乙肝表面抗原双试剂阳性HBV-DNA核酸检测阴性结果分析  

Analysis of HBV NAT negative samples implicated in HBsAg-reactive donations tested by duplicate ELISA assays

作　　者：邹亚轩[1] 王琳[1] 刘笑春 臧亮[1] ZOU Yaxuan;WANG Lin;LIU Xiaochun;ZANG Liang(Dalian Blood Center,Dalian 116001,China)

机构地区：[1]大连市血液中心,辽宁大连116001

出　　处：《中国输血杂志》2020年第9期902-905,共4页Chinese Journal of Blood Transfusion

摘　　要：目的通过分析献血者乙肝表面抗原检测双试剂阳性而核酸检测阴性的结果,探讨1遍血清学联合1遍核酸检测的新检测策略对血液安全的意义。方法对2017—2019年献血者标本中乙肝表面抗原血清学双试剂阳性的标本,无论核酸检测系统采取的是混样模式还是单检模式都同时进行核酸检测。阴性的标本使用原检测系统再进行重复检测。结果 2017—2019年献血者检测标本共计25.8万人份,乙肝表面抗原双试剂阳性标本共计195份,核酸HBV DNA阳性标本172份,阴性标本23份,其中核酸单检系统阴性标本8份,核酸混检系统阴性标本15份。单检系统的8份标本再次进行检测,至少有1次为阳性的标本有5份,混检系统的15份标本再次进行检测,至少有1次为阳性的标本有9份。结论无论单检核酸检测系统还是混检核酸检测系统都会出现乙肝表面抗原双试剂阳性而核酸检测阴性的结果,其中混检系统较单检系统的标本数量要多近1倍。重复检测结果为阳性标本的比例约为60%,为低浓度标本的机会性检出。因此采取1遍血清学联合1遍核酸进行乙肝检测的新检测策略,无论是核酸检测系统还是血清学检测系统都应进行系统的评估,比较与实验室原有检测策略的差异,避免漏检的发生,减低输血传播疾病的风险。Objective To study the HBV NAT negative samples implicated in HBsAg-reactive donations tested by duplicate ELISA assays, so as to discuss significance of new detection algorithm, i.e. testing once by ELISA and once by nucleic acid testing(NAT), on blood safety.Methods HBsAg-reactive donations, which had been tested twice by ELISA, in blood screening during 2017 to 2019 were subjected to either single virus NAT or multiplex NAT. ELISA+/NAT-samples were re-tested using the original NAT system. Results From 2017 to 2019, a total of 258 000 blood samples were tested, 195 cases were serologic reactive by duplicate ELISA assays, among which 172 cases were HBV-NAT positive and 23 HBV-NAT negative. Among the 23 HBV-NAT negative cases, 8(8/23) were detected by single virus NAT and 15(15/23) by multiplex NAT. And all those 23 cases were tested again, 5 samples presented repeat-reactivity at least once in single virus NAT and 9 samples presented repeat-reactivity at least once in multiplex NAT. Conclusion Serologic reactive donations, which have been detected by ELISA twice, may present HBV-NAT negative either in single virus NAT or multiplex NAT, which provides more than doubling of the ELISA+/NAT-donations in single virus NAT. About 60% of ELISA+/NAT-donations were repeat-reactive, which were close-missed low-viral-load cases. The risk caused by the new detection algorithm(testing once by ELISA and once by NAT) could be balanced through systematical comparison of the performance of former and current testing algorithms so as to avoid missed detection and minimize the risk of transfusion-transmitted diseases.

关 键 词：乙肝表面抗原 双试剂 乙肝病毒核酸 核酸检测 

分 类 号：R457.1[医药卫生—治疗学] R446[医药卫生—临床医学]