Bio-Rad Bio-Plex System Validation and Calibration Tools - Manual (Page 3)

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
suspension 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 suspension 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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