YY/T 1728-2021 Active Industry standards-Medicine

YY/T 1728-2021 Clinical laboratory testing and in vitro diagnostic test systems—Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases

Publish Date: 2021-03-09 Implement Date: 2022-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1728-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2021-03-09

Implement Date: 2022-04-01

Pages: 24 pages

Scope

This standard describes the method for detecting the sensitivity of yeast-like fungi to antifungal drugs, including Candida species and Cryptococcus neoformans that cause infections. The reference method described here has not yet been used for the study of yeast-like forms of dimorphic fungi, such as Blastomyces dermatitidis and/or Cryptococcus neoformans capsule variants. In addition, several other issues related to the standardization of testing for filamentous fungi (molds) are not addressed in the current procedure. A reference method for antifungal susceptibility testing of filamentous fungi using broth dilution has been developed. The currently available documents are CLSI M38 and EUCAST E.DEF 9.1 [4-8].
The broth microdilution reference method described in this standard can be implemented in one of two ways: the first is to determine the MIC visually (CLSI method) [1], and the second is to determine the MIC by photometry (EUCAST method) [2]. The MIC reflects the activity of the drug under specified test conditions and is interpreted for clinical management purposes, taking into account other factors such as the pharmacology of the drug or antifungal resistance mechanisms. MIC results can be interpreted as "sensitive" (S), "dose-dependent sensitive" (SDD), "intermediate" (I), "non-sensitive" (NS), or "resistant" (R). Additionally, MIC distributions can be used to determine wild-type or non-wild-type fungal populations. The clinical interpretation of MIC values is beyond the scope of this standard. The interpretive classification cut-points corresponding to the CLSI method and the EUCAST-derived method can be referenced from the latest interpretation tables provided by the corresponding organizations [2, 9]. It is recommended that routine sensitivity testing methods or diagnostic testing devices be compared with this reference method to ensure comparability and reliability of results during validation or registration.