Background and purpose: Recently, use of enzyme-linked immunosorbent assay (ELISA) and rapid Immunochromatographic test (ICT) in diagnosis and screening of patients with hepatitis B reduced the risk of hepatitis during blood transfusion. However, the incidence of hepatitis B is very high in high-risk patients such as hemodialysis, thalassemia and hemophilia which receive a lot of blood transfusions. Also, due to the infection with mutant type of hepatitis B virus (HBV) and false negative results, using molecular tests such as polymerase chain reaction (PCR) are necessary for detection of HBV. In this study we aimed to compare the efficacy of ELISA and rapid ICT kits with gold standard real time PCR for the detection of HBV in high risk patients.

Materials and methods: In a cross-sectional study, 100 patients consisting of hemodialysis, thalassemia and hemophilia were assessed by real time PCR as the gold standard for detection of HBV DNA, fourth-generation ELISA kits including Dia-pro®, Pishtazteb®, Pasteur® and ICT Ecotest® were applied for detection of HBSAg.

Results: Compared with real time PCR, sensitivity and specificity of fourth generation ELISA kits was 100% and positive predictive value (PPV) and negative predictive value (NPV) were 100%.

Conclusion: Recent improvements in the monoclonal antibody production against mutant hepatitis B virus and their application in fourth-generation ELISA and rapid ICT kits resulted in significant increase in sensitivity and specificity of these methods. Thus, in emergency cases or lack of real-time PCR instruments, rapid ICT and ELISA kits could be suggest for detection of HBsAg.