Luminex xPONENT for MAGPIX User Manual

xPONENT for MAGPIX 4.2

Software User Manual

Luminex Corporation, 2011. 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.

LUMINEX CORPORATION

12212 Technology Boulevard

Austin, Texas 78727-6115

U.S.A.

Voice: (512) 219-8020

Fax: (512) 219-5195

xPONENT 4.2 for MAGPIX Software User Manual

89-00002-00-239 rev. E

November 2011

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® 100™, Luminex® 100 IS®, 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.

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 support@luminexcorp.com 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 orders@luminexcorp.com or authorized resellers. For more information on obtaining updates from authorized resellers, see http:// www.luminexcorp.com.

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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 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.

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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 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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Standard Terms and Conditions for Use of Instrument Product

By opening the packaging containing this product ("Product") or by using such Product in any manner, you are consenting and agreeing to be bound by the following terms and conditions. You are also agreeing that the following terms and conditions constitute a legally valid and binding contract that is enforceable against you. If you do not agree to all of the terms and conditions set forth below, you must promptly return the Product for a full refund prior to using them in any manner.

1. Acceptance

ALL SALES ARE SUBJECT TO AND EXPRESSLY CONDITIONED UPON THE TERMS AND CONDITIONS CONTAINED HEREIN, AND UPON BUYER'S ASSENT THERETO. NO VARIATION OF THESE TERMS AND CONDITIONS SHALL BE BINDING UPON LUMINEX CORPORATION ("LUMINEX") UNLESS AGREED TO IN WRITING AND SIGNED BY AN AUTHORIZED REPRESENTATIVE OF LUMINEX. For purposes of this agreement, "Seller" shall mean either Luminex, if the Product is purchased directly from Luminex, or a Luminex authorized reseller. Buyer, by accepting the Product shall be deemed to have assented to the terms and conditions set forth herein, notwithstanding any terms contained in any prior or later communications from Buyer and whether or not Seller shall specifically or expressly object to any such terms.

2. Warranties

THIS WARRANTY IS APPLICABLE FOR PARTS AND SERVICE FOR LUMINEX INSTRUMENTS PURCHASED DIRECTLY FROM LUMINEX TO BUYER AND ONLY TO THE EXTENT SUCH INSTRUMENTS ARE LOCATED IN NORTH AMERICA AND THE COUNTRIES THAT COMPRISE THE EUROPEAN UNION. LUMINEX MAKES NO WARRANTY, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO PRODUCTS SOLD, DISTRIBUTED, LOCATED OR USED OUTSIDE OF NORTH AMERICA OR THE COUNTRIES COMPRISING THE EUROPEAN UNION. PRODUCTS SOLD OUTSIDE OF NORTH AMERICA OR THE COUNTRIES COMPRISING THE EUROPEAN UNION ARE SOLD ONLY ON AN "AS IS, WHERE IS" BASIS. NOTWITHSTANDING THE FOREGOING, LUMINEX SHALL PROVIDE BUYER A WARRANTY ON FIELD SERVICE PARTS PROCURED FROM LUMINEX FOR MAINTENANCE OF LUMINEX INSTRUMENTS IN ALL COUNTRIES IN THE WORLD AND PER THE TERMS AND CONDITIONS HEREIN. TO THE EXTENT THAT THE FOREGOING DISCLAIMERS ARE INVALID OR UNENFORCEABLE UNDER THE LAWS OF ANY JURISDICTION, THE WARRANTY, DISCLAIMER, LIMITATION OF LIABILITY AND OTHER PROVISIONS SET FORTH BELOW SHALL THEREUPON BE EFFECTIVE TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW.

Notwithstanding Buyer's acceptance thereof, if Product is purchased directly from Luminex, Luminex warrants that for a period of twelve (12) months from date of delivery that the Product shall conform in all material respects with the Product Specifications provided by Luminex with the Product. The warranty provided herein specifically excludes any software or

hardware not provided by Luminex. If Product is purchased from a Luminex authorized reseller, any warranty obligations shall be provided in writing directly by such Luminex authorized reseller to Buyer. THIS WARRANTY IS EXCLUSIVE AND LUMINEX MAKES NO OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Seller's warranties made in connection with this sale shall not be effective if Seller has determined, in its sole discretion, that Buyer has misused the Product in any manner, has failed to use the Product in accordance with industry standards or practices or has failed to use the Product in accordance with instructions, if any, furnished by Seller.

