title: What is the role of serology for the study of chronic hepatitis B virus infection in the age of molecular biology?
abstract: To assess quantitative serology in chronic hepatitis B virus (HBV) infection, testing by novel immunoassays has been carried out on 202 specimens from untreated patients and in 83 samples from 10 patients with chronic hepatitis B treated with lamivudine. Serum samples were assayed for quantitative HBsAg, in comparison with quantitative HBV-DNA, and for anti-HBc IgM and the avidity index (AI) of total anti-HBc antibodies. The AI was high (mean: 0.93 +/- 0.19) in all groups, confirming the consistency of this procedure in chronic HBV infections. A low-level positivity (2-28 Paul-Ehrlich units/ml) for IgM anti-HBc was detectable both in HBeAg-positive and in HBeAg-negative untreated chronic hepatitis cases (mean S/CO values by the Abbott Architect assay: 0.51 +/- 0.12 and 0.48 +/- 0.10, respectively; correlation between assays: r = 0.685), while treated patients (mean: 0.20 +/- 0.15) and inactive carriers (mean: 0.17 +/- 0.21), were generally negative for IgM. The levels of HBsAg (IU/ml) showed a weak correlation with HBV-DNA (IU/ml). A difference in HBsAg levels was found between inactive carriers (1,935 +/- 2,887 IU/ml) and chronic hepatitis B cases, either treated (5,199 +/- 9,259 IU/ml) or untreated (14,596 +/- 15,227 IU/ml). Pre-treatment levels of HBsAg in patients undergoing lamivudine treatment were correlated with a sustained response to therapy over 13-33 months (mean: 27.3) of follow-up: mean HBsAg values were 1,576 + 1,487 IU/ml in five responders and 6,063 + 5,142 in five nonresponders or breakthrough responders (P < 0.05). The availability of standardized quantitative immunoassays for HBsAg and anti-HBc IgM may be considered in addition to quantitative HBV-DNA in the staging and monitoring of chronic HBV infection.
authors.affiliation: Abbott Diagnostics Division, Rome, Italy. claudio.galli@abbott.com
authors.forename: Claudio
authors.initials: C
authors.lastname: Galli
authors.forename: Elisa
authors.initials: E
authors.lastname: Orlandini
authors.forename: Luigi
authors.initials: L
authors.lastname: Penzo
authors.forename: Renzo
authors.initials: R
authors.lastname: Badiale
authors.forename: Giacomo
authors.initials: G
authors.lastname: Caltran
authors.forename: Sara
authors.initials: S
authors.lastname: Valverde
authors.forename: Gianluca
authors.initials: G
authors.lastname: Gessoni
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use; D015415:Biomarkers / Q000378:metabolism; D004279:DNA, Viral / Q000097:blood / Q000235:genetics; D006510:Hepatitis B Antibodies / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000276:immunology / Q000378:metabolism; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification* / Q000378:metabolism; D019694:Hepatitis B, Chronic / Q000097:blood / Q000175:diagnosis* / Q000188:drug therapy / Q000276:immunology*; D006801:Humans; D007118:Immunoassay; D007074:Immunoglobulin G / Q000276:immunology; D007075:Immunoglobulin M / Q000276:immunology; D019259:Lamivudine / Q000627:therapeutic use; D008967:Molecular Biology / Q000379:methods*; D012698:Serologic Tests; D012699:Serology
chemical_list: D019380:Anti-HIV Agents; D015415:Biomarkers; D004279:DNA, Viral; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D019259:Lamivudine