Standard Document
First Edition
Microbiology

CLSI M57

Principles and Procedures for the Development of Epidemiological Cutoff Values for Antifungal Susceptibility Testing

This CLSI guideline provides criteria for establishing epidemiological cutoff values (ECVs) for yeasts and filamentous fungi. It offers a method to assess whether an isolate has wild-type or non-wild-type susceptibility when breakpoints are unavailable. The guideline outlines data collection, ECV development, and practical applications to guide antifungal susceptibility testing.

Supplemental tables for M57 are available in CLSI M57S.

 

April 30, 2016
Barbara D. Alexander, MD, MHS

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Abstract

Clinical and Laboratory Standards Institute guideline M57—Principles and Procedures for the Development of Epidemiological Cutoff Values for Antifungal Susceptibility Testing presents criteria for determining epidemiological cutoff values (ECVs) for yeasts and filamentous fungi. Data collection, ECV development, and indications for their use are discussed. This guideline provides an analysis of the criteria that determine whether an isolate has a wild-type or non-wild-type minimal inhibitory concentration/minimal effective concentration value and discusses how ECVs can be used for fungal species and antifungal agent combinations for which there are no breakpoints.

Scope

This guideline specifies requirements and recommendations for developing and using epidemiological cutoff values (ECVs) in antifungal susceptibility testing. The guideline’s intended users are developers of ECVs for antifungal agents, laboratory directors who provide assistance to clinicians on interpreting antifungal minimal inhibitory concentration (MIC)/minimal effective concentration (MEC) values, and clinicians who interpret MIC/MEC values for the application of proper antifungal therapy and surveillance of emerging resistance. This guideline: • Is not intended to provide an equivalent to breakpoint development • Does not discuss breakpoint development • Is not intended to provide a replacement for breakpoints

Product Details
M57Ed1E
1-56238-933-5
28
Authors
Mahmoud A. Ghannoum, MSc, PhD, EMBA
Maiken Cavling Arendrup, MD, PhD
Steven D. Brown, PhD, D(ABMM)
Ana Espinel-Ingroff, PhD, MS
Shawn R. Lockhart, PhD, D(ABMM)
Mary R. Motyl, PhD, D(ABMM)
John D. Turnidge, MD
Abstract

Clinical and Laboratory Standards Institute guideline M57—Principles and Procedures for the Development of Epidemiological Cutoff Values for Antifungal Susceptibility Testing presents criteria for determining epidemiological cutoff values (ECVs) for yeasts and filamentous fungi. Data collection, ECV development, and indications for their use are discussed. This guideline provides an analysis of the criteria that determine whether an isolate has a wild-type or non-wild-type minimal inhibitory concentration/minimal effective concentration value and discusses how ECVs can be used for fungal species and antifungal agent combinations for which there are no breakpoints.

Scope

This guideline specifies requirements and recommendations for developing and using epidemiological cutoff values (ECVs) in antifungal susceptibility testing. The guideline’s intended users are developers of ECVs for antifungal agents, laboratory directors who provide assistance to clinicians on interpreting antifungal minimal inhibitory concentration (MIC)/minimal effective concentration (MEC) values, and clinicians who interpret MIC/MEC values for the application of proper antifungal therapy and surveillance of emerging resistance. This guideline: • Is not intended to provide an equivalent to breakpoint development • Does not discuss breakpoint development • Is not intended to provide a replacement for breakpoints

M57Ed1E
1-56238-933-5
28
Authors
Mahmoud A. Ghannoum, MSc, PhD, EMBA
Maiken Cavling Arendrup, MD, PhD
Steven D. Brown, PhD, D(ABMM)
Ana Espinel-Ingroff, PhD, MS
Shawn R. Lockhart, PhD, D(ABMM)
Mary R. Motyl, PhD, D(ABMM)
John D. Turnidge, MD