Luminex xPONENT for MAGPIX User Manual

xPONENT for MAGPIX

Software User Manual IVD

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 for MAGPIX Software User Manual IVD

PN 89-00002-00-273 Rev B

January 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® Microspheres, LabMAP, xTAG

Microspheres, LumAvidin®, SeroMAP™ Microspheres, xMAP® FLEXMIR®, xMAP® FLEXMIR v2, xTAG® Kit for Factor V,II and MTHFR 677/1298, xTAG® Kit for CYP2C19, xTAG® Kit for CYP2D6, xTAG® Kit for CYP2C9+VKORC1, xTAG® Respiratory Viral Panel, xMAP® Flock Monitor™, xMAP® NeoPlex4™, xMAP® Pneumo14, xTAG® Ashkenazi Jewish Panel, xTAG

Cystic Fibrosis Kit.

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

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 DIRECTLLY 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

xPONENT for MAGPIX ii

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

iii

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,

xPONENT for MAGPIX iv

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.

End-User License Agreement (EULA) for Luminex 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.

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.

xPONENT for MAGPIX vi

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 three (3) additional computers 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. 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.

vii

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.

NO WARRANTY. THE SOFTWARE IS LICENSED “AS IS.” ANY USE OF THE

8. 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.

xPONENT for MAGPIX viii

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

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

About This Manual .......................................................................................................................................2

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

General Guidelines ......................................................................................................................................2

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

Bead (Microsphere) Handling

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

MAGPIX Technology .............................................................................................................................4

Repetitive MagPlex Bead Measurements .............................................................................................5

Classification and Reporter Fluorochromes ..........................................................................................6

Fluidics 1 and Fluidics 2 ........................................................................................................................6

Sample Volume .....................................................................................................................................6

Plates ....................................................................................................................................................7

Touch Screen ........................................................................................................................................7

................................................................................................................3

Chapter 2 Application Administrator Tasks .....................................................................9

System Setup ..............................................................................................................................................9

Viewing System Status

Application Settings .............................................................................................................................10

LIS Settings .........................................................................................................................................11

External Analysis Program Settings ....................................................................................................11

Arranging Main Navigation Buttons .....................................................................................................13

Maintenance Options ..........................................................................................................................13

Group Setup Tab .................................................................................................................................13

Setting Up Group Permissions ............................................................................................................16

User Setup .................................................................................................................................................16

User Setup Tab ...................................................................................................................................17

Global User Settings ...........................................................................................................................17

Create User Account Screen ...............................................................................................................18

Batch Options Tab ...............................................................................................................................19

Alert Options Tab ................................................................................................................................21

CSV Options Tab ................................................................................................................................24

Archive Options Tab ............................................................................................................................26

Licensing Tab ......................................................................................................................................28

Schedule Tab ......................................................................................................................................29

Report Options Tab .............................................................................................................................29

........................................................................................................................10

Chapter 3 Using xPONENT ...............................................................................................31

Starting xPONENT .....................................................................................................................................31

Initial Startup ..............................................................................................................................................31

Logging In to xPONENT ............................................................................................................................31

Logging Off of and Exiting xPONENT ........................................................................................................32

Using Online Help ......................................................................................................................................32

Screen elements ........................................................................................................................................32

System Monitor ..........................................................................................................................................34

Home Page ................................................................................................................................................35

Daily Activities .....................................................................................................................................36

Adjusting the Sample Probe Height ...........................................................................................................37

System Initialization ...................................................................................................................................38

Adding or Importing CAL and VER Kit Information ............................................................................. 39

Setting Up the System Initialization Routine ....................................................................................... 39

Running System Initialization ..............................................................................................................40

Exporting CAL or VER Kits

Deleting CAL and VER Kit Information ................................................................................................41

Creating Calibration and Verification Reports .....................................................................................41

Setting Up Batches ....................................................................................................................................41

Batches Page ............................................................................................................................................ 41

Using the Batches Page ......................................................................................................................43

Create a New Batch from an existing Protocol ....................................................................................43

Create a New Batch from a new Protocol ...........................................................................................44

Create a New Multi-Batch ................................................................................................................... 45

Running a Batch ..................................................................................................................................50

Importing a Batch ................................................................................................................................50

Exporting a Batch ................................................................................................................................50

Delete Batch ........................................................................................................................................50

Editing a Batch ....................................................................................................................................51

Settings Tab .......................................................................................................................................51

Analytes Tab ....................................................................................................................................... 53

Protocols Tab ......................................................................................................................................56

Stds and Ctrls Tab ...............................................................................................................................57

Managing Sample Lists ............................................................................................................................. 59

Create Sample Tab .............................................................................................................................61

Performing Analysis ...................................................................................................................................63

Current Batch Tab ...............................................................................................................................64

Select Replay Mode ............................................................................................................................68

Analyzing a Saved Batch .................................................................................................................... 69

Results Page ............................................................................................................................................. 72

Results Tab .........................................................................................................................................72

Settings Tab ........................................................................................................................................74

Log Tab ...............................................................................................................................................77

Sample Details Tab .............................................................................................................................78

LIS Results Tab ...................................................................................................................................79

Reports Tab .........................................................................................................................................80

Using Protocols, Lots, and Kits ..................................................................................................................82

Creating an Allele Call Protocol ...........................................................................................................82

Importing a Protocol ............................................................................................................................83

Adding a New Lot for Protocol .............................................................................................................83

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

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

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

.................................................................................................................40

Chapter 4 Performing System Maintenance ...................................................................87

Initial Startup ..............................................................................................................................................87

Adjusting the Sample Probe Height .................................................................................................... 87

xPONENT for MAGPIX x

Revive After Storage Routine ..............................................................................................................89

Calibration/Verification Routine ...........................................................................................................90

Daily Activities ............................................................................................................................................91

Defining the System Initialization Routine ...........................................................................................91

Running the System Initialization Routine ...........................................................................................91

Auto Maint Tab ..........................................................................................................................................92

Lot Management Tab ..........................................................................................................................94

Performing Individual Maintenance Commands ........................................................................................95

Cmds and Routines Tab ......................................................................................................................95

Probe and Heater Tab .............................................................................................................................101

System Info Tab .......................................................................................................................................102

System Status Tab ............................................................................................................................104

Support Utility Tab ...................................................................................................................................106

Sending a Support File ......................................................................................................................106

Shutting Down the Analyzer ....................................................................................................................107

Contacting Technical Support ..................................................................................................................107

Viewing the Luminex Website ..................................................................................................................107

Glossary ...........................................................................................................................109

Table of Contents

xPONENT for MAGPIX xii

Chapter 1: Introduction

Luminex® xPONENT® for MAGPIX® (xPONENT 4.1) IVD software was developed to improve workflow and efficiency in the laboratory. Designed for ease-of-use, xPONENT enables both new and advanced users to set up and run assays in a minimal amount of time.

This manual describes the features and functions of xPONENT for MAGPIX. To ensure that you have the most up-to-date version of this manual, visit http://www.luminexcorp.com/ support/tech_manuals.html. Versions of this manual in languages other than English are available on the Luminex website.

Software Packages

Multiple levels of user access can be licensed for xPONENT.

• Basic - Allows instrument control.

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

Additional features for which you can obtain a license:

• 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.

• 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.

About This Manual

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

Warnings, Notes and Symbols

The following informational notes and warnings are used in this manual.

NOTE: This message is used to provide general helpful information.

CAUTION: A caution advises users that failure to take or avoid a specific

action can result in loss of data.

WARNING: A warning advises users that failure to take or avoid a specific

action can result in physical harm to the user or the hardware.

You may encounter the following symbols while using xPONENT for MAGPIX. These represent warnings, conditions, identifications, and important information.

General Guidelines

Warning, Biological Hazard Heat/Hot Surface Warning

General Warning

Caution, Risk of Danger

Manufacturer Reference Manual

In Vitro Diagnostic

European Representative

xPONENT for MAGPIX 2

CAUTION: Modifying or deleting xPONENT system files may cause

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

CAUTION: Using 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.

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

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

CAUTION: This system contains electrical and mechanical components that,

if handled improperly, are potentially harmful. In addition, biological hazards may be present while operating the system. Luminex recommends that you adhere to standard laboratory safety practices. The protection provided by the equipment may be impaired or the warranty voided if Luminex MAGPIX is used in a manner not specified by the instructions or by Luminex Corporation. Refer to the Luminex® MAGPIX™ Installation and Hardware User Manual for detailed safety information.

Biological Samples

CAUTION: 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 such as gloves, gowns, laboratory coats, face shields, or mask and eye protection. Use ventilation devices. Observe all local, state, and federal biohazard handling regulations when disposing of biohazardous waste material.

Dilute concentrated biological samples, such as plasma or serum, at least 1:5 with reagents as part of assay setup or as a final dilution step to reduce the chance of system clogs. If you are running a MagPlex® kit, follow the dilution instructions in the kit’s product insert.

Bead (Microsphere) Handling

MagPlex beads come in various configurations. To reduce foaming and surface precipitation, avoid agitating the beads until you are ready to vortex and use them. The beads will settle and must be resuspended by vortexing before use. In addition:

• Multiple pipetting from the original container may affect bead concentrations.

• Protect MagPlex beads from light at all times to prevent photobleaching. Photobleaching effects are cumulative. To maintain the integrity of the beads, minimize their exposure to light during your development and manufacturing phases.

• Store MagPlex beads at 2°- 8°C.

Introduction

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

assay for additional information.

CAUTION: Do not use strong organic solvents with MAGPIX. For

information about specific compatibility, visit the Luminex Technical Support website at http://www.luminexcorp.com/ support/faqs.html.

Safety Precautions

WARNING: All samples should be regarded as potentially contaminated and

treated as infectious. 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.

WARNING: Although beads do not contain hazardous or carcinogenic

components at toxic levels, they may 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 is available upon request.

WARNING: The Drive Fluid and the solution in which MagPlex beads are

stored contain ProClin®, which may cause an allergic reaction. Use personal protective equipment, including gloves and safety glasses. Check your assay's package insert for assay component information.

Bead Concentration

Follow the instructions in the

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, and 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 produces the reporter fluorescence which identifies the analytes captured during the assay. 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

IVD kit’s product insert and use the provided software protocol.

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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.

FIGURE 1.

Interrogation of MagPlex® Beads by the Red and Green LEDs

1. Green LED 2. Camera

3. Chamber 4. Red LED

Repetitive MagPlex Bead Measurements

In a MagPlex assay, the reporter signal is the result of the assay. Due to small bead size, MagPlex bead suspension exhibits near solution-phase reaction kinetics. This means that each set of beads used for a particular assay shows a statistically even distribution of reporter molecules bound to the surface of each bead. 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. During data acquisition, numerous beads of each set are analyzed and the median statistic is computed for that set by xPONENT. The more beads of a set measured, the more confidence that can be given for that particular measurement. Luminex recommends that you use R-Phycoerythrin as your reporter fluorophore.

Follow the instructions in the IVD kit’s product insert and use the software protocol provided.

Introduction

Classification and Reporter Fluorochromes

MagPix beads in the calibration kit are used to autofocus the camera and calibrate the CL1, CL2, and RP1 channels. The beads in the verification kit are a mix of 6 different regions that cover the range of the 50-plex map. Both calibration and verification beads are triple-dyed, and the fluorescence signal of these dyes enables classification of each bead set.

TABLE 1.

MAGPIX Active Bead Regions (by Region)

Region Region Region

MC10012 MC10013 MC10014

MC10015 MC10018 MC10019

MC10020 MC10021 MC10022

MC10025 MC10026 MC10027

MC10028 MC10029 MC10030

MC10033 MC10034 MC10035

MC10036 MC10037 MC10038

MC10039 MC10042 MC10043

MC10044 MC10045 MC10046

MC10047 MC10048 MC10051

MC10052 MC10053 MC10054

MC10055 MC10056 MC10057

MC10061 MC10062 MC10063

MC10064 MC10065 MC10066

Fluidics 1 and Fluidics 2

Although it undergoes a wash step in between wells, the probe can be susceptible to carryover from well-to-well. Fluidics 1 contains one bead set. Fluidics 2 contains a buffer solution and a different control bead. The function of this maintenance procedure is to measure how much (as a percentage) of the first bead set in Fluidics 1 is found in the well where Fluidics 2 has been loaded.

