CLSI Publishes Validation and Verification of Multiplex Nucleic Acid Assays—MM17

Published by the Clinical and Laboratory Standards Institute

Wayne, Pennsylvania, USA—The Clinical and Laboratory Standards Institute has published Validation and Verification of Multiplex Nucleic Acid Assays—MM17. MM17discusses 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. Detailed recommendations for appropriate analytical validation and verification, based on the most current guidance documents, are provided.

Steven A. Miller, MD, PhD, chairholder of MM17 said, “MM17 is intended to provide guidance to laboratories performing multiplex molecular assays for clinical diagnostics use.  These tests can be complex to validate, perform and interpret, and the goal of this document was to provide a practical approach using best practices to implement these assays.  The topics covered include sample and control acquisition, especially for rare variants, test performance and interpretation, and quality control.  Using this document, laboratories can determine whether and how to implement multiplex molecular tests in their individual healthcare setting.”

MM17 provides guidance on:

• Nucleic acid assay method selection.
• Specimen and reagent assessment.
• Analytical validation of laboratory developed tests and modified in vitro diagnostic assays.
• Amplification technologies, such as multiplex PCR.

For more information about MM17, contact Patrick McGinn at pmcginn@clsi.org or +1.484.588.5933.

CLSI sets the standard for quality in medical laboratory testing. A not-for-profit membership organization, CLSI brings together the global laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine.

For nearly 50 years, our members, volunteers, and customers have made CLSI a respected, transformative leader in the development and implementation of medical laboratory testing standards. Through our unified efforts, we will continue to set and uphold the standards that drive quality test results, enhance patient care delivery, and improve health care around the world.

By using CLSI standards, laboratorians can improve process quality, speed the development of standard operating procedures, and implement safer practices with greater ease and efficiency.