Luminex IS Version 2.3 (IVD) Manuel d'utilisateur

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Page 1 - Version 2.3

Luminex® ISTM Software Manual For Version 2.3 For In Vitro Diagnostic Use

Page 2 - The Netherlands

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

Page 3

90 Luminex IS Software Manual For Version 2.3 - For In Vitro Diagnostic Use xMAP TechnologyCL1 Refers to dyes embedded in the microsphere. Also see c

Page 4

PN 89-00002-00-254 Rev. B 91xMAP Technology laserlaser Light Amplification by Stimulated Emission of Radiation (laser). This highly purified source o

Page 5

92 Luminex IS Software Manual For Version 2.3 - For In Vitro Diagnostic Use xMAP Technologyquantify an analyte. Examples of acceptable reporters are

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

PN 89-00002-00-254 Rev. B 93Output.CSVOverview This chapter describes the file specification for the Luminex IS 2.3 Output.CSV file. Although this do

Page 7 - Contents

Luminex IS Software Manual Version 2.3 - For In Vitro Diagnostic Use xMAP Technology 94Sample2...SampleMStatNStatN Header: Sample Location, Sample Na

Page 8

xMAP TechnologyPN 89-00002-00-254 Rev. B 95TemplateName, "value” (Optional) The name of the template used to create the batch. Limited to 30 c

Page 9 - PN 89-00002-00-254 Rev. B ix

Luminex IS Software Manual Version 2.3 - For In Vitro Diagnostic Use xMAP Technology 96Statistics Definitions Statistical calculations are performed f

Page 10

xMAP TechnologyPN 89-00002-00-254 Rev. B 97Statistics Column DefinitionsThe blocks of statistical data are displayed such that the first row of data

Page 11 - Luminex 2.3 Software

Luminex IS Software Manual Version 2.3 - For In Vitro Diagnostic Use xMAP Technology 98Total Events The number of events that fell with in the defined

Page 12

xMAP TechnologyPN 89-00002-00-254 Rev. B 99Luminex 100 IS Output.CSV file with no additional features enabled "Program","Luminex 100

Page 13 - PN 89-00002-00-254 Rev. B 3

PN 89-00002-00-254 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 - For In Vitro Diagnostic Use xMAP Technology 100Luminex 100 IS Output.CSV file with all additional features en

Page 15 - PN 89-00002-00-254 Rev. B 5

xMAP TechnologyPN 89-00002-00-254 Rev. B 101"Samples","8","Min Events","0""Results""DataType:

Page 16 - Figure 4 Run Batch Tab

Luminex IS Software Manual Version 2.3 - For In Vitro Diagnostic Use xMAP Technology 102"3","Std l","4450.92","75&q

Page 17 - PN 89-00002-00-254 Rev. B 7

xMAP TechnologyPN 89-00002-00-254 Rev. B 103"1","Std s","69","75","""2","Std m"

Page 18 - Figure 7 Maintenance Tab

Luminex IS Software Manual Version 2.3 - For In Vitro Diagnostic Use xMAP Technology 104"DataType:","Trimmed StdDev""Location

Page 19 - PN 89-00002-00-254 Rev. B 9

PN 89-00002-00-254 Rev. B Index-1Aanalysisview 74Analysis window, function keys 22assay errors 23assigning dilution factors to samples 61Bback up the

Page 20

Index-2 Luminex 100 IS User Manual Version 2.3 - For In Vitro Diagnostic Use xMAP Technologyraw data 37systemdrain 84errors 23trend report 78Ttabssam

Page 21 - PN 89-00002-00-254 Rev. B 11

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 2.Figure 1 Luminex IS 2.3 Main WindowThere are five major pa

Page 22 - Acquisition Detail

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 3Menu Bar The menu bar contains the following menus: File Menu, Tools Menu, and Help Me

Page 23 - PN 89-00002-00-254 Rev. B 13

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 4Toolbar The shortcut buttons on the toolbar can be found in o

Page 24

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 5Favorites. You can use the Favorites list to create a list of often-used commands and

Page 25

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 61. Microtiter plate/reservoir image 2. Temperature and Press

Page 26

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 7for the DD temperature both appear at the bottom of the thermometer, and the thermomet

Page 27 - Figure 15 System Status Bar

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 8Maintenance Tab Use the Maintenance tab to perform maintenanc

Page 28 - Diagnostics tab

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 9Instructions for maintenance procedures begin on page 83. Table 8 on page 83 shows a r

Page 29 - Disconnected

© LUMINEX CORPORATION, 2001-2011. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, or translated into any

