Evaluation of Genedia HBsAg Rapid and Genedia Anti-HBs Rapid for the Screening of HBsAg and Anti-HBs / 대한임상병리학회지

ABSTRACT

BACKGROUND: We evaluated a rapid screening kit for the detection of hepatitis surface antigen (HBsAg) and antibody (anti-HBs) using an immunochromatographic method. MATERIALS AND METHODS: We selected 499 serum specimens for the evaluation. Each specimen was tested by enzyme immunoassay (EIA; Cobas Core, Roche, Switzerland), reverse passive hemagglutination (RPHA; Serodia HBs, Asan, Korea) for HBsAg, passive hemagglutination (PHA; Serodia Anti-HBs, Asan, Korea) for anti-HBs, and with the Genedia HBsAg and Anti-HBs Rapid (Green Cross Corp., Korea) kits. Results of each assay were compared with those of the EIA. RESULTS: The sensitivities and specificities of the Genedia HBsAg Rapid kit were 98.0% and 100%, and those for the Genedia Anti-HBs Rapid kit were 95.3% and 98.0%, respectively. These were higher than those for RPHA (96.0% and 100%), and PHA (83.2% and 96.0%). Concordance rates between EIA and Genedia HBsAg Rapid, Genedia Anti-HBs Rapid, RPHA, and PHA were 98.8%, 96.4%, 97.6%, and 88.4%, respectively. Extending the incubation time from the recommended 30 minutes to 2 hours increased the sensitivities of the Genedia kits. CONCLUSION: The Genedia HBsAg and Anti-HBs Rapid kits are simple, sensitive, and inexpensive assays suitable for screening or use in emergency situations.