Navigating CLSI Breakpoint Revisions: A Practical Guide for Clinical Laboratories
Since 2010, CLSI has revised multiple antimicrobial breakpoints including fluoroquinolones for Enterobacteriaceae and P. aeruginosa, daptomycin for enterococci, and ceftaroline for S. aureus. This review catalogues all revisions and provides practical strategies for laboratory implementation, addressing challenges with FDA clearance gaps, validation requirements, and LIS/EMR system updates that complicate adoption of current breakpoints.
The original study
Understanding and Addressing CLSI Breakpoint Revisions: a Primer for Clinical Laboratories.
- Authors
- Humphries RM, Abbott AN, Hindler JA
- Journal
- Journal of clinical microbiology
- Type
- Journal Article, Review
- PMID
- 30971460
Original abstract
The Clinical and Laboratory Standards Institute (CLSI) has revised several breakpoints since 2010 for bacteria that grow aerobically. In 2019, these revisions include changes to the ciprofloxacin and levofloxacin breakpoints for the Enterobacteriaceae and Pseudomonas aeruginosa, daptomycin breakpoints for Enterococcus spp., and ceftaroline breakpoints for Staphylococcus aureus Implementation of the revisions is a challenge for all laboratories, as not all systems have FDA clearance for the revised (current) breakpoints, compounded by the need for laboratories to perform validation studies and to make updates to laboratory information system/electronic medical record builds in the setting of limited information technology infrastructure. This minireview describes the breakpoint revisions in the M100 supplement since 2010 and strategies for the laboratory on how to best adopt these in clinical testing.