Prevalence of anti-HBc in HBsAg negative blood donors using two enzyme immunoassays kits

Abstract Background and Objectives Use of kits with high sensitivity and specificity to determine the prevalence of antibodies against hepatitis B virus (anti-HBc) core antigen is important. The aim of this study was to determine the prevalence of hepatitis B virus antibody in HBsAg negative blood donors using two anti-HBc enzyme immunoassay kits (DIA.PRO and SIEMENS).   Materials and Methods In this Cross-sectional study, a number of 4313 samples of HBsAg negative blood donors were collected. All samples were tested for the detection of anti-HBc (Total, IgM & IgG) by ELISA using Diapro and Siemens kits. Anti-HBc assay was performed by both kits in duplicate. Statistical analysis of data was performed using SPSS Ver. 22.0; chi-square tests were also performed.   Results The study population consisted of 227 (5.3%) women and 4086 (94.7%) men. 498 (11.5%) and 384 (8.9%) samples reacted with Diapro and Siemens kits for Anti-HBc, respectively. All positive samples of both kits in duplicate test showed the same results as the previously reported results. 114 cases of reactive kits of DIA.PRO kit were negative in re-testing with SIEMENS kit. Significant differences were observed between the reactive results of the two kits (p = 0.00005).  The kappa coefficient for the reactive results of the two kits was 85%.   Conclusions  Considering the significant difference between the results of the two kits, it is recommended to perform anti-HBc testing with anti-HBs and /or anti-HBe to determine the prevalence of anti-HBc in blood donors with past HBV infection.