Bio-Rad Bio-Plex System Validation and Calibration Tools User Manual

Page 3

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Table of Contents

Section 1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

Section 2

Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . .2

Section 3

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

Section 4

Storage and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . .3

Section 5

Principle of Optics Validation . . . . . . . . . . . . . . . . . . . .4

Section 6

Principle of Reporter Channel Validation . . . . . . . . . . .4

Section 7

Principle of Classify Validation . . . . . . . . . . . . . . . . . . .7

Section 8

Principle of Fluidics Validation . . . . . . . . . . . . . . . . . .8

Section 9

Procedure for Bio-Plex Manager 3.0/MCV plate II . . .9

9.1

One-Step Procedure for all Validation Parameters . . . . . . . . .9

9.2

Validation of Optics Alignment . . . . . . . . . . . . . . . . . . . . . .11

9.3

Validation of Fluidics Integrity . . . . . . . . . . . . . . . . . . . . . . .13

9.4

Validation of Reporter Channel Performance . . . . . . . . . . . .15

9.5

Validation of Classify Efficiency . . . . . . . . . . . . . . . . . . . . . .16

9.6

Generating a Validation Report . . . . . . . . . . . . . . . . . . . . . .18

9.7

Validation Report Example . . . . . . . . . . . . . . . . . . . . . . . . .19

Section 10

Procedure for Bio-Plex Manager 2.0/MCV plate . . . .21

10.1

Validation of Optics Alignment . . . . . . . . . . . . . . . . . . . . . .21

10.2

Validation of Reporter Channel Performance . . . . . . . . . . . .23

10.3

Validation of Classify Efficiency . . . . . . . . . . . . . . . . . . . . . .25

10.4

Validation of Fluidics Integrity . . . . . . . . . . . . . . . . . . . . . . .26

10.5

Generating a Validation Report . . . . . . . . . . . . . . . . . . . . . .28

10.6

Validation Kit Worksheet and Report
Form Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

Section 11

Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . .32

Section 12

Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . .32

Section 13

Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

4110007c.qxd 02/25/2003 10:11 AM Page I

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