化学发光微粒子免疫法检测人附睾蛋白方法学性能评价  

Methodological evaluation of chemiluminescence microparticle immunoassay for determining HE4

作　　者：郑桂喜[1] 王传新[1] 刘延红[1] 梁永媛[1] 

机构地区：[1]山东大学齐鲁医院检验科,济南250012

出　　处：《山东大学学报（医学版）》2012年第10期73-76,共4页Journal of Shandong University:Health Sciences

基　　金：卫生部国家临床重点专科建设项目

摘　　要：目的对Abbott Architect i2000SR检测系统应用化学发光微粒子免疫技术定量测定人附睾蛋白(HE4)的分析性能进行评价。方法参考美国临床实验室标准化协会(NCCLS)文件,制定定量检测方法的方法学评价方案,通过Abbott Architect i2000SR检测系统测定HE4的批内精密度、批间精密度、线性范围、携带污染率和参考区间。结果低、高值混合血清批内精密度CV分别为1.80%、2.34%;批间精密度CV分别为2.03%、2.70%;线性范围为19.8～1 573.5 pmol/L;携带污染率为-0.02%;参考区间为0.0～140.0 pmol/L。结论 Abbott Architecti2000SR检测系统测定HE4的精密度好、线性范围宽、携带污染率低,参考区间与厂家提供的一致,检测性能可满足临床要求。Objective To evaluate the performance methodology of Chemiluminescence microparticle immunoassay （CMIA） for determining HE4 using Abbott Architect i2000SR Chemiluminescence analyzer. Methods According to a method by NCCLS recommended, we designed the evaluation program of quantitative detection methods. The within- run precision ,between-run precision ,linear range ,carry-over and biological reference interval of HFA were determined. Results The coefficient of variation （CV） of within-run precision of low and high value pooled serum were respectively 1.80% and 2.34%. The CV of between-run precision were respectively 2.03% and 2.70%. The linear range was from 19.8 pmoL/L to 1 573.5 pmol/L. The I carry-over was -0.02%. The biological reference interval was consistent with manufactures which is from 0.0 pmol/L to 140.0 pmol/L. Conclusion The within-run precision, between-run precision, linear range and carry-over of Abbott Architect i2000SR for determining HE4 meet the requirements of clinical use. The biological reference interval was consistent with that provided by the manufacturer.

关 键 词：ABBOTT ARCHITECT i2000SR检测系统 化学发光微粒子免疫技术 人附睾蛋白4 方法学评价 

分 类 号：R446.1[医药卫生—诊断学]