Sample Volume

Sample volumes range in size from 20 µL to 200 µL. Ensure that approximately 25 µL more than the sample volume remains in the well after aspiration. This amount may vary depending on the type of plate used. Your sample volume must be large enough to prevent aspirating air into the fluid line when acquiring sample, and small enough to prevent spill-over

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MC10067 MC10072 MC10073

MC10074 MC10075 MC10076

MC10077 MC10078

when the analyzer flushes the sample lines after sample acquisition and expels approximately 75 µL of sample back into the well.

Examples

• If you use a sample volume of 50 µL and aspirate 50 µL, you will acquire air bubbles.

• If you use a sample volume of 200 µL and a standard sample pickup of 50 µL, the well will

Follow the instructions in the IVD kit’s product insert and use the software protocol provided.

Do not dilute MagPix Calibration or Verification beads, or the Fluidics 1 and Fluidics 2 beads.

Plates

Follow the xMAP-based IVD kit instructions for use. Follow these guidelines when choosing plates:

overflow when the analyzer washes the sample lines after acquisition and expels fluid back into the well, because the amount of fluid expelled back into the well is approximately 75 µL.

CAUTION: Sample volume is critical to the proper functioning of your

MAGPIX instrument. Aspirating too few beads can result in insufficient bead count or insignificant data results. Aspirating too many beads can result in saturation of the chamber and prevent proper bead classification, which may also result in low bead counts or inconclusive data.

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

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

• plates.

• For unheated assays, use a 96-well plate with an overall height no greater than 0.75 inches (19 mm).

WARNING: The heater plate of the MAGPIX plate carrier may be hot. Do

See the recommended consumables list on the Luminex website at http:// www.luminexcorp.com/support/recommendedmaterials/index.html for more information.

Touch Screen

A touch screen option is available with xPONENT for MAGPIX.

not touch the heater plate.

Introduction

xPONENT for MAGPIX 8

Chapter 2: Application Administrator

Tasks

System Setup

If you have a secure version of xPONENT for MAGPIX, you must have xPONENT administrative privileges to perform System Setup tasks. If you do not have a secure version of xPONENT for MAGPIX, all users may be able to perform system setup tasks. To view administrative options, click Admin

on the navigation bar.

FIGURE 2.

System Setup Tab

Viewing System Status

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

Application Settings

These settings change graphical user interface (GUI) preferences.

Enable Virtual Keyboard -

Allow the application to be minimized - Enables you to minimize xPONENT so that you

can access the desktop. If this check box is not selected, you cannot minimize xPONENT.

Ignore user permission when attempting to exit software software regardless of whether or not they have been granted this permission in the User Setup tab

Add header when exporting data from grids -

Use Application Settings - Defines how the software runs and displays.

Select the options you want to enable in the software and click Save.

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Enables the touchscreen virtual keyboard.

Enables users to exit the

Adds a header row when exporting the data.

LIS Settings

You must have the LIS version of the software to perform this task.

To connect to the LIS, check Connect to LIS. In the Watch folder for incoming orders box, browse to the location where xPONENT should watch for incoming orders.

Select the options you want to enable in the software and click Save.

External Analysis Program Settings

Use this option if you are using a program other than xPONENT to analyze collected data. This tab contains the following fields:

Installed Analysis Programs - Lists the analysis programs currently installed.

Browse - Opens another dialog box to select the file location for the third-party analysis

program. The selected location appears in the Path box.

Command Line Parameters - Type the command line parameters for the parameters you want xPONENT to use with the external analysis program. If the information is supplied with the external analysis program documentation, use that information. Otherwise, you can type the following default parameters, built into xPONENT, in any order:

• #c - Output.csv, full file path

• #p - Protocol name

• #b - Batch name

• #u - Logged in user name

box, and the name displays in the Name

To keep the default command line settings, leave Command Line Parameters blank.

Set Default - Sets the chosen analysis program as the default analysis program for xPONENT.

OK - Saves the chosen settings and exits the dialog box.

Cancel - Cancels changes and exits the dialog box.

Remove - Removes the selected program from the Installed Analysis Programs list.

Edit - Opens the New External Analysis Program dialog box where you can edit the

settings for the selected program.

Disable Automatic launching of External Third Party Analysis when batches complete for all protocols - Disables the automatic launch of the third-party analysis program

automatically after batch acquisition.

Application Administrator Tasks

FIGURE 3.

New External Analysis Program Dialog Box

Adding an External Analysis Program

1. If the program is on an external media source such as a CD or flash drive, insert the

media into the appropriate drive on the PC.

2. Click Add New to open the

3. Type a name for the external analysis program.

4. Click Browse to navigate to the .exe file for that program. Double-click the file name.

5. Type the command line parameter for the parameters you want xPONENT to use with

the external analysis program. If the information is supplied with the external analysis program documentation, use that information. Otherwise, you can type the following default parameters built into xPONENT, in any order:

• #c - Output.csv, full file path.

• #p - Protocol name.

• #b - Batch name.

• #u - Logged in user name.

To keep the default command line settings, leave Command Line Parameters blank.

6. Click Set Default if you want to make this program the default analysis program, then

click OK to close the dialog box.

7. Click OK if you want to add the program as an installed analysis program, but not as the

default analysis program.

8. Click Save.

New External Analysis Program dialog box.

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Editing an Analysis Program

1. In the Installed Analysis Programs list, click the program you want to edit.

Click Edit. The Edit External Analysis Program dialog box opens.

3. Edit the Name, Path, or Command Line Parameters, or make this the default analysis

program if there are two or more programs installed. The default analysis program name displays in bold text.

Removing an Analysis Program

To remove an analysis program from the Installed Analysis Programs list:

1. In the Installed Analysis Programs list, select the program you want to uninstall.

2. Click Remove. To prevent the external analysis program from starting automatically,

select Disable automatic launching of External Analysis when batches complete for

all protocols.

Arranging Main Navigation Buttons

Use this section to arrange the main pages at the top of the xPONENT screen.

NOTE: The Home page, and in some instances the Admin page, cannot be

moved.

To arrange the main navigation buttons:

1. Select or clear the check boxes by each page name to hide or display the page.

2. Click a page name and use the up and down arrows to change the order in which the

pages display, from left to right.

3. Click Save.

4. Click Default if you want to restore the main navigation.

Maintenance Options

Run one of the System Initialization procedures as part of your daily startup routine.

Luminex recommends that you verify daily and calibrate weekly. You should also verify and calibrate if any of the following occurs:

• The delta calibration temperature exceeds ± 5° C.

• You move the instrument.

• You experience sample acquisition problems.

Available system initialization procedures are:

• Fluidics preparation, calibration, performance verification

• Fluidics preparation, performance verification

Group Setup Tab

This tab is accessible only in the Security or 21 CFR Part 11 packages. Use this tab to assign permissions to different groups of users. If you have the 21 CFR Part 11 package, you can require an electronic signature in order to perform selected tasks.

Application Administrator Tasks

NOTE: The 21 CFR Part 11 package also provides full access to the Secure

Package functionality.

FIGURE 4.

Group Setup Tab

Users are assigned to groups. These users then have permissions granted to their group.

This tab contains the following:

Group Profile - The following user groups are predefined:

• Administrator

• Supervisor

• Service

• Technician2

• Technician1

• Reviewer

The user will belong to the group you select.

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NOTE: Assign permissions directly to an individual by assigning the user to

a specific Group Profile on the User Setup tab.

Group Features - The Group Features a category from the list, the Features section displays the individual tasks that are a part of that category. The following categories are available

• System Administration

• Batch Management

• Protocol Management

• Lot and Std/Ctrl Kit management

• Import and export data

• Archiving

The Allowed check box next to the desired permission in the Features section enables the selected group to perform that task. The Signature Required check box next to the desired permission requires a digital signature whenever a user in the selected group performs that task.

Clear the Allowed check box and select Signature Required to require the electronic signature of another user whose account is configured to allow the action. When you do this, the current user cannot complete the action without this electronic signature.

The following permissions are available for these groups:

System Administration

• System Administration Manage Users (add, edit, or delete users)

• Manage System Configuration

• Perform Calibration and Verification

• Manage Alerts

• Manage scheduled maintenance

• Change batch and CSV options

• Allow exit software

• Batch run override system

• Create, delete, activate CAL and VER Lots and Kits

list contains permission categories. When you select

Batch Management

• Create Batch

• Edit Batch

• Delete Batch

• Run Batch

• Validate and Invalidate Results

• Approve Batch

• Reanalyze Results

• Save Batch after changing results

• Change Formula

• Reacquire errored wells for partial batch

• View Processed Batch Results

Application Administrator Tasks

• Export Processed Batch Results

• Change Sample Load Volume During Run

Protocol Management

Delete Protocol

Lot and Std/Ctrl Kit management

• Create Std/Ctrl Kit and Lots

• Edit Std/Ctrl Kit and Lots

• Delete Std/Ctrl Kit and Lots

Import and Export Data

• Export Batch, Protocol, Kit or Lot Files

• Import Batch, Protocol, Kit or Lot Files

Archiving

• Backup/Restore

• Import/Archive

When you or any user perform an action that requires an electronic signature, the Electronic Signature dialog box opens. The user ID autopopulates. Type your password and any comments. Click OK to complete the electronic signature, or Cancel to cancel the signature.

Setting Up Group Permissions

1. In the Group Profile list, click the group profile you want to set up.

3. In the Features section, select the Allowed check box next to the desired permission to

4. Click Save.

User Setup

The User Setup page includes the following information:

Global User Settings - Define global user settings.

User Setup Tab - used to create or edit a user’s credentials, view a list of users, and remove

a user from the system,

Create New User

List of Users - View and Edit

In the Group Features list, click which group features you want to set for the group profile you selected.

enable the selected group to perform that task. If you are using the 21 CFR Part 11 package, enable the Signature Required check box next to the desired permission to require a digital signature whenever a user in the selected group performs that task. These tasks are tracked in the System Log.

NOTE: You must have xPONENT administrative privileges and be using

either the 21 CFR Part 11 or Secure package of the software to perform user setup tasks.

xPONENT for MAGPIX 16

Buttons to delete or edit settings for a selected user.

User Setup Tab

Use this tab to create or edit a user account, remove a user from the system, or view a list of authorized users, along with their profile details. You must be using either the 21 CFR Part 11 or Secure package of the software to perform user setup tasks.

FIGURE 5.

User Setup Tab

This tab contains the following.

Create New User - Click to open the Create User Account screen.

Global User Settings - Settings common to all users.

Users - A list of users in the system. To edit information about a user, select the User ID and click Edit. To delete a user, select the User ID and click Delete.

Global User Settings

Use this tab to define global user settings as well as view and edit the accounts of current users.

Application Administrator Tasks

Defining Global User Settings

1. In the Global User Settings section, type a length of time (in days) for the Password

Expiration

2. Set the number of allowed Unsuccessful Login Attempts. After this number of failed

attempts to log in, the user’s account is locked.

3. Set how many seconds pass before an Automatic Logoff is initiated.

4. Type the Minimum User ID Length. The default minimum User ID length is six

characters.

5. Type the Minimum Password Length. The default minimum password length is six

characters.

6. Click Save.

. The default is 180 days.

Create User Account Screen

Use this screen to create and set options for a new user. Any user with access to this tab can assign rights to any and all users.

FIGURE 6.

