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CLSI MM03

Molecular Diagnostic Methods for Infectious Diseases

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Organization: CLSI
Publication Date: 1 February 2015
Status: active
Page Count: 110
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: MM06,3 MM09,4 MM10,5 MM13,6 MM14,7 MM17,8 and MM19.9

Document History

CLSI MM03
February 1, 2015
Molecular Diagnostic Methods for Infectious Diseases
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...
February 1, 2006
Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline
This guideline describes general principles for the development, evaluation, and application of tests designed for direct detection of microorganisms in clinical specimens and for identification of...

References

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