CLSI EP06-Ed2文件在定量测量程序线性验证中的应用 李晓博， 普智飞， 吴晓琪， 刘洋洋， 谢轩波， 单汉明， 于嘉屏 （杭州迪安医学检验中心，浙江 杭州 310030）摘要：目的 以三碘甲状腺原氨酸（T 3）、游离三碘甲状腺原氨酸（FT 3）项目为例，探讨美国临床实验 室标准化协会（CLSI ）EP06-Ed2文件在定量...
摘要：目的㊀以糖类抗原（ＣＡ５０）㊁糖类抗原１９⁃９（ＣＡ１９⁃９）㊁孕酮（Ｐｒｏｇ）为例，探讨美国临床和实验室标准协会（ＣＬＳＩ）ＥＰ０６⁃Ｅｄ２与ＥＰ０６⁃Ａ在定量测量程序线性验证应用中的差异㊂方法㊀通过选择接近线性区间上下限的样本，按比例配制７例样本，各重复测定２次㊂按...
Ed2与EP06?A在定量测量程序线性验证应用中的差异.方法 通过选择接近线性区间上下限的样本,按比例配制7例样本,各重复测定2次.按EP06?Ed2进行加权线性回归,置信区间(CI)与允许线性偏差(ADL)范围相交视为结果可接受;以EP06?A评价最适回归方程与理论线性方程之间差异小于允许偏差视为结果可接受;进而比较两者的差异....
CLSI EP19-ED2-2015 使用CLSI文件评估临床实验室测量程序的框架.pdf,2nd Edition EP19 A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures This report uses the “measurement procedure lifecycle” framework to aid users o
CLSI EP17-A2-2012 临床实验室测量程序检测能力评价.pdf,EP17-A2 Vol. 32 No. 8 Replaces EP17-A Vol. 24 No. 34 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition This document provides guidanc
CLSI EP17-A2 检出限和定量限的建立与验证.pdf,EP17-A2 Vol. 32 No. 8 Replaces EP17-A Vol. 24 No. 34 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition This document provides guidance for eva
Error is defined in terms of observed bias, using patient specimens tested with either a reference or comparative measurement 1 This assessment incorporates multiple analytical error sources, including procedure as described in CLSI document EP09. imprecision, bias, nonlinearity, interferences, specimen-...
CLSI EP30-A-2010 检验医学可互换标准物质的特性和鉴定.pdf,May 2010 EP30-A Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Approved Guideline This document provides information to help material manufacturers in