Create User Account Screen

xPONENT for MAGPIX 18

Creating a New User

1. Click Create New User. The

2. Type the user ID in the User ID box. The user ID is not case-sensitive. You can change

the required number of characters required for a user ID on the User Setup tab. Once you create and delete a user ID, you cannot use that user ID again.

3. Type the user’s name in the User box.

4. Select the Account Status check box to lock the account, or clear this check box to

unlock the account.

NOTE: If a user account is locked, the administrator is notified at each log in.

5. Type a password for the user in the Password box, then re-type it in the Reenter

Password box. If you want the user to change the password on first login, select Change password after first login. The required length for passwords is set on the Group

tab.

Setup

6. In the Group Profile list, select the role for the user you are creating.

7. Click Save or cancel to return to User Setup without saving.

Batch Options Tab

If you are using the 21 CFR Part 11 or Secure package, you must have administrative privileges to set batch options. Use this tab to set options for acquisition and batch analysis.

Create User Account screen opens.

Application Administrator Tasks

FIGURE 7.

Batch Options Tab

Batch Options. This section displays the following options:

• Allow running a batch with expired reagents - Allows batches to run with expired reagents.

• Allow running a batch if XY temperature is not in range - Allows batches to run if the XY temperature is not in range.

• Allow running a batch if the instrument is not calibrated or verified - Allows batches to run if the instrument is not calibrated.

• Prompt for reacquiring of the last errored wells for an aborted partial batch - Allows users to choose to reacquire aborted wells when resuming a stopped/partial batch or to start with the next unacquired well.

Batch Settings This section displays the following options:

• Calibration expiration days - Type the desired number of days a system calibration remains active before expiring. The default number of days is seven.

• Analysis display decimal places - Type the number of digits the system displays. The default number of digits is three.

xPONENT for MAGPIX 20

• Minimum bead count for obtaining results - Type any whole number from 0 to 1000000. This is the minimum bead count that must be observed by the instrument for a particular analyte before this data is used in statistical calculations and is displayed on the graphs and results table. This number varies based on assay. When set to a number greater than 0, the analyzer does not display data for bead sets not generating events equal to or less than this value. Type 0 to display all events. The default setting is 1.

• Allow batches to be run or saved without lot number, expiration or manufacturer Allows saving lots without normal required information.

• Run Routine after batch complete - Select this option to specify a particular routine to run after a batch is finished. If you select this option, then select a routine from the Routine to run after batch completes list.

• Run Rinse before batch starts - This options performs a Rinse at the last selected location on the Cmds and Routines page for the Rinse command. Ensure that you have sufficient room in the reservoir to perform this Rinse.

Batch Thresholds

Low bead count detection - Selecting either Error

warning if the number of successive wells in the Well Count box are run without reaching the number of beads in the Bead Count box. Click in either box to type a number other than the default. Warning pause pauses the batch to allow the user to change the load volume and then resume the batch.

Cancel - Cancels the changes.

Save - Saves the changes.

Alert Options Tab

To view this tab, click the Alert Options tab on the Admin page. Use this tab to set options for alerts about various system events.

or Warning stops the batch or logs a

Application Administrator Tasks

FIGURE 8.

Alert Options Tab

Alert Options - Offers three check boxes for each alert - Dialog, Email, and Sound. This

section displays the following events:

• Locked User - The user's account is locked and must be unlocked by an administrator.

• Batch Complete - The batch run is complete.

• Heater In Range - The plate heater is warmed to the designated range.

• Scheduled Maintenance - A scheduled maintenance routine is now due.

• Low Bead Count Detected - A bead count below the accepted range is encountered.

• Driver Fluid Low/Waste Full - The Drive Fluid level is running low and may need to be replaced soon, or the Waste fluid is full and needs to be emptied.

• Routine Complete - The currently running routine is complete.

• Delta Cal Temp Exceeded Tolerance During Batch - The delta cal temperature fell outside the designated range during the running of the batch.

Select the appropriate check boxes to display a pop-up message, send an email, or play a sound to alert you when the event occurs. All check boxes are selected by default. Cancel and Save buttons display if you change a setting.

Speakers Attached/Speakers Not Attached - Enables sounds to be played through speakers. Click this button if you have speakers attached to your system. The button title will alternate between attached/not attached status when you click it.

xPONENT for MAGPIX 22

Setup Email - Opens the Setup Email Dialog

box

FIGURE 9.

Setup Email Dialog Box

Enable or disable email notification by selecting or clearing the Email Active check box.

Contact your network administrator to determine the information needed in the Mail Server Host, From Email Address, From Email Password, and Mail Server Port boxes, and if you need to select the Enable SSL (Secure Sockets Layer) check box

The Test button tests the email settings. Select Apply to initiate the settings you’ve selected, or click OK to use the settings and exit the dialog box. Cancel exits the dialog box without saving the settings.

Setting Notification Options for System Events

1. Select Dialog if you want a dialog box to open for a specific event.

2. Select Email if you want to send an email notification for a specific event.

3. Select Sound if you want a sound to play for a specific event.

Application Administrator Tasks

4. If you choose to send an email notification for a specific event, and the email address is

not already set up, click Setup Email at the bottom of the page to open the Setup Email dialog box.

• Turn email notifications on or off by checking or clearing the Email Active check box at the bottom of the screen.

Contact your system administrator to determine the correct information for the Mail

• Server Host, From Email Address, From Email Password, and Mail Server Port boxes, and whether you need to check the Enable SSL (Secure Sockets Layer) check box.

• Type addresses to which you want to send alert notifications in the Email Addresses box; separate address with a comma (,).

• Click Test to send a test email to the addresses you have typed.

5. Click OK to apply any changes and close the dialog box or Apply to apply any changes but remain in the Setup Email dialog box.

CSV Options Tab

To view this tab, click the CSV Options tab on the Admin page. You must have administrative privileges to perform this task if you are using the 21 CFR Part 11 or Secure package. Use this tab to define what the CSV file will contain and where it will be stored.

xPONENT for MAGPIX 24

FIGURE 10.

CSV Options Tab

Automatically export results CSV file when batch is complete - Automatically export

results CSV file when batch is complete - Automatically exports the CSV file when the system finishes analyzing the batch. This allows running programs on exported data without having to manually start the export.

Automatically export batch when batch is complete - Exports batch information automatically when a batch has completed.

Maximum number of data columns in CSV file - Sets the number of columns in your CSV output file.

Use US regionalization format only - Exports data only in US regionalization format.

Include Advanced Statistics - Exports advanced statistics in the CSV file.

CSV Export Folder and Automatically Exported Batch File - Displays the path and

location where the CSV file or automatically exported batch file will be exported. Click Browse to change the file export location.

Automatically convert the raw run files to CSV format for each well in the batch Automatically converts raw run files to CSV format for each well in the batch. This option creates a CSV-formatted file for the raw bead data of each well.

Test Sort Order - Defines a method to sort the test data. The options are By Analyte Name, By Region ID, or By Setup Order.

Application Administrator Tasks

Cancel - Cancels changes.

Save - Saves changes.

Setting CSV Options

1. In the CSV and Batch Export Options section, select the options you want to apply to the CSV file. If you select Maximum number of data columns in CSV file, type a maximum number of columns.

In the CSV File Export Folder and Automatically Exported Batch Folder box, type the

2. location to which you want the file sent, or click Browse to navigate to the folder.

3. In the Test Sort Order box, select the method that you want to use to sort the tests in the protocols.

Archive Options Tab

To view this tab, click the Archive Options tab on the Admin page. Use this tab to set options for backing up, exporting, and restoring files.

FIGURE 11.

Archive Options Tab

Archive. Use this section to choose file types to archive destinations for the archive file. This

section contains the following

xPONENT for MAGPIX 26

• File Type - Choose from Protocols, Batches, Std/Ctrl Kits, Lots, Patient Samples, or

Log. The selected information appears in the list below the Archive Folder path.

• Keep data after archive - Retains data instead of deleting after you archive it.

• Exclude Raw Data Files - Select this option if you have selected Batches in the File Type

list to exclude files that contain only raw data.

• Browse- Chooses the network or local PC destination folder for the exported archive file.

The selected file displays in the Archive file export folder box.

NOTE: Files are restored from the path displayed in the Archive file export

folder box. Click Browse to select the file path if necessary.

The list below the Archive Folder path displays all the files of the type selected in the File

Type list. This list displays information for each file.

Current Storage Utilized

amount of space left, in the database and on the hard disk.

Backup System - nables backups and restores for xPONENT.

• Backup - Backs up the entire system (Click View Backup Log to view information about

the backup).

• Restore - Restores all information in the archive file to the system. This will overwrite all

information.

• View Backup Log - Displays a log of system backups.

- Displays the amount of space currently in use, as well as the

Import - Select a file type to import in the File Type list and click Import to import all files of that type from the archive. The imported files display in the list below the Archive Folder path.

Archive - Select a file type in the File Type list, and then select a file in the list below the Archive Folder path and click Archive to archive the file. If you have selected Keep data after archive, the file will still display in the list, otherwise it will no longer be displayed.

Archiving a File

1. In the File Type drop-down list, select the file type you want to archive. File type options are Protocols, Batches, Std/Ctrl Kits, Lots, Patient Samples, and Log.

2. Select the files you want to archive in the list below the Archive Folder box (this list displays all files of the selected file type in the internal database).

3. In the Archive Folder box, verify the location to which you want to archive the file(s). To change the location, click Browse, then navigate to the new location and click OK. Note: If you change the default archive location, ensure that the Archive Folder box reflects that same location when you import those archived files.

4. Select Keep data after archive if you want to keep the file in the list after archiving rather than deleting it.

Application Administrator Tasks

5. To exclude raw data files from the archive (suggested if you are archiving Batches) select Exclude raw data files.

6. Click Archive. The command executes. When complete, an Archive Successful box opens. To delete a partial batch, open the Admin page, then click the Archive tab. Clear the Keep data after archive box. Click Archive to delete the partial batch.

NOTE: To delete a partial batch, open the Admin page, then click the

Archive tab. Clear the Keep data after archive box. Click Archive

to delete the partial batch.

dialog

Backing Up xPONENT Data and Settings

1. Click Backup. A Warning

2. Click OK to continue with the backup. A progress bar displays.

NOTE: The backup file outputs by default to C:\Documents and Settings\All

Users\Documents\Backup\xPONENT.zip.

3. When the backup is complete, a System Backup dialog box opens.

dialog box displays.

Adding a Previously Archived File Back into the Database

1. In the

2. Click Browse and navigate to the archived file location if you previously changed the

3. Click Import. The Import Complete dialog box opens after the files have imported. All

4. Click OK

File Type list, click the file type you want to import.

location in the Archive Folder box.

archived files of the type selected in the File Type list will now display in the list below the

Archive Folder box, and be available for use with xPONENT.

Restoring the System Using a Backup File

1. Click Restore. A Warning dialog box displays.

CAUTION: If you click Restore, all data and settings are overwritten

2. Click OK to continue restoring the system. The File dialog box opens. The most recent backup file displays in the File Name box. To use a different backup file, click Browse to navigate to a different file.

3. Click OK to start the restore. A progress bar displays, followed by a Warning dialog box stating that xPONENT needs to be restarted.

4. Click OK to restart xPONENT. (You must restart xPONENT after the restore task is complete.)

Licensing Tab

Contact Luminex Technical Support to upgrade xPONENT for MAGPIX or to obtain a new license.

xPONENT for MAGPIX 28

NOTE: You must restart the computer for the new license to take effect.

Schedule Tab

Use the Schedule tab to enable or change the recurrence of scheduled maintenance reminders.

FIGURE 12.

Schedule Tab

• Select the time of day that you want to receive alerts in the Alert Time list.

• Select how often you want to receive reminders in the Recurrence list.

• Enable or disable the reminders by selecting or clearing the Enabled check box.

Report Options Tab

Use this tab to add your company information and logo to reports.

Application Administrator Tasks

FIGURE 13.

Report Options Tab

• Type a company name in the Company box, and any additional information in the Info:

box.

