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.
Bibliographical noteFunding Information:
The authors would like to thank Albert Kriegner for his support on HBV mutation analysis using AIT/Platomics software. Special thanks go to Professor Markus Nauck (Bioscientia, Institute for Medical Diagnostics GmbH, Ingelheim, Germany) for his contribution to the study and to Bill Johnson (Roche Diagnostics, Indianapolis, USA), Gengqin Su and Michael Walter (Roche Diagnostics GmbH, Penzberg, Germany) for their excellent data management and Medrio database support. Editorial support under the guidance of the authors was provided by Kim Brown of Roche Diagnostics International Ltd, Rotkreuz, Switzerland, and by Lucy Carrier of Gardiner-Caldwell Communications, Macclesfield, UK (supported by funding from Roche Diagnostics International Ltd).
The study was sponsored by Roche Diagnostics, who were involved in the study design, and data collection, interpretation and analysis. M.G., D.N., R.B. and G.W. are employees of Roche Diagnostics International Ltd, Rotkreuz, Switzerland. A.W. and C.R. are employees of Roche Diagnostics GmbH, Penzberg, Germany. A.S. and M.W. are employees of Labor Limbach, which received research funding from Roche Diagnostics. S.P. is an employee of AIT, which has received funds from Roche Diagnostics for carrying out statistical analysis. W.K., M.N., P.G. and E.B. are employees of Bioscientia GmbH, which received research funding from Roche Diagnostics. P.T.T. is an employee of Medic Medical Center, Ho Chi Minh City, Vietnam, which received research funding from Roche Diagnostics. B.H.H. is an employee of Ho Chi Minh City University Medical Center, Ho Chi Minh City, Vietnam, which received research funding from Roche Diagnostics. M.S. and C.W.S. are employees of UCT and Groote Schuur Hospital, Cape Town, South Africa, which received research funding from Roche Diagnostics. C.W.S. has received speaker fees and a travel grant from Gilead and is an advisory board member for AbbVie. G.B. and G.B.B. are employees of Infectious Diseases and Viral Hepatitis Unit, Second University of Naples, Italy, which received research funding from Roche Diagnostics. J.G. is an employee of Cerba Spécimen Services.
All Science Journal Classification (ASJC) codes
- Infectious Diseases