Objective To analyze the serological characteristics and HBV DNA levels of HBsAg-negative blood donors with occult HBV infection and their correlation. Methods The blood donors were screened for HBsAg by two different ELISA reagants and the qualified samples were tested for HBV DNA by nucleic acid amplification (NAT). The positive blood donors were further tested by HBV marker detection and Quantitative Real-time PCR for HBV DNA. Results A total of 29890 samples were detected HBsAg negative by twice ELISA test. Of the 29890 HBsAg-negative samples, 31 were detected positive for HBV DNA by NAT. Among the 31 donations screened non-reactive in both rounds of HBsAg testing by ELISA,3 cases were reactive for HBsAg by the means of chemiluminescence. Among the 28 HBsAg – HBV DNA + donations,2 cases (7.1%)were identified as window period infection and 26 cases (92.9%)were identified as occult HBV infection (OBI). NAT lowered the residual risk of HBV by 9.37/104. On the basis of the serological profile, OBI can be mainly distinguished into two seropositive patterns (HBsAb and HBcAb positive or isolated HBcAb positive). Of the 28 OBI donations,the HBV DNA levels with HBsAb negative was higher than that with HBsAb positive (P<0.05). Conclusion HBV remains a risk of transfusion-transmitted infection through ELISA detection in HBsAg-negative blood donors,and OBI is frequent. The application of NAT in blood screening is very important for assuring the safety of blood. The OBI blood donors with HBsAg-negative have certain serological patterns,in which HBsAb-negative donors may have a higher residual risk of transfusion-transmitted HBV infection.%目的 了解苏州地区HBsAg阴性合格献血者隐匿性乙型肝炎病毒(HBV)感染的血清学标志物的状况及其与病毒载量水平的相关性,为采供血机构制定血液安全保障措施提供参考依据.方法 使用两种ELISA试剂对献血者血液进行HBsAg筛查,阴性标本应用核酸检测技术进行HBV DNA检测,收集HBsAg阴性HBV DNA阳性献血者标本进行乙肝血清标志物检测及HBV DNA实时荧光PCR定量分析.结果 两种ELISA检测均为HBsAg阴性的标本有29890份,其中31份为HBV DNA阳性.31份HBsAg阴性的HBV DNA阳性标本经化学发光检测,发现其中3份为HBsAg假阴性标本,另28份为HBsAg阴性HBV DNA阳性.28份标本中有2份(7.1%)为疑似"窗口期"感染,26份(92.9%)为疑似"隐匿性"感染,经核酸检测后HBV残余风险可降低9.37 /万.26份隐匿性感染标本中乙肝血清学以HBsAb、 HBcAb共阳性及单独HBcAb阳性两种模式为主;HBsAb阴性组的HBV DNA载量水平显著高于HBsAb阳性组(P<0.05).结论 ELISA法检测HBsAg阴性的献血者经输血传播HBV的残余风险依然存在,感染状况多以隐匿性感染为主.核酸检测的应用能提高血液的安全性.HBsAg阴性合格献血者隐匿性HBV感染呈现特定的血清学模式,其中HBsAb阴性人群可能存在较高的输血传播HBV的风险.
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