Luminex IS User Manual

Luminex® ISTM Software Manual For

Version 2.3

For In Vitro Diagnostic Use

REP

WMDE Bergerweg 18 6085 AT Horn The Netherlands

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

12212 Technology Boulevard

Austin, Texas 78727-6115

U.S.A.

Voice: (512) 219-8020

Fax: (512) 219-5195

IVD Luminex® IS

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: Luminex, Luminex 100, Luminex 100 IS, Luminex 200, LabMAP, xMAP, LumAvidin, Luminex XYP, Luminex FlexMAP, and Luminex SD.

All other trademarks, including Windows, Cheminert, Pentium, and Dell companies.

Software Manual for Version 2.3

PN 89-00002-00-254 Rev. B

March 2011

are trademarks of their respective

The Luminex 100 IS software uses the VideoSoft ActiveX controls, which are copyrighted by VideoSoft, 2001.

The contents of this manual and the associated Luminex software are the property of Luminex and are copyrighted. Except as specified in the End User License Agreement, any reproduction in whole or in part is strictly prohibited.

® VsFlexGrid Pro 7.0, VsPrinter 7.0, and VsView 3.0

Standard Terms and Conditions For Use of 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 the Luminex authorized reseller that sells the Product to Buyer. 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 - Any warranty obligations for the Product shall be exclusively provided in writing to Buyer directly by Seller. LUMINEX MAKES NO WARRANTY WHATSOEVER REGARDING THE PRODUCT AND LUMINEX SPEFICALLY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. 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.

3. Buyer's Use of Product -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, and Buyer does not receive any right under Luminex's patent rights hereunder. Buyer acknowledges and agrees that the Product is sold and licensed only for use with Luminex's standard fluorescently dyed microspheres. Buyer further acknowledges that the Product have 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 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.

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, 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 Luminex software product identified above, which includes computer software and online or electronic documentation and may include associated media and printed materials (if any) (“SOFTWARE PRODUCT” or “SOFTWARE”).

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

1. 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 PRODUCT on a hardware platform purchased from Luminex pursuant to Luminex’s terms and conditions of sale. You may make one (1) copy of the SOFTWARE PRODUCT for backup or archival purposes only. 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.

2. RESTRICTIONS

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

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

• You may not reverse-engineer, decompile, disassemble, or otherwise attempt to derive source code from the SOFTWARE PRODUCT.

• 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 PRODUCT.

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

• You may not modify or prepare derivative works of the SOFTWARE PRODUCT.

• You may not use the SOFTWARE PRODUCT in a computer-based service business or publicly display visual output of the SOFTWARE PRODUCT.

• You may not transmit the SOFTWARE PRODUCT over a network, by telephone, or electronically by any means.

3. TERM AND TERMINATION. Your rights under this EULA are effective until termination. You may terminate this EULA at any time by destroying the SOFTWARE PRODUCT, 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 PRODUCT and erase any copies residing on your computer equipment.

4. RIGHTS IN SOFTWARE. All rights and title in and to the SOFTWARE PRODUCT 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 PRODUCT 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.

5. EXPORT RESTRICTIONS. You agree that you will not export or re-export the SOFTWARE PRODUCT 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.

6. NO WARRANTY. THE SOFTWARE PRODUCT IS LICENSED “AS IS.” ANY USE OF THE SOFTWARE PRODUCT IS AT YOUR OWN RISK. THE SOFTWARE PRODUCT 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.

7. 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 PRODUCT, EVEN IF LUMINEX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

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.

