Understanding and Addressing CLSI Breakpoint Revisions: a Primer for Clinical Laboratories.

Published on Jun 1, 2019in Journal of Clinical Microbiology5.948
· DOI :10.1128/JCM.00203-19
Romney M. Humphries8
Estimated H-index: 8
(UA: University of Arizona),
April N. Abbott11
Estimated H-index: 11
,
J. Hindler3
Estimated H-index: 3
(Los Angeles County Department of Public Health)
Sources
Abstract
The Clinical and Laboratory Standards Institute (CLSI) has revised several breakpoints for bacteria that grow aerobically since 2010. 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 mini-review describes the breakpoints revisions in the M100 Supplement since 2010, and strategies for the laboratory on how to best adopt these in clinical testing.
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