Jan 19, 2006 - mances of four HBsAg assays that recently received Conformité Européene marking, Advia Centaur HBsAg. (Bayer), Monolisa HBsAg Ultra ...
JOURNAL OF CLINICAL MICROBIOLOGY, July 2006, p. 2321–2326 0095-1137/06/$08.00⫹0 doi:10.1128/JCM.00121-06 Copyright © 2006, American Society for Microbiology. All Rights Reserved.
Vol. 44, No. 7
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 Se´bastien Bagot,3 Sylvie Gonzalo,4 Marie-Pierre Fe´rey,5 Anne Ebel,1 Elisabeth Dussaix,5 Syria Laperche,2 and Anne-Marie Roque-Afonso5 Laboratoire Claude Le´vy, Ivry sur Seine,1 Centre National de Re´fe´rence pour les He´patites B et C en Transfusion, Institut National de la Transfusion Sanguine, Paris,2 Laboratoire Franc¸ais du Fractionnement et des Biotechnologies, Les Ulis,3 Laboratoire Marcel Me´rieux, Lyon,4 and Laboratoire de Virologie, Ho ˆpital Paul Brousse, Villejuif, 5 France 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 Conformite´ Europe´ene marking, Advia Centaur HBsAg (Bayer), Monolisa HBsAg Ultra (Bio-Rad), Liaison HBsAg (Dia Sorin), and Vidas HBsAg Ultra (bioMe´rieux), 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