EULA PN: 89-30000-00-070

Contents

Luminex 2.3 Software 1

Main Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Menu Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Toolbar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Tabs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Secondary Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Analysis Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Commands. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Acquire Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Add Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Alcohol Flush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Autoscale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Autosize . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Backflush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

CAL1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

CAL2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Cancel (Command) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Cancel All . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Change Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

CON1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

CON2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Connect to Instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Create New Multi-Batch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Delete Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Density/Decaying . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Disconnect from

the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Display Confirmation Screens . . . . . . . . . . . . . . . . . . . . . . . . . 30

Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Eject/Retract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Enable Raw Data Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Export Batch Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Export CAL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Export CON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Export Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

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Luminex IS Software Manual For Version 2.3 - For In Vitro Diagnostic Use xMAP Technology

Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Import Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Import Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Import Template. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Insert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Invalidate Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Invalidate Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Load Patient List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Log/Linear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Maximize/Minimize. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Next Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

New Advanced Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

New Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

New CAL Targ. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

New CON Targ. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

New Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Open Batch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Open Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Open Incomplete Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Open Multi-Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Pause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Previous Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Prime . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Print Batch Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Print Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Replay Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Report Raw Fluorescence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Resume. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Sample Probe Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Sanitize. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Save and Load . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Save Only. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Self Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Show Bead . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Single Step . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Skip [wells] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Soak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Start Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Start (Plate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Test Sort Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Validate Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Validate Standard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

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xMAP Technology Contents

View Batch Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Warmup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Wash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Zoom. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Using the Online Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Setting Software Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Setting up the Favorites List . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Startup Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Batch Setup Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Managing Assay Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Analyzing Batches and Multi-Batches . . . . . . . . . . . . . . . . . . . 67

Data Analysis Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Running Reports and Analyses. . . . . . . . . . . . . . . . . . . . . . . . . 77

Database Management Procedures . . . . . . . . . . . . . . . . . . . . . . 81

Maintenance Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Daily Shutdown Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Overall Design. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Blank Lines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Field Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Statistics Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

Statistics Column Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Luminex 100 IS Output.CSV file with no additional features enabled 99 Luminex 100 IS Output.CSV file with all additional features enabled 100

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Luminex IS Software Manual For Version 2.3 - For In Vitro Diagnostic Use xMAP Technology

Luminex 2.3 Software

This manual describes how to use the Luminex IS 2.3 software. It includes a glossary and information regarding the CSV file setup. The software user should have a basic familiarity with computers and Microsoft® Windows®. Commands are often available through more than one method, such as from the main menu bar, the toolbar, or on different windows. However, each procedure in this manual will describe only one method of accessing commands.

This chapter has the following sections:

• Main Window - This section describes the main window of the Luminex IS 2.3 software, including tabs and commands. Use this section to become familiar with the main functions of the software.

• Secondary Windows - This section describes the secondary windows in the Luminex IS 2.3 software, including the Analysis Window and Batch Setup Window.

• Commands - This section describes the functions of the commands in the Luminex IS 2.3 software.

• Procedures - This section describes how to perform tasks using the Luminex IS 2.3 software.

When using microtiter plates, use plates with wells that will hold at least 185 µL (the extra 25 µL from the sample, plus an extra 160 µL that is dispensed back into the well following acquisition).

Warn in g: If you are running an assay using xMAP Technology as an

in-vitro diagnostic, the assay must be run according to the instructions provided with the assay.

Main Window The Luminex IS 2.3 software starts automatically when you log into

Windows.

When the first software User window opens, the Main window is open, with the Home tab displayed, as shown in Figure 1

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1. Title bar 4. Tabs

2. Menu bar 5. Status bar

3. Tool bar

Figure 1 Luminex IS 2.3 Main Window

There are five major parts in the Main window: Title bar, Menu bar, Tool bar, Tabs, and Status bar. A brief description of each of these components is shown below.

The Title Bar displays the name of the software.

The Menu Bar contains three menus, File, Tools, and Help menu. A more thorough description of the Menu is shown on page 3.

The Too lb ar - has shortcut buttons for frequently-used commands. A more thorough description of the Toolbar is shown on page 4.

There are five Ta bs , organized by function. The tab that displays when the software starts up is the Home tab. A more thorough description of each of these tabs begins on page 4.

The Status bar displays the system status at the bottom of the main window. A more thorough description of the Status bar is shown on page 17.

xMAP Technology Luminex 2.3 Software

Menu Bar The menu bar contains the following menus: File Menu, Tools Menu,

and Help Menu.

