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Journal of Clinical Microbiology, July 2006, p. 2321-2326, Vol. 44, No. 7
0095-1137/06/$08.00+0     doi:10.1128/JCM.00121-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Sensitivities of Four New Commercial Hepatitis B Virus Surface Antigen (HBsAg) Assays in Detection of HBsAg Mutant Forms

Thoai Duong Ly,1* Annabelle Servant-Delmas,2 Sébastien Bagot,3 Sylvie Gonzalo,4 Marie-Pierre Férey,5 Anne Ebel,1 Elisabeth Dussaix,5 Syria Laperche,2 and Anne-Marie Roque-Afonso5

Laboratoire Claude Lévy, Ivry sur Seine,1 Centre National de Référence pour les Hépatites B et C en Transfusion, Institut National de la Transfusion Sanguine, Paris,2 Laboratoire Français du Fractionnement et des Biotechnologies, Les Ulis,3 Laboratoire Marcel Mérieux, Lyon,4 Laboratoire de Virologie, Hôpital Paul Brousse, Villejuif, France5

Received 19 January 2006/ Returned for modification 13 March 2006/ Accepted 13 April 2006

Mutations in hepatitis B virus surface antigen (HBsAg) involving amino acid substitution within the immunodominant "a" determinant may affect the performance of commercial HBsAg assays. The performances of four HBsAg assays that recently received Conformité Européene marking, Advia Centaur HBsAg (Bayer), Monolisa HBsAg Ultra (Bio-Rad), Liaison HBsAg (Dia Sorin), and Vidas HBsAg Ultra (bioMérieux), were compared with that of the routinely used HBsAg assay AxSYM HBsAg V2 (Abbott). Assays were evaluated for (i) analytical sensitivity performance with a national reference HBsAg panel (including 10 samples with calibrated HBsAg concentrations from 0.04 to 2.24 ng/ml) and (ii) the detection of HBsAg mutants by studying a panel of 35 HBsAg mutants (23 collected from patients and 12 recombinant mutants). The limits of detection of these assays were <0.15 ng/ml (from 0.089 to 0.121 ng/ml). The sensitivity performances for mutant virus detection varied, ranging from 37.1% to 91.4%. The lack of detection of these mutants by commercial assays was probably due to the epitope recognition of the anti-HBs assay reagents in the capture phase and in the conjugates. The prevalence and clinical impact of HBsAg mutants are under investigation. However, the manufacturers must be vigilant in the design of the assays in order to reduce the risk of missing a broad range of described S gene mutants.

* Corresponding author. Mailing address: Laboratoire Claude Lévy, 78 av de Verdun, 94200 Ivry sur Seine, France. Phone: 33-149591720. Fax: 33-149591798. E-mail: t.ly{at}lablcl.com.

Journal of Clinical Microbiology, July 2006, p. 2321-2326, Vol. 44, No. 7
0095-1137/06/$08.00+0     doi:10.1128/JCM.00121-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.





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