BUYER'S EXCLUSIVE REMEDY WITH RESPECT TO PRODUCT PROVED TO SELLER'S SATISFACTION TO BE DEFECTIVE OR NONCONFORMING SHALL BE REPAIR OR REPLACEMENT OF SUCH PRODUCTS WITHOUT CHARGE OR REFUND OF THE PURCHASE PRICE, IN SELLER'S SOLE DISCRETION, UPON THE RETURN OF SUCH PRODUCTS IN ACCORDANCE WITH SELLER'S INSTRUCTIONS BELOW. NEITHER SELLER NOR LUMINEX SHALL IN ANY EVENT BE LIABLE FOR INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES OF ANY KIND RESULTING FROM ANY USE OR FAILURE OF THE PRODUCT, EVEN IF SELLER OR LUMINEX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE INCLUDING, WITHOUT LIMITATION, LIABILITY FOR LOSS OF WORK IN PROGRESS, DOWN TIME, LOSS OF REVENUE OR PROFITS, FAILURE TO REALIZE SAVINGS, LOSS OF PRODUCTS OF BUYER OR OTHER USE OR ANY LIABILITY OF BUYER TO A THIRD PARTY ON ACCOUNT OF SUCH LOSS, OR FOR ANY LABOR OR ANY OTHER EXPENSE, DAMAGE OR LOSS OCCASIONED BY SUCH PRODUCT INCLUDING PERSONAL INJURY OR PROPERTY DAMAGE UNLESS SUCH PERSONAL INJURY OR PROPERTY DAMAGE IS CAUSED BY SELLER'S GROSS NEGLIGENCE.

In the event that Product is located outside of North America or the European Union and fails to conform to the warranty set forth herein, during the warranty period: (i) Buyer shall notify Luminex in a timely manner in writing that such Product failed to conform and shall furnish a detailed explanation of any alleged nonconformity; (ii) Buyer at it's expense will contract either Luminex or a Luminex trained service engineer to assess the issue and identify the defective FS-PART; and (ii) at Luminex's option and election, Buyer shall either return such nonconforming Product to Luminex's manufacturing facility or destroy such Product and provide Luminex with written certification of destruction. In the event that a FS-PART is returned to Luminex's manufacturing facility, Luminex may analyze such FS-PART for defects. In the event that Luminex determines that such FS-PART is not defective, the FSPART shall be shipped to Buyer then Buyer shall be responsible for the payment for such FSPART and related shipping charges. Furthermore, in the event that Luminex determines that such FS-PART is defective then Luminex shall be responsible for the payment for such FSPART and related shipping charges. Except as expressly provided herein, Buyer shall not have the right to return a Product to Luminex without Luminex's prior written consent.

3. Buyer's Use of Product

Buyer shall not use this Product for any commercial purpose, including without limitation performance of testing services, unless expressly agreed to in writing by Luminex or as specifically authorized by Luminex through a Luminex distributor. Buyer agrees that no rights or licenses under Luminex's patents shall be implied from the sale of the Product, except as expressly provided herein or as specifically agreed to in writing by Luminex, and Buyer does not receive any right under Luminex's patent rights hereunder. Buyer acknowledges and agrees that the Product are sold and licensed only for use with Luminex's laser based fluorescent analytical test instrumentation. Buyer further acknowledges that, unless otherwise

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indicated on the Product label, the Product has not received approval from the United States Food and Drug Administration or other federal, state or local regulatory agencies and have not been tested by Seller or Luminex for safety or efficacy in food, drug, medical device, cosmetic, commercial or any other use, unless otherwise stated in Seller's technical specifications or material data sheets furnished to Buyer. Buyer expressly represents and warrants to Seller that Buyer will use the Product in accordance with the Product label, if applicable, and will properly test and use any Product in accordance with the practices of a reasonable person who is an expert in the field and in strict compliance with the United States Food and Drug Administration and all applicable domestic and international laws and regulations, now and hereinafter enacted.

BUYER HEREBY GRANTS TO LUMINEX A NONEXCLUSIVE, WORLDWIDE, UNRESTRICTED, ROYALTY-FREE, FULLY PAID-UP LICENSE, WITH THE RIGHT TO GRANT AND AUTHORIZE SUBLICENSES, UNDER ANY AND ALL PATENT RIGHTS IN INVENTIONS COMPRISING MODIFICATIONS, EXTENSIONS, OR ENHANCEMENTS MADE BY BUYER TO THE PRODUCT OR TO THE MANUFACTURE OR USE OF THE PRODUCT ("IMPROVEMENT PATENTS"), TO MAKE, HAVE MADE, USE, IMPORT, OFFER FOR SALE OR SELL ANY AND ALL PRODUCT; EXPLOIT ANY AND ALL METHODS OR PROCESSES; AND OTHERWISE EXPLOIT IMPROVEMENT PATENTS FOR ALL PURPOSES. NOTWITHSTANDING THE FOREGOING, "IMPROVEMENT PATENTS" SPECIFICALLY EXCLUDES PATENT CLAIMS CONCEIVED AND REDUCED TO PRACTICE BY BUYER CONSISTING OF METHODS OF SAMPLE PREPARATION, METHODS OF CONJUGATING PRODUCT TO ANALYTES, THE COMPOSITION OF MATTER OF THE SPECIFIC CHEMISTRIES OF THE ASSAYS DEVELOPED BY BUYER AND METHODS OF PERFORMING THE ASSAYS (I.E., THE PROTOCOL FOR THE ASSAY).

