Luminex IS Version 2.3 Manuel d'utilisateur

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Page 1 - Version 2.3

Luminex IS Software Manual For Version 2.3 Lum/nex® TM

Page 2

iv PN 89-00002-00-110 Rev. B Luminex IS Software Manual For Version 2.3 xMAP Technology

Page 3

Luminex IS Software Manual for Version 2.3 xMAP Technology 90 PN 89-00002-00-110 Rev. B 2. Click OK. The system processes the various self- diagnost

Page 4

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 91the desired files to delete and click OK. Windows deletes the files and closes the

Page 5

Luminex IS Software Manual for Version 2.3 xMAP Technology 92 PN 89-00002-00-110 Rev. B  To sanitize the fluidics in the analyzer:1. On the Mainten

Page 6 - EULA PN: 89-30000-00-070

PN 89-00002-00-110 Rev. B 93Glossaryagglutination The coalescing of small particles that are suspended in solution; these larger masses are then (u

Page 7 - Contents

94 PN 89-00002-00-110 Rev. B Luminex IS Software Manual For Version 2.3 xMAP TechnologyCL1 Refers to dyes embedded in the microsphere. Also see class

Page 8

PN 89-00002-00-110 Rev. B 95xMAP Technology Luminex xMAP microsphere setLuminex xMAP microsphere setLuminex multi-analyte microspheres containing a

Page 9 - Output.CSV 97

96 PN 89-00002-00-110 Rev. B Luminex IS Software Manual For Version 2.3 xMAP Technologyquantify an analyte. Examples of acceptable reporters are Phyc

Page 10

PN 89-00002-00-110 Rev. B 97Output.CSVOverview This chapter describes the file specification for the Luminex IS 2.3 Output.CSV file. Although this

Page 11 - Luminex 2.3 Software

Luminex IS Software Manual Version 2.3 xMAP Technology 98 PN 89-00002-00-110 Rev. B Sample2...SampleMStatNStatN Header: Sample Location, Sample Name

Page 12

xMAP TechnologyPN 89-00002-00-110 Rev. B 99TemplateName, "value” (Optional) The name of the template used to create the batch. Limited to 30

Page 13

PN 89-00002-00-110 Rev. B 1Luminex 2.3 SoftwareThis manual describes how to use the Luminex IS 2.3 software. It includes a glossary and information

Page 14

Luminex IS Software Manual Version 2.3 xMAP Technology 100 PN 89-00002-00-110 Rev. B Statistics Definitions Statistical calculations are performed fo

Page 15

xMAP TechnologyPN 89-00002-00-110 Rev. B 101Statistics Column DefinitionsThe blocks of statistical data are displayed such that the first row of da

Page 16 - Figure 4 Run Batch Tab

Luminex IS Software Manual Version 2.3 xMAP Technology 102 PN 89-00002-00-110 Rev. B Total Events The number of events that fell with in the defined

Page 17

xMAP TechnologyPN 89-00002-00-110 Rev. B 103Luminex 100 IS Output.CSV file with no additional features enabled "Program","Luminex 10

Page 18 - Figure 7 Maintenance Tab

Luminex IS Software Manual Version 2.3 xMAP Technology 104 PN 89-00002-00-110 Rev. B Luminex 100 IS Output.CSV file with all additional features enab

Page 19 - Figure 8 Diagnostics Tab

xMAP TechnologyPN 89-00002-00-110 Rev. B 105"Samples","8","Min Events","0""Results""DataType

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Luminex IS Software Manual Version 2.3 xMAP Technology 106 PN 89-00002-00-110 Rev. B "3","Std l","4450.92","75&quo

Page 21

xMAP TechnologyPN 89-00002-00-110 Rev. B 107"1","Std s","69","75","""2","Std m&quo

Page 22 - Acquisition Detail

Luminex IS Software Manual Version 2.3 xMAP Technology 108 PN 89-00002-00-110 Rev. B "DataType:","Trimmed StdDev""Location&q

Page 23 - 4. Acquisition Detail Toolbar

PN 89-00002-00-110 Rev. B Index-1Aanalysis 36view 79Analysis window, function keys 21assay errors 22assigning dilution factors to samples 60auto-star

Page 24

Luminex IS Software Manual for Version 2.3 xMAP Technology 2 PN 89-00002-00-110 Rev. B .Figure 1 Luminex IS 2.3 Main WindowThere are five major pa

Page 25

Index-2 PN 89-00002-00-110 Rev. B Luminex 100 IS User Manual Version 2.3 xMAP TechnologySSample Errors 22sample progress 11samples tab 21sanitize 41,

