WARNING: We do not support Internet Explorer. It is not secure and will not work correctly. Please come back using a newer web browser.


CLSI MM03

Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition

This report 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, quality assurance, regulatory issues, and recommendations for manufacturers and clinical laboratories. 

This document is available in electronic format only.

Member price:

List Price:
  PDF  Add to Cart
Log in/sign up to see your price

Details

Chairholder: Frederick S. Nolte, PhD, D(ABMM), F(AAM)

Date of Publication: February 27, 2015

Order Code PDF: CLSI MM03Ed3E
ISBN Number: 1-56238-998-X

Order Code Print: print not available

Edition: Third

Pages: 110

CLSI MM03 Additional Details

If interested in ordering larger quantities of this document in print, please contact us here.

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 archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of January 2020. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI MM03 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.