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New CLSI Guideline Provides Protocols for Verification and Validation of Multiplex Nucleic Acid Assays
April 28th, 2008
2008 APR 28 -- Multiplex assays detect the presence of and discriminate two or more analytes simultaneously 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. Multiplex testing provides significant challenges to the laboratory with regards to appropriate verification and validation testing, and especially the acquisition of appropriate control and reference materials to conduct the testing. Clinical and Laboratory Standards Institute (CLSI) has recently published a new document, Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline (MM17-A), which provides recommendations for analytic verification and validation of multiplex assays, as well as a review of different types of biologic and synthetic reference materials. Michael A. Zoccoli, PhD, General Manager, IVD Business, Celera, and Co-Chairholder of the CLSI committee that developed the document, describes MM17-A as, "The best information available in this field at the present time for laboratories interested in developing and offering these complex assays for diagnostic use. The sections on reference materials and data analysis will be especially useful for the laboratory community for its information on defining and acquiring the appropriate reference materials for verification and validation testing and on analyzing the testing data to evaluate assay performance." Jean Amos Wilson, PhD, FACMG, Sequenom, Inc., and Co-Chairholder of the CLSI committee that developed the document, says, "This guidance, written by the top experts in clinical molecular genetics, will be an invaluable tool for any diagnostic laboratory that is implementing new genetic tests. Almost all of the new clinical tests are based on multiplexing of analytes, and there is currently no other reference available for this purpose." Keywords: Clinical and Laboratory Standards Institute. This article was prepared by Pharma Business Week editors from staff and other reports. Copyright 2008, Pharma Business Week via NewsRx.com.
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