CLSI M24S

Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes

Body

CLSI

Number

CLSI M24S

FDA recognition no.

7-326

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Table 1. Broth Microdilution Breakpoints and Interpretive Categories for MTBC Tested in Middlebrook 7H9 Broth Supplemented With OADC Using MIC Panels Table 2. Susceptibility Testing of MTBC to Second-Line Drugs Using the Fluorescence-based Commercial Shorter-Incubation Liquid Media System Table 3. Antimicrobial Agents and Breakpoints for Testing MAC Table 4. Antimicrobial Agents and Breakpoints for Testing Mycobacterium kansasii Table 5. Antimicrobial Agents and Breakpoints for Testing Slowly Growing Nontuberculous Mycobacteria Other Than MAC and Mycobacterium kansasii Table 6. Antimicrobial Agents and Breakpoints for Testing Rapidly Growing Mycobacteria Table 7. Antimicrobial Agents and Breakpoints for Testing Nocardia spp. and Other Aerobic Actinomycetes Table 8. Expected Antimicrobial Susceptibility Patterns of the Most Commonly Isolated Nocardia spp Exceptions are noted on the FDA Antimicrobial Susceptibility Test Interpretive Criteria (STIC) (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575163.htm). In the absence of interpretive criteria and quality control parameters on this FDA webpage, consult the FDA technical contacts below.

Scope source: FDA 认可共识标准库

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