流式微球分析技术检测人心肌钙蛋白T的方法学性能评价  

The evaluation methodology of cytoometric bead assay for human cardiac troponin T

作　　者：田禾[1] 黄山[1] 许健[1] 令狐颖[1] 袁军[1] 刘志琴[1] 

机构地区：[1]贵州省临床检验中心,贵阳550002

出　　处：《贵州医药》2010年第9期771-773,共3页Guizhou Medical Journal

基　　金：贵州省科学技术基金(黔科合J字[2007]2113号);贵州省科技计划课题(黔科合S字[2007]1057号)资助

摘　　要：目的对自建的流式微球分析技术(Cytoometric bead assay,CBA)检测人肌钙蛋白T(cTnT)的方法进行性能评价。方法参照美国临床和实验室标准化协会(CLSI)系列文件,结合工作实际,对方法的精密度、准确度、分析灵敏度、分析测量范围、回收试验、干扰试验进行了评价,并进行试验比对。结果 CBA检测cTnT在高低浓度范围内批内变异系数分别为5.21%和11.31%,批间变异系数分别为6.24%和13.16%,准确度相对偏倚在3.17%～5.39%之间,回收率在94.7%～111.5%之间;检测灵敏度为16.00ng/L,分析测量范围为16.00～5000ng/L,人体正常含量或含量偏高的三酰甘油、胆固醇和胆红素对cTnT检测的干扰很小,与电化学发光分析技术无显著差异。结论自建CBA检测cTnT技术性能较好,符合公认的质量指标,可在临床工作中推广使用。Objective To evaluate the methodology of by using self-development of cytometric bead assay（cytometric bead assay,CBA）for human cardiac troponin T （cTnT）.Methods American Association of Clinical and Laboratory Standards （CLSI） series of documents were referred and combined with actual work on the method precision,accuracy,analytical sensitivity,analytical measurement range,recovery tests,interference tests were evaluated,and a pilot comparison.Results CBA detected high and low concentrations of cTnT in the range of the coefficient of variation was 5.21%、11.31%,and inter-assay CV was 6.24%、13.16%,and accuracy of the relative bias was 3.17% ～5.39% and the recovery was 94.7%～111.5%;detection sensitivity was 16.00 ng /L,analytical measurement range was 16.00～ 5 000 ng /L,normal human levels or high triglyceride levels,cholesterol and bilirubin on detection of cTnT interference was very little.There was no statistical significant difference with the electrochemiluminescence technology.Conclusion Detection cTnT by self-development of CBA technical performance was better,consistent with generally accepted quality indicators.It could be used widely in clinical practice.

关 键 词：心肌钙蛋白T 流式微球分析技术 方法学评价 

分 类 号：R446[医药卫生—诊断学]