https://scholars.lib.ntu.edu.tw/handle/123456789/581794
標題: | Clinical evaluation of IntelliPlexTM HCV genotyping kit for hepatitis C virus genotyping | 作者: | JIA-HORNG KAO Lin C.-Y. Chuang W.-L. Cheng Y.-Y. Hu J.-Y. Liang W.-K. Friebe P. Palmer S. Huang C.-S. |
關鍵字: | Genotype; HCV; IntelliPlex HCV genotyping kit; PlexBio; Sensitivity; Specificity | 公開日期: | 2019 | 出版社: | Elsevier Inc. | 卷: | 94 | 期: | 4 | 起(迄)頁: | 344-348 | 來源出版物: | Diagnostic Microbiology and Infectious Disease | 摘要: | Genotyping of the hepatitis C virus (HCV) is crucial for determining the most efficient anti-viral therapy. The clinical sensitivity and specificity of the IntelliPlexTM 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. ? 2019 Elsevier Inc. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85063980065&doi=10.1016%2fj.diagmicrobio.2019.02.020&partnerID=40&md5=54bddbf8dcac0bb04d4294ea052df39f https://scholars.lib.ntu.edu.tw/handle/123456789/581794 |
ISSN: | 0732-8893 | DOI: | 10.1016/j.diagmicrobio.2019.02.020 | SDG/關鍵字: | antiviral therapy; article; clinical evaluation; clinical laboratory; controlled study; diagnostic test accuracy study; genotype; Hepatitis C virus; human tissue; in vitro study; nonhuman; Sanger sequencing; sensitivity and specificity; virus load; diagnostic kit; evaluation study; genetics; genotype; genotyping technique; Hepacivirus; hepatitis C; human; virology; virus RNA; Genotype; Genotyping Techniques; Hepacivirus; Hepatitis C; Humans; Reagent Kits, Diagnostic; RNA, Viral; Sensitivity and Specificity; Viral Load |
顯示於: | 臨床醫學研究所 |
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