临床实验室测试和体外诊断试验系统.检测体外抗菌剂抗传染病中酵母菌的活性的标准方法

[中文适用范围]： 本文件描述了一种测试酵母（包括念珠菌属）抗真菌剂敏感性的方法。 和引起感染的新型隐球菌。 此处描述的参考方法尚未用于二态性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。 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，该方法可以通过两种途径之一实施。 其中一种途径涉及 MIC 的目视测定（CLSI 方法）[1][5]；第二条途径涉及 MIC 的分光光度测定（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耐药机制）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种群。 MIC 值的临床解释超出了本文件的范围；特定于 CLSI 和 EUCAST 派生方法的解释类别断点可以通过查阅各组织提供的最新解释表来找到[5][15]。 常规药敏试验方法或诊断测试设备可以与该参考方法进行比较，以确保为验证或注册目的提供可比且可靠的结果。 [外文原描述]： 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.