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

Page 11

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3.

If the control numbers on the BizCard CD already exist in the database, you
will receive the message that the control numbers are already installed and
the program will exit. Click on the OK button and remove the BizCard CD.

4.

If the control numbers on the BizCard CD are not found in the database, you
will see a dialog asking you to press OK to install the control numbers with
their specifications. Click on the OK button.

5.

A dialog box will appear informing you that control numbers installation is
complete. You may now proceed with validation in Bio-Plex Manager using
the current control number.

Section 10
Procedure for Performing Validation

Introduction

This section provides instructions for use of the Bio-Plex

®

validation kit 4.0 using

either Bio-Plex Manager™ 4.0/4.1 software with MCV plate III or Bio-Plex
Manager 5.0 and later with MCV plate IV. Either software version provides a fully
automated validation routine that sequentially performs all the validation tests
without further user intervention. To perform all validations in a single step, follow
instructions in Section 10.1. If you wish to perform an individual validation routine,
consult Sections 10.2–10.5.

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10.1 One-Step Procedure for all Validation Parameters

Procedure

1.

Turn on the Bio-Plex array reader, microplate platform, and computer as
specified in the Bio-Plex hardware and Bio-Plex Manager user manuals.

2.

Perform start-up procedure as directed.

3.

Calibrate Bio-Plex array reader using Cal1 and Cal2 beads found in the
Bio-Plex calibration kit according to the Bio-Plex Manager software manual.

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4.

Remove all validation bead sets from 4°C storage and vortex each bottle for
30 sec. This is very important for proper validation.

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