Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
|Publication Date:||1 January 2018|
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.