Bio-Rad Bio-Plex System Validation and Calibration Tools User Manual
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Section 1
Introduction
Qualification of analytical instruments is a formal process of documenting that an
instrument is fit for its intended use and that it is kept maintained and calibrated.
The Bio-Plex validation kit is used for operational qualification (OQ) of the Bio-Plex
protein array system. The validation kit is designed to validate the operation of all of
the primary components of the system and is a valuable tool that allows the user to
discriminate between assay and instrumentation problems.
The Bio-Plex validation kit consists of beads to evaluate the following components
of the Bio-Plex protein array system: 1) optics alignment, 2) integrity of fluidics, 3)
reporter channel performance, and 4) classify efficiency. A brief definition of the
parameter and the principle of each procedure is described, along with complete
procedures for evaluating each of the primary components. An explanation of the
potential impact of each process on a typical Bio-Plex cytokine assay is included to
assist the user in assay troubleshooting and development.
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For research use only. Not for diagnostic procedures.
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