脑脊液微量总蛋白检测体系最低检出限的非参数评估方案

摘要

目的 利用非参数统计的评估方案,评估脑脊液微量总蛋白检测体系的最低检出限(LoD).方法 根据数据分布模型,以非参数统计的方法确定空白标本检测结果的第95百分位数作为空白检测限(LoB),通过LoD=LoB+tβ×s低值的数学模型来评估LoD.结果 脑脊液微量总蛋白检测体系的LoD为0.036g/L,通过验证程序证明该LoD值有效.结论 采用非参数统计原理设计的评估方法可用于空白标本检测结果不符合正态分布,标准曲线为非直线线性的检测体系的LoD评估.%Objective To estimate the limit of detection(LoD) of quantitative system of cerebrospinal fluid total protein(CSF-Pro) by procedure based on nonparametric theory.Methods By using theoretical distribution models and nonparametric approach to determine the 95th percentile of the blank measurements defines the limit of blank (LoB),then LoD of quantitative system of CSF-Pro is estimated as:LoD =LoB + tβ × SDs.Results The LoD of CSF-Pro detection system was 0.036g/L,and was proved effective by verification procedures.Conclusion The proposed approach that partly procedure was based on the theory of nonparametric theory appeared useful for application in the field that blank distributions are asymmetric,nongaussian distribution,and a nonlinear calibration curve.