642. Facility Reported vs. CLSI MIC Breakpoint Comparison of Carbapenem Non-susceptible (Carb-NS) Enterobacteriaceae (ENT) from 2016-2019: A Multicenter EvaluationBACKGROUND. Carbapenem (Carb) minimum inhibitory concentration (MIC) breakpoints were lowered by CLSI in 2010 and recognized by FDA in ...
Based on new PK/PD data from two studies [7,8] and considering noticeable differences between the CLSI and FDA breakpoints of levofloxacin for S. maltophilia, the CLSI subcommittee ad-hoc working group (AHWG) evaluated multiple studies which used in vivo PK/PD models to evaluate levofloxacin ...
CLSI 折点更新进展(08-30)
For 10 agents, the MIC data were evaluated using two sets of breakpoints: (i) the Vitek 2 breakpoints, which utilized the 2009 FDA breakpoints at the time of the study and are equivalent to the 2009 CLSI M100-S19 breakpoints, and (ii) the 2014 CLSI M100-S24 breakpoints. There was an...
12、reiivs rules that may be applied to antimicrobial s usee otibil it/testing in order to reduce errors and make appropriate recommendations for reporting particular Links心 Website changesWarning! On the 27ih of April 2010 EUCAST published new breakpoints for 3rd and 4th gen ce 13、phalospo...
宗旨：是为实现临床微生物实验室标准化，改善医疗保健部门医疗质量起一个引导作用 一个经企业、政府和医疗保健专家三者达成共识，为临床微生物实验室操作制定最好的操作指南，并促进世界各地均使用该指南而努力工作的机构 Fresno11/00zhu_dm@fudan.edu.cn CLSI和FDA的标准 细菌 肠杆菌科细菌铜绿假单胞菌 金...
(SDD) Interpretive Category 18 Summary of CLSI Processes for Establishing Interpretive Criteria and Quality Control Ranges 22 CLSI Reference Methods vs Commercial Methods and CLSI vs FDA Interpretive Criteria (Breakpoints) 23 Subcommittee on Antimicrobial Susceptibility Testing Mission Statement 26 Instructions...
一个经企业、政府和医疗保健专家三者达成共识，为临床微生物实验室操作制定最好的操作指南，并促进世界各地均使用该指南而努力工作的机构 Fresno11/00zhu_dmfudan.edu CLSI和FDA的标准 细菌 肠杆菌科细菌铜绿假单胞菌 金葡菌 抗菌药 多立培南黏菌素左氧氟沙星万古霉素 S、I、R标准(mg/L)CLSI FDA 缺 ≤0.5、...
没有必要进行ESBL初筛和确证试验来报告结果以指导病人治疗 采用纸片扩散法的临床实验室即可采用新的折点向临床报告药敏结果 在商品化药敏系统 中目前受到限制,需要修改软件系统中的折点,并需进行实验室内验证 新的折点适用于美国FDA批准的给药方案,各医疗机构的药物剂量和药物调整政策需要重新评估,以保证与CLSI推荐折...
年12月13日FDA在网站上发布了抗微生物药物敏感性试验解释标准,其中包括对许多CLSI的纸片扩散法及最低抑菌浓 度(minimal inhibitory concentration,MIC)法解释标准(亦称为折点)的认可。这是CLSI和FDA的一项重大成果。两 个团队的成员均为实现该目标而辛勤工作,我们赞扬他们的努力!我们强烈建议您登陆网站关注这一进展,...