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

Hyon Suk Kim, Xinyue Chen, Min Xu, Cunling Yan, Yali Liu, Haohui Deng, Bui Huu Hoang, Pham Thi Thu Thuy, Terry Wang, Yiwen Yan, Zhen Zeng, Mikael Gencay, Gaston Westergaard, Stephan Pabinger, Albert Kriegner, Markus Nauck, Anja Seffner, Peter Gohl, Kirsten Hübner, Wolfgang E. Kaminski

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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.

Original languageEnglish
Pages (from-to)48-56
Number of pages9
JournalJournal of Clinical Virology
Volume103
DOIs
Publication statusPublished - 2018 Jun

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All Science Journal Classification (ASJC) codes

  • Virology
  • Infectious Diseases

Cite this

Kim, H. S., Chen, X., Xu, M., Yan, C., Liu, Y., Deng, H., Hoang, B. H., Thuy, P. T. T., Wang, T., Yan, Y., Zeng, Z., Gencay, M., Westergaard, G., Pabinger, S., Kriegner, A., Nauck, M., Seffner, A., Gohl, P., Hübner, K., & Kaminski, W. E. (2018). 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. Journal of Clinical Virology, 103, 48-56. https://doi.org/10.1016/j.jcv.2018.04.005