title: Validation of a solid-phase electrochemical array for genotyping hepatitis C virus.
abstract: Hepatitis C viral infection is a major cause of progressive liver disease. HCV genotype is one of the most significant baseline predictors of response to HCV antiviral therapy. The objective was to evaluate an HCV genotyping method that targets the 5'-untranslated region (UTR) to detect genotypes/subtypes using the GenMark eSensor® XT-8 system. The HCV amplicon of major genotypes/subtypes from the Roche TaqMan® HCV assay served as a template for the nested PCR followed by a direct analysis on the XT-8 detection system. The assay was validated for limit of detection (LOD), specificity, accuracy and precision. The LOD determined was below 175 IU/ml for all the subtypes except 6ab. The genotypes detected using this assay were in concordance with the LiPA assay. The high performance characteristics (LOD, specificity, intra- and inter-assay precision, and accuracy), make this assay particularly well suited for clinical HCV genotyping in order to guide antiviral therapy.
authors.affiliation: Department of Pathology, Dartmouth-Hitchcock Medical Center, Lebanon, NH 03756, USA. Soya.S.Sam@hitchcock.org
authors.forename: Soya S
authors.initials: SS
authors.lastname: Sam
authors.forename: Heather B
authors.initials: HB
authors.lastname: Steinmetz
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Tsongalis
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Tafe
authors.forename: Joel A
authors.initials: JA
authors.lastname: Lefferts
mesh_terms: D020121:5' Untranslated Regions; D004563:Electrochemistry / Q000379:methods*; D060005:Genotyping Techniques / Q000379:methods*; D016174:Hepacivirus / Q000235:genetics*; D006526:Hepatitis C / Q000821:virology; D006801:Humans; D057230:Limit of Detection; D012680:Sensitivity and Specificity
chemical_list: D020121:5' Untranslated Regions
keywords: Genotyping; HCV infection; Viral load; eSensor XT-8 system