Development and validation of a hepatitis B virus DNA sequencing assay for assessment of antiviral resistance, viral genotype and surface antigen mutation status
Development and validation of a hepatitis B virus DNA sequencing assay for assessment of antiviral resistance, viral genotype and surface antigen mutation status
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DOI：
10.1016/j.jviromet.2011.06.009
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发表时间：
2011-10-01
影响因子：
3.1
通讯作者：
Hillyard, David R.
中科院分区：
文献类型：
--
作者：
Mallory, Melanie A.;Page, Sam R.;Hillyard, David R.
本研究的目的是开发一种DNA测序检测方法，该方法能够灵敏可靠地检测HBV基因组逆转录酶编码区的所有保守结构域，以检测抗病毒耐药相关突变，同时为精确的基因分型和HBsAg突变的测定提供充足的信息。该检测方法用于检查来自美国各地的广泛的HBV患者人群的1000份已知病毒载量的去识别HBV DNA阳性样本。这些。946例成功检测。在104个样本中鉴定了抗病毒耐药相关突变。在0.8%的患者样本中鉴定出表面抗原中的逃逸突变sG 145 R。A、B、C、D、E、F、G和H基因型的感染率分别为36.6%、19.6%、21.7%、13.5%、3.6%、0.7%、2.2%和0.5%。15份样本（1.6%）出现多重基因型感染，如整个序列电泳图中存在双峰所示。本试验的检测限约为150 IU/mL。(C)2011 Elsevier B. V.保留所有权利。
The objective of this study was to develop a DNA sequencing assay that examines sensitively and reliably all conserved domains of the reverse transcriptase-encoding region of the HBV genome for antiviral resistance-associated mutations while simultaneously producing ample information for precise genotyping and determination of HBsAg mutation. This assay was used to examine 1000 de-identified HBV DNA positive samples with known viral loads from a broad-based, unselected patient population from across the United States. Of these. 946 were assayed successfully. Antiviral resistance-associated mutations were identified in 104 samples. The escape mutation sG145R in the surface antigen was identified in 0.8% of patient samples. Infections with genotypes A, B, C, D, E, F, G and H were observed in 36.6%, 19.6%, 21.7%, 13.5%, 3.6%, 0.7%, 2.2%, and 0.5% of patient samples respectively. Fifteen samples (1.6%) appeared to harbor infections with multiple genotypes as shown by the presence of double peaks throughout sequence electropherograms. The limit of detection of this assay was approximately 150 IU/mL. (C) 2011 Elsevier B.V. All rights reserved.