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Diagnostic Laboratory Immunology

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

Sarah Maylin, Anders Boyd, Constance Delaugerre, Fabien Zoulim, Fabien Lavocat, François Simon, Pierre-Marie Girard, Karine Lacombe
Sarah Maylin
aLaboratoire de Virologie, Hôpital Saint-Louis, AP-HP, Paris, France
bInserm U941, Paris, France
cUniversité Paris-Diderot, Paris, France
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Anders Boyd
dInserm UMR-S707, Paris, France
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Constance Delaugerre
aLaboratoire de Virologie, Hôpital Saint-Louis, AP-HP, Paris, France
bInserm U941, Paris, France
cUniversité Paris-Diderot, Paris, France
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Fabien Zoulim
eInserm, U1052, Lyon, France
fService d'Hépatologie, Hôpital de la Croix-Rousse, Hospices Civils, Lyon, France
gUniversité Lyon 1, Lyon, France
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Fabien Lavocat
eInserm, U1052, Lyon, France
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François Simon
aLaboratoire de Virologie, Hôpital Saint-Louis, AP-HP, Paris, France
bInserm U941, Paris, France
cUniversité Paris-Diderot, Paris, France
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Pierre-Marie Girard
dInserm UMR-S707, Paris, France
hService de Maladies Infectieuses, Hôpital Saint-Antoine, Paris, France
iUniversité Pierre et Marie Curie, Paris VI, France
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Karine Lacombe
dInserm UMR-S707, Paris, France
hService de Maladies Infectieuses, Hôpital Saint-Antoine, Paris, France
iUniversité Pierre et Marie Curie, Paris VI, France
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DOI: 10.1128/CVI.05454-11
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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 log10 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.

  • Copyright © 2012, American Society for Microbiology. All Rights Reserved.
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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
Sarah Maylin, Anders Boyd, Constance Delaugerre, Fabien Zoulim, Fabien Lavocat, François Simon, Pierre-Marie Girard, Karine Lacombe
Clinical and Vaccine Immunology Jan 2012, 19 (2) 242-248; DOI: 10.1128/CVI.05454-11

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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
Sarah Maylin, Anders Boyd, Constance Delaugerre, Fabien Zoulim, Fabien Lavocat, François Simon, Pierre-Marie Girard, Karine Lacombe
Clinical and Vaccine Immunology Jan 2012, 19 (2) 242-248; DOI: 10.1128/CVI.05454-11
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