Performance of ELISA HBsAg Test Kits with Use of the Different Types of Panels Containing HBsAg.

Serological diagnostics of hepatitis B in clinical laboratories is mainly based on detection of HBs antigen (HBsAg) in human serum or plasma using commercial ELISA kits. In manufacturing and laboratory practice, sensitivity of ELISA kit is measured against either international or national reference standard. This approach is necessary, but limited as it does not take into account factors that influence on HBsAg detection kit potency at low HBsAg concentration and when HBsAg subtypes/variants are present in species.