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.
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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
CLSI MM03 Additional Details
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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.