Description

CLSI MM06-A2 (R2018) – Quantitative Molecular Methods for Infectious Diseases; Approved Guideline, MM06A2E

Approved Guideline–Second Edition recognizes the increased use of quantitative molecular methods for determining theconcentration of microorganisms in patients. CLSI document MM06 provides guidance for the development and use ofquantitative molecular methods, such as nucleic acid probes and nucleic acid amplification techniques of the target sequencesspecific to particular microorganisms, and presents recommendations for quality assurance, proficiency testing, and interpretationof results.

Issues specific to the quantification of nucleic acid in diagnostic testing and monitoring, particularly in viral diseases, include anupdate on technologies used in molecular quantification; specimen handling and preparation; standards, calibrators, and referencematerials; analytical and clinical verification/validation; reporting and interpreting results; clinical utility; and recommendationsfor manufacturers and clinical laboratories.