Buyer has the responsibility and hereby expressly assumes the risk to verify the hazards and to conduct any further research necessary to learn the hazards involved in using the Product. Buyer also has the duty to warn Buyer's customers, employees, agents, assigns, officers, successors and any auxiliary or third party personnel (such as freight handlers, etc.) of any and all risks involved in using or handling the Product. Buyer agrees to comply with instructions, if any, furnished by Seller or Luminex relating to the use of the Product and not misuse the Product in any manner. Buyer shall not reverse engineer, decompile, disassemble or modify the Product. Buyer acknowledges that Luminex retains ownership of all patents, trademarks, trade secrets and other proprietary rights relating to or residing in the Product and Buyer receives no rights to such intellectual property rights by virtue of its purchase of Product other than as expressly set forth herein. Buyer shall have no right to use any trademarks owned or licensed to Luminex without the express written permission of Luminex.

4. Buyer's Representations, Release and Indemnity

Buyer represents and warrants that it shall use the Product in accordance with Paragraph 2, "Buyer's Use of Product," and that any such use of Product will not violate any law, regulation, judicial order or injunction. Buyer agrees to release, discharge, disclaim and renounce any and all claims, demands, actions, causes of action and/or suits in law or equity, now existing or hereafter arising, whether known or unknown, against Seller and Luminex, and their respective officers, directors, employees, agents, successors and assigns (collectively the "Released Parties"), with respect to the use of the Product. Buyer agrees to indemnify and hold harmless the Released Parties from and against any suits, losses, claims, demands, liabilities, costs and expenses (including attorney, accounting, expert witness, and consulting fees) that any of the Released Parties may sustain or incur as a result of any claim against such Released Party based upon negligence, breach of warranty, strict liability in tort,

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contract or any other theory of law or equity arising out of, directly or indirectly, the use of the Product or by reason of Buyer's failure to perform its obligations contained herein. Buyer shall fully cooperate with the Released Parties in the investigation and determination of the cause of any accident involving the Product which results in personal injury or property damage and shall make available to the Released Parties all statements, reports, recordings and tests made by Buyer or made available to Buyer by others.

5. Patent Disclaimer

Neither Seller nor Luminex warrants that the use or sale of the Product will not infringe the claims of any United States or other patents covering the product itself or the use thereof in combination with other products or in the operation of any process.

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

Safety Precautions .......................................................................................................................................1

Elements of the Software .............................................................................................................................1

Home Page ...........................................................................................................................................1

Screen Elements ...................................................................................................................................3

System Monitor .....................................................................................................................................4

Help .......................................................................................................................................................5

Quick Start .............................................................................................................................................6

System Info Tab ....................................................................................................................................6

Basic Procedures .........................................................................................................................................7

Starting xPONENT ................................................................................................................................7

Adding a New License Key ...................................................................................................................8

Logging On to xPONENT ......................................................................................................................8

Initial Startup .........................................................................................................................................9

Daily Activities .....................................................................................................................................13

Shutting Down the Analyzer ................................................................................................................13

Logging Off and Exiting .......................................................................................................................14

Using Online Help ...............................................................................................................................14

Luminex Support ........................................................................................................................................15

Luminex Website .................................................................................................................................15

Contacting Technical Support .............................................................................................................15

Software Packages ....................................................................................................................................15

MAGPIX Technology .................................................................................................................................16

Running Assays with MAGPIX ..................................................................................................................17

General Guidelines ..............................................................................................................................17

Biological Samples ..............................................................................................................................18

Bead (Microsphere) Handling ..............................................................................................................18

Repetitive MagPlex Bead Measurements ...........................................................................................18

Classification and Reporter Fluorochromes ........................................................................................19

Fluidics 1 and Fluidics 2 ......................................................................................................................19

Sample Volume ...................................................................................................................................19

Plates ..................................................................................................................................................20

Chapter 2 Samples Page ..................................................................................................23

Samples Page Functionality ......................................................................................................................23

Edit Samples and Create Sample Subtab .................................................................................................24

Creating a New Sample List ................................................................................................................25

Editing a Sample List ...........................................................................................................................27

Chapter 3 Batches Page ...................................................................................................29

Batches Page Functionality .......................................................................................................................29

Setting Up Batches ....................................................................................................................................30

Using the Batches Page ............................................................................................................................30

Create a New Batch from an existing Protocol ....................................................................................31

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

Create a New Multi-Batch ................................................................................................................... 50

Batch Procedures ......................................................................................................................................52

Running a Pending Batch ....................................................................................................................52

Importing a Batch ................................................................................................................................52

Exporting a Batch ................................................................................................................................53

