ISO 20776-1:2019 感染性药物的敏感性试验和抗菌药物敏感性试验装置的性能评价 第1部分：测定抗菌药物对涉及传染病的快速生长的需氧菌的体外活性的肉汤微量稀释参照法

标准编号：ISO 20776-1:2019

中文名称：感染性药物的敏感性试验和抗菌药物敏感性试验装置的性能评价 第1部分：测定抗菌药物对涉及传染病的快速生长的需氧菌的体外活性的肉汤微量稀释参照法

英文名称：Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Broth micro-dilution reference method for testing the in vitro activity

发布日期：2019-06

标准范围

本文件描述了一种测定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南，通过考虑其他因素，如药物药理学、药代动力学或细菌耐药性机制，反映药物在所述试验条件下的活性。这允许将细菌分类为“易感”（S）、“中间”（I）或“抗性”（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，但某些抗菌剂需要修改基本方法-细菌组合有助于临床解释。这些修改包含在本文件的单独附件中。有必要将其他敏感性测试方法（如圆盘扩散或诊断测试设备）与该验证参考方法进行比较，以确保结果具有可比性和可靠性。

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.

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