Page 30 - Secondary

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 10heater block temperature is out of range or experiencing un

Page 31 - PN 89-00002-00-254 Rev. B 21

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 11The Detailed Sample Progress section displays the percentage of completion for each b

Page 32

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 12• Green text represents a successful system calibration, ver

Page 33 - PN 89-00002-00-254 Rev. B 23

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 13 Figure 11 Acquisition Detail TabThe Batch Name and Description section displays th

Page 34

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 14Figure 12 Acquisition Detail Toolbar The Histogram, in the

Page 35

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 15Figure 13 Set DD Gate ExampleThe Histogram contains the Show Bead menu and four but

Page 36 - Figure 19 Competitive Assay

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 16Figure 14 Dot Plot Display ExampleFour buttons appear at t

Page 37 - Averaging

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 17Status Bar The Status Bar displays information about the Command State, Device Status

Page 38

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 18The Status Bar displays status information as the software p

Page 39 - PN 89-00002-00-254 Rev. B 29

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 19Standby The Luminex analyzer is ready and waiting to perform a command.Yellow Connect

Page 40

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

Page 41 - PN 89-00002-00-254 Rev. B 31

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 20Secondary WindowsIn addition to the main window, there are o

Page 42

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 21• Control Info group box• New Lot buttonThe Batch Info group box has text boxes in wh

Page 43 - PN 89-00002-00-254 Rev. B 33

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 22• Errors tab—lists errors that occur during batch acquisitio

Page 44

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 23Figure 16 Analysis Window - Errors Tab OpenStandards Tab The Standards tab lists al

Page 45 - PN 89-00002-00-254 Rev. B 35

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 24on the three tabs of the Analysis window is determined by th

Page 46

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 25competitive assays are shown in Table 6. Figure 18 shows what a standard curve for a

Page 47 - Tab Information

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 26Figure 19 Competitive AssayThe standards tab displays an E

Page 48 - Information Tab

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 27The system does not flag results as normal or abnormal according to a defined range.

Page 49 - Define Data Export

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 28The AVG entry appears immediately after the wells being aver

Page 50 - Setting up the Favorites

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 29Commands This section describes the different commands used in the Luminex IS 2.3 sof

Page 51 - Startup Procedures

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 52

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 30Create New Multi-Batch This command opens the Luminex Multi-

Page 53 - Temperature

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 31Help Opens the help file. Use this command if you need instructions on using a featur

Page 54 - Calibrators

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 32Advanced Batch button, the Options dialog box opens, where y

Page 55 - PN 89-00002-00-254 Rev. B 45

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 33Print Batch Worklist Prints the status of each of the commands in the command list, a

Page 56 - Controls

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 34• DSP capture test• High voltage module• Channel backgrounds

Page 57 - PN 89-00002-00-254 Rev. B 47

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 35• Sequential by Region ID - the tests are sorted numerically by bead ID#. • Template

Page 58

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 36Procedures This section explains how to perform functions in

Page 59 - C:\Program

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 37Setting Software Options Set up and select the system software and enter your company

Page 60

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 38Figure 21 Options Dialog Box—General TabDefine CompanyInfo

Page 61 - PN 89-00002-00-254 Rev. B 51

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 39Define Data ExportTab InformationUse the Data Export tab to configure your export dat

Page 62

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

Page 63 - PN 89-00002-00-254 Rev. B 53

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 40Setting up the Favorites List To add templates to the Favor

Page 64 - The Open Batch

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 41Startup ProceduresWarm Up theSystemWarm up the system to prepare the optics prior to

Page 65 - Create a Multi

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 42During a backflush, the system draws sheath fluid from the s

Page 66 -  To open a multi-batch:

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 43Set Luminex XYPInstrument HeaterTemperatureRefer to your assay kit instructions to se

Page 67 - Process Multiple

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 44discriminator channel. Control xMAP microspheres are used to

Page 68

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 456. On the Maintenance tab, click Prime. Click OK and wait for the Prime to finish (ab

Page 69 - PN 89-00002-00-254 Rev. B 59

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 4612. Click CAL2, then click OK. Wait until CAL2 completes. Th

Page 70 -  To edit a patient list:

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 47Figure 26 Update CON Targets Dialog Box4. Ensure that the analyzer is set to draw C

Page 71 - Dilution Factors

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 489. Click OK and wait until the wash completes. The device st

Page 72

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 49the Backup folder (directory) found in C:\Program Files\Luminex\Luminex 100 IS\Backup

Page 73 - PN 89-00002-00-254 Rev. B 63

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 74 - Unused Template

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 50• Green well: with command number—sample notacquired.• Yello

Page 75 - Used Template

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 51 Figure 27 Luminex Batch Setup Window4. Enter the batch name (if different from the

Page 76

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 5210. To add a patient file to the batch, click Load Pa List.

