2023 Breakpoint Implementation Toolkit (2023 BIT)
Effective January 2024, clinical laboratories performing antimicrobial susceptibility testing (AST) will be required to use breakpoints currently recognized by Clinical and Laboratory Standards Institute (CLSI) or US Food and Drug Administration (FDA).
Together 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 Breakpoint Implementation Toolkit (BIT) to assist clinical laboratories in updating minimal inhibitory concentration (MIC) breakpoints.
The kit is provided in a streamlined format and designed to guide performance of a verification or validation study required to update breakpoints. Also included 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.
- Introduction: 2023 Breakpoint Implementation Toolkit
- How to Use 2023 Breakpoint Implementation Toolkit
- Definitions/References/Resources
- Pathway for Updating Breakpoints (Figure 1)
- Part A. Breakpoints in Use
- Template for Documenting Breakpoints in Use
- Part B. CLSI vs FDA Breakpoints
- Listing of all current CLSI breakpoints (M100-Ed33) and corresponding FDA breakpoints
- Part C. Breakpoint Implementation Summary
- Template for documenting results of a validation study to update breakpoints
- Part D. CDC and FDA AR Bank BIT Isolate Sets
- CDC and FDA Antibiotic Resistance Isolate Bank isolate sets available for use in breakpoint verification and validation studies
- Part E. Instructions for Use of 2023 BIT Part F
- Instructions for using the prefilled Excel workbook
- Part F. AR Bank Data Entry and Calculations
- Excel workbook prefilled with the AR Bank BIT set isolates and their results
- Part G. Blank Form for Data Entry
- Template for validations or verifications using isolates other than those listed in the AR Bank BIT sets included in this toolkit