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- Title
Setting Antimicrobial Susceptibility Testing Breakpoints: A Primer for Pediatric Infectious Diseases Specialists on the Clinical and Laboratory Standards Institute Approach.
- Authors
Pierce, Virginia M; Mathers, Amy J
- Abstract
Breakpoints are the values used by clinical microbiology laboratories to interpret the results of antimicrobial susceptibility testing (AST) and classify isolates as susceptible or resistant. Whether the breakpoints applied by laboratories accurately predict the likelihood of successful treatment with a particular antimicrobial is an issue of critical importance to quality clinical care. In the United States, the Food and Drug Administration (FDA) sets breakpoints, and globally, breakpoints are also set by 2 standards development organizations, the Clinical and Laboratory Standards Institute (CLSI) and the European Committee on Antimicrobial Susceptibility Testing (EUCAST); individual laboratories may choose which breakpoints to implement. Many CLSI breakpoints are recognized by FDA, facilitating their incorporation into widely used commercial AST devices. The CLSI Subcommittee on AST's consensus approach to establishing (and as needed, revising) breakpoints involves integration of currently available microbiological, pharmacokinetic-pharmacodynamic, and clinical data. Here, an overview of the CLSI process for establishing breakpoints is provided.
- Subjects
COMMUNICABLE diseases; INFORMATION storage &; retrieval systems; MEDICAL databases; UNITED States. Food &; Drug Administration; MEDICAL laboratories; DRUG resistance in microorganisms; MICROBIAL sensitivity tests; MEDICAL specialties &; specialists
- Publication
Journal of the Pediatric Infectious Diseases Society, 2022, Vol 11, Issue 2, p73
- ISSN
2048-7193
- Publication type
Article
- DOI
10.1093/jpids/piab106