Page 26 - Figure 15 System Status Bar

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 3Menu Bar The menu bar contains the following menus: File Menu, Tools Menu, and Help

Page 27

Luminex IS Software Manual for Version 2.3 xMAP Technology 4 PN 89-00002-00-110 Rev. B Toolbar The shortcut buttons on the toolbar can be found in o

Page 28 - Disconnected

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 5Favorites. You can use the Favorites list to create a customized list of often-used

Page 29 - Secondary

Luminex IS Software Manual for Version 2.3 xMAP Technology 6 PN 89-00002-00-110 Rev. B 1. Microtiter plate/reservoir image 2. Temperature and Press

Page 30

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 7for the DD temperature both appear at the bottom of the thermometer, and the thermom

Page 31

Luminex IS Software Manual for Version 2.3 xMAP Technology 8 PN 89-00002-00-110 Rev. B Maintenance Tab Use the Maintenance tab to perform maintenanc

Page 32

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 9Instructions for maintenance procedures begin on page 88. Table 11 on page 88 shows

Page 33

© LUMINEX CORPORATION, 2001-2005. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, or translated into any

Page 34

Luminex IS Software Manual for Version 2.3 xMAP Technology 10 PN 89-00002-00-110 Rev. B heater block temperature is out of range or experiencing un

Page 35 - Figure 19 Competitive Assay

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 11The Detailed Sample Progress section displays the percentage of completion for each

Page 36

Luminex IS Software Manual for Version 2.3 xMAP Technology 12 PN 89-00002-00-110 Rev. B • Green text represents a successful system calibration, ver

Page 37 - Averaging

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 13 Figure 11 Acquisition Detail TabThe Batch Name and Description section displays

Page 38

Luminex IS Software Manual for Version 2.3 xMAP Technology 14 PN 89-00002-00-110 Rev. B Figure 12 Acquisition Detail Toolbar The Histogram, in the

Page 39

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 15The Histogram contains the Show Bead menu and four buttons: • Autoscale•Zoom • Log/

Page 40

Luminex IS Software Manual for Version 2.3 xMAP Technology 16 PN 89-00002-00-110 Rev. B accumulation of events. Increasing density is indicated by c

Page 41

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 17The Status Bar displays status information as the software processes commands. Tabl

Page 42

Luminex IS Software Manual for Version 2.3 xMAP Technology 18 PN 89-00002-00-110 Rev. B status bar. Additionally, information displays as text on t

Page 43

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 19Secondary WindowsIn addition to the main window, there are other windows that are d

Page 44

Standard Terms and Conditions For Use of ProductBy opening the packaging containing this product ("Product") or by using such Product in any

Page 45

Luminex IS Software Manual for Version 2.3 xMAP Technology 20 PN 89-00002-00-110 Rev. B • Command button group box• Save group box• Standard Info gr

Page 46 - Tab Information

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 21Analysis Window When the system analyzes batches, it displays the data in a three-t

Page 47 - Information Tab

Luminex IS Software Manual for Version 2.3 xMAP Technology 22 PN 89-00002-00-110 Rev. B Errors Tab The Errors tab displays a list of errors that occ

Page 48 - Define Data Export

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 23Standards Tab The Standards tab lists all the batch tests with system comments spec

Page 49 - Setting up the Favorites

Luminex IS Software Manual for Version 2.3 xMAP Technology 24 PN 89-00002-00-110 Rev. B high or low end. Examples of out-of-range sample labeling f

Page 50 - Startup Procedures

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 25Figure 19 Competitive AssayThe standards tab displays an Expected Concentration c

Page 51

Luminex IS Software Manual for Version 2.3 xMAP Technology 26 PN 89-00002-00-110 Rev. B Samples Tab The Samples tab lists tests from your batch and

Page 52 - Temperature

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 27ReplicateAveragingStandard and control replicates are predefined in the template. Y

Page 53 - Calibrators

Luminex IS Software Manual for Version 2.3 xMAP Technology 28 PN 89-00002-00-110 Rev. B Commands This section describes the different commands used

Page 54

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 29Create New Multi-Batch This command opens the Luminex Multi-Batch dialog box, in wh

Page 55 - Controls

BUYER HEREBY GRANTS TO LUMINEX A NONEXCLUSIVE, WORLDWIDE, UNRE-STRICTED, ROYALTY-FREE, FULLY PAID-UP LICENSE, WITH THE RIGHT TO GRANT AND AUTHORIZE SU

Page 56

Luminex IS Software Manual for Version 2.3 xMAP Technology 30 PN 89-00002-00-110 Rev. B Help Opens the help file. Use this command if you need instr

Page 57

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 31Acquisition Detail tab. When you click on the New Advanced Batch button, the Option

