CLSI Methods Development and Standardization Working Group Best Practices for Evaluation of Antimicrobial Susceptibility Tests

Author:

Humphries Romney M.1,Ambler Jane2,Mitchell Stephanie L.3,Castanheira Mariana4,Dingle Tanis56,Hindler Janet A.7,Koeth Laura8,Sei Katherine9

Affiliation:

1. Accelerate Diagnostics, Tucson, Arizona, USA

2. Wockhardt, Morton Grove Pharmaceuticals, Morton Grove, Illinois, USA

3. Clinical Microbiology Laboratory, Children's Hospital of Pittsburgh of UPMC and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA

4. JMI Laboratories, North Liberty, Iowa, USA

5. Provincial Laboratory for Public Health, Edmonton, Alberta, Canada

6. Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta, Canada

7. Department of Pathology & Laboratory Medicine, University of California, Los Angeles, Los Angeles, California, USA

8. Laboratory Specialists, Inc., Westlake, Ohio, USA

9. Beckman-Coulter, West Sacramento, California, USA

Abstract

ABSTRACT Effective evaluations of antimicrobial susceptibility tests (ASTs) require robust study design. The Clinical and Laboratory Standards Institute (CLSI) Subcommittee on Antimicrobial Susceptibility Testing has recognized that many published studies reporting the performance of commercial ASTs (cASTs) suffer from major design and/or analysis flaws, rendering the results difficult or impossible to interpret. This minireview outlines the current consensus of the Methods Development and Standardization Working Group of the CLSI Subcommittee on Antimicrobial Susceptibility Testing regarding best practices for systematic evaluation of the performance of an AST, including the analysis and presentation of essential data intended for publication.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Reference18 articles.

1. Carbapenem-Resistant Enterobacteriaceae Detection Practices in California: What Are We Missing?

2. Impact of Delays between Clinical and Laboratory Standards Institute and Food and Drug Administration Revisions of Interpretive Criteria for Carbapenem-Resistant Enterobacteriaceae

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4. Clinical and Laboratory Standards Institute. 2018. Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically; approved standard—10th ed. M07-A11. Clinical and Laboratory Standards Institute, Wayne, PA.

5. Clinical and Laboratory Standards Institute. 2018. Performance standards for antimicrobial disk susceptibility tests; approved standard—12th ed. M02-A13. Clinical and Laboratory Standards Institute, Wayne, PA.

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