Hee Jin Huh1, Seok-Lae Chae, Young Joo Cha. 1. Department of Laboratory Medicine, College of Medicine, Dongguk University, Gyeonggi Province, Korea.
Abstract
BACKGROUND: The serological detection of the surface antigen (HBsAg) of hepatitis B virus (HBV) is the basis of detection of HBV infections in blood donors and patients with hepatitis. The aim of this study was to compare the performance of HBsAg enzyme-linked immunosorbent assay (ELISA) and HBsAg chemiluminescence immunoassay used in Korea. METHODS: We compared seven assays: Architect i2000 (Abbott Laboratories, USA), Elecsys 2010 immunoanalyzer (Roche Diagnostics, Germany), Advia Centaur (Bayer Healthcare, USA), Murex HBsAg version 3 (Abbott Laboratories, USA), Enzygnost HBsAg 5.0 (DADE Behring, Germany), LG HBsAg ELISA (LG, Korea), and Genedia HBsAg ELISA 3.0 (Greencross Medical Science, Korea). We evaluated the sensitivity of each assay by testing serially diluted WHO HBsAg reference material, two seroconversion panels, and recombinant HBsAg with three mutations in the 'a' determinant. RESULTS: The lowest HBsAg level detected by each assay using WHO reference material was variable from 0.05 (Murex and Advia) to 0.2 IU/mL. When testing 21 seroconversion panels, the total number of positive samples was 15 by Murex and 14 by Architect. Murex, LG, and Architect detected all of the 3 mutant samples tested. CONCLUSIONS: Analytical sensitivity and mutant detecting ability among HBsAg commercial assays were variable and not related to the analytical methods, but related to the manufacturer's reagents. We suggest that each laboratory should select an HBsAg assay based on analytical performance, test throughput, and the applicability of full automation.
BACKGROUND: The serological detection of the surface antigen (HBsAg) of hepatitis B virus (HBV) is the basis of detection of HBV infections in blood donors and patients with hepatitis. The aim of this study was to compare the performance of HBsAg enzyme-linked immunosorbent assay (ELISA) and HBsAg chemiluminescence immunoassay used in Korea. METHODS: We compared seven assays: Architect i2000 (Abbott Laboratories, USA), Elecsys 2010 immunoanalyzer (Roche Diagnostics, Germany), Advia Centaur (Bayer Healthcare, USA), Murex HBsAg version 3 (Abbott Laboratories, USA), Enzygnost HBsAg 5.0 (DADE Behring, Germany), LG HBsAg ELISA (LG, Korea), and Genedia HBsAg ELISA 3.0 (Greencross Medical Science, Korea). We evaluated the sensitivity of each assay by testing serially diluted WHO HBsAg reference material, two seroconversion panels, and recombinant HBsAg with three mutations in the 'a' determinant. RESULTS: The lowest HBsAg level detected by each assay using WHO reference material was variable from 0.05 (Murex and Advia) to 0.2 IU/mL. When testing 21 seroconversion panels, the total number of positive samples was 15 by Murex and 14 by Architect. Murex, LG, and Architect detected all of the 3 mutant samples tested. CONCLUSIONS: Analytical sensitivity and mutant detecting ability among HBsAg commercial assays were variable and not related to the analytical methods, but related to the manufacturer's reagents. We suggest that each laboratory should select an HBsAg assay based on analytical performance, test throughput, and the applicability of full automation.