GB/T 40672-2021Clinical laboratory testing - Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing (English PDF)

1 Scope

This document gives the standard description and performance standards of the physical properties of dehydrated MH broth (dMHB) and dehydrated MH agar (dMHA).

In this way, manufacturers can evaluate the performance characteristics of their dMHB and dMHA production batches. Batches of broth or agar can then be used by all users (Including the manufacturer of in vitro susceptibility testing equipment) as a medium for conducting antimicrobial susceptibility testing.

This document does not describe additives (such as blood or blood products) that are added to the culture medium to support the growth of fastidious bacteria (CLSI method

Method)[3][4][5][6]. These additives are added as a final product when the dehydrated medium is prepared as a liquid, which is beyond the scope of this document. Although dMHA can be used for the agar dilution method[4][6] or gradient diffusion method to determine MIC. This document only contains in accordance with the American Association for Clinical and Laboratory Standards (CLSI) [5] and European Committee for Antimicrobial Susceptibility Testing (EUCAST) [3] performance test using the paper diffusion method.

2 Normative references

The content of the following documents constitutes an indispensable clause of this document through normative references in the text. Among them, dated quotations

Only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to

This document.

YY/T 0688.1-2008 Clinical laboratory testing and in vitro diagnostic system infection pathogen susceptibility test and antimicrobial susceptibility

Performance evaluation of test equipment. Part 1.Reference for the in vitro activity detection of antibacterial agents for rapid-growing aerobic bacteria related to infectious diseases

Method (ISO 20776-1.2006, MOD)

Note. There is no technical difference between the quoted content of YY/T 0688.1-2008 and the quoted content of ISO 20776-1.2006.

ISO 20776-1 Infectious pathogen susceptibility test and performance evaluation of antibacterial agent susceptibility test equipment Part 1.Antibacterial agent pair

The broth microdilution reference method for the in vitro activity detection of rapidly growing aerobic bacteria related to infectious diseases (Susceptibility testing of infectiousagentsandevaluationofperformanceofantimicrobialsusceptibilitytestdevices-Part 1.

Brothmicro-dilutionreferencemethodfortestingtheinvitroactivityofantimicrobialagentsagainst rapidlygrowingaerobicbacteriainvolvedininfectiousdiseases)

CLSIM100 Antimicrobial Agent Sensitivity Test Implementation Standard; Informational Supplement (Performance Standards for Antimicrobial

SusceptibilityTesting;InformationalSupplement)

3 Terms and definitions

The following terms and definitions apply to this document.