Wayne, Pennsylvania, USA—March 2015—The Clinical and Laboratory Standards Institute (CLSI) has published Molecular Diagnostic Methods for Infectious Diseases (MM03-Ed3).This report addresses topics relating to clinical applications, amplified and nonamplified nucleic acid methods, selection and qualification of nucleic acid sequences, establishment and evaluation of test performance characteristics, inhibitors, and interfering substances, controlling false-positive reactions, reporting and interpretation of results, quality assurance, regulatory issues, and recommendations for manufacturers and clinical laboratories.
This revision of the document describes general principles for the development, evaluation, and application of tests designed for direct detection of microorganisms in clinical specimens and for identification of microorganisms grown in culture. MM03 includes new test descriptions as well as figures in the text and appendix that reflect current technology.
“Nucleic acid–based testing methods have revolutionized the practice of clinical microbiology and are now the standards of care for patients with many infectious diseases. The revised document addresses changes in technology, clinical practice, and the regulatory environment that have occurred since it was last published in 2006,” highlights Frederick S. Nolte, PhD, D(ABMM), F(AAM), Chairholder of the Consensus Committee on Molecular Methods and Professor of Pathology and Laboratory Medicine, Vice-Chair of Laboratory Medicine, and Director of Clinical Laboratories at Medical University of South Carolina, Charleston, South Carolina, USA. “It is an essential tool for laboratories offering molecular diagnostic tests for infectious diseases.”
This document is intended for use by clinical laboratories, test developers and manufacturers, and regulatory agencies.