Page 58 - C:\Program

Luminex IS Software Manual for Version 2.3 xMAP Technology 32 PN 89-00002-00-110 Rev. B Print Batch Worklist Prints the status of each of the comman

Page 59

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 33Self Diagnostics Performs a self-diagnostics to see if the Luminex 200 analyzer and

Page 60

Luminex IS Software Manual for Version 2.3 xMAP Technology 34 PN 89-00002-00-110 Rev. B Test Sort Orders This command is in the Data Export Tab of t

Page 61

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 35Procedures This section explains how to perform functions in the software.Using the

Page 62

Luminex IS Software Manual for Version 2.3 xMAP Technology 36 PN 89-00002-00-110 Rev. B Setting Software Options Set up and customize the system sof

Page 63 - The Open Batch

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 37Figure 21 Options Dialog Box—General TabDefine CompanyInformation TabYou can ente

Page 64 - Create a Multi

Luminex IS Software Manual for Version 2.3 xMAP Technology 38 PN 89-00002-00-110 Rev. B Define Data ExportTab InformationUse the Data Export tab to

Page 65

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 39Setting up the Favorites List To add templates to the Favorites list:1. On the Fav

Page 66

End-User License Agreement (EULA) for Luminex® SoftwareThis Luminex End-User License Agreement (“EULA”) is a legal agreement between you (either an in

Page 67 - Incomplete Batch

Luminex IS Software Manual for Version 2.3 xMAP Technology 40 PN 89-00002-00-110 Rev. B Startup ProceduresWarm Up theSystemWarm up the system to pre

Page 68 - With a Barcode

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 41During a backflush, the system draws sheath fluid from the sheath fluid container a

Page 69

Luminex IS Software Manual for Version 2.3 xMAP Technology 42 PN 89-00002-00-110 Rev. B Set Luminex XYPInstrument HeaterTemperatureRefer to your ass

Page 70 - Dilution Factors

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 43discriminator channel. Control xMAP microspheres are used to verify calibration and

Page 71 - Advanced Batch

Luminex IS Software Manual for Version 2.3 xMAP Technology 44 PN 89-00002-00-110 Rev. B 6. On the Maintenance tab, click Prime. Click OK and wait fo

Page 72

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 4512. Click CAL2, then click OK. Wait until CAL2 completes. The Device Status section

Page 73

Luminex IS Software Manual for Version 2.3 xMAP Technology 46 PN 89-00002-00-110 Rev. B Figure 26 Update CON Targets Dialog Box4. Ensure that the

Page 74

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 479. Click OK and wait until the wash completes. The device status section in the sta

Page 75

Luminex IS Software Manual for Version 2.3 xMAP Technology 48 PN 89-00002-00-110 Rev. B the Backup folder (directory) found in C:\Program Files\Lumi

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xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 49• Green well: with command number—sample notacquired.• Yellow well: sample currentl

Page 77

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.

Page 78

Luminex IS Software Manual for Version 2.3 xMAP Technology 50 PN 89-00002-00-110 Rev. B Figure 27 Luminex Batch Setup Window4. Enter the batch na

Page 79 - Unused Template

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 5110. To add a patient file to the batch, click Load Pa List. An Open Patient List Fi

Page 80

Luminex IS Software Manual for Version 2.3 xMAP Technology 52 PN 89-00002-00-110 Rev. B 2. Double-click on the desired batch. The system loads the b

Page 81 - Template

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 53batch. If you reprocess a batch using changed parameters, the system may obtain dif

Page 82 - Multi-Batches

Luminex IS Software Manual for Version 2.3 xMAP Technology 54 PN 89-00002-00-110 Rev. B .Figure 29 Analyze Open BatchThe Analysis window opens, sh

Page 83 - Analysis Settings

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 55 To create a multi-batch with new batches: 1. Click New Multi-Batch. The Luminex M

Page 84

Luminex IS Software Manual for Version 2.3 xMAP Technology 56 PN 89-00002-00-110 Rev. B  To create a multi-batch with existing batches:1. Click New

Page 85

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 57Figure 31 Processing Multiple PlatesAfter the first microtiter plate in a multipl

Page 86

Luminex IS Software Manual for Version 2.3 xMAP Technology 58 PN 89-00002-00-110 Rev. B 2. Click Start to continue where the batch left off. Note th

Page 87

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 59The format must be like the following example or it will not load properly. Double-

Page 88 - Analysis

PN 89-00002-00-110 Rev. B iLuminex 2.3 Software 1Main Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1M

Page 89

Luminex IS Software Manual for Version 2.3 xMAP Technology 60 PN 89-00002-00-110 Rev. B Edit a Patient List Use this procedure to open a previously

