(FDA 13年2月1日批准),纸片扩散法 MIC法 如E-试验等,46,47,Additional CLSI Changes and Topics Under Evaluation,Continuing reevaluation of breakpoints Enterobacteriaceae cefepime Acinetobacter and other non Enterobacteriaceae carbapenems Fluoroquinolones and others Colistin / Polymyxin B Reexamine best met 17...
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...
In the United States, the Food and Drug Administration (FDA) also establishes interpretive breakpoints for all new antimicrobics; however, the FDA does not have a well- established mechanism to routinely review its breakpoints to ensure that they accurately reflect the current body of knowledge ...
it is recommended that it be reported as “S. aureus complex (S. argenteus),” and S. aureus phenotypic testing method recommendations, breakpoints, and interpretive categories should be used.
CLSI折点增补/修改从2010年 ceftaroline 3 主要改变（1）增加了Ceftaroline（头孢洛林）肠杆菌科 推荐对沙门氏菌药敏试验的氟喹诺酮类药物和判断标准 葡萄球菌属 •取消了除苯唑西林、头孢西丁和青霉素外的所有β内酰胺类抗生素的折点（判断标准）;•增加了头孢洛林的折点(具有抗MRSA活性的头孢...
(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...
(FDA 2月1日同意)纸片扩散法MIC法 如E-试验等Additional CLSI Changes and Topics Under EvaluationContinuing reevaluation of breakpoints – Enterobacteriaceae – cefepime – Acinetobacter and other non Enterobacteriaceae– carbapenems – Fluoroquinolones –…and othersColistin / Polymyxin B – Reexamine best ...
CLSI和FDA设定的折点都是针对美国的。CLSI和FDA建立的折点二者有少许不同商业化药敏系统必须使用FDA折点临床实验室即可使用CLSI也可使用FDA 折点 Remember–wewillnotseerevisedCLSIbreakpointsoncommercialASTdevicesuntilFDArevisesthosebreakpoints–ASTmanufacturersMUSTuseFDAbreakpoints!Checkwithmanufacturertodeterminewhich...
第32页/共48页头孢菌素治疗42例产ESBL的大肠和肺克临床及预后OutcomeMIC<=1ug/mlMIC2ug/mlMIC4ug/mlMIC8ug/ml成功13(81%)4(67%)3(27%)1(11%)失败3(19%)2(33%)8(73%)8(89%)第33页/共48页EUCAST同CLSI折点的差异第34页/共48页Notethus,wherethesenewbreakpointsareemployed,specificESBLtesting,...
(FDA 13年2月1日批准) 纸片扩散法 MIC法 如E-试验等 * 第四十四页,共57页。 * 第四十五页,共57页。 Additional CLSI Changes and Topics Under Evaluation Continuing reevaluation of breakpoints – Enterobacteriaceae – cefepime – Acinetobacter and other non Enterobacteriaceae– carbapenems – ...