File menu - contains the following commands:

• Import Template

•New Batch

• Open Batch

• Delete Batch

• Edit Patient List

• Open Incomplete Batch

• Batch Comment

• New Multi-Batch

• Open Multi-Batch

• Data Analysis

• Export Batch Data

• Print Report

•Exit

Tools menu - contains the following commands:

• Connect

• Disconnect

• Database Backup

• Database Restore

• Erase Database

• Update CAL Targets

• Update CON Targets

• New Assay Lot

• Options

•Cleanup

For information on each of these commands, see the Commands section, beginning on page 29.

Help menu - this contains menu selections that open the online help and describe the software and hardware.

• Contents opens the online help

• About the Device opens a dialog box that shows the version

and serial numbers of the Luminex instruments you are using.

• About the Software opens a dialog box that shows the

version of the Luminex Software you are using.

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Toolbar The shortcut buttons on the toolbar can be found in other locations in

the software. The Help button opens the online help. The Single Step option on the toolbar allows you to pause the system in between each command or sample acquisition within a batch.

1. Import Template 8. Print Report

2. New Batch 9. Connect to the Instrument

3. Open Batch 10. Disconnect from the Instrument

4. Create New Multi-Batch 11. Eject/Retract

5. Open Multi-Batch 12. Open Help File

6. Start Analysis 13. Single Step

7. Export Batch Data

Figure 2 Luminex IS 2.3 Toolbar

Tabs This section describes the tabs in the Main window.

Home tab This is the default tab. It is organized by the order of system use. It

contains a Favorites list and five button groups representing data acquisition and maintenance categories.

1. Favorites List 2. Button Groups

Figure 3 Home Tab

xMAP Technology Luminex 2.3 Software

Favorites. You can use the Favorites list to create a list of oftenused commands and templates. Items appear in alphabetical order for easy locating. For more information on setting up the Favorites list, see page 40.

Button Groups. Button groups are grouped according to function.

•The Daily Startup group contains the Warmup, Prime,

Alcohol Flush, and Wash Commands. For more information on daily startup, see page 41. For more information on the commands, see the Commands section on page 29.

•The Instrument Calibration group contains the CAL1,

CAL2, CON1, and CON2 buttons. For more information on calibrating the system, see page 43. For more information about these commands, see the Commands section on page 29.

•The Batch Setup group contains the New Batch, New

Multibatch, and New Lot buttons. For more information on creating and running batches and multibatches, see page 49. For more information about these commands, see the Commands section on page 29.

•The Reports and Analysis group contains the Analysis and

Print buttons. For more information on running reports and analyses, see page 77. For more information about the Analyses and Print commands, see the Commands section on page 29. For IVD assays use the analysis recommended in the IVD kit package insert instructions for use.

•The Daily Shutdown group contains command buttons that

you can use when shutting down the system. For more information on performing a daily shutdown, see page 86. For more information on the Sanitize and Soak commands, see the Commands section starting on page 29.

Run Batch Tab The Run Batch tab contains a microtiter plate and reservoir image,

XYP and DD temperature readbacks, a sheath pressure gauge, print button, command list displaying batch commands and their status, and plate and XYP command buttons. See Figure 4.

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1. Microtiter plate/reservoir image 2. Temperature and Pressure Gauges

3. Command List

Figure 4 Run Batch Tab

The command buttons on the Run Batch tab are:

• Print Worklist • Eject/Retract

•Start Plate •Resume

• Cancel Command • Pause

• Cancel all

For more information on these commands, see the Commands section, starting on page 29. For more information on setting up batches, see See “Batch Setup Procedures” on page 49.

The microtiter plate and reservoir image represents where you place samples or other fluids used in running or maintaining the system. Samples are analyzed vertically, from top to bottom within the column, and then from left to right for subsequent columns.

The Temperature and Pressure Gauges show information about the analyzer and the XYP instrument. The XYP heater temperature measures the internal Luminex XYP instrument plate temperature. The DD temperature measures the doublet discriminator temperature. DD temperature shifting indicates a need for system recalibration. If you have not calibrated, the arrows showing the temperature range

xMAP Technology Luminex 2.3 Software

for the DD temperature both appear at the bottom of the thermometer, and the thermometer appears in red. An out-of-range temperature logs an error, but does not halt the acquisition.

For information on setting the XYP instrument heater temperature, see page 43.