• Click Import Logo and then Open after navigating to the desired file to import a graphic for

the report header.

• Click Clear Logo to remove the logo.

• Save saves all changes.

xPONENT for MAGPIX 30

NOTE: Use a logo file with 920 x 125 pixels. To make the logo to appear to

the right of your company name, include 120 pixels of white space to the left of the logo, in the graphic file; otherwise, the logo may appear behind the company information.

Chapter 3: Using xPONENT

Starting xPONENT

Perform the following steps if xPONENT does not launch automatically after starting you turn on the computer.

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

Luminex > xPONENT > Luminex xPONENT

• If you have a trial license, click OK in the dialog box that opens.

• 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.

Initial Startup

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

1. Adjust the Sample Probe Height

2. Revive After Storage (Luminex) Routine

3. Calibration/Verification Routine

Logging In to xPONENT

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

Programs >

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

inaccurate data and test results. Personnel who will use

xPONENT must read this manual 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 opens.

Logging Off of and Exiting xPONENT

1. Click Log Off.

2. Click OK in the Confirm Logout dialog box. If you do not want to exit the software, stop here. To exit all of the way out, continue with step 3.

3. Click Exit.

4. In the Do you want to exit the software now? dialog box, click Yes.

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

page

that page or 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, 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.

Screen elements

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

xPONENT for MAGPIX 32

FIGURE 14.

Screen Elements

Page

The main elements at the top of the window are Pages. Click a page to go to that page in the software. All of the pages except the Home page, and in some cases the Admin page, can be moved or deleted.

Tab

The elements on the left side of the window are Tabs. Click a tab to display information and tasks on that tab. Some tabs are numbered and must be completed sequentially.

Right-click Menus

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

• Print Selection - Prints only the selected section or cell

• Import - Imports a file

• Export - Opens a File Dialog dialog box. Click Browse to select a location, file name, and

file type (TXT or CSV) for the export. This exports all data from the right-clicked item

- Prints all sections or cells of the item

1. Page 2. Tab 3. Right-Click Menu

• Cut - Cuts the selected data

Using xPONENT

• Copy All - Copies all data

• Copy - Copies only selected data

• Paste

• Delete - Erases text or data from the selection

- Pastes previously copied text or data into the box

System Monitor

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

FIGURE 15.

System StatusButton - 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 or other important user notification, the button is yellow with an X.

Connection Status or Disconnected). To ensure the analyzer connects to the PC, turn on the analyzer before you start xPONENT.

Command Display - Displays the following:

System Monitor

1. System Status Button 2. Connection Status

3. Command Display 4. Progress Bar and Buttons

5. Eject XY Button 6. Drive Fluid Level

7. Waste Fluid Level 8. Delta Cal Temperature

9. XY Status 10. Power Off Button

Displays the status of the analyzer’s connection to the PC (Connected

• The command currently running.

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

• Date and time.

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.

xPONENT for MAGPIX 34

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 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 there is enough Drive Fluid in the container to run one plate or less. The system stops if the container is empty.

Waste Fluid Level - The waste fluid container liquid level sensor warns you when the waste fluid container is almost full. The system stops if the tank is full.

Home Page

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

Eject button changes to Retract.

Using xPONENT

FIGURE 16.

Home Page

Daily Activities

System Initialization - Perform a system initialization routine.

Shutdown -

Probe and Heater

Drive Fluid Lot -

fluid container was shipped. This information is optional.

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.

Sys Info - Opens the System Info tab of the Maintenance page. The System Information

page displays licensing information, the instrument serial number, the date of the last CAL Calibration, VER Verification, Fluidics tests, and other important information.

Reports - Opens the Reports tab of the Results page.

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

xPONENT for MAGPIX 36

Perform a shutdown routine.

- Adjust the probe height or plate heater.

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

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 Heater tab opens.

2. Based on the type of plate you are using, place alignment disks or an alignment sphere from the Height Alignment Kit in the well, as specified below:

• Filter-bottom plate - two (2) 5.08mm disks

• Mylar-bottom plate - two (2) 5.08mm disks

• Conical (V-shaped) plate - one (1) sphere

If you are using a standard 96-well plate, you do not need to use any of the disks or spheres in the Height Alignment Kit.

3. Ensure that the well location is selected on the plate image. Luminex recommends that you use well D6 (this is the center of a standard 96-well plate). A green pin marks the selected well.

4. Click Eject to eject the plate holder.

5. Place a strip well in the off-plate reagent block.

6. In the Strip Wells section, click D1.

7. Verify that the reservoir is empty.

8. In the Reservoir section, click well RB1.

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

10. Place the plate on the plate holder with well A1 in the marked position.

11. Click Retract to retract the plate holder.

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

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

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

15. Click Save to save the probe height settings for the plate and the well.

Probe &

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

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

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

the system.

Using xPONENT

CAUTION: 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. To adjust the height of the sample probe, follow the steps above.

FIGURE 17.

Sample Probe Height Adjustment

1. Well D6 2. Well D1 3. Well RB1

System Initialization

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

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

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

support/calibration/index.html.

xPONENT for MAGPIX 38

Calibrate your system at least once a week using the Calibration/Verification button on the Auto Maint tab of the Maintenance

• The delta calibration temperature exceeds ± 5° C.

• You move the instrument.

• You experience sample acquisition problems.

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. 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/calibration/index.html.

NOTE: Do not move the system waste line while calibrating the system.

page. In addition, recalibrate the system if:

Adding or Importing CAL and VER Kit Information

You can add CAL and VER Kit information from the Home page or from the Maintenance page.

To add or import CAL and VER kit information from the Home

On the Home page, click System Initialization.

b. Click Import Kit at the bottom right side of the window. The Import Calibration or

Performance Kit dialog box opens.

c. Locate the MagPix calibrator or verifier kit information file and click Open.

2. To add or import kits from the Maintenance page:

page:

a. Open the Maintenance page, then open the Lot Management tab.

b. Click Import Kit. The Import Calibration or Performance Kit dialog box opens.

c. Select the MagPix calibrator or verification information file you want to import, then

click Open.

Setting Up the System Initialization Routine

You can set up the system initialization routine to include calibration and verification under the Admin page, System Setup tab, Maintenance Options section.

Using xPONENT

FIGURE 18.

Select System Initialization Routine

Running System Initialization

1. On the Home

2. Select the Calibration Kit active (current) lot number from the list.

3. Select the Performance Verification Kit active (current) lot number from the list.

4. Vortex the calibration and verification beads for twenty seconds. Do not dilute the reagents.

5. Click Eject on the Status Bar.

6. Place the off-plate reagent block on the heater plate.

7. Add at least 5 drops of the reagents to the wells, as indicated in the plate image or according to the kit instructions.

8. Click Retract.

9. Click Run.

Automated maintenance options are also available on the Maintenance page, Auto Maint tab.

page, click System Initialization under Daily Activities.

Exporting CAL or VER Kits

1. Open the Maintenance page, then open the Lot Management tab.

2. In the Active Reagents section, select the kit you want to export from the Calibration Kit or Performance Verification Kit lists.

3. Click Export.

4. In the Export Calibrator or Verification Lot dialog box, select an export location for the kit.

5. Type the kit name for the exported kit into the File Name box.

6. Click Save. The dialog box closes.

xPONENT for MAGPIX 40

Deleting CAL and VER Kit Information

1. Open the Maintenance

2. In the Active Reagents section, select the kit you want to delete from the Calibration Kit or Performance Verification Kit lists.

3. Click Delete Kit.

CAUTION: There is no confirmation dialog box when you delete a kit.

page, then open the Lot Management tab.

Creating Calibration and Verification Reports

Open the

2. In the Report drop-down list, select Calibration and Verification Reports.

3. In the Type drop-down list, select ALL, CAL, VER, or Fluidics.

4. Type a Start date and a Through date for the date range you want to view.

5. Click Generate to display the report.

6. Use the left or right Page arrows to navigate to the different report pages.

7. Click Print to print the report, or Save to save the report.

8. Click New Report to generate another report.

Results

page, then open the Reports tab.

Setting Up Batches

Batches consist of protocols and samples for acquisition and can span more than one plate. Protocols contain predefined commands that must be included in every batch acquisition.

You can group batches together as a multi-batch. Multi-batches can consist of any number of batches that have been set up from different protocols and are processed consecutively. Multi-batches cannot be run on multiple plates.

NOTE: When setting up a batch, if the number of samples exceeds the

number of wells in one microtiter plate, you can add additional plates in the Add and Change Plate are identified on the bottom of the plate image as Plate a of b, where

is the plate number and b

Batches Page

Options on the Batches tab on the Batches page are:

• Create a New Batch from an existing Protocol

• Create a New Multi-Batch

Depending on your selection, this page displays the following tabs:

secondary window. Additional plates

is the total number of plates.

Using xPONENT

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

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

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

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

NOTE: These tabs (except New MultiBatch) are sequential. You must

complete each screen in a specific order.

FIGURE 19.

Batches Page

The following fields and actions are available on the Batches tab:

The Pending Batches list displays the name of the protocol used with the batch, the protocol version, date, and status for each pending batch. The following buttons only appear if the pending batches have data:

Single Step - Instructs the system to acquire one well and then pause. This ensures that the system is working correctly before you run an entire batch.

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

Plate Layout - Opens the Report dialog box, which includes the Batch Plate Layout Report. Confirm that the plate layout conforms to your specific assay instructions.

Import - Imports a batch.

xPONENT for MAGPIX 42

Export - Exports a batch

Delete - Deletes a batch.

Edit - Edits a batch.

Run - Runs a batch.

Using the Batches Page

1. Open the Batches page.

Click one of the following:

• Create a New Batch from an Existing Protocol

• Create a New Multi-Batch

3. Type the batch name in the Batch Name box.

4. Type an optional description of the batch in the Enter Optional Description box.

5. If you are creating a batch from an existing protocol, select the protocol in the list. Click Next. If the protocol uses standards and/or controls, the Stds & Ctrls tab displays.

6. The Plate Layout tab appears. View the details of the active reagents, apply different assay standards/controls, or manually enter new information. Confirm that the plate layout conforms to your specific assay instructions. Click Next.

7. On the Plate Layout tab, assign well commands for this batch.

8. Click Run Batch to begin batch acquisition, or click Save to save batch information to the

Pending Batch list to be run at a later time.

NOTE: If the batch spans more than one plate, the tray ejects automatically

when all defined wells have been acquired. A dialog box displays prompting you to insert the next plate.

Create a New Batch from an existing Protocol

This option creates a new batch using a selected protocol from the Installed Protocols list.

When you click this option, the following tabs appear:

1. Protocols

2. Stds & Ctrls

3. Plate Layout - Confirm that the plate layout conforms to your specific assay instructions.

These tabs are numbered because you must complete the steps on each tab sequentially. For example, you must complete the Protocols tab before you can access theStds & Ctrls tab.

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

• Name

• Version

• Manufacturer

• Date

Using xPONENT

NOTE: Luminex recommends that you analyze the manufacturer’s assay kit

controls with each batch.

To create a new batch from an existing protocol:

1. Read the instructions provided with the assay kit you are using.

2. Open the

3. Click Create a New Batch from an existing Protocol.

4. Type the batch name in the Batch Name box.

5. If you want a description for the batch, type it in the Enter Optional Description box.

• Click the existing protocol that you want to use. If the protocol uses standards and/or

controls, you can view the active reagents. If the selected protocol uses standards/ controls, the next tab that appears is the Stds & Ctrls tab. You can view details about the active reagents, apply different standards/controls, or manually add new information on this tab.

• If the selected protocol does not use standards/controls, the next tab that appears is

the Plate Layout tab. You can assign well commands for this batch on this tab. Confirm that the plate layout conforms to your specific assay instructions.

6. Click Next.

7. Click Run Batch to begin batch acquisition, or click Save to save the batch information as a pending batch. Pending batches can be run at any time.

