临床实验室测试和体外诊断测试系统——传染源的敏感性试验和抗菌剂敏感性试验设备性能的评估第1部分:抗菌剂对感染性疾病中快速生长的需氧菌体外活性试验的参考方法

[中文适用范围]： 本文件描述了一种用于测定 MIC 的参考方法，即肉汤微量稀释法。MIC 可以作为临床医生的指导，并反映药物在所描述的测试条件下的活性，同时考虑其他因素，例如药物药理学、药代动力学或细菌耐药机制。这允许将细菌分类为“敏感”（S）、“中等”（I）或“耐药”（R）。此外，MIC 分布可用于定义野生型或非野生型细菌种群。虽然 MIC 值的临床解释超出了本文件的范围，但某些抗菌剂 - 细菌组合需要对基本方法进行修改，以方便临床解释。这些修改包含在本文件的单独附件中。有必要将其他药敏试验方法（例如纸片扩散或诊断测试设备）与此参考方法进行比较以进行验证，以确保结果具有可比性和可靠性。 [外文原描述]： This document describes one reference method, broth micro-dilution, for determination of MICs. The MIC can be a guide for the clinician, and reflects the activity of the drug under the described test conditions, by taking into account other factors, such as drug pharmacology, pharmacokinetics, or bacterial resistance mechanisms. This allows categorisation of bacteria as "susceptible" (S), "intermediate" (I), or "resistant" (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of this document, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate annex of this document. It is necessary to compare other susceptibility testing methods (e.g. disc diffusion or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.