GB/T 46454-2025 Clinical laboratory testing and in vitro diagnostic test systems—Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases

Scope

This document describes methods for detecting the sensitivity of yeast-like fungi to antifungal drugs, including Candida species and Cryptococcus neoformans that cause infections. The reference methods described in this document have not yet been used for the study of the yeast phase of dimorphic fungi, such as Blastomyces dermatitidis and/or Cryptococcus neoformans capsular variants. In addition, several other issues related to the standardization of testing filamentous fungi (molds) are not addressed in the current procedures and are therefore beyond the scope of this document. The reference method of microdilution in broth described in this document can be implemented in one of two ways. First, the MIC can be determined visually (CLSI method) [1, 5]. Second, the MIC can be determined by photometry (EUCAST method) [2, 10]. The MIC reflects the activity of the drug under specified experimental conditions and can be interpreted for clinical management purposes considering other factors, such as the pharmacology of the drug or antifungal resistance mechanisms. Additionally, the distribution of MIC values can be used to identify wild-type or non-wild-type fungal populations. The clinical interpretation of MIC values is beyond the scope of this document. For the CLSI method and EUCAST-derived methods, refer to the latest interpretation tables provided by the corresponding institutions [5, 15]. It is recommended to compare routine sensitivity testing methods or diagnostic testing devices with this reference method to ensure the comparability and reliability of results during validation or registration.

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