CLSI M52

Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems, 1st Edition

This guideline includes recommendations for verification of commercial US FDA-cleared microbial identification and antimicrobial susceptibility testing systems by clinical laboratory professionals to fulfill regulatory or quality assurance requirements for the use of these systems for diagnostic testing.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of January 2020. The document’s next scheduled review is generally five years after the reaffirmation date.

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Details

Chairholder: Linda M. Mann, PhD, D(ABMM) and Dee Shortridge, PhD

Date of Publication: August 25, 2015

Order Code PDF: CLSI M52Ed1E
ISBN Number: 1-56238-912-2

Order Code Print: CLSI M52Ed1
ISBN Number: 1-56238-911-4

Edition: First

Pages: 92

CLSI M52 Abstract

Clinical and Laboratory Standards Institute document M52—Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems provides recommendations for verification of commercial US Food and Drug Administration–cleared antimicrobial susceptibility testing (AST) and microbial identification (ID) systems by clinical laboratory professionals to fulfill regulatory or QA requirements for the use of these systems for diagnostic testing. This guideline focuses on instrument-based systems commonly used in clinical laboratories and may also be applicable to manual methods for ID and AST.