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Journal of Clinical Microbiology, May 2003, p. 1901-1906, Vol. 41, No. 5
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.5.1901-1906.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

New Enzyme Immunoassay for Detection of Hepatitis B Virus Core Antigen (HBcAg) and Relation between Levels of HBcAg and HBV DNA

R&D Division, Advanced Life Science Institute, Inc., Wako, Saitama 351-0112,¹ Second Department of Internal Medicine, Shinshu University School of Medicine, Matsumoto, Nagano 390-8621, Japan²

Received 16 August 2002/ Returned for modification 20 January 2003/ Accepted 17 February 2003

A new enzyme immunoassay specific for hepatitis B virus (HBV) core antigen (HBcAg) was developed. In order to detect HBcAg, specimens were pretreated with detergents to release HBcAg from the HBV virion and disassemble it to dimers, and simultaneously, the treatment inactivated anti-HBc antibodies. HBcAg detected by the assay peaked with HBV DNA in density gradient fractions of HBV-positive sera. The assay showed a wide detection range from 2 to 100,000 pg/ml. We observed no interference from anti-HBc antibody or blood components, but the assay was inhibited by very high concentrations (>1 µg/ml; corresponding to 80 signal/cutoff) of HBeAg. When the cutoff value was tentatively set at 4 pg/ml, all healthy control (HBsAg and HBV DNA negative, n = 160) and anti-hepatitis C virus-positive (n = 55) sera were identified as negative. HBcAg concentrations correlated very closely with HBV DNA (r = 0.946, n = 145) in 216 samples from 72 hepatitis B patients. In seroconversion panels, HBcAg concentrations changed in parallel with HBV DNA levels. The assay, therefore, offers a simple method for monitoring hepatitis B patients. With a series of sera during lamivudine therapy, HBV DNA levels fell sharply and the HBcAg concentration also decreased, but the change in HBcAg was smaller and more gradual. The supposed mechanism of these changes and their clinical significance are discussed.

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• Kimura, T., Ohno, N., Terada, N., Rokuhara, A., Matsumoto, A., Yagi, S., Tanaka, E., Kiyosawa, K., Ohno, S., Maki, N. (2005). Hepatitis B Virus DNA-negative Dane Particles Lack Core Protein but Contain a 22-kDa Precore Protein without C-terminal Arginine-rich Domain. J. Biol. Chem. 280: 21713-21719 [Abstract] [Full Text]