Application of ELISA combined with nucleic acid testing for blood screening and residual risk analysis in blood donors / 中华实验和临床病毒学杂志

ABSTRACT

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.