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.

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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

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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

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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.

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For In Vitro Diagnostic Use

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xPONENT® 3.1 Rev. 2 Software User Manual vi

For In Vitro Diagnostic Use

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

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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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xPONENT® 3.1 Rev. 2 Software User Manual x

For In Vitro Diagnostic Use

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. Definitions

Type of Note	Meaning
NOTE	This message is used to provide general helpful
	information. No safety or performance issues are
	involved.
CAUTION	This message is used in cases where the hazard
	is minor or only a potential hazard is present.
	Failure to comply with the caution may result in
	hazardous conditions.
WARNING	This message is used in cases when danger to
	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,		Heat/Hot Surface Warning
	Biological Hazard
	General Warning,		Authorized Representative in
	Caution, or Risk of		the European Community
	Danger

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TABLE 2. Symbols Continued

Manufacturer

In-vitro Diagnostic Device

Conformité

Europeénne

(European Union

Conformity)

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.

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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	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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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. Reporter Fluorchromes Wavelengths

	R-Phycoerythrin	Alexa 532
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

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)

•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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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

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.

Help

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.

Log Off

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

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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

1 Page

2 Tab

3Right-click Menu

•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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•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 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

9Total Events status

•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.

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	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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•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.

Samples

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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•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.

Batches

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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