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临床实验室检测和体外诊断系统 感染性疾病相关酵母样真菌抗菌剂的体外活性检测参考方法 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
发布日期: 2021-03-09
实施日期: 2022-04-01
本标准描述了检测酵母样真菌抗真菌药物的敏感性的方法,包括引起感染的念珠菌属和新型隐球菌。本标准描述的肉汤微量稀释参考法可通过两种途径之一实现,第一种途径通过肉眼确定MIC (CLSI 方法); 第二种途径通过光度法确定MIC (EUCAST 方法)。MIC反映了在规定试验条件下药物的活性,并在考虑到其他因素下对临床管理目的进行解释,如药物的药理学或抗真菌耐药机制。MIC结果解释可被分为“敏感” (S), “剂量依赖性敏感” (S-DD), “中介” (I), “非敏感” (NS) 或“耐药” (R)。 另外MIC分布可用于确定野生型或非野生型真菌群落。MIC值的临床解释不在本标准的范围。对应于CLSI方法和 EUCAST衍生方法的解释性分类折点可查询相应机构提供的最新解释表。推荐常规敏感性试验方法或诊断检验器械与此参考方法进行比较,以保证验证或注册时结果的可比性和可靠性
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