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.
出处
《山东大学学报（医学版）》
CAS
北大核心
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
