CLSI M23

Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters, 6th Edition

This guideline includes the necessary and recommended data for selecting appropriate breakpoints and quality control ranges for antimicrobial agents.

This document is available in electronic format only.

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Chairholder: Avery Goodwin, MS, PhD and Matthew A. Wikler, MD, FIDSA, MBA

Date of Publication: July 31, 2023

Order Code PDF: CLSI M23Ed6E
ISBN Number: 978-1-68440-186-4

Order Code Print: print not available

Edition: Sixth

Pages: 126

CLSI M23 Additional Details

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

CLSI M23 Abstract

Clinical and Laboratory Standards Institute guideline M23—Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters offers guidance for developing breakpoints and QC ranges for antimicrobial susceptibility tests against aerobic and anaerobic bacteria, as well as selected fungi, according to CLSI antimicrobial susceptibility testing documents. It describes the data used by the CLSI Subcommittees on Antimicrobial Susceptibility Testing and Antifungal Susceptibility Tests to establish these breakpoints and QC ranges for antimicrobial agents, including microbiological data, pharmacokinetic and pharmacodynamic characteristics, and clinical data. As additional experience is accrued with the individual antimicrobial agents, new data may be used to reassess breakpoints or QC ranges. Users of this guideline should understand that susceptibility test results cannot predict clinical outcomes with absolute certainty. They should be used along with best clinical judgment and laboratory support to best serve the patient.