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CLSI M23

Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters

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Organization: CLSI
Publication Date: 1 January 2018
Status: active
Page Count: 84
scope:

This guideline provides direction for determining breakpoints and QC parameters for antimicrobial agents that have a direct action on microorganisms. The intended audience includes sponsors (eg, antimicrobial agent manufacturers) planning to submit data to establish or revise QC ranges and susceptibility testing breakpoints and interpretive categories for inclusion in CLSI susceptibility testing documents. The methods described do not apply to:

  • Slow-growing mycobacteria, for which specific guidance is available (see CLSI document M2412)
  • Antimicrobial agents formulated for direct administration to skin or mucous membranes or for inhalation
  • Antimicrobial agents that are intended to exert activity within the gut lumen

Guidance presented in M23 applies only to CLSI procedures and documents.

Document History

CLSI M23
January 1, 2018
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
This guideline provides direction for determining breakpoints and QC parameters for antimicrobial agents that have a direct action on microorganisms. The intended audience includes sponsors (eg,...
October 1, 2008
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline
Guidelines for interpretive criteria and quality control (QC) ranges are established by the Subcommittee on Antimicrobial Susceptibility Testing after review of extensive data. This guideline...
January 1, 1992
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Tentative Guideline Second Edition
A description is not available for this item.

References

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