Clinical evaluation of IntelliPlex TM HCV genotyping kit for hepatitis C virus genotyping

Genotyping of the hepatitis C virus (HCV) is crucial for determining the most efficient anti-viral therapy. The clinical sensitivity and specificity of the IntelliPlex HCV Genotyping Kit was determined by comparing the assay results of 307 specimens with the results obtained by Sanger sequencing. Ou...

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Bibliographic Details
Published inDiagnostic microbiology and infectious disease
Main Authors Kao, Jia-Horng, Lin, Chun-Yen, Chuang, Wan-Long, Cheng, Yao-Yun, Hu, Jui-Yu, Liang, Wen-Kai, Friebe, Peter, Palmer, Stuart, Huang, Chin-Shiou
Format Journal Article
LanguageEnglish
Published United States 12.03.2019
Subjects
Sensitivity
Specificity
IntelliPlex HCV genotyping kit
Genotype
HCV
PlexBio
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Summary:Genotyping of the hepatitis C virus (HCV) is crucial for determining the most efficient anti-viral therapy. The clinical sensitivity and specificity of the IntelliPlex HCV Genotyping Kit was determined by comparing the assay results of 307 specimens with the results obtained by Sanger sequencing. Out of 202 HCV-positive specimens tested, 8 samples yielded discrepant results between the IntelliPlex HCV Genotyping Kit and Sanger sequencing. For 5 of these discrepant samples, the IntelliPlex HCV Genotyping Kit classified the correct genotype but failed to show the same single or dual infected status as determined by Sanger sequencing. A total of 105 samples which tested negative for HCV by In-Vitro-Diagnostics (IVD)-approved viral load assay tested negative for HCV by the IntelliPlex HCV Genotyping Kit. The IntelliPlex HCV Genotyping Kit has a clinical specificity of 100% and a clinical sensitivity of 96.9% and is suited to be used in clinical laboratories to genotype HCV.
ISSN:1879-0070