Batches page.

NOTE: If the batch spans more than one plate, the tray ejects automatically

when all defined wells have been acquired. A dialog box displays prompting you to insert the next plate.

Create a New Batch from a new Protocol

Click this option to create a new batch from a new protocol. This option enables you to create a protocol while your are creating the batch.

To create a new batch from a new protocol:

Open the Batches page.

Click Create a New Batch from a new protocol to open the Settings tab.

3. Type a name in the Name box.

4. Type a description in the Description box.

5. Define the settings in the Acquisition Settings section.

If you select Qualitative, Qualitative, or Allele Call from the Analysis Type list, you can select Analyze results while acquiring samples to view real-time analysis. If you select None as your analysis setting, you cannot analyze results using xPONENT.

6. Click Next. The Analytes tab opens. Click the analytes of interest in the numbered grid. Information about the analytes appears in a list on the right side of the grid. Name the analytes.

7. To change the Default Analysis, click Change. The Analysis Settings dialog box opens.

8. Select the analysis method from the Method list. Click OK to change the default analysis for analytes to be selected. Click Apply to All Analytes to apply the selection to all analytes. The Analysis dialog box closes.

xPONENT for MAGPIX 44

9. Type a unit of measurement in the Units box.

10. Type the desired bead count for each analyte in the Count box.

If you click Apply All, this applies to all analytes.

11.

12. To change individual units or counts, change them in the analyte table.

13. Type the desired bead count for each analyte in the Count box.

14. Click Next. The Stds & Ctrls tab opens if you selected an analysis type other than None.

• If you are using an assay standard/control kit, click Apply Std/Ctrl Kit. In the Select

Std/Ctrl Kit dialog box, click the kit from the list and click OK. Applying a kit only works for kits already installed, but you can also manually type the information.

• If you are not using a kit, type the appropriate information in the Standard Information

and Control Information sections. The number of standards and/or controls in these sections is defined on the Settings tab in the Analysis Settings section. If your batch uses controls, enter the appropriate values for Expected Values. Click Low Value from the Show list, and enter the low value for each analyte. Click High Value from the Show list, and enter the high value for each analyte. Reagent information is not required for a custom batch unless you want to use the analysis feature.

15. Click Next. The Plate Layout tab opens.

• To add well commands, click the appropriate wells and mark them as unknown,

standard, control, background, or wash. You can also delete commands that you’ve added, and change the starting location on the plate. If you want to run in replicate, change the Replicate Count to the appropriate number and the Grouping to your preferred grouping method.

• As you add commands to your plate, they appear in the Command Sequence list.

Here you can give each of your wells an ID. You can also import an ID list and move your commands up and down to change the order in which they will be acquired.

16. Click Single Step to acquire the first well, then pause acquisition.

17. Click Run Batch to start acquisition, or Save to save the batch for a later time. You can also save the protocol and/or standard and control information by clicking Save Prtcl.

NOTE: If the batch spans more than one plate, the tray ejects automatically

when all defined wells have been acquired. A dialog box displays prompting you to insert the next plate.

Create a New Multi-Batch

Use this button to add or remove batches to the multi-batch set up and to run a multi-batch.

A multi-batch is a set of batches that you want to process consecutively. You add batches to the multi-batch from pending batches in your database. You can also create a new batch to add to the database for the multi-batch. You can include as many batches as you need. The software does not limit you to a certain number of batches per multi-batch. This feature enables you to conserve plates.

You must ensure the batches fit on one plate. After you add each batch, the software automatically adds the next batch to the first well of the next column or row (depending on the plate direction) as long as space remains on the plate. You can also select a well first, which places the next batch in your chosen location. If space limitations create an overlap, an error message appears. Results for each batch are saved as individual batch files.

Using xPONENT

FIGURE 20.

New Multibatch Tab

This page contains the following:

Multi-Batch Name - Use this field to create a name for new multi-batches.

Select Pending Batch - Contains a list of all pending batches. This list includes name,

protocol, protocol version, date, and status information for each pending batch. Select the batch you want to add to the plate. Click OK. A plate layout diagram automatically populates the wells for the batch. Confirm that the plate layout conforms to your specific assay instructions. Click Add to open this box again and add additional batches.

To create a new Multi-Batch:

1. Open the Batches page.

2. Click Create a New Multi-Batch. The New MultiBatch tab and Select Pending Batch dialog box open simultaneously.

3. In the Select Pending Batch list, select the batch to add. Click OK.

4. Click Add to open the Select Pending Batchdialog box. Select the new batch that appears and click OK. Repeat for all batches to be run.

5. Click New Batch to open the Select Protocol for New Batch tab or click the Protocols tab. Follow the steps for creating a new batch from a new or existing protocol.

xPONENT for MAGPIX 46

6. Click Save to return to the New Multibatch tab.

7. Click Run

to run the multi-batch.

FIGURE 21.

Select Pending Batch Dialog Box

Using xPONENT

FIGURE 22.

New MultiBatch Tab with Plate Layout

xPONENT for MAGPIX 48

FIGURE 23.

Multibatch Report Dialog Box

Save Multi-batch

After creating a multi-batch, you can save it to the Select Pending Batch list. When saved to this list, the protocol appears as “Multibatch.”

Batches saved to a multi-batch cannot be edited or deleted unless they are removed from the multi-batch. However, you can edit the multi-batch itself. To remove a batch from a multibatch, click a well in the plate layout, and click Remove.

To save a multi-batch:

1. Create a new multi-batch.

2. Select a pending batch.

Type the name for the multi-batch in the Multi-Batch Name field.

4. Click Save. You are returned to the Batches page, and the multi-batch is added to the pending batches list.

Using xPONENT

Running a Batch

To run a batch, click Run Batch to open the Batches page. Select the pending batch that you want to run, then click Run.

NOTE: If the batch spans more than one plate, the tray ejects automatically

when all defined wells have been acquired. A dialog box displays prompting you to insert the next plate.

Importing a Batch

You only need to import batches to the system once. You must type lot information for the standard and control reagents as specified in the protocol. This lot information is used for every batch set up using the protocol, until it is changed.

To import a batch:

Open the Batches

2. Click Import. The Import Batch dialog box opens. Batch files are MDF files.

3. Click Browse to open the Select File dialog box. Navigate to the batch file you want to import, then click Open.

4. Click OK in the Import Batch dialog box. The batch displays in the Pending Batches list.

page.

Exporting a Batch

1. Open the Batches page.

2. In the Pending Batches section, click the batch you want to export, then click Export. The Export Batch dialog box opens.

NOTE: You can export batches, but not multi-batches.

3. Click Browse. The Select File dialog box opens.

Navigate to the location to which you want to save the file, then click Save

Click OK in the Export Batch dialog box.

NOTE: When exporting a large batch and including the LXB files, the export

process may take ten minutes or more.

Delete Batch

You can only delete unprocessed batches. Batches are deleted from the Open Batch list and moved to the Open Incomplete Batch list.

To delete a batch:

xPONENT for MAGPIX 50

1. Open the Batches page.

2. In the Pending Batches The Delete Pending Batch dialog box opens.

3. Click Yes.

NOTE: Batches saved to a multi-batch cannot be edited or deleted unless

they are removed from the multi-batch. However, you can edit the multi-batch itself. To remove a batch from a multi-batch, click a well in the plate layout, then click Remove.

NOTE: To delete a partial batch, open the Admin page, then click the

Archive tab. Clear the Keep data after archive box. Click Archive

to delete the partial batch.

Editing a Batch

section, click the batch you want to delete, then click Delete.

Open the

2. Click the batch you want to edit, then click Edit. The Protocol tab opens.

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

4. Click Save on the Plate Layout tab.

NOTE: Batches saved to a multi-batch cannot be edited or deleted unless

Settings Tab

Use this tab to name your new batch and configure acquisition settings. For existing batches, you can view the acquisition parameters of the selected saved batch and print the batch settings report.

Batches

they are removed from the multi-batch. However, you can edit the multi-batch itself. To remove a batch from a multi-batch, click on a well in the plate layout, and click Remove.

page.

Using xPONENT

FIGURE 24.

Settings Tab

This tab contains the following:

Name and description boxes - Type the name and description in the appropriate box.

Acquisition Settings: -

• Volume - This is the volume the instrument will aspirate into the system for analysis.

• XY heater - Select to enable the XY heater. In the box type the desired value in degrees

Celsius. The temperature range is 35 to 60° C.

• Plate name - The name assigned to the plate during sample probe height adjustment.

• Sample wash - This automatically washes each sample within the instrument.

Analysis Settings - Displays the analysis type to be used for the batch.

xPONENT for MAGPIX 52

CAUTION: Acquiring data before the heater has reached the proper

temperature can compromise test results.

• Analysis Type - Use this list to choose from the following analysis types:

• None - No analysis. Select if you have your own data post-processing program and want to obtain only fluorescent intensity results. You cannot apply standards or controls when you select None. You cannot analyze acquisitions with this setting.

• Qualitative - Qualitative analysis determines results as either positive or negative, reactive or non-reactive. The software is flexible in defining custom result ranges, such as negative, low positive, or high positive. Determinations are based on a single standard. For qualitative analysis the Luminex software uses a specific algorithm: .

• Quantitative - Determines the sample concentrations from standard curves using regression and Logistic 5P. Type the desired values for standards and controls in the Number of

Standards and Number of Controls boxes. Select either Fit of All Standards or Mean of Replicates for the calculation of the curve fit.

• Analyze results while acquiring samples - The software allows real-time viewing of the results as the instrument analyzes samples. This feature is not available if you select None as your analysis type.

• Number of Standards - Displays the number of standards for the protocol.

• Use External Analysis Program - This indicates the use of a third-party program to analyze data.The Analysis Program list becomes active when this is selected. Applies only to qualitative and quantitative analyses.

• Number of Controls - Displays the number of controls for the protocol.

• Analysis Program - Displays which program is used for data analysis.

• Fit of all Standards - The standard curve will be determined by using each individual standard replicate when calculating the standard curve. For example, if you run duplicates of a 7-point standard curve, the software will calculate the standard curve by using 14 points. Applies only to quantitative analysis.

• Mean of Replicates - The standard curve will be determined by averaging the individual standard replicates when calculating the standard curve. For example, if your un duplicates of a 7-point standard curve, the software calculates the standard curve by using 14 points. Applies only to quantitative analysis.

• Cancel - Returns you to the main Batches tab.

method specified in the IVD assay protocol. methods , Linear, Logistic 4P,

Analytes Tab

Use this tab to select or edit analytes used in the batch or protocol.

Using xPONENT

FIGURE 25.

Analytes Tab

This tab contains the following:

Analyte grid - A grid representing each analyte from 1 to 50. Select All selects all analytes, and Deselect All deselects all analytes. Click a numbered analyte to select it; click the analyte again to deselect it. You can also click and drag to select groups of analytes. Selected analytes are red. Deselected analytes are gray. An analyte marked as an intra-well normalization bead is blue.

Default Analysis - The default analysis changes based on the Analysis Type selected in the Settings tab. You can change the analysis settings for all analytes by clicking Change if this button is enabled in this tab. This displays the Analysis Settings dialog box.

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FIGURE 26.

Analysis Settings Dialog Box

If you selected Quantitative on the Settings tab, the default analysis formula is 5P Weighted. To change the default, select one of the following from the Method list:

• No Analysis

• Cubic Spline

• Linear Fit

• Logistic 4P

• Logistic 5P

If you selected Logistic 4P or Logistic 5P, select a weight type of either None or 1/y2. .

If you selected Qualitative on the Settings tab, the default analysis is Luminex Qualitative. Change the default value by selecting either Luminex Qualitative or No Analysis.

Click Apply to All Analytes to apply your selection to all selected analytes. Click OK to change the default analysis to the analysis you selected. Click Cancel to close the dialog box without saving.

Units - Type the desired units for the analytes in this box.

