title: Evaluation of the Abbott Real Time HCV genotype II assay for Hepatitis C virus genotyping.
abstract: OBJECTIVE
  The determination of HCV genotypes and subtypes is very important for the selection of antiviral therapy and epidemiological studies. The aim of this study was to evaluate the performance of Abbott Real Time HCV Genotype II assay in HCV genotyping of HCV infected patients in Kayseri, Turkey.
  
  
  METHODS
  One hundred patients with chronic hepatitis C admitted to our hospital were evaluated between June 2012 and December 2012, HCV RNA levels were determined by the COBAS® AmpliPrep/COBAS® TaqMan® 48 HCV test. HCV genotyping was investigated by the Abbott Real Time HCV Genotype II assay. With the exception of genotype 1, subtypes of HCV genotypes could not be determined by Abbott assay. Sequencing analysis was used as the reference method.
  
  
  RESULTS
  Genotypes 1, 2, 3 and 4 were observed in 70, 4, 2 and 24 of the 100 patients, respectively, by two methods. The concordance between the two systems to determine HCV major genotypes was 100%. Of 70 patients with genotype 1, 66 showed infection with subtype 1b and 4 with subtype 1a by Abbott Real Time HCV Genotype II assay. Using sequence analysis, 61 showed infection with subtype 1b and 9 with subtype 1a. In determining of HCV genotype 1 subtypes, the difference between the two methods was not statistically significant (P>0.05). HCV genotype 4 and 3 samples were found to be subtype 4d and 3a, respectively, by sequence analysis. There were four patients with genotype 2. Sequence analysis revealed that two of these patients had type 2a and the other two had type 2b.
  
  
  CONCLUSIONS
  The Abbott Real Time HCV Genotype II assay yielded results consistent with sequence analysis. However, further optimization of the Abbott Real Time HCV Genotype II assay for subtype identification of HCV is required.
authors.affiliation: Fatma Mutlu Sariguzel, Department of Microbiology, Kayseri Education and Research Hospital, Kayseri, Turkey.
authors.forename: Fatma Mutlu
authors.initials: FM
authors.lastname: Sariguzel
authors.affiliation: Elife Berk, Department of Microbiology, Erciyes University Medical School, Kayseri, Turkey.
authors.forename: Elife
authors.initials: E
authors.lastname: Berk
authors.affiliation: Selma Gokahmetoglu, Department of Microbiology, Erciyes University Medical School, Kayseri, Turkey.
authors.forename: Selma
authors.initials: S
authors.lastname: Gokahmetoglu
authors.affiliation: Baris Derya Ercal, Department of Microbiology, Erciyes University Medical School, Kayseri, Turkey.
authors.forename: Baris Derya
authors.initials: BD
authors.lastname: Ercal
authors.affiliation: Ilhami Celik, Department of Infectious Diseases and Clinical Microbiology, Kayseri Education and Research Hospital, Kayseri, Turkey.
authors.forename: Ilhami
authors.initials: I
authors.lastname: Celik
keywords: Abbott RealTime HCV Genotype II assay; HCV genotypes; Sequencing