化学发光微粒子免疫法检测人附睾蛋白方法学性能评价

山东大学学报(医学版) ›› 2012, Vol. 50 ›› Issue (10): 73-76.

化学发光微粒子免疫法检测人附睾蛋白方法学性能评价

郑桂喜，王传新，刘延红，梁永媛

山东大学齐鲁医院检验科，济南 250012

收稿日期:2012-07-06 出版日期:2012-10-10 发布日期:2012-10-10
通讯作者: 王传新（1963- ），男，博士，教授，主要从事肿瘤免疫与分子生物学研究。E-mail:wcx6601@126.com
作者简介:郑桂喜（1980- ），女，硕士，技师，主要从事肿瘤免疫与分子生物学研究
基金资助:
卫生部国家临床重点专科建设项目

Methodological evaluation of chemiluminescence microparticle
immunoassay for determining HE4

ZHENG Gui-xi， WANG Chuan-xin， LIU Yan-hong， LIANG Yong-yuan

Department of Clinical Laboratory Medicine, Qilu Hospital of Shandong University, Jinan 250012， China

Received:2012-07-06 Online:2012-10-10 Published:2012-10-10

摘要/Abstract

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19.8~1573.5 pmol/L；携带污染率为-0.02%；参考区间为0.0~140.0pmol/L。结论 Abbott Architect i2000SR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。

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

Abstract:

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 HE4 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 1carry-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.

Key words: Abbott architect i2000SR chemiluminescence analyzer；CMIA；HE4； Methodological evaluation

中图分类号:

R446.1

郑桂喜，王传新，刘延红，梁永媛. 化学发光微粒子免疫法检测人附睾蛋白方法学性能评价[J]. 山东大学学报(医学版), 2012, 50(10): 73-76.

ZHENG Gui-xi， WANG Chuan-xin， LIU Yan-hong， LIANG Yong-yuan. Methodological evaluation of chemiluminescence microparticle
immunoassay for determining HE4[J]. JOURNAL OF SHANDONG UNIVERSITY (HEALTH SCIENCES), 2012, 50(10): 73-76.

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