Detection of in vivo hepatitis B virus surface antigen mutations-A comparison of four routine screening assays
Autor: | Giuseppina Brancaccio, Teresa Santantonio, Jérémie Gautier, Peter Gohl, G.B. Gaeta, P. T. T. Thuy, C. Reinsch, B. H. Hoang, Massimo Fasano, Stephan Pabinger, C. W. Spearman, E. Brill, Gaston Westergaard, Mark W. Sonderup, A. Woeste, Anja Seffner, Mikael Gencay, Hyun-Seok Kim, Wolfgang E. Kaminski, Richard Batrla, Dionissios Neofytos, M. Weizenegger |
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Přispěvatelé: | Gencay, M, Seffner, A, Pabinger, S, Gautier, J, Gohl, P, Weizenegger, M, Neofytos, D, Batrla, R, Woeste, A, Kim, H S, Westergaard, G, Reinsch, C, Brill, E, Thuy, P T T, Hoang, B H, Sonderup, M, Spearman, C W, Brancaccio, G, Fasano, M, Gaeta, Giovanni Battista |
Jazyk: | angličtina |
Rok vydání: | 2018 |
Předmět: |
0301 basic medicine
HBsAg Hepatitis B virus Genotype Economic shortage “a” determinant region Hepatitis b surface antigen Sensitivity and Specificity Cohort Studies 03 medical and health sciences Hepatitis B Chronic In vivo Virology Siemens ADVIA Centaur HBsAg mutations Hbv genotype Medicine Humans Mass Screening HBV mutations Immunoassay Hepatitis B virus surface Antigen Routine screening Hepatitis B Surface Antigens Hepatology business.industry Diagnostic Tests Routine HBV mutation virus diseases Hepatitis B digestive system diseases 030104 developmental biology Infectious Diseases mutation spectrum Mutation business HBsAg mutation |
Popis: | An important requirement for a state-of-the-art hepatitis B surface antigen (HBsAg) screening assay is reliable detection of mutated HBsAg. Currently, there is a striking shortage of data regarding the detection rates of in vivo HBsAg mutations for these clinically important assays. Therefore, we compared the detection rates of four commercial HBsAg screening assays using a global cohort of 1553 patients from four continents with known HBV genotypes. These samples, which represent the broadest spectrum of known and novel HBsAg major hydrophilic region (MHR) mutations to date, were analyzed for the presence of HBsAg using the Roche Elecsys® HBsAg II Qualitative, Siemens ADVIA Centaur XP HBsAg II, Abbott Architect HBsAg Qualitative II and DiaSorin Liaison® HBsAg Qualitative assays, respectively. Of the 1553 samples, 1391 samples could be sequenced; of these, 1013 (72.8%) carried at least one of the 345 currently known amino acid substitutions (distinct HBsAg mutation) in the HBsAg MHR. All 1553 patient samples were positive for HBsAg using the Elecsys® HBsAg II Qual assay, with a sensitivity (95% confidence interval) of 99.94% (99.64%-100%), followed by the Abbott Architect 99.81% (99.44%-99.96%), Siemens ADVIA 99.81% (99.44%-99.96%) and DiaSorin Liaison® 99.36% (98.82%-99.69%) assays, respectively. Our results indicate that the Elecsys® HBsAg II Qual assay exhibits the highest sensitivity among the commercial HBsAg screening assays, and demonstrate that its capacity to detect HBV infection is not compromised by HBsAg MHR mutants. |
Databáze: | OpenAIRE |
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