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Review
. 2019 May 24;57(6):e00203-19.
doi: 10.1128/JCM.00203-19. Print 2019 Jun.

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

Romney M Humphries  1   2 , April N Abbott  3 , Janet A Hindler  4
Affiliations
Review

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

Romney M Humphries et al. J Clin Microbiol. .

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.

Keywords: CLSI; FDA; antimicrobial susceptibility testing; breakpoints.

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Figures

FIG 1
FIG 1
Process for revised breakpoint implementation on cASTs; roles of the CLSI, FDA, and cASTs manufacturers. cASTs, commercial antimicrobial susceptibility test system; cASTs MAN, commercial antimicrobial susceptibility test system manufacturer.
See this image and copyright information in PMC

References

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