PATHFAST检测系统检测高敏感心肌肌钙蛋白Ⅰ的分析性能评价

摘要

Objective To establish and evaluate the analysis performance of high sensitive cardiac troponin Ⅰ (hscTnI) detected by PATHFAST chemiluminescence enzyme-immunoassay system.The data included precision,the function sensitivity (FS),the limit of blank(LoB),the limit of detection(LoD),the limit of quantity(LoQ),the lowlimit of detection (LLD),the biological limit of detection (BLD) and the linearity range,and the biology reference intervals offered by manufactures were verified.Methods PATHFAST was performed to detect blank samples and series low-concentration samples of hs-cTnI according to the document of Clinical and Laboratory Standards Institute (CLSI) EP17-A and EP5-A2.The corresponding statistical method was used to define the LoB,LoD,LoQ and the linearity range of hs-cTnI in plasma in accordance with the distribution of the data.Simultaneously,the LLD,BLD and FS of hs-cTnI were established by traditional method.According to National Committee for Clinical Laboratory Standards (NCCLS) C28-A2 recommendation method and the laboratory standard operation procedure (SOP),the biology reference interval was verified.Results By PATHFAST,the within-run and between-run coefficients of variation (CV)were 4.70％ and 5.05％ in high-concentration of hs-cTnI (2.65 ng/mL),were 5.16％ and 5.23％ in middleconcentration of hs-cTnI (0.65 ng/mL),and were 5.30％ and 6.07％ in low-concentration of hs-cTnI (0.025 ng/mL).According to the document of CLSI EP17-A,the LoB was 0.001 ng/mL,LoD was 0.008 ng/mL,and LoQ was 0.008 ng/mL.The LLD was 0.001 ng/mL,BLD was 0.002-0.004 ng/mL,and FS was 0.019 8 ng/mL by traditional method.The equation of linearity range of the expectant value and detected value was Y =1.015X +0.152,r2 =0.993.The results of 95％ samples were within the biology reference intervals offered by manufactures.Conclusions The imprecision is higher than the value offered by manufactures.FS is basically consistent with the value offered by manufactures.The LoB and LLD established by the 2 methods are same.The biology reference interval being used is suitable for the laboratories.%目的 建立并评价即时检验(POCT)平台PATHFAST全自动化学发光酶免疫分析仪(简称PATHFAST)检测高敏肌钙蛋白Ⅰ(hs-cTnI)的精密度、功能灵敏度(FS)、空白限(LoB)、检出限(LoD)、定量检测限(LoQ)、检测低限(LLD)、生物检测限(BLD)、线性范围并对厂家提供的生物参考区间进行了验证.方法 参考美国临床实验室标准化协会(CLSI) EP17-A及EP5-A2文件,将hs-cTnI空白样品和系列低浓度样品在PATHFAST上进行测定,依据数据的分布规律,采用相应的统计学方法确定PATHFAST检测血浆hs-cTnI的LoB、LoD和LoQ及线性范围；同时用传统方法建立hs-cTnI的LLD、BLD和FS.参照美国临床实验室标准化委员会(NCCLS) C28-A2文件按仪器标准操作程序(SOP)要求进行规范检测,验证生物参考区间.结果 PATHFAST检测hs-cTnI高值样品(2.65 ng/mL)的批内变异系数(CV)和批间CV分别为4.70％和5.05％；中值样品(0.65 ng/mL)批内CV和批间CV分别为5.16％和5.23％；低值样品(0.025 ng/mL)批内CV和批间CV分别为5.30％和6.07％.按CLSI EP17-A文件建立的LoB为0.001 ng/mL、LoD为0.008 ng/mL; LoQ为0.008 ng/mL;应用常规方法建立的LLD为0.001 ng/mL、BLD为0.002～0.004 ng/mL、FS为0.019 8 ng/mL.在检测范围内,PATHFAST预期值和实测值的线性方程为Y=1.015X+0.152,R2=0.993.生物参考区间验证结果显示95％结果落在厂家提供的生物参考区间范围内.结论 PATHFAST检测hs-cTnI在2个浓度水平的不精密度高于厂商说明书提供的值；本研究所得FS与厂家说明书提供的FS基本一致；应用2种方法分别建立的LoB和LLD一致；厂家提供的生物参考区间适用于本实验室.