Editing a Batch ....................................................................................................................................53

Deleting a Batch ..................................................................................................................................54

Chapter 4 Results Page ....................................................................................................55

Results Page Functionality ........................................................................................................................55

Performing Analysis ...................................................................................................................................56

Current Batch Tab ..................................................................................................................................... 57

Saved Batches Tab ................................................................................................................................... 61

Replaying a Batch ...............................................................................................................................65

Results Subtab ....................................................................................................................................66

Settings Subtab ..................................................................................................................................70

Log Subtab ..........................................................................................................................................71

Sample Details Subtab ........................................................................................................................72

LIS Results Tab .........................................................................................................................................73

Reports Tab ...............................................................................................................................................75

Generating a Report ............................................................................................................................76

Chapter 5 Protocols Page .................................................................................................77

Protocols Page Functionality .....................................................................................................................77

Protocol Procedures ..................................................................................................................................78

Creating an Allele Call Protocol ...........................................................................................................78

Creating a Quantitative Assay Protocol ...............................................................................................79

Creating a Qualitative Assay Protocol .................................................................................................82

Deleting a Protocol ..............................................................................................................................83

Editing a Protocol ................................................................................................................................83

Exporting a Protocol ............................................................................................................................84

Importing a Protocol ............................................................................................................................84

Adding a New Lot for Protocol .............................................................................................................84

Lots and Kits Procedures ...........................................................................................................................84

Creating a Lot ......................................................................................................................................84

Editing a Lot ........................................................................................................................................ 85

Deleting a Lot ......................................................................................................................................85

Exporting a Lot ....................................................................................................................................85

Importing a Lot .................................................................................................................................... 85

Creating a Kit .......................................................................................................................................85

Protocols Tab .............................................................................................................................................86

Settings Subtab ...................................................................................................................................87

Plate Layout Subtab ............................................................................................................................90

Standards and Controls (Stds/Ctrls) Details Subtab ..........................................................................93

Analytes Subtab ..................................................................................................................................94

Standards and Controls (Stds & Ctrls) Tab ............................................................................................... 99

Standards and Controls (Stds/Ctrls) Details Subtab ........................................................................100

Chapter 6 Maintenance Page .........................................................................................103

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

System Initialization ...........................................................................................................................105

Running the Performance Verification Routine .................................................................................105

Running Calibration and Verification .................................................................................................106

Lot Management Tab ...............................................................................................................................106

Importing CAL or VER Kits ................................................................................................................107

Deleting CAL and VER Kit Information ..............................................................................................108

Commands and Routines (Cmds & Routines) Tab ..................................................................................108

Creating a New Routine ....................................................................................................................111

Editing a Routine ...............................................................................................................................112

Deleting a Routine .............................................................................................................................112

Running a Routine .............................................................................................................................112

Importing a Routine ...........................................................................................................................113

Exporting a Routine ...........................................................................................................................113

Probe and Heater Tab .............................................................................................................................113

Adjusting the Sample Probe Height ..................................................................................................115

System Info Tab .......................................................................................................................................117

System Status Tab ..................................................................................................................................118

Schedule Tab ...........................................................................................................................................119

Support Utility Tab ...................................................................................................................................120

Sending a Support.zip File ................................................................................................................121

Chapter 7 Admin Page ....................................................................................................123

System Setup Tab ...................................................................................................................................123

Adding an External Analysis Program ...............................................................................................125

Editing an Analysis Program .............................................................................................................126

Removing an Analysis Program ........................................................................................................126

Arranging Main Navigation Buttons ...................................................................................................126

Maintenance Options ........................................................................................................................126

Group Setup Tab .....................................................................................................................................128

Setting Up Group Permissions ..........................................................................................................131

User Setup Tab ........................................................................................................................................131

Create User Account Window ...........................................................................................................132

Edit User Account Window ................................................................................................................133

Define Global User Settings ..............................................................................................................135

Batch Options Tab ...................................................................................................................................135

Alert Options Tab .....................................................................................................................................138

Alert Options Tasks ...........................................................................................................................140

CSV Options Tab .....................................................................................................................................140

Archive Options Tab ................................................................................................................................142

Archive Utility .....................................................................................................................................142

Licensing Tab ..........................................................................................................................................146

Adding a New License Key ...............................................................................................................147

Schedule Tab ...........................................................................................................................................147

Editing Maintenance Schedule Settings ............................................................................................148

Report Options Tab .................................................................................................................................149

Table of Contents

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Chapter 1: Introduction

Safety Precautions

DANGER: Samples and waste fluid can contain biohazardous infectious

agents. Handle them at Biosafety level 2, as recommended for any potentially infectious human serum or blood specimen in the DCE/NIH manual, Biosafety in Microbiological and Biomedical Laboratories, 1984.