Page 77 - Multi-Batches

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 53 Exporting BatchData To export Batch Data:Right-click in the Batch Data area of the

Page 78 - System is performing data

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 542. The Open Template dialog box opens. Click on the desired

Page 79 - PN 89-00002-00-254 Rev. B 69

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 55If you need to recover a deleted batch, select Open Incomplete Batch from the File me

Page 80

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 564. To reassign the positions of the batches within the multi

Page 81 - PN 89-00002-00-254 Rev. B 71

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 574. Load the first microtiter plate onto the plate holder.5. Click Start Plate to retr

Page 82

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 585. Click Resume. The system resumes the acquisition process.

Page 83 - Analysis

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 59• The first line of text in the file must be “LX100IS Patient List”.• The second line

Page 84

PN 89-00002-00-254 Rev. B viiLuminex 2.3 Software 1Main Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Page 85 - Standards and

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 60batch has an unassigned value, the system applies the first

Page 86

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 61Figure 33 Edit Patient List Dialog BoxAssign SampleDilution FactorsIndicate the sam

Page 87 - Analyses

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 62Figure 34 Luminex Batch Setup for Dilution4. To change the

Page 88

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 63• If you have entered lot information and have used the template to set up a batch (e

Page 89 - PN 89-00002-00-254 Rev. B 79

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 64Figure 37 Update Lot Information Dialog Box4. Enter the ex

Page 90 - Analysis Report

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 65 Figure 38 Update Lot Information Dialog Box3. Change or edit the expiration date a

Page 91 - Procedures

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 66Import Lot to anExisting TemplateUse this procedure to impor

Page 92

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 67 To export a lot from an existing template:1. On the Home tab, click New Lot. The Op

Page 93

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 68You may direct the system to acquire samples in replicate re

Page 94 -  To run self diagnostics:

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 69 Figure 40 Customization Dialog Box—General TabCustomization Dialog Box Buttons:OK:

Page 95 - Using the Cleanup

viiiLuminex IS Software Manual For Version 2.3 - For In Vitro Diagnostic Use xMAP TechnologyHelp . . . . . . . . . . . . . . . . . . . . . . . . . . .

Page 96 - Daily Shutdown

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 70Customization dialog box tabs:• General Tab—Use this tab to

Page 97 - PN 89-00002-00-254 Rev. B 87

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 71Figure 42 Customization Dialog Box—Axis Tab• Font Tab—Use the Font tab to change th

Page 98

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 72Graph Foreground: this is the color used for the bounding re

Page 99 - Glossary

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 73 To modify features using the Graph Menu:Most of these menu items provide a shortcut

Page 100

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 74Figure 47 Options Dialog Box—Select Auto-start Analysis2.

Page 101 - PN 89-00002-00-254 Rev. B 91

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 75tabs to observe the tests errors under the Errors tab and unknown results under the S

Page 102

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 76 To validate or invalidate a standard or control entry usin

Page 103 - Output.CSV

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 77Figure 50 Choose Lot Dialog Box—Standard Only3. To create a new lot from this dialo

Page 104 - Field Definitions

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 78Batch Summary Report - prints batch information in a sample

Page 105

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 79Figure 52 Batch Selection Dialog Box3. Enter the information (in this example, a pa

Page 106 - Statistic Description

PN 89-00002-00-254 Rev. B ixxMAP Technology ContentsView Batch Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Warmup

Page 107 - Definitions

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 80Figure 54 Open Batch Dialog Box—Select Batch2. Select the

Page 108 - Column Name Description

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 81Figure 55 Data Interpretation Report (Print Preview)Database Management ProceduresT

Page 109

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 822. Choose the file name and location of the database that yo

Page 110

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 83information for CAL 1, CAL2, CON1, and CON2 reagents are correct.5. Click OK to verif

Page 111

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 84Drain the Analyzer When draining, you do not need to supply

Page 112

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 852. Click OK. The system processes the various self- diagnostic tests. When tests are

Page 113

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 86the desired files to delete and click OK. Windows deletes th

Page 114

xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 87 To sanitize the fluidics in the analyzer:1. On the Maintenance tab, click Eject/Ret

Page 115

Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 88

Page 116 - Index-2

PN 89-00002-00-254 Rev. B 89Glossaryagglutination The coalescing of small particles that are suspended in solution; these larger masses are then (usu

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