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J Viral Hepat. 2018 Oct;25(10):1132-1138. doi: 10.1111/jvh.12915. Epub 2018 Jun 7.

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

Author information

1
Roche Diagnostics International Ltd, Rotkreuz, Switzerland.
2
Department of Molecular Genetics and Microbiology, MVZ Labor Dr. Limbach & Kollegen GbR, Heidelberg, Germany.
3
Health and Environment Department, Molecular Diagnostics, Austrian Institute of Technology, Vienna, Austria.
4
Cerba Spécimen Services, Saint-Ouen l'Aumône, France.
5
Bioscientia, Institute for Medical Diagnostics GmbH, Ingelheim, Germany.
6
Roche Diagnostics GmbH, Penzberg, Germany.
7
Department of Laboratory Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, Korea.
8
Roche Diagnostics GmbH, Mannheim, Germany.
9
Hepatology Department, Medic Medical Center, Ho Chi Minh City, Vietnam.
10
Gastroenterology Department, Ho Chi Minh City University Medical Center, Ho Chi Minh City, Vietnam.
11
Division of Hepatology and Department of Medicine, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa.
12
Infectious Diseases and Viral Hepatitis Unit, University of Campania Luigi Vanvitelli, Naples, Italy.
13
Infectious Diseases Unit, Department of Clinical and Experimental Medicine, University of Foggia, Foggia, Italy.

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.

KEYWORDS:

HBV mutations; HBsAg mutations; mutation spectrum; “a” determinant region

PMID:
29660206
DOI:
10.1111/jvh.12915
[Indexed for MEDLINE]

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