CAUTION: Although beads do not contain hazardous or carcinogenic

components at toxic levels, they can be toxic if swallowed. In addition, contact with acids liberates toxic gases. If beads come into contact with skin, wash immediately with copious amounts of water. In case of an accident, seek medical advice immediately and show the product label or container to your medical provider. A material safety data sheet (MSDS) is available upon request.

CAUTION: Luminex reagents can contain ProClin® as a preservative. This

can cause an allergic reaction in some people. Use personal protective equipment (PPE), including gloves and safety glasses. Check the assay package insert for assay component information.

NOTE: Do not use strong organic solvents with this instrument. Contact

Luminex Technical Support when in doubt about compatibility of cleaning and decontamination agents or materials.

Elements of the Software

Home Page

Home > Home

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

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 from a New Protocol - Creates a new batch from a new

protocol. This allows you to create a new protocol while you are creating the batch. Choose this function if you want to quickly create a batch and run it and you do not already have a protocol that is appropriate for use. This is useful for one time batches you do not expect to rerun frequently. However, you always have the option of saving a protocol once a batch is created.

• Click to Create a new Batch using the highlighted Protocol below - Creates a new batch using a selected protocol from the Installed Protocols list.

• 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.

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• 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.

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

Maintenance page.

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

• Sys Info - Opens the System Info tab of the Maintenance page.

• Reports - Opens the Reports tab of the Results page.

Screen Elements

This section shows screen elements and the terms used in this help or book to describe them.

Introduction

Navigation Elements

1. Page - Across the window, above the content pane, are pages. Click a page to go to that

part of xPONENT.

2. Tab - On the left side of the window, along the left side of the content pane, are tabs.

Click a tab to go to that subsection of the software.

3. Subtab - A tab can have one or more subtabs. These are located below the tab, are

smaller, and are identified by the circle on the left end of the subtab. The circle is red when the subtab is open. For some workflows, you must move through the subtabs of a tab sequentially, completing the work on one subtab and clicking Next to move to the next subtab.

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 right-clicked.

• 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 dialog box. Use the Browse button to select a location, file name, and file type (either a text or CSV file) for the export. 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 is displayed at the bottom of all xPONENT windows. It displays the physical state of the Luminex system. Values are reported directly from the Luminex system.

1. System Status Button 2. Connection Status

3. Check Cal/Ver Status 4.Command Display

5. Progress bar, Stop button, Pause button 6. Eject Button for plate carrier

7. Drive Fluid Level 8. Waste Fluid Level

xPONENT for MAGPIX 4.2 Software User Manual 4

9. Delta Cal Temperature 10. XY Status

11. Power Off button

System Status Button - This button has two functions: When clicked, it opens the system log. 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, out of calibration condition, or other important user notification, the button is yellow with an exclamation point.

Connection Status - Displays the status of the analyzer’s connection to the PC (Connected or Disconnected). To ensure the analyzer connects to the PC, turn on the analyzer before you start xPONENT.

Check Cal/Ver - If this displays a white X, there is a failed calibration or verification. Click the scales to open the System Information tab to see details about the last calibration and other important instrument information.

Command Display - Displays the following:

• The command currently running.

• The system state (i.e. running, idle, etc.).

• Date and time.

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. Pause the system before stopping it so that it will finish the current command and store the pending batch and then resume exactly where it left off.

Stop - Stops the system, regardless of command status. Use this only if it does not matter whether the data from the current well is lost.

Help

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 the system was calibrated, in degrees Celsius. If the temperature is out of tolerance, this shows a high or low arrow. When clicked, it opens the Auto Maint 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 & Heater tab.

Drive Fluid Level - The Drive Fluid liquid level sensor warns you when the Drive Fluid is low. There can be enough Drive Fluid left in the container to finish a plate. The system does NOT stop until a air bubble is detected in the line coming from the Drive Fluid container.

Waste Fluid Level - The waste fluid container liquid level sensor stops the current plate if the waste container is full.

To display online help for the tab in which you are currently working, click the blue “i” icon at the upper right of the xPONENT window. This opens a help window with information specific to that tab.

To display system-level help, click the blue question mark at the top of the xPONENT window, then click Contents and Index. The online help opens and you can navigate to any available topic.

Introduction

To display quick start information, click the blue question mark at the top of the xPONENT window, then click Quick Start. This displays information about the seven basic steps to start the system.

Quick Start

The five steps to starting and using xPONENT are the following:

To Go to Expanded Help

Adjust the sample probe height Home > Probe and Heater Adjusting the Sample Probe

Initialize the system Home > System Initialization Running the System Initialization

Routine

Run an assay Home > Create a new Batch

Analyze Results > Saved Batches Performing Analysis

Print reports Results > Reports Reports Tab

System Info Tab

Maintenance > System Info

from a new protocol, or Home > Create a new Batch using the highlighted protocol below

Create a New Batch from a New Protocol

Create a New Batch from an Existing Protocol

Use this tab to view information and diagnostics about the Luminex instrument.

