Quality assurance for multiplexed assays – how can it be achieved?

Abstract

Multiplexed assays are now a common form of analysis in routine clinical and research laboratories. Assuring the quality of this type of complex, massively-parallel testing poses challenges not encountered in the traditional single-plex assay. A range of quality assurance measures is implemented at different stages in a multiplex assay, beginning in the manufacturing process, and the ensuing analytical and data interpretation stages. This article explores quality issues and the quality assurance measures that have been devised for multiplex assays ranging from simple two-plex assays to the types of assays that involve simultaneous testing on millions of test sites on a single analytical device.

Keywords:

• Algorithm
• bead array
• controls
• FDA
• IVDMIA
• lab developed test
• microarray
• MAQC

Disclosure statement

The author reports no conflicts of interest. The author alone is responsible for the content and writing of the paper.