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.
EN ISO 20776-1:2020由欧洲标准化委员会 IX-CEN 发布于 2020-07-01,并于 2020-10-31 实施,于 2023-07-31 废止。
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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....
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。...
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