This tab contains the following information:

• Software

• Version

• Operating System

• Licensing

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• Instrument Type

• Serial Number

• Firmware Version

• XYP Heater Temp

• Calibration/Verification Status

• Delta Calibration Temp

• System Temperature

• Last CAL Calibration

• Last VER Verification

• Last Fluidics Test

• Drive Fluid

• Waste Fluid

Items in this list relating to calibration and verification have one of the following states:

• Passed - Indicates that the process completed successfully.

• Failed - Indicates that the process was not completed successfully. Failed items appear in red.

• Not Current - Indicates that verifiers are not current. Verifiers are not current if you have not calibrated the system since the last time you ran the verifiers.

• Not Yet Run - Indicates that this process has not yet been run on the machine.

Copy - Copies the system information to the Windows clipboard. You can then paste it into a text editor such as Notepad.

Save - Opens the Save As dialog box to specify a file name and location to save the system information file.

Basic Procedures

Starting xPONENT

Perform the following steps to launch xPONENT:

• On the PC desktop, click the Luminex xPONENT icon, or click Start > All Programs > Luminex > xPONENT > Luminex xPONENT.

• If you have a trial license, contact Luminex Technical Support to obtain a full license, or click OK in the dialog box to continue.

• If this is the first time you have started the software, the User License Agreement may display. Read the license agreement. Select I accept the terms of this license

agreement, then click OK.

NOTE: For safety and legal information, refer to the MAGPIX Installation and

Hardware User Manual that you received with your instrument.

Introduction

Adding a New License Key

Contact Luminex Technical Support if you have any difficulty saving or adding a new license key.

1. Access the Admin page, then the Licensing tab.

2. Click License (bottom right corner of window).

3. Copy and paste the new key into the License Code field. The License File field remains

blank.

4. Click OK. This closes xPONENT, applies the license, and restarts xPONENT.

Logging On to xPONENT

If your version of xPONENT is licensed for 21 CFR Part 11, Security, or both, an application administrator must set up user IDs (and passwords, if required). If you are not using a version with 21 CFR Part 11, the security module, or both, users can log in with any username or with no username.

NOTE: Contact Luminex Technical Support if you have problems logging on.

If you want to purchase a license for 21 CFR Part 11 or the security module, contact Luminex to place an order.

xPONENT for MAGPIX 4.2 Software User Manual 8

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

inaccurate data and test results. Users of xPONENT must read the documentation thoroughly before operating the software.

1. On the System Login tab, type your user ID.

2. If you are using a secure version of the software, type your password. The Home page

opens.

Initial Startup

When you turn on the system for the first time, perform the following procedures:

Introduction

1. Adjusting the Sample Probe Height

2. Revive After Storage (Luminex) Routine

3. Calibration/Verification

Adjusting the Sample Probe Height

Adjust the sample probe height to ensure that the probe drops far enough into the well to acquire sample.

NOTE: Ensure that there is no liquid in the wells or reservoirs before

adjusting the sample probe height.

1. On the Home page, click Probe and Heater under Daily Activities. The Probe &

Heater tab opens.

2. Use well D6 (this is the center of a standard 96-well plate).

3. Ensure that the well location is selected on the plate image. A green pin marks the

selected well.

4. Based on the type of plate you are using, place alignment disks or an alignment sphere in

the well.

• For a standard 96-well plate - none

• For a Filter-bottom plate - two 5.08 mm disks

• For a Mylar-bottom plate - two 5.08 mm disks

• For a conical (v-shaped) plate - one sphere

5. Click Eject to eject the plate carrier.

6. Place the off plate reagent block on the plate carrier. Make sure it is well seated so that it

clips into place.

7. Place a strip well (provided with the Calibration and the Performance Verification kit) in

the off-plate reagent block.

8. In the Strip Wells section, click SD1.

9. Verify that the reservoir is empty.

10. In the Reservoir section, click well RB1.

11. Verify that the plate is not warped. Warped plates can lead to incorrect probe height

adjustment.

12. Place the plate on the plate carrier with well A1 positioned as indicated on the plate

carrier.

13. Click Retract to retract the plate carrier.

14. Type a name for the plate in the Plate Name box.

15. Click Auto Adjust Height. The probe automatically adjusts itself to the locations you

selected.

NOTE: The probe height is automatically set to 0.98 mm. The probe

automatically adjusts this distance from the bottom of the plate, or calibration disks or spheres.

16. Click Eject to eject the plate holder. If you used alignment disks or spheres, remove them

from the plate.

xPONENT for MAGPIX 4.2 Software User Manual 10

NOTE: When you adjust and save the probe height settings for all three

areas under a plate name, all areas retain the adjustment.

WARNING: Correct sample probe height is critical to successful sample

acquisition and calibration. Problems with the sample probe can lead to fluid leaks and inhibit sample acquisition.

