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现行 ISO 20776-1:2019
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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 传染病药敏试验和药敏试验装置性能评价第1部分:抗感染性疾病中快速生长需氧菌的抗菌剂体外活性试验用肉汤稀释参考法
发布日期: 2019-06-05
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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发布单位或类别: 国际组织-国际标准化组织
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研制信息
归口单位: ISO/TC 212
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