Page 90

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 61 To assign sample dilution factors:1. On the File menu, click New Batch. The Open

Page 91

Luminex IS Software Manual for Version 2.3 xMAP Technology 62 PN 89-00002-00-110 Rev. B Use plates with wells that will hold at least 185 µL (the ex

Page 92 - Analyses

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 63•Select Total Beads to continue analyzing until the selected beads meet total beads

Page 93

Luminex IS Software Manual for Version 2.3 xMAP Technology 64 PN 89-00002-00-110 Rev. B 8. Click the Plate Layout tab. See Figure 37. On this tab yo

Page 94

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 65Figure 38 Plate Layout Tab Command Menu11. Establish preliminary off-plate comman

Page 95 - Analysis Report

Luminex IS Software Manual for Version 2.3 xMAP Technology 66 PN 89-00002-00-110 Rev. B Figure 40 Plate Layout Tab, Off-Plate Commands12. Insert o

Page 96 - Database Management

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 67Managing Assay Lots You can edit standard and control lot information. Once a lot i

Page 97

Luminex IS Software Manual for Version 2.3 xMAP Technology 68 PN 89-00002-00-110 Rev. B b.) If the template has associated lot information, the Upda

Page 98

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 695. Enter the standard concentration values provided in the kit manufacturer’s instr

Page 99 -  To run self diagnostics:

ii PN 89-00002-00-110 Rev. B Luminex IS Software Manual For Version 2.3 xMAP TechnologyHelp . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Page 100 -  To perform a disk cleanup:

Luminex IS Software Manual for Version 2.3 xMAP Technology 70 PN 89-00002-00-110 Rev. B Edit LotInformation on aUsed Template To edit lots on a use

Page 101 - Procedures

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 71 Figure 45 Update Lot Information Dialog BoxExport a Lot froman ExistingTemplateU

Page 102

Luminex IS Software Manual for Version 2.3 xMAP Technology 72 PN 89-00002-00-110 Rev. B After responding to the confirmation dialog boxes, regarding

Page 103 - Glossary

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 73The system can analyze only batches that it acquires using qualitative or quantitat

Page 104

Luminex IS Software Manual for Version 2.3 xMAP Technology 74 PN 89-00002-00-110 Rev. B Cancel: click to abort selections and exit.Apply: Apply is s

Page 105

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 75Font Size: The Graph supports three font sizes, Large, Medium, and Small. When prin

Page 106

Luminex IS Software Manual for Version 2.3 xMAP Technology 76 PN 89-00002-00-110 Rev. B Figure 49 Customization Dialog Box—Font Tab• Color Tab—Us

Page 107 - Output.CSV

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 77 Figure 50 Customization Dialog Box—Color Tab• Style Tab—use the Style tab for co

Page 108 - Field Definitions

Luminex IS Software Manual for Version 2.3 xMAP Technology 78 PN 89-00002-00-110 Rev. B Figure 52 Graph Menu ItemsEnable AutomaticAnalysisYou can

Page 109

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 79AnalyzeProcessed BatchDataYou can analyze only processed batches. If you acquire or

Page 110 - Statistic Description

PN 89-00002-00-110 Rev. B iiixMAP Technology ContentsValidate Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34View

Page 111 - Definitions

Luminex IS Software Manual for Version 2.3 xMAP Technology 80 PN 89-00002-00-110 Rev. B Invalidating controls—You can invalidate or remove a control

Page 112 - Column Name Description

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 81Change Lot Use the Change Lot command to edit the lot that is applied to the batch

Page 113

Luminex IS Software Manual for Version 2.3 xMAP Technology 82 PN 89-00002-00-110 Rev. B  To create a new lot for use within a batch:1. Click New Lo

Page 114

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 831. Click Print Report. The Report Selection dialog box opens. Figure 57 Report Se

Page 115

Luminex IS Software Manual for Version 2.3 xMAP Technology 84 PN 89-00002-00-110 Rev. B Figure 59 Patient Selection Dialog Box4. Select the desire

Page 116

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 85Print DataAnalysis ReportA printed batch report includes the following criteria tha

Page 117

Luminex IS Software Manual for Version 2.3 xMAP Technology 86 PN 89-00002-00-110 Rev. B Figure 61 Data Interpretation Report (Print Preview)Databa

Page 118

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 872. Choose the file name and location of the database that you want to back up. The

Page 119

Luminex IS Software Manual for Version 2.3 xMAP Technology 88 PN 89-00002-00-110 Rev. B information for CAL 1, CAL2, CON1, and CON2 reagents are cor

Page 120

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-110 Rev. B 89Drain the Analyzer When draining, you do not need to supply solution. Draining take

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