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

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). 

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. 

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.