【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。更多还原

【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.更多还原