilution - Applies the dilution selected in the Dilution list.

NOTE: Click a column header to resort the display.

NOTE: Click the Reagent column header to resort the order from the

highest number standard to standard number one. This is useful for
applying dilutions in which the last standard is the highest standard.

Assay Control Information - Lists the selected control reagents. The list displays the
Reagent, Name, Lot Number, Expiration, and Manufacturer. Existing control lot

information can be applied or new information can be typed manually.

• Apply Ctrl Lot - Opens the Select Lot dialog box. Select a lot from the list and then click
OK.

• Show Value - Expected, Low, and High set the expected, lowest, or highest acceptable
concentration of the analyte in the sample.

• Apply Values - Applies a value down or across the list of analytes.

Cancel - Returns to the Batches tab.

Back - Returns to the previous tab.

Next - Opens the Plate Layout tab.

Plate Layout Tab

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

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FIGURE 9.

Plate Layout Tab

This tab contains the following:

• Plate Image - This is a representation of the plate. Each well appears as a circle on the
grid. Well commands appear in the appropriate circles as you assign them to wells on the
plate.

• Command Sequence - Contains the command sequence for the active plate. The list
includes all active wells, the type of command (Unknown, Standard, Control, Background,
or assigned maintenance command), ID, and dilution factor. Double click the ID field to
type an ID. Double click the Dilution field to type a dilution factor.

A command’s ID and Dilution fields have a blue border around them if they can be double
clicked to type information.

• Move Command - These arrows move a selected command up or down in the Command
Sequence list, changing the acquisition order.

• Import List - Opens the Open dialog box to import an existing command sequence list.

• Replicate Count - Defines a quantity of replicate sets from one to nine.

• Grouping - Selects the sequence in which the replicates are laid out in plate wells. The
options are:

• 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 on to the next set in

numerical order.

You can assign the following well commands. Each command is associated with a color. You
can click and drag to highlight a series of wells, click a column or row header to highlight the

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

• Unknown (U): Yellow

• Background (B): Purple

• Control (C): Red

• Standard (S): Green

The Delete and Start at Well commands are also available to assign as well commands.
Delete removes the well command for the selected well. The Start at Well command enables
you to begin acquisition at a well other than A1.

NOTE: You should first delete all standards from the plate layout if any of

the standards need to be rearranged, and all controls from the plate
layout if any of the controls need to be rearranged.

NOTE: Wells and commands you assign to the protocol plate layout are

saved into the protocol settings and execute each time you use the
protocol to run a batch. Standards and controls associated with a
given protocol typically remain constant, while the number of
unknown wells often vary. You can assign a specific number of
unknown wells to the plate when setting up a batch.

Commands - Assigns maintenance commands that run before or after single wells, ranges of
wells, and rows or columns of wells. Select a well, and then select one of the following
commands:

• Alcohol Flush

• Prime

• Sanitize

• Soak

• Wash

NOTE: These commands are run from a reservoir in the Off-Plate Area.

After selecting a maintenance command, click one of the following buttons:

• Before Well - The system performs the command before acquiring the well. An open dot
appears in the upper left corner of the selected well on the plate image. The command
appears in the command sequence list before the selected well.

• After Well - The system performs the command after acquiring the well. A closed dot
appears in the lower right corner of the selected well on the plate image. The command
appears in the command sequence list after the selected well.

• Clear Command - Select a well and click Clear Commands to remove all maintenance
commands from the well.

Plate - Specifies the plate to display in the plate image in the list. Add Plate adds a new plate
to the batch, and Delete Plate deletes the plate highlighted in the list.

Direction - Specifies the direction to run the plate commands. Select either horizontally or
vertically. The selected direction also dictates how wells are added to the plate when
assigning multiple unknowns, standards, and controls at one time.

Plate Navigation - Displays a smaller plate image for the current batch.

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