以EP06-A判断最低浓度的偏差为-23.8158 U/mL,超过允许偏差±6 U/mL,线性区间验证不可接受.Prog以EP06-Ed2判断浓度2均值为33.45 ng/mL,在ADL之外,但部分CI在ADL范围内,线性区间验证在统计学上可接受;以EP06-A判断最低浓度的偏差为1.1890 ng/mL,超过允许偏差±0.64 ng/mL,线性区间验证不可接受.结论CLSI ...
目的以三碘甲状腺原氨酸(T3),游离三碘甲状腺原氨酸(FT3)项目为例,探讨美国临床实验室标准化协会(CLSI)EP06-Ed2文件在定量测量程序线性验证中的应用.方法收集接近线性区间上,下限的样本,按比例配制7份线性样本,各重复测定2次,以稀释比例和重复测定均值(x)进行加权线性回归分析,计算预期值,将线性偏差的95%可信区间...
The CLSI recently released guideline EP06-Ed2 on the Evaluation of Linearity of Quantitative Measurement Procedures , which replaces the EP06-A published in 2003. EP06-A relied on fitting a linear (straight line), 2nd (parabolic) and 3rd (sigmoidal) order polynomials to the d...
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 EP07-2018 标准名称:干扰测试在临床化学中的应用 适用范围: 本指南旨在促进医疗实验室测量程序中干扰特性的评估统一性。它描述了潜在干扰物筛选、干扰效应量化以及患者样本中确认干扰的程序。该指南还详细介绍了临床实验室验证干扰声明和调查由未预期干扰引起的异常结果的方法。
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
允许线性偏差EP06-Ed2文件目的以三碘甲状腺原氨酸(T3),游离三碘甲状腺原氨酸(FT3)项目为例,探讨美国临床实验室标准化协会(CLSI)EP06-Ed2文件在定量测量程序线性验证中的应用.方法收集接近线性区间上,下限的样本,按比例配制7份线性样本,各重复测定2次,以稀释比例和重复测定均值(x)进行加权线性回归分析,计算预期值...
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 EP33-2016 在医学实验室使用Delta检查.pdf,1st Edition EP33 Use of Delta Checks in the Medical Laboratory This guideline provides approaches for selecting measurands for which delta checks are useful, establishing delta check limits and rules for compa
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-...