Count - Type the desired bead count for the analytes by clicking in the Count box. If each

selected bead set does not acquire this number of events, a warning is added to the log that not enough bead events were acquired.

Using xPONENT

Apply All - Applies the information in the Units and Counts fields to all analytes.

You can also specify the minimum allowable bead count per well that xPONENT analyzes. This excludes data from any beads carried over during acquisition.

Selected Analytes List - Selected analytes appear in a list on the right side of the analyte grid. This list includes the following information

• Name - The name of the analyte. Click and type to rename the analyte.

• Analysis - To change the type of analysis for an analyte, click this field to open the

Analysis Settings

In the Analysis Settings dialog box:

• Select a method from the Method list.

• If necessary, select a weight type from the Weight Type list.

• Apply the analysis to all analytes in the list by clicking Apply to All Analytes.

• Select Mark as Intra-Well Normalization Bead to make the analyte an intra-well normalization bead.

• Add a range to the analysis by clicking Add Range.

• Select Use Threshold Ranges to enable ranges for the analysis.

• Click Add Range to add a range.

• Type a Range Name, a Low Value, a High Value, and select Inclusive if you wish to include the low and high values in the range. Click OK to exit the dialog box.

• Units - The unit of measurement you specified in the Unit box. Click this box to type a value for the analyte.

• Count - Type the desired bead count for the analytes by clicking in the Count box. If each selected bead set does not acquire this number of events, a warning is added to the log that not enough bead events were acquired.

• Region - Refers to the specific analyte selected. This is a number between 12 and 78.

dialog box and select another analysis from the list.

Group - If you have selected Allele Call from the Analysis Type in the Settings tab, this button displays. Click Group to group 2, 3, or 4 analytes for the group. Multiple groups can be defined.

Cancel - Click Cancel to return to the Batches tab.

Back - Click Back to return to the Settings tab.

Next - Click to go to the next tab. If the Analysis Type selected in the Settings tab was None or Allele, this takes you to the Plate Layout tab. If the Analysis Type selected was Quantitative or Qualitative, this button takes you to the Stds & Ctrls tab.

Protocols Tab

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

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FIGURE 27.

Protocols Tab

This tab contains the following:

Batch Name/Description - Used to name and describe a batch.

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. Confirm that the

plate layout conforms to your specific assay instructions. If you have selected a protocol with standards and controls, clicking Next continues to the Stds & Ctrls tab.

Stds and Ctrls Tab

Use this tab to apply a kit or lot to the batch. Standards and controls are also accessible from the Protocols page.

Using xPONENT

FIGURE 28.

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 click OK 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. You can also 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.

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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.

• 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 re-sort the display.

NOTE: Click the Reagent

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 Concentration - 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.

Managing Sample Lists

Use the Samples page to create new samples, view the details of a sample list, or to create a new batch. Samples can also be added with a Lab Information System (LIS). To learn more about how to use a LIS with xPONENT, see LIS Settings on page 11.

column header to re-sort the order from the

Using xPONENT

FIGURE 29.

Samples Tab

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.

These tabs are numbered because you must complete the steps on each tab sequentially. For example, you must complete the Protocols tab before you can access the Stds & Ctrls tab.

After you select a protocol, this tab displays the following:

Create New Samples - Opens the Create New Samples tab. This tab contains the following:

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WARNING: Human and animal samples may contain biohazardous

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 version number of the protocol. This cannot be edited.

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 sample orders. You can only view or run a sample list created in the LIS; you cannot edit it. If you do not have the LISenabled version of the software, use Create New Samples to create a new sample. After you have typed and saved the sample information, it appears in the list to the left. The list displays the samples you have already created. To reorder the sample’s acquisition location, use the Move arrows.

The Delete, New, Edit, and Undo buttons display depending on the actions you take in the

Create Sample tab.

Delete - Deletes the selected sample.

New - Creates a new sample.

Edit - Edits a selected 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.

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 Protocols tab to create a batch.

Create Sample Tab

Click Create New Sample on the Sample page to display this tab. Use this tab to type and view sample information.

Using xPONENT

FIGURE 30.

Create Sample Tab

This tab contains the following:

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

Version - Displays the protocol version number. This cannot be edited.

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. Use Create New Samples to create a new sample. After 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.

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.

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list.

Save - Saves changes made to the Sample list.

Close - Returns to the Samples tab.

Creating a New Sample List

1. Open the Samples

2. In the Sample Lists section, select the protocol you are using for the sample list, then

click Create New Samples. The Create Sample tab opens.

3. In the ID box, type the sample ID.

4. Type a patient first name in the First name box if desired.

5. Type a patient last name in the Last name box if desired.

6. To add a comment about the sample, type it in the Comment box; this is optional.

7. Click Save to add the sample to the Sample list.

8. To add more samples, click New. Repeat step 3 through step 7 until you have added all

of the samples you want in your samples list.

9. Once you have added the all desired samples, click Close.

page.

Editing a Sample List

1. Open the Samples page.

2. In the Samples Lists section, choose the protocol you want to edit, then click Details.

The Edit Samples tab opens.

NOTE: If the number in the Number of Samples

samples attached to the protocol.

3. Click a sample, then use the Move

changing the order in which they will be acquired.

arrows to move it up or down in the sample list,

column is “0”, there are no

4. To add a new sample to the list, click New, then perform the following steps:

a. In the ID box, type the sample ID.

b. Type a patient first name in the First name box if desired

c. Type a patient last name in the Last name box if desired.

d. To add a comment about the sample, type it in the Comment box; this is optional.

e. Click Save to add the sample to the Sample list.

5. To edit an existing sample, click the sample, then click Edit.

6. Once you have completed editing the sample list, click Close.

Performing Analysis

If you are using third-party software to perform analysis, follow the data analysis instructions provided in the IVD assay kit insert.

You may direct the system to acquire samples in replicate regardless of batch type. For qualitative batches, qualitative results for replicates are averaged and the reported interpretation is determined from this replicate average.

Using xPONENT

Current Batch Tab

To view the Current Batch tab, click the Results page. The Current Batch tab also displays when you run a batch. Use this tab to view results, statistics, and log information related to the current batch, and to perform statistical analysis on batch results. This tab offers real-time monitoring of batch sampling during acquisition through a display of sample bead statistics and analytes. The statistics available on this tab are intra-well statistics.

The statistics displayed change according to the analysis type selected . The buttons on this tab change based on your user settings.

FIGURE 31.

Current Batch Tab

Fields and entries available on this tab are:

Statistic - Select the statistic you want to view from the drop-down list.

Analyte - Contains a list of analytes that were run in the batch. Select an analyte to view all

statistics for that analyte.

Current Well - Displays the statistics of the well currently being analyzed (this changes to Displayed Well if you are viewing a batch using the Open button of the Saved Batches tab).

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Single Step - Allows analysis of one well at a time. Select or clear this check box to turn this function on or off.

Scroll Arrows - Use the up, down, left, and right arrow buttons to scroll through the table.

Maximize/Minimize - Use this toggle button to maximize and minimize the Plate Image, Dot

Plot, and List.

Plate - Select a plate from the drop-down list.

Save Image - Saves the information displayed on this page as an image file.

Progress - Click this button to display the Current Batch Run screen and to view real-time

batch processing results.

Analyze Current Batch

When you run a batch, the Current Batch tab opens. Here, you can view real-time analysis of acquired analytes. Use this tab to view results, statistics, and log information related to the current batch, and to perform statistical analysis on batch results. To view a single statistic type for all analytes, click the statistic you want to view in the Statistics list. To view all statistic types for a single analyte, click the analyte in the Analyte list. This tab offers realtime monitoring of batch sampling during acquisition through a display of sample bead statistics and analytes. The statistics available on this tab are intra-well bead statistics. They do not describe replicate well assay results.

Statistic

• Median - The point in a data set where there are as many values occurring above it as there are below it.

• Test Result - The calculated analysis value for quantitative or qualitative assays derived from standards with known values.

• Range - A semi-quantitative result for a particular numerical result falling between a predefined set of values such as “Normal” or “Negative”.

• Net MFI (Median Background) - Net MFI median background.

• Mean - Average of all values in a set of results.

• % CV of microspheres - The measure of relative dispersion within the distribution.

% CV = 100 x Std Dev / Mean

• Standard Deviation - For calculating sample variability or dispersion, Luminex uses the standard deviation formula.

• Peak - The value that is equal to the largest number of data points within the distribution. For example, in data set {1,2,2,3,3,3,4,5}, 3 is the peak because it occurs the largest number of times in the distribution list.

• Trimmed Count*

• Trimmed Mean*

- To view a particular statistic for analytes in a batch, select one of the following:

• Trimmed % CV of microspheres*

• Trimmed Standard Deviation*

• Trimmed Peak*

• % CV of Replicates - The measure of relative dispersion within the distribution of results for replicate samples.

% CV = 100 X Std Dev / Mean

Using xPONENT

• % Recovery - A measure of how accurately your observed results match your expected results following regression analysis.

(Observed concentration) / (Expected concentration) x 100%

• Expected Result - The known or expected test result value for a standard or control.

• Control Range - Low - The lowest value for an assay control used to determine pass/fail criteria for an assay.

• Control Range - High - The highest value for an assay control used to determine pass/fail criteria for an assay.

• Normalized Net Median - For each analyte in a well the Normalized Net Median (NNM) = (net median of analyte) / (net median of normalization bead)

• Units - The unit of measure for an analyte, for example, pg/mL.

*Trimmed statistics remove the lower and upper five percent of the extreme statistic values, then use the remaining values for the Mean, Standard Deviation, or % CV calculations.

The statistics displayed change according to the analysis type selected.

Analyte - Contains a list of analytes run in the batch. Select an analyte to view all statistics for that analyte.

Current Well - Displays the statistics of the well currently being displayed (this changes to Displayed Well if viewing a batch using the Open button of the Saved Batches tab).

Single Step - Allows analysis one well at a time. Click to turn this function on or off.

Results

buttons to move through the table, or use the scroll bars. The Maximize/Minimize toggle icon expands the batch table and returns it to the standard size.

Plate - A list of the available plates (if more than one).

- Displays statistics related to the batch. Use the up, down, left, and right arrow

CAUTION: If using multiple plates, ensure that plates are used in the proper

order. Failure to do so can result in inaccurate data and test results.

Right-click inside the dot plot area to access the following options:

Display Mode - Select either Logarithmic or Linear display. The software defaults to Logarithmic display. Click maximize for a magnified view of the dot plot.

Log - Displays a log of system processes. The log includes the following information:

• Date

• Message

• Code

Log entries indicating warnings are highlighted yellow. Errors are highlighted red. Other log entries are not highlighted. Click the Maximize icon to maximize the log. The log expands to fill the whole window. Click the Minimize icon to return to the standard size.

Save Image - Opens a Save As dialog box to save a screen capture.

Details - Opens the Results tab, enabling more analysis and results.

Progress - Click to display counts per region of the selected well. Analyte counts are

displayed in a bar graph as they are acquired. The scroll bar at the bottom of the Progress display scrolls through the analyte list.

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• Maximize - Maximizes the Progress display to fill the window.

• Zoom - Enable a closer look at the analyte progress.

• Save Image - Opens a Save As dialog box to save a screen capture.

• Default - Returns to the dot plot display.

Well Report - Displays a representation of the plate and the status of sample acquisition. Wells will display one of three possible states:

• Yellow - Well acquired, with a problem (select the Log tab for more information).

• Green - Well acquired successfully.

- Well acquisition unsuccessful. The system may have stopped, depending on the

• Red circumstances (select Log tab for more information).

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

All Regions - Displays all regions of the batch.

Default - Returns to the dot plot display.

Using xPONENT

Select Replay Mode

To replay a batch, open the Results page, then the Saved Batches tab. Select the batch that you want to replay and click Replay at the bottom of the screen. This opens the Select Replay Mode dialog box. Select Replay batch or Recalculate data as described below. The information that you must enter to replay or recalculate is the same.

