Multicenter study of a new fully automated HBsAg screening assay with enhanced sensitivity for the detection of HBV mutants |
| |
Authors: | 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 |
| |
Affiliation: | 1. Universit?tsklinik für Blutgruppenserologie und Transfusionsmedizin der Paracelsus Medizinischen Privatuniversit?t Salzburg, Salzburg, Austria 2. Laboratoires Réunis, Luxembourg and Institute for Medical Virology, Johann Wolfgang Goethe University, Frankfurt, Germany 3. Service d′Immunologie et d′allergie, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland 4. Centro de Transfusión de Galicia, Santiago de Compostela, Spain 5. Department of Microbiology, Siriraj Hospital, Mahidol University, Bangkok, Thailand 6. Medizinisches Versorgungszentrum Labor Dr. Tiller und Kollegen, Munich, Germany 7. Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, South Korea 8. Gemeinschaftspraxis für Laboratoriumsmedizin, Mikrobiologie und Humangenetik, M?nchengladbach, Germany 9. Ospedale Amedeo di Savoia, Laboratorio di Virologia e Microbiologia, Turin, Italy 10. Service of Diagnostic Microbiology, National Centre of Microbiology, Instituto de Salud Carlos III, Madrid, Spain
|
| |
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. |
| |
Keywords: | HBV mutant detection HBsAg screening assay Blood donor screening |
本文献已被 PubMed SpringerLink 等数据库收录! |
|