The Clinical and Laboratory Standards Institute (CLSI) recently published a revised document, Quantitative Molecular Methods for Infectious Diseases; Approved Guideline-Second Edition (MM06-A2). The document recognizes the increased use of quantitative molecular methods for determining the concentration of microorganisms in patients.
CLSI document MM06 provides guidance for the development and use of quantitative molecular methods, such as nucleic acid probes and nucleic acid amplification techniques of the target sequences specific to particular microorganisms, and presents recommendations for quality assurance, proficiency testing, and interpretation of results.
Co-chairholders of the subcommittee that created the document, Angela M Caliendo, MD, PhD, Emory University School of Medicine, and Helen Fernandes, PhD, UMDNJ - University Hospital, say, "MM06-A2 serves as a roadmap for professionals developing quantitative molecular tests for infectious diseases. This document is particularly relevant at a time when oversight of laboratory-developed tests is being discussed by regulatory and accrediting agencies. The guideline was written by a diverse group of experts and is designed to be a practical user-friendly document, applicable to all entities involved in molecular testing."
The guideline focuses on:
* Quantification of nucleic acid in diagnostic testing and monitoring, particularly in viral diseases
* Technologies used in molecular quantification
* Specimen handling and preparation
* Standards, calibrators, and reference materials
* Analytical and clinical verification and validation
* Reporting and interpreting results
* Quality control (QC) and clinical utility
* Recommendations for manufacturers and clinical laboratories
This document constitutes the second edition of MM06 and specifically addresses the changes in technology, performance, assay verification, interpretation, and QC for quantitative molecular methods in the diagnosis and monitoring of infectious diseases.
The intended users of this guideline are manufacturers or laboratories that develop tests, laboratories that perform or intend to implement such tests, clinicians who use the results to diagnose or manage patients, and agencies that regulate their use.
CLSI
