Standard Document
Second Edition
Molecular Diagnostics

CLSI MM06

Quantitative Molecular Methods for Infectious Diseases

This CLSI guideline provides guidance on the development and use of quantitative molecular methods, including nucleic acid probes and amplification techniques, for detecting and measuring microorganism concentrations in patients. MM06 also includes recommendations for quality assurance, proficiency testing, and result interpretation, ensuring accuracy in infectious disease diagnostics.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of April 2016.

November 30, 2010
Angela M. Caliendo, MD, PhD and Helen Fernandes, PhD

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Abstract

Clinical and Laboratory Standards Institute document MM06-A2—Quantitative Molecular Methods for Infectious Diseases; Approved Guideline—Second Edition 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. Issues specific to the quantification of nucleic acid in diagnostic testing and monitoring, particularly in viral diseases, include an update on technologies used in molecular quantification; 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.

Overview of Changes

This document is an update of MM06—Quantitative Molecular Methods for Infectious Diseases; Approved Guideline that was published in 2003. MM06 established the original guidelines for laboratory tests that quantified viruses for the purpose of diagnosis and monitoring of infected patients. This guideline is to be used in conjunction with CLSI document MM03.1 This document constitutes the second edition of MM06 and specifically addresses the changes in technology, performance, assay verification, interpretation, and quality control (QC) for quantitative molecular methods in the diagnosis and monitoring of infectious diseases.

Scope

This guideline is to be used for implementation of tests for diagnostic purposes after the benefits and potential risks associated with the use of the test in clinical practice have been considered. Specimen handling and preparation; standards, calibrators, and reference materials; analytical and clinical verification/validation; reporting and interpreting results; and QC and clinical utility are the focus of this document. This document does not establish a clinically acceptable limit of quantification (LoQ) because consensus for most assays is currently lacking on this issue. This document is intended for manufacturers or laboratories that develop tests, laboratories that perform or intend to implement such tests, clinicians that use the results to diagnose or manage patients, and agencies that regulate their use.

Product Details
MM06A2E
1-56238-736-7
76
Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This document is available in electronic format only.

Authors
Angela M. Caliendo, MD, PhD
Phillip T. Moen, Jr, PhD
Helen Fernandes, PhD
Dave Petrich, MBA
Christina Egan, PhD, CBSP
Mangalathu S. Rajeevan, PhD
Haja Sittana El Mubarak, PhD
Venkatakrishna Shyamala, PhD
Mark J. Espy, MS
Linda D. Starr-Spires, PhD
Hawazin Faruki, DrPH
Yi-Wei Tang, MD, PhD, D(ABMM)
David Hillyard, MD
Jan Turczyn, MT(ASCP), CLS
Michael A. Lewinski, PhD, D(ABMM)
Alexandra Valsamakis, MD, PhD
Li Li, MS
Belinda Yen-Lieberman, PhD
Abstract

Clinical and Laboratory Standards Institute document MM06-A2—Quantitative Molecular Methods for Infectious Diseases; Approved Guideline—Second Edition 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. Issues specific to the quantification of nucleic acid in diagnostic testing and monitoring, particularly in viral diseases, include an update on technologies used in molecular quantification; 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.

Overview of Changes

This document is an update of MM06—Quantitative Molecular Methods for Infectious Diseases; Approved Guideline that was published in 2003. MM06 established the original guidelines for laboratory tests that quantified viruses for the purpose of diagnosis and monitoring of infected patients. This guideline is to be used in conjunction with CLSI document MM03.1 This document constitutes the second edition of MM06 and specifically addresses the changes in technology, performance, assay verification, interpretation, and quality control (QC) for quantitative molecular methods in the diagnosis and monitoring of infectious diseases.

Scope

This guideline is to be used for implementation of tests for diagnostic purposes after the benefits and potential risks associated with the use of the test in clinical practice have been considered. Specimen handling and preparation; standards, calibrators, and reference materials; analytical and clinical verification/validation; reporting and interpreting results; and QC and clinical utility are the focus of this document. This document does not establish a clinically acceptable limit of quantification (LoQ) because consensus for most assays is currently lacking on this issue. This document is intended for manufacturers or laboratories that develop tests, laboratories that perform or intend to implement such tests, clinicians that use the results to diagnose or manage patients, and agencies that regulate their use.

Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This document is available in electronic format only.

Authors
Angela M. Caliendo, MD, PhD
Phillip T. Moen, Jr, PhD
Helen Fernandes, PhD
Dave Petrich, MBA
Christina Egan, PhD, CBSP
Mangalathu S. Rajeevan, PhD
Haja Sittana El Mubarak, PhD
Venkatakrishna Shyamala, PhD
Mark J. Espy, MS
Linda D. Starr-Spires, PhD
Hawazin Faruki, DrPH
Yi-Wei Tang, MD, PhD, D(ABMM)
David Hillyard, MD
Jan Turczyn, MT(ASCP), CLS
Michael A. Lewinski, PhD, D(ABMM)
Alexandra Valsamakis, MD, PhD
Li Li, MS
Belinda Yen-Lieberman, PhD