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Validation, Validation kit, Validation kit control number – Bio-Rad Bio-Plex Software® Upgrades and Conversions User Manual

Page 53: Validation kit validation kit control number

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Validation

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Validation

Validation of the array reader is a formal process for documenting that the
instrument is fit for its intended use and that it is kept in a state of
maintenance and calibration.

NOTE: Validation is performed after startup and calibration have been
performed. Validation is dependent on successful calibration for accuracy.

You should perform a validation reading:

Once a month

Each time you move the array reader, or

To diagnose any problems with the array reader that cannot be
solved by other procedures (calibrating, washing, unclogging, etc.)

Validation Kit

Bio-Plex Manager requires the use of Bio-Plex Validation Kit 4.0 to perform
validation. It must be used in conjunction with the Bio-Plex MCV Plate IV.
Each Bio-Plex Validation Kit consists of reagents and procedures to evaluate:

Optical alignment

Reporter channel performance

Efficiency of multiplexing

Integrity of fluidics

The Bio-Plex Validation Kit validates the operation of all of the primary
components of the array system, and can also be used to discriminate
between assay and instrumentation problems.

Validation Kit Control Number

Each Bio-Plex Validation Kit has a control number linked to the specifications
for the kit. You must use the mini-CD included in the kit to install the control
number on your computer. After installation, you can select the control
number in Bio-Plex Manager, as described in the following section.

See the Bio-Plex Validation Kit 4.0 Instruction Manual for more information.

BioPlex_6.book Page 41 Friday, September 23, 2011 11:55 AM