CRO Breakpoint Implementation Toolkit
This toolkit provides simplified tools and resources to assist laboratories that perform commercial antibiotic susceptibility testing (cAST), to utilize the most current breakpoints for carbapenem resistant organisms (CRO).
Contact the Infectious Diseases team: [email protected]
Laboratories performing antimicrobial susceptibility testing (AST) are required to use current interpretive breakpoints recognized by the US Food and Drug Administration (FDA) or the Clinical and Laboratory Standards Institute (CLSI). However, the adoption of updated breakpoints can be challenging due to the necessary verification or validation study that must be completed according to CLIA requirements. APHL, in collaboration with other public health and clinical organizations, have contributed to the development of resources to assist laboratories implement updated breakpoints.
Breakpoint Implementation Toolkit
The Breakpoint Implementation Toolkit (BIT) is a collaborative toolkit created by CLSI, APHL, ASM, College of American Pathologists (CAP) and US Centers for Disease Control and Prevention (CDC). This toolkit is designed to guide the performance of a verification or validation study to update breakpoints and provide additional resources explaining the rationale and regulatory requirements.
APHL CRO Breakpoint Implementation Toolkit
The APHL CRO Breakpoint Implementation Toolkit, developed by the APHL-ASM AR Laboratory Workgroup, focuses on the verification study needed to update carbapenem susceptibility breakpoints. Carbapenem-resistant organisms (CROs), such as strains of Enterobacterales, Pseudomonas aeruginosa and Acinetobacter baumanii, have been characterized as Urgent Threats by CDC’s AR Threats Report that require urgent and aggressive action.