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现行 EN ISO 20776-1:2020
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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 of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2019, including Corrected version 2019-12) 临床实验室检测和体外诊断试验系统 - 感染物质的敏感性检测和抗菌药敏试验装置的性能评估 - 第1部分:测试抗菌药物对参与传染病的快速生长有氧细菌的体外活性的参考方法
发布日期: 2020-07-01
实施日期: 2020-07-01
本文介绍了一种测定MICs的参考方法:肉汤微量稀释法。MIC可作为临床医生的指南,并通过考虑其他因素,如药物药理学、药代动力学或细菌耐药机制,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分布可以用来定义野生型或非野生型细菌种群。尽管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,以便于临床解释。这些修改包括在本文件的单独附件中。有必要将其他敏感性试验方法(如圆盘扩散或诊断试验装置)与本参考方法进行比较,以进行验证,以确保结果具有可比性和可靠性。
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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归口单位: CEN/TC 140-
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