CAUTION: Ensure that the probe height is set correctly before calibrating

the system.

FIGURE 1.

Sample Probe Height Adjustment

Revive After Storage Routine

NOTE: The Revive After Storage routine is necessary when the system

runs for the first time and is recommended when the system has been idle for more than a week.

After you have adjusted the sample probe height, run the Revive After Storage (Luminex) routine.

1. Open the Maintenance page, then the Cmds & Routines tab.

2. Select Revive After Storage (Luminex) from the drop-down list. The Revive After

Storage routine performs the following commands:

• Prime

• Rinse

• Alcohol Flush

• Rinse

Introduction

3. Add 70% isopropanol or ethanol to reservoir RB1 on the off-plate reagent block as

indicated on the Cmds & Routines tab.

NOTE: The rinse reservoir (RD1) should be empty.

4. Click Retract.

5. Click Run.

After the Revive After Storage routine is complete, run the System Initialization routine.

System Initialization

xPONENT for MAGPIX contains a pre-defined routine to prepare the analyzer for data acquisition. This section describes calibration and performance verification of the system.

Calibrator magnetic beads are used to normalize the settings for the reporter channel and classification channels. Verification magnetic beads are used to verify calibration and optical integrity of the system. Fluidics beads are used to assess well-to-well carryover.

If the system is not fully calibrated, a warning message opens.

Once calibrated, the values remain until you recalibrate. You can track system calibration and verification results through the Calibration and Verification report. Target value information for calibration and verification beads is available on the Luminex website at http:// www.luminexcorp.com/Support/index.htm.

Calibrate your system at least once a week using the Calibration/Verification button on the Auto Maint tab of the Maintenance page. In addition, recalibrate the system if any of the following things occur:

• The delta calibration temperature exceeds ± 5° C.

• You move the instrument.

• You experience sample acquisition problems.

• The instrument undergoes hardware maintenance, such as replacement of a part.

Verify the system daily using the Performance Verification button on the Auto Maint tab of the Maintenance page. Refer to your assay kit instructions for additional calibration frequency requirements.

Before you can calibrate the system, you must import MAGPIX calibrator and verification bead lot information. Do this using the Lot Management tab of the Maintenance page. This information is available on the CD that accompanies the Performance Verification Kit and Calibration Kit, and is also available on the Luminex website at http://www.luminexcorp.com/ Support/index.htm.

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Running the System Initialization Routine

1. On the Home page, click System Initialization under Daily Activities. The Auto Maint

tab opens. On the Auto Maint tab, the System Initialization option is automatically selected.

2. Verify that the correct lot kit is displayed in the Calibration and Performance

Verification drop down field and that the correct reagents (for example, VER and Fluidics reagents) have been added to the off-plate reagent block.

3. Fill reservoir RB1 3/4 full of 70% isopropanol or ethanol.

4. Verify that the Rinse reservoir RD1 is empty.

5. Click Retract.

6. Click Run.

Daily Activities

System Initialization - Perform a system initialization routine.

NOTE: Luminex recommends weekly calibration and daily verification. For

Shutdown - Perform the shutdown routine.

Probe and Heater - Adjust the probe height or plate heater.

Drive Fluid Lot - Enter the Drive Fluid lot number, which is printed on the box in which the

fluid container was shipped. This information is optional.

Create a New Batch from a new Protocol - Creates a new batch from a new protocol by opening the Settings tab of the Batches page. You can create protocols while creating a batch, and can save the protocol before or after you run the batch.

Create a New Batch from the highlighted Protocol below - Creates a new batch using a selected protocol from the Installed Protocols list. This button displays the same fields as the Create a new batch from existing Protocol button on the Batches page.

Scroll - Use the up and down arrows to scroll through the list of installed 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.

Sys Info - Opens the System Info tab of the Maintenance page. If the instrument is connected and powered on, the System Information page displays licensing information, the instrument serial number, the date of the last Calibration, Verification, Fluidics tests, and other important information.

Reports - Opens the Reports tab of the Results page.

daily use, verify your System Initialization setting is set to Fluidics Prep and Performance Verification in the Admin System Setup tab. Refer to Maintenance Page for detailed maintenance instructions.

Return to the Home page at any time by clicking Home at the top of the screen.

Shutting Down the Analyzer

Run the daily shutdown routine to prevent clogs and crystallization of salt in the sample probe. Clogs and crystallization of salt in the sample probe can cause problems with calibration, verification, and data acquistion; they can also cause sample splashing. Shut down the system properly to ensure system integrity.

Introduction

1. On the Home page, click Shutdown. The Auto Maint tab opens, with System

Shutdown selected.

