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Journal of Clinical Microbiology, April 2007, p. 1140-1145, Vol. 45, No. 4
0095-1137/07/$08.00+0     doi:10.1128/JCM.01982-06
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Improvement of Hepatitis C Virus (HCV) Genotype Determination with the New Version of the INNO-LiPA HCV Assay{triangledown}

Françoise Bouchardeau,1 Jean François Cantaloube,2 Stéphane Chevaliez,3 Christine Portal,1 Annie Razer,1 Jean-Jacques Lefrère,4 Jean Michel Pawlotsky,3 Philippe De Micco,2 and Syria Laperche1*

Centre National de Référence pour les Hépatites B et C en Transfusion, Laboratoire d'Expertise en Virologie, Institut National de la Transfusion Sanguine, Paris, France,1 Unité des Virus Émergents EA3292, Etablissement Français du Sang Alpes-Méditerranée, Marseille, France,2 Centre National de Référence des Hépatites B, C, et Delta, Laboratoire de Virologie and INSERM U635, Hôpital Henri Mondor, Université Paris 12, Créteil, France,3 Département des Agents Transmissibles par le Sang, Institut National de la Transfusion Sanguine, Paris, France4

Received 25 September 2006/ Returned for modification 12 November 2006/ Accepted 13 January 2007

Hepatitis C virus (HCV) isolates have been classified into six main genotypes. Genotyping methods, and especially the widely used line probe assay (LiPA), are frequently based on the 5'-untranslated region (5'UTR). However, this region is not appropriate for discriminating HCV strains at the subtype level and for distinguishing many genotype 6 samples from genotype 1. We investigated the capacity of a novel LiPA (Versant HCV Genotype 2.0 assay) based on the simultaneous detection of 5'UTR and Core regions for genotypes 1 and 6 to provide correct HCV genotypes (characterized with a phylogenetic analysis) in a set of HCV strains mainly encountered in Western countries. The improvement was assessed by comparing the results to those obtained with the previous version of the assay. Of the 135 tested samples, 64.7% were concordant for genotype group and subtype with sequencing reference results using the Versant HCV Genotype 2.0 assay versus 37.5% with the previous version. The yield was mainly related to a better characterization of genotype 1, since the accuracy, tested in 62 genotype 1 samples, increased from 45.2% with the first version to 96.8% with the new one. However, this new version necessitates a specific PCR and could no longer be used after 5'UTR PCR used for current HCV infection diagnosis. Moreover, the information provided by 5'UTR hybridization is not reliable for correctly identifying the diversity within genotypes 2 and 4. Thus, the Versant HCV Genotype 2.0 assay remains a useful tool for clinical practice when only the discrimination between major HCV genotypes is necessary.


* Corresponding author. Mailing address: Institut National de la Transfusion Sanguine, 6 Rue Alexandre-Cabanel, 75015 Paris, France. Phone: 44 49 30 52. Fax: 44 49 30 59. E-mail: slaperche{at}ints.fr

{triangledown} Published ahead of print on 24 January 2007.


Journal of Clinical Microbiology, April 2007, p. 1140-1145, Vol. 45, No. 4
0095-1137/07/$08.00+0     doi:10.1128/JCM.01982-06
Copyright © 2007, American Society for Microbiology. All Rights Reserved.




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