title: INNO-LiPA HBV genotyping is highly consistent with direct sequencing and sensitive in detecting B/C mixed genotype infection in Chinese chronic hepatitis B patients and asymptomatic HBV carriers.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  INNO-LiPA is accurate and sensitive in detecting B, C, D and B/C mixed genotype infection in Chinese CHB patients and asymptomatic carriers.
authors: Peking University People's Hospital, Peking University Hepatology Institute, Beijing, 100044, China.
authors: Ruifeng
authors: R
authors: Yang
authors: Xu
authors: X
authors: Cong
authors: Zhihui
authors: Z
authors: Xu
authors: Dongping
authors: D
authors: Xu
authors: Weijin
authors: W
authors: Huang
authors: Rikkert
authors: R
authors: Maertens
authors: Lai
authors: L
authors: Wei
mesh_terms: D044466:Asian People; D058345:Asymptomatic Infections; D002353:Carrier State / Q000097:blood*; D003001:Cloning, Molecular; D004279:DNA, Viral / Q000097:blood / Q000235:genetics; D005838:Genotype; D006515:Hepatitis B virus / Q000235:genetics* / Q000502:physiology*; D019694:Hepatitis B, Chronic / Q000097:blood*; D006801:Humans; D012189:Retrospective Studies; D017422:Sequence Analysis, DNA
chemical_list: D004279:DNA, Viral