Publication: Multicenter study of a new fully automated HBsAg screening assay with enhanced sensitivity for the detection of HBV mutants
Issued Date
2008-03-01
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ISSN
03008584
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2-s2.0-36448940149
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Mahidol University
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SCOPUS
Bibliographic Citation
Medical Microbiology and Immunology. Vol.197, No.1 (2008), 55-64
Suggested Citation
A. Mühlbacher, B. Weber, P. Bürgisser, A. Eiras, J. Cabrera, S. Louisirirotchanakul, F. W. Tiller, H. S. Kim, J. V. Helden, V. Bossi, J. M. Echevarria Multicenter study of a new fully automated HBsAg screening assay with enhanced sensitivity for the detection of HBV mutants. Medical Microbiology and Immunology. Vol.197, No.1 (2008), 55-64. doi:10.1007/s00430-007-0059-9 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/19370
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Title
Multicenter study of a new fully automated HBsAg screening assay with enhanced sensitivity for the detection of HBV mutants
Other Contributor(s)
Univ. Klin. F. Blutgruppenserologie und Transfusionsmedizin der Paracelsus Med. Privatuniv. Salzburg
Laboratoires Reunis Kutter-Lieners-Hastert Centre Langwies
Goethe-Universitat Frankfurt am Main
Centre Hospitalier Universitaire Vaudois
Centro de Supercomputacion de Galicia
Mahidol University
Medizinisches Versorgungszentrum Labor Dr. Tiller und Kollegen
Yonsei University College of Medicine
Mikrobiologie und Humangenetik
Ospedale Amedeo di Savoia
Centro Nacional de Microbiologia
Laboratoires Reunis Kutter-Lieners-Hastert Centre Langwies
Goethe-Universitat Frankfurt am Main
Centre Hospitalier Universitaire Vaudois
Centro de Supercomputacion de Galicia
Mahidol University
Medizinisches Versorgungszentrum Labor Dr. Tiller und Kollegen
Yonsei University College of Medicine
Mikrobiologie und Humangenetik
Ospedale Amedeo di Savoia
Centro Nacional de Microbiologia
Abstract
In a multicenter study a new, fully automated Roche Diagnostics Elecsys® HBsAg II screening assay with improved sensitivity to HBsAg mutant detection was compared to well-established HBsAg tests: AxSYM HBsAg V2 (Abbott), Architect HBsAg (Abbott), Advia Centaur HBsAg (Bayer) Enzygnost HBsAg 5.0 (Dade-Behring), and Vitros Eci HBsAg (Ortho). A total of 16 seroconversion panels, samples of 60 HBsAg native mutants, and 31 HBsAg recombinant mutants, dilution series of NIBSC and PEI standards, 156 HBV positive samples comprising genotypes A to G, 686 preselected HBsAg positive samples from different stages of infection, 3,593 samples from daily routine, and 6,360 unselected blood donations were tested to evaluate the analytical and clinical sensitivity, the detection of mutants, and the specificity of the new assay. Elecsys® HBsAg II showed a statistically significant better sensitivity in seroconversion panels to the compared tests. Fifty-seven out of 60 native mutants and all recombinant mutants were found positive. Among 156 HBV samples with different genotypes and 696 preselected HBsAg positive samples Elecsys® HBsAg II achieved a sensitivity of 100%. The lower detection limit for NIBSC standard was calculated to be 0.025 IU/ml and for the PEI standards ad and ay it was <0.001 and <0.005 U/ml, respectively. Within 2,724 daily routine specimens and 6.360 unselected blood donations Elecsys® HBsAg II showed a specificity of 99.97 and 99.88%, respectively. In conclusion the new Elecsys HBsAg II shows a high sensitivity for the detection of all stages of HBV infection and HBsAg mutants paired together with a high specificity in blood donors, daily routine samples, and potentially interfering sera. © 2007 Springer-Verlag.