Historical
MM06-A
Quantitative Molecular Methods for Infectious Diseases; Approved Guideline
Recognizing the increased use of quantitative molecular methods for determining the concentration of microorganisms in patients, NCCLS document MM6 has been created to provide 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. Issues specific to the quantitation of nucleic acid in diagnostic testing and monitoring, particularly in viral diseases include: an update on technologies used in molecular quantitation; specimen handling and preparation; standards, calibrators and reference materials; analytical and clinical verification/validation; reporting and interpreting results; clinical utility; and recommendations for manufacturers and clinical laboratories.
Clinical And Laboratory Standards Institute [clsi]