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

Romney M Humphries; Jane Ambler; Stephanie L Mitchell; Mariana Castanheira; Tanis Dingle; Janet A Hindler; Laura Koeth; Katherine Sei; CLSI Methods Development and Standardization Working Group of the Subcommittee on Antimicrobial Susceptibility Testing

doi:10.1128/JCM.01934-17

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

J Clin Microbiol. 2018 Mar 26;56(4):e01934-17. doi: 10.1128/JCM.01934-17. Print 2018 Apr.

Authors

Romney M Humphries¹, Jane Ambler², Stephanie L Mitchell³, Mariana Castanheira⁴, Tanis Dingle^{5

6}, Janet A Hindler⁷, Laura Koeth⁸, Katherine Sei⁹; CLSI Methods Development and Standardization Working Group of the Subcommittee on Antimicrobial Susceptibility Testing

Collaborators

CLSI Methods Development and Standardization Working Group of the Subcommittee on Antimicrobial Susceptibility Testing:
Dwight Hardy, Barbara Zimmer, Susan Butler-Wu, Jennifer Dien Bard, Bill Brasso, Ribhi Shawar, Tanis Dingle, Romney Humphries, Katherine Sei, Laura Koeth

Affiliations

¹ Accelerate Diagnostics, Tucson, Arizona, USA rhumphries@axdx.com.
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

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.

Keywords: CLSI; antimicrobial susceptibility testing; evaluations.

Publication types

Review

MeSH terms

Clinical Laboratory Techniques / methods*
Clinical Laboratory Techniques / standards*
Humans
Microbial Sensitivity Tests / methods*
Microbial Sensitivity Tests / standards*