Recently Approved Documents
Protocols for Evaluating Dehydrated Mueller-Hinton Agar (M6-A2); Molecular Diagnostic Methods for Infectious Diseases (MM3-A2); Genotyping for Infectious Diseases (MM10-A); Metrological Traceability and Its Implementation (X5-R);

MM3-A2—Molecular Diagnostic Methods for Infectious Diseases; Approved
Guideline—Second Edition
This guideline 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.
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MM10-A—Genotyping for Infectious Diseases: Identification and Characterization;
Approved Guideline
This guideline describes currently used analytical approaches and methodologies applied to identify the clinically important genetic characteristics responsible for disease manifestation, outcome, and response to therapy in the infectious disease setting. It also provides guidance on the criteria to be considered for design, validation, and determination of clinical utility of such testing.
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X5-R— Metrological Traceability and Its Implementation; A Report
This document provides guidance to manufacturers for establishing and reporting metrological traceability. A CLSI–IFCC joint project.
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Second Notice

M6-A2—Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard—Second Edition
This standard describes three protocols for the evaluation of dehydrated Mueller-Hinton agar in the disk diffusion procedure for antimicrobial susceptibility testing—the first for use by manufacturers to evaluate production lots of Mueller-Hinton agar; and the second and third for selection and stability testing of primary and secondary reference lots of Mueller-Hinton agar.
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Our procedures have been designed to ensure that consensus has been achieved when a standard or guideline is published at the approved level. This means that a document has been rigorously reviewed by the authoring subcommittee, the area committee overseeing the project, the Board of Directors, and the medical-testing community that participates in the consensus process by carefully reviewing and commenting on the standard or guideline.

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