TY - JOUR
T1 - Frequency of hepatitis B surface antigen variants (HBsAg) in hepatitis B virus genotype B and C infected East- and Southeast Asian patients
T2 - Detection by the Elecsys ® HBsAg II assay
AU - Kim, Hyon Suk
AU - Chen, Xinyue
AU - Xu, Min
AU - Yan, Cunling
AU - Liu, Yali
AU - Deng, Haohui
AU - Hoang, Bui Huu
AU - Thuy, Pham Thi Thu
AU - Wang, Terry
AU - Yan, Yiwen
AU - Zeng, Zhen
AU - Gencay, Mikael
AU - Westergaard, Gaston
AU - Pabinger, Stephan
AU - Kriegner, Albert
AU - Nauck, Markus
AU - Seffner, Anja
AU - Gohl, Peter
AU - Hübner, Kirsten
AU - Kaminski, Wolfgang E.
N1 - Publisher Copyright:
© 2018
PY - 2018/6
Y1 - 2018/6
N2 - 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.
AB - 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.
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U2 - 10.1016/j.jcv.2018.04.005
DO - 10.1016/j.jcv.2018.04.005
M3 - Article
C2 - 29655170
AN - SCOPUS:85045476252
VL - 103
SP - 48
EP - 56
JO - Journal of Clinical Virology
JF - Journal of Clinical Virology
SN - 1386-6532
ER -