The Command List displays commands associated with batches, new advanced batches or multi-batches loaded for processing on the system. The Command List shows the status of each command as the system processes it, and whether the command completes successfully or fails. Figure 5 shows that the first two commands were successful, the third command is running, and the rest of the commands are pending. Figure 6 shows that the third command failed.

Figure 5 Command List Section of the Run Batch Tab

Figure 6 Command Failure Notation in the Command List

Errors are recorded in the Message Log on the Diagnostics tab. See page 9 for more information about the Diagnostics tab. Double-click on failed commands in the Message Log for additional information. You can right-click a highlighted row to copy data to the clipboard or clear the batch from the screen.

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Maintenance Tab Use the Maintenance tab to perform maintenance, XYP, daily startup,

calibration, and verification commands to maintain your system and keep it in optimal working order.

Figure 7 Maintenance Tab

See the Commands section starting on page 29 for detailed information about these commands:

•Warmup

•Prime

•Backflush

• Alcohol Flush

• Sanitize

•Wash

•Drain

•Soak

• Self Diagnostics

• Calibration Commands: CAL 1, CAL2, CON 1, CON2, New CAL target and New CON target

• Sample Probe Down

• Eject/Retract

xMAP Technology Luminex 2.3 Software

Instructions for maintenance procedures begin on page 83. Table 8 on page 83 shows a recommended use schedule for maintenance operations.

Diagnostics tab Use the Diagnostics tab to monitor the progress of commands you

initiate in the system. Features on this tab monitor the state of system components. This tab displays the System Monitor, Detailed Sample Progress chart, and Message Log. The Text on the Diagnostics tab turns red if the system encounters an error. The Message Log on the Diagnostics tab indicates where the error occurred.

Figure 8 Diagnostics Tab

Use these tools to find information about the system and what occurs during sample acquisition and other functions. For example, you may look on the Message Log to see the last completed command or the one currently in progress.

The System Monitor provides information about the physical state of the Luminex analyzer including lasers and system calibration status. The values displayed are reported directly from the Luminex analyzer and the Luminex XYP instrument. It shows whether the calibration or control results completed successfully by displaying green text for successful events and red text for failed events.

The system diagnoses real-time system problems related to fluidics and optics. The system also detects and reports if the Luminex XYP

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heater block temperature is out of range or experiencing unacceptable temperature conditions, including these items:

• Luminex XYP heater block temperature time-out

• heat circuit failure

• temperature out-of-range sensing

• temperature change since calibration, or a change in channel temperature

Table 1 defines the values listed in the System Monitor. These values are useful for diagnostic purposes when communicating with Luminex Technical Support.

Table 1. System Monitor Values

Property Value Units of Measure

Air Pressure PSI, air pressure to the sheath

container from the air pump

Sheath Pressure PSI, sheath pressure from the

sheath container through the system

Delta Cal Temperature °C, temperature deviation from

the last calibration

Board Temperature °C, temperature of the analog

board

DD Temperature °C, DD temperature at the U

block inside the optics platform

CL1 Temperature °C, CL1 temperature at the U

block inside the optics platform

CL2 Temperature °C, CL2 temperature at the U

block inside the optics platform

XYP Board Temperature °C, temperature of the XYP

board inside the Luminex XYP instrument

XYP Heater Temperature °C, temperature of the XYP

heaters inside the Luminex XYP instrument

XYP Heater Temperature In Range

Indicates if the XYP heater is in the set range

xMAP Technology Luminex 2.3 Software

The Detailed Sample Progress section displays the percentage of completion for each bead ID or test. The graph shows real-time progress, so that as each sample is analyzed, the graph adjusts to show progress. Use the zoom button to view up to 20 tests at a time. Use the toggle button to view the bead ID or test name. Use the Expand Margin (up/down and left/right) arrows to expand the chart margins and view longer test names. See Figure 9.

1. Zoom button

2. Toggle button

3. Expand Margin arrows

Figure 9 Detailed Sample Progress

The Message Log is the lower pane on the Diagnostic tab. It displays a list of completed commands, errors, and warnings. It also displays command progress, time and date, and results. See Figure 10.

