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J Clin Virol. 2018 Jun;103:48-56. doi: 10.1016/j.jcv.2018.04.005. Epub 2018 Apr 5.

Frequency of hepatitis B surface antigen variants (HBsAg) in hepatitis B virus genotype B and C infected East- and Southeast Asian patients: Detection by the Elecsys® HBsAg II assay.

Author information

1
Department of Laboratory Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, South Korea.
2
Department of Liver Diseases, You'an Hospital, Capital Medical University, Beijing, China.
3
Hepatology Department, Guangzhou No. 8 People's Hospital, Guangzhou, China.
4
Department of Clinical Laboratory, Peking University First Hospital, Beijing, China.
5
Gastroenterology Department, Ho Chi Minh City University Medical Center, Ho Chi Minh City, Vietnam.
6
Hepatology Department, Medic Medical Center, Ho Chi Minh City, Vietnam.
7
Roche Diagnostics Ltd., Shanghai, China.
8
Roche Diagnostics International Ltd., Rotkreuz, Switzerland.
9
AIT Austrian Institute of Technology, Molecular Diagnostics, Center for Health and Bioresources, Vienna, Austria.
10
Platomics GmbH, Vienna, Austria.
11
Bioscientia Institute for Medical Diagnostics GmbH, Ingelheim, Germany.
12
MVZ Labor Dr. Limbach & Kollegen GbR, Department of Molecular Genetics and Microbiology, Heidelberg, Germany.
13
Bioscientia Institute for Medical Diagnostics GmbH, Ingelheim, Germany. Electronic address: wolfgang.kaminski@bioscientia.de.

Abstract

BACKGROUND:

To avoid false negative results, hepatitis B surface antigen (HBsAg) assays need to detect samples with mutations in the immunodominant 'a' determinant region, which vary by ethnographic region.

OBJECTIVE:

We evaluated the prevalence and type of HBsAg mutations in a hepatitis B virus (HBV)-infected East- and Southeast Asian population, and the diagnostic performance of the Elecsys® HBsAg II Qualitative assay.

STUDY DESIGN:

We analyzed 898 samples from patients with HBV infection from four sites (China [Beijing and Guangzhou], Korea and Vietnam). HBsAg mutations were detected and sequenced using highly sensitive ultra-deep sequencing and compared between the first (amino acids 124-137) and second (amino acids 139-147) loops of the 'a' determinant region using the Elecsys® HBsAg II Qualitative assay.

RESULTS:

Overall, 237 distinct amino acid mutations in the major hydrophilic region were identified; mutations were present in 660 of 898 HBV-infected patient samples (73.5%). Within the pool of 237 distinct mutations, the majority of the amino acid mutations were found in HBV genotype C (64.8%). We identified 25 previously unknown distinct mutations, mostly prevalent in genotype C-infected Korean patients (n = 18) followed by Chinese (n = 12) patients. All 898 samples were correctly identified by the Elecsys® HBsAg II Qualitative assay.

CONCLUSIONS:

We observed 237 distinct (including 25 novel) mutations, demonstrating the complexity of HBsAg variants in HBV-infected East- and Southeast Asian patients. The Elecsys® HBsAg II Qualitative assay can reliably detect HBV-positive samples and is suitable for routine diagnostic use in East and Southeast Asia.

KEYWORDS:

Detection; HBsAg mutations; Hepatitis B; Immunoassay; Immunodominant ‘a’ determinant region; Screening

PMID:
29655170
DOI:
10.1016/j.jcv.2018.04.005
[Indexed for MEDLINE]
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