A batch can be reprocessed multiple times.

NOTE: When replaying or recalculating large batches, the operation may

take 1 hour or more to complete. Batch replay cannot be stopped while in progress. Allow adequate time for the operation to complete. The operation is complete when all progress bars have disappeared.

NOTE: The initial batch data and output file always remain intact and

unchanged. Each time you replay or recalculate a batch, the system handles it as if it is a new batch, creating a separate batch entry and output file.

FIGURE 32.

Select Replay Mode Dialog Box

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Analyzing a Saved Batch

Open the Results page, then open the Saved Batches tab. Select the batch name, then click Open

• Click the Results tab to view statistical information about the batch.

• Click the Log tab to view a log for the activity that occurred during acquisition of the selected batch.

• Click the Sample Details tab to view sample details for each sample in the batch. If you are using the LIS package, click Transmit to transmit the data to the LIS.

Saved Batches Tab

Use this tab to open a batch that has been run and view its details, and export, approve, or replay a batch.

. The Results, Log, and Sample Details tabs appear.

FIGURE 33.

Saved Batches Tab

Completed Batches - Displays a list of completed batches that includes the Name, Protocol, Protocol Version, Date, Status, and User information, for each batch. Batches

that have not been run are not included.

Filter - Opens the Filter Setup dialog box.

Using xPONENT

FIGURE 34.

This dialog box lets you choose the saved batch that you want to display in the Completed Batches list, based on the options you select or clear in the following check boxes:

• Batch Name

• Protocol

• Batch Status

• Lot ID

• Kit ID

• Analyte

• Sample ID

• First Name

• Last Name

• User ID

• Date

Filter Setup Dialog Box

Reset - Clears all check boxes.

OK - Closes the dialog box and applies any changes you made.

Cancel - Closes the dialog box and cancels any changes you made.

Save Prtcl - Saves the protocol and kit information for the selected batch.

Plate Layout - Opens the Report dialog box, which includes the Batch Plate Layout Report. Confirm that the plate layout conforms to your specific assay instructions.

Approve - Opens the Batch Approval Confirmation dialog box to approve the selected

batch. Only approved batches can be transmitted to the LIS. If your software is licensed for LIS use, you can transmit batches to the LIS from the Sample Results tab. Once you have approved a batch, the status of the batch changes to Approved in the Completed Batches list.

Exp Results - Opens the Save As dialog box to choose an export destination for the CSV file containing your results.

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Import - Opens the Open dialog box to choose a batch file (.mdf) to import. Select Include Raw Files (LXB) to import the raw data file as well.

Export - Opens the

Select Include Raw Files (LXB) to include the raw file in the export. Select Overwrite to overwrite pre-existing files.

Open - Opens the Results tab. Use this tab to view the saved batch results for the selected batch.

Export Batch dialog box to choose a destination for the batch file (.mdf).

Invalidate Standards and Controls

NOTE: It is possible to invalidate or remove a control in data analysis.

However, Luminex does not recommend invalidating controls.

For information on assay controls and guidelines regarding accepting or rejecting control values, contact the assay kit manufacturer.

To invalidate standards and controls:

1. Open the Results

2. Open the Saved Batches tab.

3. Click the batch name, then click Open. The Results tab opens.

4. Click the square area next to left of the standard you wish to invalidate, then click

Invalidate. The whole row turns red.

page, then open the Saved Batches tab.

Viewing Batch Settings

1. Open the Results page, then open the Saved Batches tab.

2. Click Saved Batches, then click the batch for which you want to view details.

3. Click Open, then click the Settings tab.

4. Click the left and right Page arrows to view the pages of the batch settings report.

5. Click Save to open the Save As dialog box. Navigate to the location where you want to

save the batch settings report, and click Save.

Viewing Batch Logs

1. Open the Results page, then open the Saved Batches tab.

2. Click Saved Batches, then click the batch for which you want to view details.

3. Click Open. The Results tab opens.

4. Click Log to open the Log tab.

Viewing Sample Details

1. Open the Results page, then open the Saved Batches tab.

2. Click Saved Batches, then click the batch for which you want to view details.

3. Click Open, then click Sample Details. The Sample Details tab opens. If you are using

an LIS licensed package of the software, click Transmit to transmit sample details to the LIS database. You can transmit either a single analyte per sample or the entire sample.

Using xPONENT

Results Page

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

• Current Batch tab

• Saved Batches tab

• Results tab

• Log tab

• Sample Details tab

• LIS Results

• Reports tab

The information that you can view and the actions you can perform differ depending on which of these tabs you click.

Results Tab

Access this tab by clicking the Results page, then Saved Batches. The Results tab opens.

tab

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FIGURE 35.

Results Tab

This tab displays the following:

• Results

• Statistic

• Analyte

• Displayed Well

• Well information (Well, Sample, Run Statistic; Analytes by number)

• Plate Layout image. Confirm that the plate layout conforms to your specific assay instructions.

• Bead Map

The Results tab has the same Save Image and Progress buttons as the Current Batch tab. The following buttons are added to the Results tab:

• Formula - Opens the Change Analysis dialog box with a list of analytes used in the batch. Click an analyte to open the Analysis Settings dialog box from which you can select a new analysis setting for the analyte.

• Approve - Opens the Batch Approval Confirmation dialog box, which contains the data for analytes selected in the Results tab. Click Yes to approve the batch. The dialog box confirms the approval.

Using xPONENT

• Validate - Validates an entire selected row or cell in the Results table. Average rows or cells cannot be selected. If you haven’t selected an item or the item you selected does not need to be validated, a warning dialog box displays. Your xPONENT system administrator must give you privileges to invalidate standards if you are using the Secure xPONENT package.

• Invalidate - Invalidates an entire selected row or cell in the Results table. The selection will turn red when invalidated. Select the same item and click Validate to remove the invalidation status.

• Save - Saves the batch. This button only appears if a change was made to the batch.

• Analyze clicked Invalidate on a portion of the data, or if you have clicked Validate on an invalidated portion of the data. This will analyze the data again with the invalidated standard removed.

• Close - Closes the batch and reopens the Saved Batches tab.

Click the Results page, then open the Saved Batches tab. Click the batch name, then click Open. The Results Settings, Log, and Sample Details tabs appear.

• Click the Results tab to view statistical information about the batch.

• Click the Log tab to view a log for the activity that occurred during acquisition of the selected batch.

Click the Sample Details tab to view sample details for each sample in the batch. If you are using the LIS package, click Transmit to transmit the data to the LIS.

- Analyzes data that has been invalidated. This button only appears if you have

Settings Tab

Use this tab to view the acquisition parameters of the selected saved batch and print the batch settings report.

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FIGURE 36.

Settings Tab

Name and description boxes - Type the name and description in the appropriate box.

Acquisition Settings:

• Volume - This is the volume the instrument will aspirate into the system for analysis. Type the desired sample volume in microliters. Use values from 10 to 200 µl. To avoid air intake, add at least 25 µl to the sample well in addition to the sample size. The default value is 50 µl.

• XY heater - Select Enabled to enable the XY heater. In the box type the desired value in degrees Celsius. The temperature range is 35 to 60° C.

CAUTION: Acquiring data before the heater has reached the proper

temperature can compromise test results.

• Plate name - The name assigned to the plate. You can select a different plate from the list.

• Sample wash - Select this option for assays without a final wash step prior to reading the plate on the instrument. This automatically washes each sample within the instrument. Final washes are required for proper analysis.

Using xPONENT

Analysis Settings - Use this section to set the analysis type, set the number of standards and controls, select an external analysis program, and choose whether to analyze results while acquiring samples.

Analysis Type - Use this list to choose from the following analysis types:

• None - No analysis. Select if you have your own data post-processing program and

want to obtain only fluorescent intensity results. You cannot apply standards or controls when you select None. You cannot analyze acquisitions with this setting.

• Qualitative - Qualitative analysis determines results as either positive or negative,

reactive or non-reactive. The software is flexible in defining custom result ranges, such as negative, low positive, or high positive. Determinations are based on a single standard. For qualitative analysis the Luminex software uses a specific algorithm, shown below.

Where:

FI = Fluorescent Intensity

Ki = a “Quali” value entered in lot information to determine the value or the qualitative assay standard.

The “Quali” value determines a cutoff or threshold. This, in conjunction with ranges using the Lum Qual formula or an edited range specific for your assay, helps to determine qualitative results for unknown samples.

Two predefined formulas using the algorithm are included in the system. You can use them as-is or edit their range values to meet your requirements.

• Quantitative - Determines the sample concentrations from standard curves using

regression methods Cubic Spline, Linear, Logistic 4P, and Logistic 5P. Type the desired values for standards and controls in the Number of Standards and Number of Controls boxes. Select either Fit of All Standards or Mean of Replicates for the calculation of the curve fit.

NOTE: Luminex recommends Fit of All Standards as the most accurate

calculation of the curve fit.

Based on a range of quantitative, numerical results, a threshold range can be applied to a quantitative analysis, for example, high, low, saturated, and expected.

• Allele Call - Sets analysis for an allele call. Analytes must be put in groups of 2, 3, or 4

analytes.

• Min MFI Enabled - Select this box to enable a minimum MFI for the Allele Call analysis. Type a value in this box to set the minimum MFI for analysis.

• Number of Standards - Click to type the number of standards for the protocol. Applies only to qualitative and quantitative analyses.

• UseExternal Analysis Program - Select this check box to use a third-party program to analyze the data. The Analysis Program list becomes active when this is selected. Applies only to qualitative and quantitative analyses.

• Number of Controls - Click to type the number of controls for the protocol. Applies only to qualitative and quantitative analyses.

• Analysis Program - Use this list to select which program to use for data analysis.

xPONENT for MAGPIX 76

• Fit of all Standards - The standard curve will be determined by using each individual standard replicate when calculating the standard curve. For example, if you run duplicates of a seven-point standard curve, the software will calculate the standard curve by using 14 points. Applies only to quantitative analysis.

• Mean of Replicates - The standard curve will be determined by averaging the individual standard replicates when calculating the standard curve. For example, if your un duplicates of a seven-point standard curve, the software calculates the standard curve by using 14 points. Applies only to quantitative analysis.

Cancel- Returns you to the main Batches tab.

Next - Click to advance to the Analytes tab.

Log Tab

This tab displays a log of the activity that occurred during the acquisition of the selected batch.

FIGURE 37.

Log Tab

This tab displays the following information about each activity:

Using xPONENT

• Date

• Message

• Code

Log entries are displayed in yellow if a well was acquired with a warning. Log entries are displayed in red if a problem occurred during acquisition.

- Prints the log.

Export - Opens the Save As dialog box so that you can save the log file. Browse to a location and click Save.

Close - Reopens the Saved Batches tab.

Sample Details Tab

Use this tab to view sample results.

FIGURE 38.

Sample Details Tab

Arrows - Scroll through the sample details.

Transmit - For systems configured for LIS transmission, select a single analyte or the entire sample and click Transmit to send the results.

Close - Reopens the Saved Batches tab.

xPONENT for MAGPIX 78

LIS Results Tab

This tab displays saved batches containing LIS samples.

FIGURE 39.

LIS Results Tab

Filter- Opens the Filter Setup dialog box.

Clear - Click to turn off the filter.

Completed Samples - Displays Name, Protocol, Sample Count, Date, Status, and User

information for each batch displayed in this list.

Transmit - Transmits a batch to a LIS if a licensed version of xPONENT is connected to one.

Details - Opens the Sample Details tab to view sample results.

To transmit a batch to an LIS:

1. Open the Results page, then open the LIS Results tab.

2. Select a batch, then click Open.

3. Click Yes to approve and transmit the batch to the LIS database.

Using xPONENT

Reports Tab

Use this tab to view, generate, and print reports. xPONENT can format your batch or multibatch results in a variety of export formats and provide different types of information in three different types of reports:

• Batch Reports

• Protocol Reports

•

System Log Reports

FIGURE 40.

