Sensitivity and specificity of Czechoslovak ELISA HBsAg Sevac tests: comparison with other third-generation tests and counter-immunoelectrophoresis.

Two variants of sandwich-type ELISA (Enzyme Linked Immunosorbent Assay) kits for HBsAg detection (Sevatest ELISA HBsAg Macro I and Sevatest ELISA HBsAg Micro I) in human sera and plasmas were developed. As the solid phase, the ELISA Macro kit and ELISA Micro kit make use of polystyrene microtubes, and polystyrene microtitration plates, respectively, of Czechoslovak production (Koh-i-noor, Dalecín). Capture anti HBs antibody for adsorption to solid phase and rabbit anti HBs antibody for labelling with horse-radish peroxidase were prepared for both tests. The sensitivity of both ELISA kits for HBsAg, equal to approx. 2 ng/ml, was determined by titrating six selected HBsAg-positive sera and the WHO Agk 76 panel of HBsAg-positive sera and the results were compared with those obtained by ELISA, RIA (Radioimmunoassay) and RPHA (Reverse passive hemagglutination) kits of different producers and by counter-immunoelectrophoresis (CIEP). The sensitivity of the new ELISA kits was comparable to that of other producers' ELISA kits, higher than that of RPHA kits and only a little lower than that of RIA kits. A set of sera of patients hospitalised with different diagnoses was tested for HBsAg. The detection rate by ELISA Macro kit 2.8 and 1.5 times higher than by CIEP and RPHA (Raphadex B), respectively, and 1.1 time lower than by RIA (Austria II).