Peking University People's Hospital, Peking University Hepatology Institute, Beijing, 100044, China.
Clin Chim Acta. 2010 Dec 14;411(23-24):1951-6. doi: 10.1016/j.cca.2010.08.011. Epub 2010 Aug 13.
Different HBV genotypes have effect on the progression and outcome of chronic hepatitis B (CHB) and on the response to antiviral therapy. Accurate and sensitive genotyping methods are needed in clinical practice.
In this multicenter retrospective study, 504 HBV DNA positive serum or plasma samples of CHB patients or asymptomatic carriers were genotyped by INNO-LiPA HBV genotyping and direct sequencing. A part of the consistent and discrepant results were confirmed by clonal sequencing.
Except two samples with indeterminate results by INNO-LiPA, 463 had the same genotype results by INNO-LiPA and direct sequencing with a concordance of 92.23% (463/502). However 24 had completely inconsistent results by the two methods, seven of which were confirmed by clonal sequencing as the same genotype as by direct sequencing. Fifteen samples were determined as B/C mixed genotypes by INNO-LiPA but singe B or C genotype by direct sequencing, five of which were confirmed by clonal sequencing as B/C mixed infection. Further studies showed INNO-LiPA could detect 6% of genotype B and genotype C among mixed genotype samples at HBV DNA ≥3×10(3) IU/ml.
INNO-LiPA is accurate and sensitive in detecting B, C, D and B/C mixed genotype infection in Chinese CHB patients and asymptomatic carriers.
不同的乙型肝炎病毒（HBV）基因型会影响慢性乙型肝炎（CHB）的进展和结局，并影响抗病毒治疗的反应。临床实践中需要准确和敏感的基因分型方法。
在这项多中心回顾性研究中，通过 INNO-LiPA HBV 基因分型和直接测序对 504 例 CHB 患者或无症状携带者的 HBV DNA 阳性血清或血浆样本进行了基因分型。部分一致和不一致的结果通过克隆测序进行了确认。
除了 INNO-LiPA 判定为不确定结果的两个样本外，INNO-LiPA 和直接测序的结果完全一致的有 463 例，一致性为 92.23%（463/502）。然而，这两种方法有 24 例完全不一致的结果，其中 7 例通过克隆测序证实与直接测序的基因型相同。INNO-LiPA 判定为 B/C 混合基因型的 15 例样本通过直接测序确认为单一 B 型或 C 型基因型，其中 5 例通过克隆测序证实为 B/C 混合感染。进一步的研究表明，INNO-LiPA 可以在 HBV DNA≥3×10(3) IU/ml 的混合基因型样本中检测到 6%的基因型 B 和基因型 C。
INNO-LiPA 能够准确、敏感地检测中国 CHB 患者和无症状携带者中的 B、C、D 和 B/C 混合基因型感染。
