ISO 20776-1:2006 临床实验室测试和体外诊断试验系统 传染物易感性测试和抗菌剂易感性测试设备的性能评估 第1部分：抑制传染病中快速生长需氧菌的抗菌剂的体外活性的测试参照法

标准编号：ISO 20776-1:2006

中文名称：临床实验室测试和体外诊断试验系统 传染物易感性测试和抗菌剂易感性测试设备的性能评估 第1部分：抑制传染病中快速生长需氧菌的抗菌剂的体外活性的测试参照法

英文名称：Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Refe

发布日期：2006-11

标准范围

ISO 20776-1:2006描述了一种测定MIC的参考方法，即肉汤微量稀释法。MIC反映了药物在所述试验条件下的活性，并可通过考虑其他因素（如药理学或细菌耐药性机制）来解释临床管理目的。这允许将细菌分类为易感细菌、中间细菌或耐药细菌。此外，MIC分布可用于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ISO 20776的范围-1:2006，某些抗菌剂-细菌组合需要修改基本方法，以便于临床解释。这些修改包含在单独的表格中。建议将其他敏感性测试方法（如常规方法或诊断测试设备）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。

ISO 20776-1:2006 describes one reference method, broth microdilution, for determination of MICs. The MIC reflects the activity of the drug under the described test conditions, and can be interpreted for clinical management purposes by taking into account other factors, such as drug pharmacology or bacterial resistance mechanisms. This allows categorization 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 ISO 20776-1:2006, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate table. It is advisable to compare other susceptibility testing methods (e.g. routine methods or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.

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