Detection of in vivo hepatitis B virus surface antigen mutations—A comparison of four routine screening assays

M. Gencay; A. Seffner; S. Pabinger; J. Gautier; P. Gohl; M. Weizenegger; D. Neofytos; R. Batrla; A. Woeste; H. S. Kim; G. Westergaard; C. Reinsch; E. Brill; P. T.T. Thuy; B. H. Hoang; M. Sonderup; C. W. Spearman; G. Brancaccio; M. Fasano; G. B. Gaeta; T. Santantonio; W. E. Kaminski

doi:10.1111/jvh.12915

Detection of in vivo hepatitis B virus surface antigen mutations—A comparison of four routine screening assays

M. Gencay, A. Seffner, S. Pabinger, J. Gautier, P. Gohl, M. Weizenegger, D. Neofytos, R. Batrla, A. Woeste, H. S. Kim, G. Westergaard, C. Reinsch, E. Brill, P. T.T. Thuy, B. H. Hoang, M. Sonderup, C. W. Spearman, G. Brancaccio, M. Fasano, G. B. GaetaT. Santantonio, W. E. Kaminski

Department of Laboratory Medicine

Research output: Contribution to journal › Article › peer-review

7 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	1132-1138
Number of pages	7
Journal	Journal of Viral Hepatitis
Volume	25
Issue number	10
DOIs	https://doi.org/10.1111/jvh.12915
Publication status	Published - 2018 Oct

Bibliographical note

Funding Information:
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.

Publisher Copyright:
© 2018 The Authors. Journal of Viral Hepatitis Published by John Wiley & Sons Ltd.

All Science Journal Classification (ASJC) codes

Hepatology
Virology
Infectious Diseases

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1111/jvh.12915

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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., ... Kaminski, W. E. (2018). Detection of in vivo hepatitis B virus surface antigen mutations—A comparison of four routine screening assays. Journal of Viral Hepatitis, 25(10), 1132-1138. https://doi.org/10.1111/jvh.12915

@article{49d364ef22b64208adfe5ffccf0575e4,

title = "Detection of in vivo hepatitis B virus surface antigen mutations—A comparison of four routine screening assays",

abstract = "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{\textregistered} HBsAg II Qualitative, Siemens ADVIA Centaur XP HBsAg II, Abbott Architect HBsAg Qualitative II and DiaSorin Liaison{\textregistered} 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{\textregistered} 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{\textregistered} 99.36% (98.82%-99.69%) assays, respectively. Our results indicate that the Elecsys{\textregistered} 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.",

author = "M. Gencay and A. Seffner and S. Pabinger and J. Gautier and P. Gohl and M. Weizenegger and D. Neofytos and R. Batrla and A. Woeste and Kim, {H. S.} and G. Westergaard and C. Reinsch and E. Brill and Thuy, {P. T.T.} and Hoang, {B. H.} and M. Sonderup and Spearman, {C. W.} and G. Brancaccio and M. Fasano and Gaeta, {G. B.} and T. Santantonio and Kaminski, {W. E.}",

note = "Funding Information: 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 Sp{\'e}cimen Services. Publisher Copyright: {\textcopyright} 2018 The Authors. Journal of Viral Hepatitis Published by John Wiley & Sons Ltd.",

year = "2018",

month = oct,

doi = "10.1111/jvh.12915",

language = "English",

volume = "25",

pages = "1132--1138",

journal = "Journal of Viral Hepatitis",

issn = "1352-0504",

publisher = "Wiley-Blackwell",

number = "10",

}

Gencay, M, Seffner, A, Pabinger, S, Gautier, J, Gohl, P, Weizenegger, M, Neofytos, D, Batrla, R, Woeste, A, Kim, HS, Westergaard, G, Reinsch, C, Brill, E, Thuy, PTT, Hoang, BH, Sonderup, M, Spearman, CW, Brancaccio, G, Fasano, M, Gaeta, GB, Santantonio, T & Kaminski, WE 2018, 'Detection of in vivo hepatitis B virus surface antigen mutations—A comparison of four routine screening assays', Journal of Viral Hepatitis, vol. 25, no. 10, pp. 1132-1138. https://doi.org/10.1111/jvh.12915

TY - JOUR

T1 - Detection of in vivo hepatitis B virus surface antigen mutations—A comparison of four routine screening assays

AU - Gencay, M.

AU - Seffner, A.

AU - Pabinger, S.

AU - Gautier, J.

AU - Gohl, P.

AU - Weizenegger, M.

AU - Neofytos, D.

AU - Batrla, R.

AU - Woeste, A.

AU - Kim, H. S.

AU - Westergaard, G.

AU - Reinsch, C.

AU - Brill, E.

AU - Thuy, P. T.T.

AU - Hoang, B. H.

AU - Sonderup, M.

AU - Spearman, C. W.

AU - Brancaccio, G.

AU - Fasano, M.

AU - Gaeta, G. B.

AU - Santantonio, T.

AU - Kaminski, W. E.

N1 - Funding Information: 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. Publisher Copyright: © 2018 The Authors. Journal of Viral Hepatitis Published by John Wiley & Sons Ltd.

PY - 2018/10

Y1 - 2018/10

N2 - 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.

AB - 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.

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Detection of in vivo hepatitis B virus surface antigen mutations—A comparison of four routine screening assays

Abstract

Bibliographical note

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UN SDGs

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