ISO 20776-1:2019
临床实验室测试和体外诊断测试系统——传染源的敏感性试验和抗菌剂敏感性试验设备性能的评估第1部分:抗菌剂对感染性疾病中快速生长的需氧菌体外活性试验的参考方法
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
ISO 20776-1:2019 发布历史
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.
ISO 20776-1:2019由国际标准化组织 IX-ISO 发布于 2019-06-05，并于 0000-00-00 实施。
ISO 20776-1:2019的历代版本如下：
- 2019年 ISO 20776-1:2019 临床实验室测试和体外诊断测试系统——传染源的敏感性试验和抗菌剂敏感性试验设备性能的评估第1部分:抗菌剂对感染性疾病中快速生长的需氧菌体外活性试验的参考方法
- 2006年 ISO 20776-1:2006 临床实验室试验和在玻璃试管内诊断试验系统.传染介质易传染性试验和抗菌易传染性试验装置性能评估.第1部分:和传染疾病相关的抗有氧细菌快速增长的抗菌介质试管活性试验参照法
推荐
通知 | CNAS《临床微生物检验程序验证指南》征求意见
参考文献[1] 国家食品药品监督管理局，YY/T 0688.2-2010 《临床实验室检测和体外诊断系统感染病原体敏感性试验与抗菌剂敏感性试验设备的性能评价》，中国标准出版社，北京：2010.[2] Verification and validation of procedures in the clinical microbiology laboratory . Cumitech 31A....
Cell：首例临床用噬菌体成功清除耐药性脓肿分枝杆菌肺部感染！
他们对噬菌体进行改造，去除了部分阻遏基因，使之成为裂解噬菌体。经过反复筛选验证，噬菌体被扩增并纯化至高效价且证明是无菌和无内毒素的。分枝杆菌噬菌体给药的临床反应噬菌体给药于 2020 年 9 月开始，当时患者因肺部恶化住院期间接近基线临床状态。持续每天 iv 两次给药，耐受性良好，没有归因于治疗的不良事件。他在噬菌体治疗开始后第 5 天出院。...