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

This part of ISO 20776 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 valve is beyond the scope of this part of ISO 20776, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. There modifications are included in a separate table. It is advisable to compare other susceptiblity 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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