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Correlation of Bio-Plex Suspension Array Reader Validation With Multiplex Cytokine Assay Performance, Rev A

Chloe Etienne, Allan Gandy, Diana Davis, and Aiguo Zhang, Bio-Rad Laboratories, Inc., 2000 Alfred Nobel Drive, Hercules, CA 94547 USA


Introduction
The Bio-Plex suspension array system is an integrated system consisting of hardware, software, and assay kits. The system employs bead-based Luminex technology to simultaneously analyze up to 100 targets in a single microplate well. The Bio-Plex validation kit is a tool designed for operational qualification of the system. The kit validates the performance of the fluidics and optics systems, the two primary components of the suspension array reader. A high correlation exists between the validation kit parameters and assay performance; therefore, proper validation of the system is essential for ensuring optimal assay performance. In this technical study, the optics system of a reader was deliberately misaligned to varying degrees to demonstrate the effect of a poorly maintained system on assay performance. At varying degrees of misalignment, reporter channel performance was evaluated using the Bio-Plex validation kit. The effect of misaligned optics was further illustrated by analyzing a 3-plex cytokine assay at each degree of system misalignment.

Validation Kit Parameters
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 (Bedson and Sargent 1996). The Bio-Plex validation kit is used for operational qualification of the Bio-Plex suspension array system. The validation kit consists of four sets of beads that are used to evaluate the performance parameters listed in Table 1.

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