Standard Document
Third Edition
Molecular Diagnostics

CLSI MM03

Molecular Diagnostic Methods for Infectious Diseases

This CLSI guideline provides comprehensive guidance on nucleic acid-based methods for detecting and characterizing microorganisms in clinical specimens, revolutionizing clinical microbiology and infectious disease diagnostics. It covers amplified and nonamplified nucleic acid methods, test performance evaluation, quality assurance, regulatory considerations, and result interpretation.

MM03 helps laboratories optimize test accuracy, minimize false positives, and implement best practices for molecular infectious disease testing.

February 27, 2015
Frederick S. Nolte, PhD, D(ABMM), F(AAM)

{{FormatPrice(currentPrice)}}

Free

{{FormatPrice(nonMemberPrice)}} List Price
This is your member pricing.
Notify Me About New Editions
Abstract

Nucleic acid methods for the detection and characterization of microorganisms in clinical specimens are now firmly established in laboratory medicine. These methods offer opportunities for clinical laboratories to provide more rapid and accurate results, and have changed the practice of clinical microbiology and infectious diseases. Clinical and Laboratory Standards Institute document MM03—Molecular Diagnostic Methods for Infectious Diseases 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, QA, regulatory issues, and recommendations for manufacturers and clinical laboratories.

Overview of Changes

With the change in format and category definitions for all CLSI documents, MM03 has been recategorized as a report and replaces MM03-A2. Although MM03 has been revised for the purpose of keeping information current, the revisions do not significantly affect the scope or purpose of the document, nor do they change the methodology used. 

Revisions to the document include: 
• Formatting and template design have been updated to reflect current CLSI style. 
• References to most trademarked products have been deleted. 
• CLSI references have been updated to reflect current document numbers and editions. 
• International Organization for Standardization definitions and references have been updated to reflect current editions. 
• New test descriptions and figures have been added to the text and the appendix in order to reflect current technology.

Scope

This 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. The document provides evidence-based recommendations, where appropriate. 

The following content areas are addressed: 
• 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 
• QA 
• Regulatory issues 
• Recommendations for manufacturers and clinical laboratories 

This document is intended for use by clinical laboratories, test developers and manufacturers, and regulatory agencies. It is not intended to be a compilation of successful protocols for detection/characterization of microorganisms, but rather to describe general principles for the development, evaluation, and application of these tests. Users are directed to the Manual of Clinical Microbiology1 and Molecular Microbiology: Diagnostic Principles and Practice2 for more information on specific applications. This document should be used in conjunction with the following related CLSI documents: MM06, MM09, MM10, MM13, MM14, MM17, and MM19.

Product Details
MM03Ed3E
1-56238-998-X
110
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.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.

Authors
Stephen P. Day, PhD
Cynthia L. Jackson, PhD
Frederick S. Nolte, PhD, D(ABBM), F(AAM)
Zivana Tezak-Fragale, PhD
Abstract

Nucleic acid methods for the detection and characterization of microorganisms in clinical specimens are now firmly established in laboratory medicine. These methods offer opportunities for clinical laboratories to provide more rapid and accurate results, and have changed the practice of clinical microbiology and infectious diseases. Clinical and Laboratory Standards Institute document MM03—Molecular Diagnostic Methods for Infectious Diseases 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, QA, regulatory issues, and recommendations for manufacturers and clinical laboratories.

Overview of Changes

With the change in format and category definitions for all CLSI documents, MM03 has been recategorized as a report and replaces MM03-A2. Although MM03 has been revised for the purpose of keeping information current, the revisions do not significantly affect the scope or purpose of the document, nor do they change the methodology used. 

Revisions to the document include: 
• Formatting and template design have been updated to reflect current CLSI style. 
• References to most trademarked products have been deleted. 
• CLSI references have been updated to reflect current document numbers and editions. 
• International Organization for Standardization definitions and references have been updated to reflect current editions. 
• New test descriptions and figures have been added to the text and the appendix in order to reflect current technology.

Scope

This 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. The document provides evidence-based recommendations, where appropriate. 

The following content areas are addressed: 
• 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 
• QA 
• Regulatory issues 
• Recommendations for manufacturers and clinical laboratories 

This document is intended for use by clinical laboratories, test developers and manufacturers, and regulatory agencies. It is not intended to be a compilation of successful protocols for detection/characterization of microorganisms, but rather to describe general principles for the development, evaluation, and application of these tests. Users are directed to the Manual of Clinical Microbiology1 and Molecular Microbiology: Diagnostic Principles and Practice2 for more information on specific applications. This document should be used in conjunction with the following related CLSI documents: MM06, MM09, MM10, MM13, MM14, MM17, and MM19.

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.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.

Authors
Stephen P. Day, PhD
Cynthia L. Jackson, PhD
Frederick S. Nolte, PhD, D(ABBM), F(AAM)
Zivana Tezak-Fragale, PhD