深圳地区抗-HCV阴性/NAT初筛阳性献血者的HCV窗口感染期确认  

Study on the confirmation of HCV during window period from anti-HCV negative donors but screened positive in nucleic acid screening in Shenzhen

作　　者：张宏[1] 郑欣[1] 曾劲峰[1] 吴桂丹 熊文[1] 许晓绚[1] 杜鹏[1] 

机构地区：[1]深圳市血液中心,广东深圳518035

出　　处：《中国输血杂志》2015年第10期1263-1266,共4页Chinese Journal of Blood Transfusion

基　　金：广东省医学科研青年基金立项课题(2014358)

摘　　要：目的了解深圳地区血液筛查中抗-HCV阴性/NAT初筛阳性献血者的检出情况及其HCV窗口感染期的确认。方法 2008-2014年本中心采用酶免(ELISA)及病毒核酸检测方法(NAT)筛查492 325份无偿献血者样品,获得6例抗-HCV阴性/NAT初筛阳性献血者,使用荧光定量检测方法(QPCR)和巢式PCR(Nested-PCR)确认其HCV RNA是否存在并随访跟踪复查,以确定6例献血者核酸检测结果假阳性或HCV窗口感染期的性质。结果本中心在这7年期间,492 325份献血者的抗-HCV阴性/NAT初筛阳性检出率为1/82 054(6/492 325);6例抗-HCV阴性/NAT初筛阳性献血者,确认1/6例(16.7%)处于HCV窗口感染期,1/6例(16.7%)判定为核酸检测采血管血样污染HCV造成假阳性结果,4/6例(66.7%)判定为核酸仪器检测过程中出现假阳性导致NAT初筛阳性。故本中心目前献血者HCV窗口感染期检出率为1:492 325。结论目前核酸检测存在假阳性情况,需建立额外核酸扩增方法及追踪随访才能确定样品性质,确保病毒感染窗口期结果的准确性。Objective To investigate the detection rate of anti-HCV-/HCV NAT ＋ samples in blood donors from Shenz- hen and to confirm HCV samples obtained during window period. Methods From 2008 to 2014, a total of 492 325 donated blood samples collected in Shenzhen Blood Center were screened by ELISA and NAT, of which, 6 were anti-HCV-/HCV RNA ＋ samples. In order to make the false-positive or window-period confirmation, those donors were followed up and the existence of HCV RNA was identified using QPCR and Nested-PCR. Results Among 492 325 donated blood samples, there were 6 samples （1/82 054） screened as anti-HCV-/HCV RNA ＋, 1 of them （1/6） was confirmed as HCV positive from window-period, 1/6 was confirmed as false-positive samples caused by blood contamination, and the rest, 4/6 samples were confirmed as false-positive samples caused by NAT testing process. In all, the detection rate of HCV window-period samples was 1 out of 492 325 in Shenzhen Blood Center. Conclusion According to our study, false-positive results may happen in routine NAT testing, The follow-up and further detection methods （QPCR and Nested-PCR） for the identification of HCV RNA were needed to confirm the accuracy of results from window-period.

关 键 词：无偿献血者 抗-HCV阴性/NAT阳性 检出率 QPCR 窗口期 

分 类 号：R446[医药卫生—诊断学]