Verification and Validation of Multiplex Nucleic Acid Assays

Multiplex assays simultaneously detect the presence of and discriminate two or more analytes in the same sample. The number of commercially available multiplex assays is increasing rapidly, as is the number of laboratory-developed multiplex assays, and these use a variety of technologies and instrument platforms.

Published by the Clinical and Laboratory Standards Institute (CLSI; Wayne, PA, USA), the new guideline includes appropriate analytic verification and validation testing of multiplex nucleic acid assays, as well as a review of different types of biologic and synthetic reference materials.

An overview of currently available technologies, as well as recommendations for evaluating new ones, is provided. An extensive review of the design, acquisition, and appropriate use of different types of control materials, including blood samples, residual patient samples, products of whole genome amplification, synthetic oligonucleotide simplex and multiplex controls, and plasmids are included. Current assay formats are used to illustrate proper verification and validation protocols, and appropriate data analysis and result reporting for multiplex assays are described.


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Clinical and Laboratory Standards Institute