时间分辨荧光免疫检测应用于献血者HBsAg筛查的研究  

Application of time-resolved fluorescence immunoassay in HBsAg screening of blood donors

作　　者：徐明华 谭思思 龚华斐 杨建 Xu Minghua;Tan Sisi;Gong Huafei;Yang Jian(Department of Detection,Yantai Central Blood Station,Yantai 264003,China;Research and Development Department of Shanghai Haoyuan Biotechnology Co.,Ltd.Shanghai 201703,China)

机构地区：[1]烟台市中心血站检验科,烟台264003 [2]上海浩源生物科技有限公司研发部,上海201703

出　　处：《中华实验和临床病毒学杂志》2023年第4期418-421,共4页Chinese Journal of Experimental and Clinical Virology

基　　金：烟台市科技计划项目(2019YD055)。

摘　　要：目的通过与酶联免疫法(enzyme-linked immunosorbent assay,ELISA)进行对比分析,探讨时间分辨荧光检测技术(time-resolved fluorescence immunoassay,TRFIA)在献血者样本乙型肝炎表面抗原(HBsAg)筛查中的应用价值。方法分别采用两个厂家的ELISA HBsAg试剂和TRFIA试剂检测国家卫生健康委临床检验中心HBsAg血清盘和烟台中心血站献血者样本,分析两种检测方法的灵敏度、特异性等性能指标。结果对于HBsAg血清盘检测结果TRFIA的灵敏度为99.43%,特异性为97.54%,阳性预测值(positive predictive value,PPV)为98.88%,阴性预测值(negative predictive value,NPV)为98.76%,约登指数为0.9697,均显著高于ELISA。对于5317例无偿献血者的筛查结果,TRFIA的灵敏度为100.00%,特异性为99.87%,PPV为66.67%,NPV为100.00%,约登指数为0.9987,灵敏度、NPV和约登指数三项指标优于ELISA,三者检测结果差异无统计学意义。结论TRFIA的检测灵敏度优于ELISA,适于向血液筛查推广。Objective Comparing with enzyme-linked immunosorbent assay(ELISA),to explore the application value of time-resolved fluorescence immunoassay(TRFIA)in HBsAg screening.Methods Plasma samples of blood donors and HBsAg panels were screened to verify two HBsAg kits including ELISA kits(two different manufacturing companies),and TRFIA kit.Results For HBsAg panel detection result,the sensitivity of TRFIA was 99.43%,the specificity was 97.54%,the positive predictive value(PPV)was 98.88%,the negative predictive value(NPV)was 98.76%,and the Youden index was 0.9697,which were all significantly higher than those of ELISA.For the screening result of 5317 unpaid blood donors,the sensitivity of TRFIA was 100.00%,the specificity was 99.87%,the PPV was 66.67%,the NPV was 100.00%,the Youden index was 0.9987,and the sensitivity,NPV and Youden index were 0.9987.The last three indicators were better than those of ELISA,and there was no significant difference in the test result between the two method.Conclusions The detection sensitivity of TRFIA was higher than that of ELISA,therefore TRFIA is suitable for promotion in blood screening.

关 键 词：发光免疫标记 献血者 时间分辨 酶免 乙肝表面抗原 

分 类 号：R446.6[医药卫生—诊断学] R457.1[医药卫生—临床医学]