J Clin Pathol Qual Control.  1999 Dec;21(2):371-377.

Evaluation of Genedia ELISA kit for Hepatitis B (Anti-HBs, HBeAg/ Anti-HBe)

• Oh EJ
• Jang HS
• Lee HI
• Park YJ
• Kim BK

Abstract

BACKGROUND: The purpose of this study was to evaluate the newly improved domestic enzyme immunoassay (EIA) kits, Genedia(R) Anti-HBs ELISA 3.0 (Green Cross, Korea), Genedia(R) HBe ELISA (Green Cross, Korea) for detecting serologic markers for hepatitis B, anti-HBs and HBeAg/anti-HBe.
METHODS
The six hundred clinical samples for qualitative testing anti-HBs were subjected to compare Genedia(R) anti-HBs ELISA with Enzygnost(R) anti-HBs micro (Behring Diagnostics GmbH, Germany), based on positive cut off level 5 mIU/mL. The discordant samples were retested quantitatively with both EIA kit based on positive cut off level 10 mIU/mL and Abbott(R) 2.0 (Abbott Lab. USA). One hundred clinical samples for testing HBeAg/anti-HBe were subjected to compare Genedia(R) HBe ELISA with Enzygnost(R) HBe monoclonal (Behring Diagnostics GmbH, Germany). The discordant samples were analysed with radioimmunoassay (RIA) and Abbott 2.0 (Abbott Lab. USA). We also evaluated the reproducibility and detection limit.
RESULTS
Overall agreement between Genedia and Behring anti-HBs EIA was 98.8% (593 of 600 tests). Of discordant 7 samples, 3 samples were available for confirm test with Abbott EIA kit. Among these three samples, 2 and 1 samples had agreement with Behring and Genedia EIA, respectively. Overall agreement in HBeAg and anti-HBe was 100% and 93%, respectively. Results of anti-HBs, HBe Ag and anti-HBe from both EIA kits were constant on repeated tests. In terms of detection limit, Behring kits for anti-HBs and anti-HBe showed 10-fold higher sensitivity than Genedia, but both EIA kits revealed same sensitivity for HBeAg.
CONCLUSIONS
Qualitative EIA kits, Genedia anti-HBs and HBeAg/anti-HBe showed comparable results with Behring EIA kit and considered to be useful in clinical laboratories.

MeSH Terms

Enzyme-Linked Immunosorbent Assay*
Hepatitis B e Antigens
Hepatitis B*
Hepatitis*
Immunoenzyme Techniques
Limit of Detection
Radioimmunoassay
Hepatitis B e Antigens