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2023 Breakpoint Implementation Toolkit (2023 BIT)


Clinical laboratories performing antimicrobial susceptibility testing (AST) should use breakpoints currently recognized by Clinical and Laboratory Standards Institute (CLSI) or US Food and Drug Administration (FDA).

CLSI, Association of Public Health Laboratories (APHL), American Society for Microbiology (ASM), College of American Pathologists (CAP), and Centers for Disease Control and Prevention (CDC), have jointly developed this toolkit to assist clinical laboratories in updating minimal inhibitory concentration (MIC) breakpoints. It is provided in a streamlined format and designed to guide performance of a verification or validation study required to update breakpoints. There are links to other resources that explain the rationale behind breakpoint updates, regulatory requirements for updating breakpoints, and detailed instructions for performing an AST breakpoint validation or verification. Manufacturers of AST systems can provide guidance on breakpoints used and clearance status with their systems.

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