Objective To analyze the residual risk of transfusion transmitted hepatitis B virus (HBV) infection by enzyme-linked immunosorbent assay (ELISA) method in hepatitis B surface antigen (HBsAg) negative blood donors,and to assess the infection status.Methods A total of 45551 samples were collected from blood donors.All samples were tested by 2 different ELISA kids of HBsAg and nucleic acid testing (NAT) individually of hepatitis B virus (HBV),hepatitis C virus (HCV) and human immunodeficiency virus (HIV).Those ELISA HBsAg negative and NAT single reactive (HBsAg-/HBV DNA +) specimens were analyzed by quantitative detection of HBV DNA and by serologic testing of HBV antigen and antibody.Results A total of 44 HBsAg-/HBV DNA + samples were detected,including 42 occult HBV infections (OBI) and 2 window period infections (WP).The detection rate of OBI rate was 0.90‰,and 32 samples of OBI sample HBV DNA was less than 20 IU/ml,and the OBI detection rate was significantly different between different genders,ages and blood donation times (P ＜ 0.05).In the OBI sample,there were 6 serological models,92.9％ (39/42) OBI samples hepatitis B core antibody (HBcAb) positive,and 76.9％ (30/39) HBV DNA in HBcAb positive samples were less than 20 IU/ml;29.5％ (13/42) of OBI blood donors hepatitis B e antigen (HBeAb) and HBcAb were also positive,of whom 84.6％ (11/13) were HBV DNA quantitatively ＜ 20 IU/ml.Conclusions HBV residual risk of transfusion-transmitted infection may occur through HBsAg-and single NAT reactive blood donors,mainly include OBI,and HBV DNA low level.Blocking of single NAT reactive blood donors could reduce transfusion-transmitted HBV infection.%目的 分析乙型肝炎病毒(hepatitis B virus,HBV)(简称乙肝)表面抗原(HBsAg)酶联免疫法(ELISA)检测阴性献血者血液输血存在乙肝病毒(HBV)感染的残余风险,评价其感染状况.方法 选择初筛合格的45 551份无偿献血者样本,采用2种不同的ELISA试剂盒进行HBsAg检测,同时三联荧光病毒单人份核酸扩增检测技术(NAT)检测HBV、丙型肝炎病毒和人类免疫缺陷病毒-1,并对有反应的样本再进行核酸鉴别试验来检测病毒类型,对HBsAg-ELISA阴性且NAT单反应(HBsAg-/HBV DNA+)样本进行HBV定量和血清学检测.结果 共检出44份HBsAg-/HBV DNA+样本,42份为隐匿性HBV感染(OBI),2份为窗口期感染(WP).OBI发生率0.90％,32份OBI样本HBV DNA定量小于20 IU/ml,OBI检出率不同性别、年龄及献血次数人群间差异有统计学意义(P＜0.05).血清学检测OBI样本存在6种模式,HBcAb阳性最多39份92.9％(39/42),其中HBcAb阳性样本中76.9％(30/39) HBV DNA定量小于20 IU/ml;29.5％ (13/42)的OBI献血者HBeAb和HBcAb同时阳性,其中84.6％ (11/13) HBV DNA定量小于20 IU/ml.结论 HBsAg-献血者部分NAT单反应献血者为HBV感染者,多以OBI为主,且HBV DNA浓度低,屏蔽NAT单反应样本对预防经输血传播HBV具有重要意义.
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