Comparison between Elecsys HBsAg II and architect HBsAg QT assays for quantification of hepatitis B surface antigen among patients coinfected with HIV and hepatitis B virus

Clin Vaccine Immunol. 2012 Feb;19(2):242-8. doi: 10.1128/CVI.05454-11. Epub 2011 Dec 21.

Abstract

Hepatitis B surface antigen (HBsAg) quantification has been steadily gaining interest as a clinical marker of therapeutic efficacy, for which two commercial assays are currently available: Architect HBsAg QT (Architect) and Elecsys HBsAg II (Elecsys). HBsAg quantification was evaluated using both assays in 126 human immunodeficiency virus (HIV) and hepatitis B virus (HBV)-coinfected patients initiating treatment with tenofovir dipivoxil fumarate. Linear regression and correlation were used to establish the relationship between the two methods. Bland-Altman analysis was performed to determine mean between-assay difference and limits of agreement (LOA) (±2 standard deviations [SD]) both overall and stratified on HBV (hepatitis B envelope antigen [HBeAg] status, replication, genotype, HBV mutants) or HIV (CD4(+) cell count) cofactors. There was a significant correlation between Elecsys and Architect assays (correlation coefficient, r = 0.959; P < 0.001). HBsAg quantification using the Elecsys assay was on average 0.200 log(10) IU/ml (LOA, -0.500, 0.800) higher than that using Architect, which was consistent across levels of CD4(+) cell count, presence of precore and YMDD mutations, and HBeAg status. A slightly larger mean between-assay difference was observed with genotypes A and G (0.196 and 0.201, respectively) versus HBV genotypes D and E (0.036 and 0.030, respectively). Mutations on the S region at position s120/s145 were the only determinant in which the mean between-assay difference in HBsAg quantification was lower than the null value (-0.078). In conclusion, the Elecsys assay, with automatic on-board dilution, is capable of quantifying serum HBsAg levels in HIV-HBV-coinfected patients, with very high correlation with the Architect assay.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenine / analogs & derivatives
  • Adenine / therapeutic use
  • Adult
  • Anti-HIV Agents / therapeutic use
  • CD4 Lymphocyte Count
  • Coinfection / immunology
  • Coinfection / virology
  • Female
  • Genotype
  • HIV Infections / complications*
  • HIV Infections / drug therapy
  • HIV Infections / immunology
  • Hepatitis B / complications
  • Hepatitis B / diagnosis*
  • Hepatitis B / immunology
  • Hepatitis B Surface Antigens / blood*
  • Hepatitis B Surface Antigens / immunology
  • Hepatitis B e Antigens / immunology
  • Hepatitis B virus / immunology*
  • Humans
  • Male
  • Middle Aged
  • Organophosphonates / therapeutic use
  • Reagent Kits, Diagnostic*
  • Tenofovir

Substances

  • Anti-HIV Agents
  • Hepatitis B Surface Antigens
  • Hepatitis B e Antigens
  • Organophosphonates
  • Reagent Kits, Diagnostic
  • Tenofovir
  • Adenine