title: Direct comparison of hepatitis C virus genotypes tested by INNO-LiPA HCV II and TRUGENE HCV genotyping methods.
abstract: BACKGROUND
  Hepatitis C virus (HCV) is a major cause of chronic liver disease worldwide. It is associated with the development of end-stage liver disease and hepatocellular carcinoma. Studies have shown that patients infected with different genotypes of HCV may respond to interferon-ribavirin therapy differently and thus HCV genotype information is very important in helping physicians to better managing their patients.
  
  
  OBJECTIVE
  Compare the end results of HCV typing of the two commercially available tests.
  
  
  METHODS
  TRUGENE Genotyping test (Visible Genetics) was used to analyze clinical specimens obtained from North America. The 5' NC was amplified with the Roche COBAS Amplicor HCV Monitor Test. Amplification products were blinded and genotyped by the TRUGENE HCV 5'NC method. Genotype results were compared with those obtained by the reverse hybridization based INNO-LiPA HCV II (Innogenetics) assay. Additional sequencing of the NS5B region was done to resolve discrepancies.
  
  
  CONCLUSIONS
  Among the total of 110 consecutively collected serum specimens submitted for HCV genotyping, 108/110 could be typed by the sequencing method and 107/110 were typable by LiPA HCV II method. Our experiences with the tests suggest that at type level, HCV genotype results are 100% concordant between the two tests studied for those 106 specimens successfully typed by both methods. More sensitive amplification, such as qualitative PCR, is needed to test specimens with viral load lower than 20000 IU/ml. Both tests can be easily adapted by a clinical diagnostic laboratory.
authors.affiliation: Diagnostic Laboratory Services, The Queen's Health Systems and University of Hawaii School of Medicine, Honolulu, HI, USA. xtzheng@childrensmemorial.org
authors.forename: Xiaotian
authors.initials: X
authors.lastname: Zheng
authors.forename: Minnie
authors.initials: M
authors.lastname: Pang
authors.forename: Amelia
authors.initials: A
authors.lastname: Chan
authors.forename: Ann
authors.initials: A
authors.lastname: Roberto
authors.forename: Diane
authors.initials: D
authors.lastname: Warner
authors.forename: Belinda
authors.initials: B
authors.lastname: Yen-Lieberman
mesh_terms: D020121:5' Untranslated Regions / Q000032:analysis / Q000235:genetics*; D005821:Genetic Techniques; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics* / Q000302:isolation & purification; D006801:Humans; D016133:Polymerase Chain Reaction / Q000379:methods; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D017422:Sequence Analysis, DNA
chemical_list: D020121:5' Untranslated Regions; D011933:Reagent Kits, Diagnostic