HBsAg阴性献血者人群HBV感染的检测和输血残余风险分析

Detection of HBV DNA in voluntary blood donors with HBsAg negative and analysis on blood transfusion residual risk

目的了解献血人群乙型肝炎病毒（HBV）感染状况和血液经酶免疫法（EIA）筛查乙型肝炎病毒表面抗原（HBsAg）后经血传播HBV感染的残余风险。方法采用国产和进口两种EIA试剂对献血者血液进行HB-sAg筛查,罗氏诊断COBAS Ampliscreens NAT血筛系统检测EIA检测合格标本中HBV DNA,对HBV DNA阳性标本进行半套式PCR检测,并对PCR扩增产物进行测序和病毒基因亚型分析。结果共筛查1998-2008年的献血者232 305例,发现HBsAg阳性2 999例,阳性率为1.3%;对2002-2007年EIA检测合格的113 639例献血者血液标本进行NAT检测,检测出13份HBV DNA阳性、HBsAg阴性的献血者血液,HBV残余风险高达1.1/10000。结论 EIA筛查后血液安全性有了很好的保障,经血传播HBV残余风险依然处于较高的水平,NAT应用对提高血液安全,降低输血传播HBV残余风险意义重大。

Objective To estimate the residual risk of transfusion-transmitted HBV infection in blood donations after HBsAg screening by enzyme immunoassay（EIA）.Methods The samples of blood donors were tested for HBsAg antibody by enzyme EIA.The samples of EIA-negative reaction for HBsAg were tested HBV DNA by MP-nucleic acids test（NAT） using COBAS AmpliScreens HBV test reagents.The samples of HBV NAT positive were further detected for HBV DNA from plasma by semi-nested PCR method.The partial S genome of HBV was sequenced and genotyped.Results The HBsAg positive was tested in 2999 of 232305 blood donations during the period 1998-2008.The positive rate was 1.3%.Of 113639 serologically negative blood donations,13 were positive for HBV DNA,but negative for HBsAg.The residual risk of transfusion-transmitted HBV infection was 1.1/10000.Conclusion There exists high residual risk of transfusion-transmitted HBV infection in blood donations.NAT screening can further enhance the blood safety and decrease the risk of HBV infection by transfusion.