Figure 10 Message Log

The log displays actions in color-coded text and shading. Items in the Message Log appear in the following color codes:

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Caution: Do not alter kit manufacturer’s predefined templates or

create alternative templates for off-the-shelf IVD kits.

• Green text represents a successful system calibration, verification command, acquisition, or maintenance functions.

• Red text represents failed commands, errors, or warnings.

• Black text represents normal processes and actions.

• Yellow shading indicates that a detailed description about the

Note: The Message log can be

found at:

processes or actions is available. This color may vary depending on your tool tip color system settings.

C:\Program Files\Luminex\Luminex 100 IS\MessageLog

Acquisition Detail

Tab

To view details of a message, double-click the shaded row. A dialog box opens providing details. To clear the Message log, right-click in the Message Log area, and click Clear on the menu.

The Acquisition Detail tab offers advanced batch sample monitoring and “on the fly” data acquisition without templates. The primary function is real-time monitoring of batch sampling during acquisition through a display of sample bead statistics, histogram, and dot plot data.

During batch acquisition, bead statistics can be useful if batch errors occur. For example, if samples are constantly failing due to insufficient bead count, you can monitor whether the failure is due to low bead concentration or if other assay problems are present.

Acquisition Detail tab features:

• Batch Name and Description

• Batch Data Area

• Acquisition Detail Toolbar

• Histogram

• Dot Plot

Acquisition Detail tab features:

• Batch Name and Description

• Batch Data Area

• Acquisition Detail Toolbar

• Dot Plot

Figure 11 identifies the major features of the Acquisition Detail tab.

xMAP Technology Luminex 2.3 Software

1. Luminex IS 2.3 Toolbar 5. Status Bar

2. Batch Name and Description 6 Histogram

3. Batch Data Area 7 Dot Plot

4. Acquisition Detail Toolbar

Figure 11 Acquisition Detail Tab

The Batch Name and Description section displays the name of the batch as well as its description.

The Batch Data area displays sample results. The left column shows plate location and Sample ID description. The remaining columns display selected bead sets for the assay. Each row represents the data for each bead set from one well.

The Acquisition Detail Toolbar shown in Figure 12 provides functions to acquire raw data without using templates. For more information about the commands on the Acquisition Detail Toolbar, see the Command section, beginning on page 29.

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1 Replay Batch 6 Cancel All

2 New Advanced Batch 7 Eject/Retract

3 View Batch Data 8 Pause

4Start Plate 9Resume

5 Cancel Command

Figure 12 Acquisition Detail Toolbar

The Histogram, in the lower left section of the Acquisition Detail tab, defaults to display the Doublet Discriminator (DD) on the X axis and Events on the Y axis. Doublets appear when two microspheres stick together, creating undesired results. When you enable the gate, two vertical red, dashed lines appear to represent gate positions determined by the template. You cannot change the gate position during batch acquisition. You can change the gate positions before data acquisition, after the system finishes acquiring data, or after pausing the system. The change is visual. The data is still collected according to the gate positions set in the assay template. The gate in effect when the system collects data determines which values to use to obtain the result. Applying a gate or changing a gate for existing data does not change your calculated values. The gate positions, also located in the lower corner of the histogram, are used while collecting data are the numerical values selected in the template.

xMAP Technology Luminex 2.3 Software

1Gate

Boundaries

2 Aggregate

Beads

Figure 13 Set DD Gate Example

3 Numerical

Gate Position

The Histogram contains the Show Bead menu and four buttons:

• Autoscale

•Zoom

• Log/Linear

• Maximize

For more information on these commands, see the Commands section beginning on page 29.

The Dot Plot (or bead map) appears in the lower-right section of the Acquisition Detail tab. See Figure 14. The dot plot shows a graphical display of real-time data collection.

Luminex recommends using the default settings to collect data. The default axes are Classification 1 on the X axis and Classification 2 on the Y axis. To see the dot plot, you must use the default axis. To display the bead set information, hover the mouse pointer over the desired region. You can change the X axis and Y axis of the dot plot for troubleshooting purposes, although you should use the default settings in all other scenarios.