2. Click Eject.

3. Fill reservoir RA1 with 3/4 of DI water.

4. Fill reservoir RC1 with 3/4 of 10%-20% household bleach solution.

5. Verify that reservoir RD1 is empty.

6. Click Retract.

7. Click Run.

Logging Off and Exiting

To log off and exit xPONENT:

1. Click Logoff at the top of the page.

2. When the Confirm dialog box opens, click OK. This opens the Log In page, with Exit on

the left tab.

3. Click Exit to exit the application.

Using Online Help

English-language help is available at all times while you are using xPONENT. To display online help for the page or tab in which you are currently working, click the blue “i” icon at the upper-right of the xPONENT window. This opens a help window with information specific to that page or tab.

xPONENT for MAGPIX 4.2 Software User Manual 14

To display system-level help, click the blue question mark at the top of the xPONENT window, then click Contents and Index. The online help opens, where you can navigate to any available topic.

To display quick start information, click the blue question mark at the top of the xPONENT window, then click Quick Start. This displays information about the basic steps to start the system.

To display software information, click the blue question mark at the top of the xPONENT window, then click About Luminex xPONENT. The xPONENT information dialog box opens, displaying the software version information.

Luminex Support

Luminex Website

Additional information is available on the Luminex website. FAQs are available at http:// www.luminexcorp.com/Support/index.htm.

You can access the Technical Support Website using a user name and password at https:// oraweb.luminexcorp.com/OA_HTML/jtflogin.jsp.

Contacting Technical Support

Luminex Technical Support representatives are ready to help you. If the question or problem relates to materials from the assay kit, contact the kit provider directly.

Luminex Technical Support is available to users in the U.S. and Canada by calling 1-877-785-BEAD (2323). Users outside of the U.S. and Canada can contact us at +1 512-381-4397. Inquiries may also be sent by email to support@luminexcorp.com.

Software Packages

Multiple levels of user access can be licensed for xPONENT.

Basic - Allows instrument control.

Additional features for which you can obtain a license:

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

• 21 CFR Part 11 - Includes all of the Secure package features as well as the option to require electronic signatures to perform certain tasks. (Electronic signatures are listed in the system log.)

• Automation - Includes the ability to communicate with external hardware.

• Allele - Enables you to use allelic ratios.

Introduction

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

• LIS - Enables the system to communicate with an external Laboratory Information System (LIS) database. The LIS package enables you to export and import patient result data in ASTM file format.

You must have an instrument control license to operate the instrument.

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

MAGPIX Technology

The MAGPIX system operates by using magnetic beads (microspheres) that are coated with a reagent specific to a particular bioassay, enabling the capture and detection of specific analytes from a sample. The sample mixture is aspirated by the sample probe and conveyed via Drive Fluid into the camera chamber, where the beads are pulled down into a monolayer by the magnet, immobilized, and imaged. Within the chamber, beads are exposed to a red LED and a green LED, which excite both the internal dyes that identify each bead’s color signature and the reporter fluorescence from the surface of the beads. The red LED is responsible for classifying the beads. The CL1 and CL2 filters function to categorize the beads based on color signature and place them properly on the bead map as well as throw out any doublets that may exist. The green LED with the RP1 filter excites the reporter fluorescence, which identifies the quantity of analyte captured for each bead region. The beads are then flushed to the waste container, clearing room for the next sample.

Calibration is important to ensure that the optical system functions effectively and that different Luminex MAGPIX systems report similar results. Calibrating the MAGPIX system normalizes the settings for the classification channels (CL1 and CL2) and the reporter channel (RP1). Use the Luminex MAGPIX Calibration Kit to accomplish this.

Following calibration, use the Luminex MAGPIX Performance Verification Kit to check all of the optical channels in the system for correct calibration. It is essential to verify every time you calibrate. If there is a problem with optical integrity or fluidics, MAGPIX may pass calibration but fail performance verification. The Luminex MAGPIX Performance Verification Kit includes reagents to verify the calibration and optical integrity for the Luminex MAGPIX system as well as reagents to verify the fluidics channels using observations of bead count and well-to-well carryover.

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FIGURE 2.

LED Image-Based Analysis

1 Beads in chamber

2 Red LED (635 nm)

3 CCD Imager

4 Green LED (525 nm)

Running Assays with MAGPIX

General Guidelines

WARNING: Modifying or deleting xPONENT system files can cause

degradation of system performance. Repair modified or deleted xPONENT system files by uninstalling and re-installing the xPONENT software. Luminex recommends that you contact Luminex Technical Support before uninstalling and reinstalling xPONENT.

WARNING: Using unauthorized third-party software with xPONENT

software can result in corruption or failure of the xPONENT software. Use third-party software at your own risk. The operation of the system software is validated only when it runs alone on the dedicated PC.

NOTE: If you are using a screen saver on the PC on which xPONENT is

installed, xPONENT prevents it from activating. A dialog box opens each time xPONENT is launched, recommending that the screen saver and any power management settings be turned off.

Introduction

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