CLSI MM17

Validation and Verification of Multiplex Nucleic Acid Assays, 2nd Edition

Nucleic acid testing is one of the fastest growing fields in laboratory medicine. This guideline includes recommendations for analytical validation and verification of multiplex assays, with a review of biological and synthetic reference materials.

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Chairholder: Steven A. Miller, MD, PhD

Date of Publication: May 31, 2018

Order Code PDF: CLSI MM17Ed2E
ISBN Number: 978-1-68440-005-8

Order Code Print: print not available

Edition: Second

Pages: 118

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A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

CLSI MM17 Abstract

Clinical and Laboratory Standards Institute guideline MM17—Validation and Verification of Multiplex Nucleic Acid Assays discusses analytical validation and verification of qualitative multiplex nucleic acid assays. Topics covered include sample preparation, a general discussion of multiplex methods and technologies, reference and quality control materials, data analysis, and results reporting. Clinical validity and utility are briefly reviewed. Because of the variety and breadth of multiplex testing, specific protocols for validation and verification are not included. However, detailed recommendations for appropriate analytical validation and verification, based on the most current guidance documents, are provided.