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Figure 14 Dot Plot Display Example

Four buttons appear at the top of the frame to control the display:

• Density/Decaying

• Log/Linear

•Zoom

• Maximize

You can toggle between two types of dot plots using the Density/ Decaying button. The Decaying Dot Plot plots only the 100 mostrecent acquired events. The Density Dot Plot displays a constant accumulation of events. Increasing density is indicated by contrasting colors. See Table 2 for the density dot plot color legend.

Table 2. Dot Plot Color Legend

Layer Color

0 1 2 3 4 5 6 7 8

none dark blue pink dark green cyan light blue light green orange dark red

The density dot plot allows visual elimination of data values determined to be insignificant to the display. Luminex recommends you collect your data in density dot plot mode to observe all collected events. Post acquisition does not display decaying dot plot; it’s only a real-time function.

xMAP Technology Luminex 2.3 Software

Status Bar The Status Bar displays information about the Command State,

Device Status, Device Activity, Laser Status, Total Events per Second, and Region Events per Second. Color coding indicates the urgency of each item’s status. Device Activity uses no color coding.

Figure 15 System Status Bar

Table 3 describes the types of status bar messages in relation to the message color coding.

Table 3. Status Bar Color Coding

Category Color Indicates

Command State

Device Status Indicates the current process of or warning about the

Device Activity

Indicates communication status of the Luminex analyzer or operations being processed

Green Idle or processing

Yellow Connecting, pausing, or paused

Red Disconnected or locked out

Luminex analyzer

Green Running or standby

Yellow Busy, pressurizing, sheath is empty, or warming

Red Not ready or disconnected

Indicates the activity that the Luminex analyzer is performing. Note: The device activity has no color code.

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Table 3. Status Bar Color Coding (Continued)

Category Color Indicates

• Idling: waiting for a command

• Aspirating: drawing in sample

• Collecting Data: collecting data

• Sanitizing: sanitizing the instrument

• Washing: washing the sample line

• Priming: priming the instrument

• Calibrating: calibrating the instrument

• Canceling: canceling a command

• Backflushing: backflushing the instrument

• Draining: draining the instrument

• Warming Up: warming up the instrument

• Verifying: verifying calibration

• Soaking: soaking the probe

• Adjusting sample probe

• Self Diagnosing: performing self-diagnostic routine

Laser Status Laser temperature and readiness status

Green Lasers warmed up

Yellow Warmup timer countdown in seconds from 1800

Red Lasers off

Total Events/ Second

Region Events/ Second

Number of total bead events detected per second

Number of bead events detected per second that are classified in a region

The Status Bar displays status information as the software processes commands. Table 4 shows the typical messages that appear in the status bar. Additionally, information displays as text on the Diagnostics tab.

Table 4. Status Bar

Communication Message Details

Status Bar

Color

Message Indicates

Green Idle Waiting to process the next

command.

xMAP Technology Luminex 2.3 Software

Table 4. Status Bar

Communication Message Details (Continued)

Status Bar

Message Indicates

Color

Standby The Luminex analyzer is ready

and waiting to perform a command.

Yellow Connecting The software is attempting to

connect to the instrument.

Processing The instrument is communicating

with the software as it processes commands.

Pausing The instrument has stopped

processing the list of commands, but finishing the active command.

Paused The software stopped processing

the list of commands. A “resume” function becomes available to change the state back to “processing.”

Busy The instrument is processing a

maintenance command.

Red

Disconnected

The software has not yet attempted to connect or fails to connect to the instrument.

Locked Out Another application currently has

control of the instrument. The software locks out as long as the other application runs. To remove the locked out status, close the other application or wait until the application completes.

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Secondary Windows

In addition to the main window, there are other windows that are displayed when you select certain commands. These are the Batch Setup Window and Analysis Window.

In the Batch Setup window, you define information used to create batches. All of the commands are on the same page; there are no tabs. The window opens when you click New Batch and select a template.

The following features are part of the Batch Setup Window:

• Batch Info group box

• Template Info group box

• Insert command

• Command list

• Microtiter Plate image

• Command button group box

• Save group box

• Standard Info group box

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