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The Clinical and Laboratory Standards Institute Subcommittee on Antimicrobial Susceptibility Testing: Background, Organization, Functions, and Processes
Open accessAbstract
The Clinical and Laboratory Standards Institute (CLSI) Subcommittee on Antimicrobial Susceptibility Testing (AST SC) is a volunteer-led, multidisciplinary consensus body that develops and publishes standards and guidelines (among other products) for antimicrobial susceptibility testing (AST) methods and results interpretation in the United States and internationally. The Subcommittee (SC) meets face-to-face twice yearly, and its working groups (WGs) are active throughout the year via teleconferences. All meetings are open to the public. Participants include clinical microbiologists, infectious disease (ID) pharmacists, and infectious disease physicians representing the health care professions, government, and industry. Individuals who work for a company with a primary financial dependency on drug sales cannot serve as voting members, and well-defined conflict of interest polices are in place. In addition to developing and updating susceptibility breakpoints, the SC develops and validates new testing methods, provides guidance on how results should be interpreted and applied, sets quality control ranges, and educates users through seminars, symposia, and webinars. Based on its work, the SC publishes print and electronic standards and guidelines, including an annual update, the Performance Standards for Antimicrobial Susceptibility Testing (M100). This commentary will describe the background, organization, functions, and operational processes of the AST SC.
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The agar diffusion assay has been extensively validated and is recognized as a reliable method by regulatory authorities such as the Clinical and Laboratory Standards Institute (CLSI).
“Lastly, the agar diffusion assay has been extensively validated and is recognized as a reliable method by regulatory authorities such as the Clinical and Laboratory Standards Institute (CLSI) [32].”
From Methods for screening and evaluation of antimicrobial activity: A review of protocols, advantages, and limitations (2024) · cites this paper as [32]
The paper describes CLSI as a standards-development organization and says its antimicrobial susceptibility testing subcommittee assesses methods, including agar diffusion tests (Background and History; Organization of the Subcommittee, page not available in our copy). It does not establish that the agar diffusion assay generally has been extensively validated or is reliable, and it does not describe CLSI as a regulatory authority. (LLM, conf=0.86)
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Research works printed but not linked: 9
- Clinical and Laboratory Standards Institute. 2018. Performance standards for antimicrobial disk susceptibility tests, 13th ed. CLSI standard M02. Clinical and Laboratory Standards Institute, Wayne, PA.
- Clinical and Laboratory Standards Institute. 2018. Performance standards for dilution antimicrobial susceptibility tests for bacteria that grow aerobically, 11th ed. CLSI standard M07. Clinical and Laboratory Standards Institute, Wayne, PA.
- Clinical and Laboratory Standards Institute. 2018. Methods for antimicrobial susceptibility testing of anaerobic bacteria, 9th ed. CLSI standard M11. Clinical and Laboratory Standards Institute, Wayne, PA.
- Clinical and Laboratory Standards Institute. 2016. Methods for antimicrobial dilution and disk susceptibility testing of infrequently isolated or fastidious bacteria, 3rd ed. CLSI guideline M45. Clinical and Laboratory Standards Institute, Wayne, PA.
- Clinical and Laboratory Standards Institute. 2020. Performance standards for antimicrobial susceptibility testing, 30th ed. CLSI supplement M100. Clinical and Laboratory Standards Institute, Wayne, PA.
- Clinical and Laboratory Standards Institute. 2018. Development of in vitro susceptibility testing criteria and quality control parameters, 5th ed. CLSI standard M23. Clinical and Laboratory Standards Institute, Wayne, PA.
- 10.1128/JCM.00203-19 · DOI
- 10.1128/JCM.01129-19 · DOI
- 10.1128/JCM.40.9.3269-3276.2002 · DOI
Cited by
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Hossain, T. J. (2024) · European Journal of Microbiology and Immunology · doi:10.1556/1886.2024.00035 · Cited by 392
Ali, F., Silvy, T. N., Hossain, T. J., Uddin, M. K., & Uddin, M. S. (2021) · International Journal of One Health · doi:10.14202/ijoh.2021.158-164 · Cited by 13
Metadata
- Authors
- Weinstein, M. P., & Lewis, J. S.
- Affiliations
- Rutgers, The State University of New Jersey (US)
- Oregon Health & Science University (US)
- ORCID
- Lewis, James S.
- Venue
- Journal of Clinical Microbiology
- Publisher
- American Society for Microbiology
- Published
- 2020-02-24
- Volume
- 58
- Issue
- 3
- ISSN
- 0095-1137 (ISSN-L)
- 1098-660X
- PMC
- PMC7041576
- OpenAlex
- W3000425138
- Cited by
- 567
- References
- 0
- Citations by year
- 2026: 79 · 2025: 137 · 2024: 131 · 2023: 102 · 2022: 67 · 2021: 38 · 2020: 13
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Clinical Microbiology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Microbiology (medical) › Bacterial Identification and Susceptibility Testing
- Health Sciences › Medicine › Infectious Diseases › Antibiotic Use and Resistance
- Health Sciences › Medicine › Microbiology (medical) › Antibiotic Resistance in Bacteria
- Keywords
- antimicrobial susceptibility testing, susceptibility breakpoints, conflict of interest policies, working groups, standards and guidelines
- MeSH terms
- Anti-Infective Agents, Anti-Bacterial Agents, Humans, Laboratories, Microbial Sensitivity Tests, Reference Standards, United States, Clinical Laboratory Services
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