ISO 16256:2021 临床实验室测试和体外诊断试验系统 测试传染病酵霉菌抗生素体外活性的标准方法

标准编号：ISO 16256:2021

中文名称：临床实验室测试和体外诊断试验系统 测试传染病酵霉菌抗生素体外活性的标准方法

英文名称：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 infec

发布日期：2021-10

标准范围

本文件描述了一种测试酵母(包括念珠菌属)对抗真菌剂的敏感性的方法。和引起感染的新生隐球菌。本文所述的参考方法尚未用于二型真菌的酵母形式的研究，例如皮炎芽生菌和/或荚膜组织胞浆菌变种荚膜。此外，测试丝状真菌（霉菌）在标准化中引入了当前程序未解决的几个额外问题。这些方法超出了本文档的范围。本文件描述了肉汤微量稀释参考方法，其可以通过两种途径中的任何一种实施。一种途径涉及MICs的目视测定（CLSI方法）[1][5]；第二种途径包括分光光度法测定MICs（EUCAST方法）[2][10]。MIC反映了药物在所述测试条件下的活性，并且可以通过考虑其他因素（例如药物药理学或抗真菌抗性机制）来解释用于临床管理目的。此外，MIC分布可用于定义野生型或非野生型真菌群体。MIC值的临床解释超出了本文档的范围；特定于CLSI和EUCAST派生方法的解释类别断点可以通过查阅组织提供的最新解释表找到[5][15]。常规药敏试验方法或诊断试验器械可与该参考方法进行比较，以确保验证或注册的结果具有可比性和可靠性。

This document describes a method for testing the susceptibility to antifungal agents of yeasts, including Candida spp. and Cryptococcus neoformans, that cause infections. The reference method described here has not been used in studies of the yeast forms of dimorphic fungi, such as Blastomyces dermatitidis and/or Histoplasma capsulatum variety capsulatum. Moreover, testing filamentous fungi (moulds) introduces several additional problems in standardization not addressed by the current procedure. Those methods are beyond the scope of this document.This document describes the broth micro-dilution reference method, which can be implemented by either of two pathways. One pathway involves visual determination of MICs (CLSI method)^[1][5]; the second pathway involves spectrophotometric determination of MICs (EUCAST method)^[2][10]. The MIC reflects the activity of the drug under the described test conditions and can be interpreted for clinical management purposes by taking into account other factors, such as drug pharmacology or antifungal resistance mechanisms. In addition, MIC distributions can be used to define wild type or non-wild type fungal populations. Clinical interpretation of the MIC value is beyond the scope of this document; interpretive category breakpoints specific to the CLSI- and EUCAST-derived methods can be found by consulting the latest interpretive tables provided by the organizations^[5][15]. Routine susceptibility testing methods or diagnostic test devices can be compared with this reference method in order to ensure comparable and reliable results for validation or registration purposes.

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