Reports Tab

Report and Type lists - Choose a report from one of the following categories:

Batch Reports - A list of batches appears below the Type list. The list includes Name, Protocol, Protocol Version, Date, Status, and User information. Choose from the following

reports:

• Data Interpretation

• Batch Settings

• Plate Layout

xPONENT for MAGPIX 80

• Batch Audit

• Patient Report

If you choose Data Interpretation displays a list of the analytes in the batch. Select the analytes you want to include in the report. Select All to select all the analytes in the list. Select Clear to clear all the analytes in the list.

A series of new buttons appears when you click Generate Report:

• Analyte arrows - This feature is directly below the Report list. Use the left and right arrows to display information for individual analytes of those selected for the report.

• Page arrows - use the arrows to scroll through the pages being displayed.

• Save All - Click to open the Browse For Folder dialog box. Select a location to save the file, and click OK. This file includes all selected analytes.

• Print All - Click to print the information for all the analytes in the report.

• Save - Click to open the Save As dialog box. Select a location and click Save. This saves only the analyte information currently being viewed.

• Print - Click to print the analyte information currently being viewed.

• New Report - Click to return to the main Reports window.

NOTE: If running a data interpretation of an allele call batch report, be aware

that when choosing analytes from the Select Analytes list, selecting one analyte will select all analytes in that group.

, a Select Analytes section appears on the right and

Protocol Reports - A list of protocols displays. Choose from the following reports:

• Protocol Settings

• Plate Layout

• Protocol Audit

Select a protocol and then click Generate to generate the report.

Calibration and Verification Reports - Displays a list of calibrations and verifications. Choose from the following selections:

CALVER - Select a calibration component, a date from the Date list, and click Generate to generate the report.

Performance Verification Reports following:

• Condensed

• Detailed

Select a report type, a date range from the Date list, and click report.

System Log Reports - Displays a list of system log reports. Choose from the following selections:

• All

• Maintenance

• Security

• Warning and Errors

- Displays two report types. Choose either of the

Generate to generate the

Using xPONENT

Select a system log report, a date from the Date list, and click Generate to generate the

report.

Advanced Reports - Enables a single option, User Report

Click Generate to generate the report.

NOTE: Install the printer before initiating the Print command.

To generate, view, and print a report:

1. Open the Results page, then open the Reports tab.

2. In the Report list, click the report you want to view.

3. In the Type list, select the report type you want to view.

4. Select the item for which you want to generate the report. If you are creating a batch

report, select the analyte to include in the report.

5. Click Generate. The report displays in the lower part of the Reports tab.

6. Click Print to print the report, or Save to save the report.

Using Protocols, Lots, and Kits

Protocols for IVD assay kits should be supplied by the IVD kit manufacturer.

, in the list.

Creating an Allele Call Protocol

This protocol contains no standards or controls. An allele call compares groups of two, three, or four analytes to identify genotypes.

To create an allele call protocol:

1. Open the Protocols page, then open the Protocols tab. Click Create New Protocol.

The Protocol Settings tab opens.

2. In the Name box, type the name of the protocol.

3. In the Description box, type a description of the protocol.

4. In the Version box, type the version of the protocol.

5. In the Manufacturer box, type the manufacturer information for the protocol.

6. Define the settings in the Acquisition Settings section. For information about each of

these settings, #unique_117.

7. Define settings in the Analysis Settings section, selecting Allele Call as the analysis

type. For information about the settings in this section, #unique_117.

8. Click Next. The Analytes tab opens.

9. Click the desired analyte (bead ID) in the numbered grid. Information about the analyte

appears in a list on the right side of the grid. For an allele call analysis, you must select a group of two, three, or four analytes.

10. Click Group to group the analytes for the allele call. The grouped analytes display in a list

to the right. Select more analytes and then click Group again if you want to add another group to the analysis.

11. Click and type an analyte name in the Name column to the right of the analyte grid.

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12. In the Count box, type the total desired bead count for each analyte. Click Apply All.

13. To set a bead count and the units for a single analyte, click in the Units

columns directly to the right of the analyte grid, and type a units value and bead count.

14. Click in the Call % column and type a value to set an individual analyte’s call percentage.

15. Click Next. The Plate Layout tab opens.

• To add well commands, highlight the appropriate wells and mark them as unknown, standard, control, background, or wash. You can also delete commands that you’ve added, and change the starting location on the plate. If you want to run in replicate, change the Replicate Count to the appropriate number and the Grouping to your preferred grouping method.

• Delete a command by clicking the well, and clicking Delete. The Delete Options dialog box opens. Select Delete just the selected wells to delete a single well command, or Delete all wells containing these samples to delete all wells with the same command.

• As you add commands to your plate, they appear in the Command Sequence list. Type a well ID in the ID field. Here, you can give each of your wells an ID. You can also import a protocol file by clicking Import List.

• Move commands up or down in the sequence by highlighting a command and using the Move Command arrows to move the command up or down in the list.

16. Click Save.

and Count

Importing a Protocol

1. Open the Protocols page, then open the Protocols tab. Click Import.

2. In the Open dialog box, navigate to the protocol file you want to import, then click Open.

3. The imported protocol displays in the Installed Protocols list.

Adding a New Lot for Protocol

1. Open the Protocols page, then open the Protocols tab. Click the protocol to which you want to add a lot.

2. Open the Stds & Ctrls tab.

3. Click Create New Std/Ctrl Lots and select a protocol from the drop down list in the Select Protocol dialog box, then click OK. The Std/Ctrl Details tab opens.

4. Click Apply Std/Ctrl Kit to associate a kit with the protocol. If you are not using a kit, type the appropriate Standard and Controls information in the Assay Standard Information and Assay Control Information sections.

5. Click Save.

Deleting a Protocol

1. Open the Protocols page, then open the Protocols tab.

2. Select a protocol.

3. Click Delete. The Delete Protocol dialog box opens.

4. Click Yes.

Using xPONENT

Exporting a Protocol

1. Open the Protocols

2. Select a protocol.

3. Click Export. The Save as dialog box opens.

4. Select a location to export the file to, and click Save.

Lots and Kits

Assay kits include standards and/or controls. After you enter the assay kit information, it can be used in multiple protocols. However, you should create separate kits specifically for use with each protocol. For assay reagents specified in protocols, you can create new lots, edit lot information, select pre-existing lots for reuse, import lots, and export lots.

Once a lot is used, changing or modifying it will prompt you for a new lot name.

Creating a Kit

To create a kit:

1. Open the Protocols page, then open the Protocols tab. Select the protocol that you want to use for the kit, then click NewStd/Ctrl. The Std/Ctrl Details tab opens.

2. Click on the protocol that you want to use for the kit, then click New Std/Ctrl. The Std/ Ctrl Details tab opens.

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

4. Click Apply Std Lot if you want to apply a standard lot. The Select Lot dialog box opens. Click a lot and select OK.

page, then open the Protocols tab.

5. Click Apply Ctrl Lot to apply a control lot. The Select Lot dialog box opens. Select a lot and click OK.

6. Alternatively, type the appropriate information in the AssayStandard Information and Assay Control Information sections. The number of standards and/or controls in these sections is defined in the protocol. If your batch uses controls, select Expected, Low or High from theShow Value options. Use the Apply Values arrows to apply values down or across the range of analytes.

7. Click Save.

Creating Lot

To create lots, you must use a protocol that uses either Quantitative or Qualitative analysis settings.

To create a lot:

1. Open the Protocols page, then open the Protocols tab. Click the Stds & Ctrls tab, then click Create New Std/Ctrl Lots.

2. In the Select Protocol dialog box, select the protocol you want to use for this lot, then click OK. The Std/Ctrl Details tab opens.

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

4. Alternatively, click Apply Std/Ctrl Kit and select a lot from the Select Lot Click OK to apply the lot.

5. If your batch uses controls, select Expected, Low, or High from the Show Value options. Use the Apply Values arrows to apply values down or across the range of analytes.

6. Click Save.

dialog box.

Importing a Lot

1. Open the Protocols page, then open the Protocols tab. Click the Stds & Ctrls tab, and then click Import.

2. In the Open dialog box, navigate to the file, then click Open.

Deleting a Lot

To delete a lot:

1. Open the Protocols page, then open the Protocols tab. Click the Stds & Ctrls tab.

2. In the Installed Kits And Lots section, click the lot you want to delete, then click Delete.

Exporting a Lot

NOTE: Lots and kits can only be exported if the protocol they were originally

created with exists within the system. If the protocol has been deleted, the lot or kit cannot be exported.

To export a lot:

1. Open the Protocols

2. In the Installed Kits And Lots section, click the lot you want to export, then click Export. The Save As dialog box opens.

3. Navigate to the location you want to export the file to, then click Save.

page, then open the Protocols tab. Click the Stds & Ctrls tab.

Editing a Lot

To edit a lot:

1. Open the Protocols page, then open the Protocols tab. Click the Stds & Ctrls tab.

2. In the Installed Kits And Lots section, select a lot and then click Edit. The Std/Ctrl Details tab opens. Change the lot information as appropriate.

Using xPONENT

xPONENT for MAGPIX 86

Chapter 4: Performing System

Maintenance

Initial Startup

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

1. Adjust the Sample Probe Height

2. Revive After Storage (Luminex) Routine

3. Calibration/Verification Routine

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. Based on the type of plate you are using, place alignment disks or an alignment sphere from the Height Alignment Kit in the well, as specified below:

• Filter-bottom plate - two (2) 5.08mm disks

•

Mylar-bottom plate - two (2) 5.08mm disks

• Conical (V-shaped) plate - one (1) sphere

If you are using a standard 96-well plate, you do not need to use any of the disks or spheres in the Height Alignment Kit.

3. Ensure that the well location is selected on the plate image. Luminex recommends that you use well D6 (this is the center of a standard 96-well plate). A green pin marks the selected well.

4. Click Eject to eject the plate holder.

5. Place a strip well in the off-plate reagent block.

6. In the Strip Wells section, click D1.

Luminex xPONENT for MAGPIX User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of Contents

Software Packages

About This Manual

Warnings, Notes and Symbols

General Guidelines

Biological Samples

Bead (Microsphere) Handling

Safety Precautions

Bead Concentration

MAGPIX Technology

Repetitive MagPlex Bead Measurements

Classification and Reporter Fluorochromes

Fluidics 1 and Fluidics 2

Sample Volume

Plates

Touch Screen

System Setup

Viewing System Status

Application Settings

LIS Settings

External Analysis Program Settings

Adding an External Analysis Program

Editing an Analysis Program

Removing an Analysis Program

Arranging Main Navigation Buttons

Maintenance Options

Group Setup Tab

Setting Up Group Permissions

User Setup

User Setup Tab

Global User Settings

Defining Global User Settings

Create User Account Screen

Creating a New User

Batch Options Tab

Alert Options Tab

Setting Notification Options for System Events

CSV Options Tab

Setting CSV Options

Archive Options Tab

Archiving a File

Backing Up xPONENT Data and Settings

Adding a Previously Archived File Back into the Database

Restoring the System Using a Backup File

Licensing Tab

Schedule Tab

Report Options Tab

Starting xPONENT

Initial Startup

Logging In to xPONENT

Logging Off of and Exiting xPONENT

Using Online Help

Screen elements

System Monitor

Home Page

Daily Activities

Adjusting the Sample Probe Height

System Initialization

Adding or Importing CAL and VER Kit Information

Setting Up the System Initialization Routine

Running System Initialization

Exporting CAL or VER Kits

Deleting CAL and VER Kit Information

Creating Calibration and Verification Reports

Setting Up Batches

Batches Page

Using the Batches Page

Create a New Batch from an existing Protocol

Create a New Batch from a new Protocol

Create a New Multi-Batch

Save Multi-batch

Running a Batch

Importing a Batch

Exporting a Batch

Delete Batch

Editing a Batch