Clinical evaluation of IntelliPlexTM HCV genotyping kit for hepatitis C virus genotyping

Jia Horng Kao; Chun Yen Lin; Wan Long Chuang; Yao Yun Cheng; Jui Yu Hu; Wen Kai Liang; P. Friebe; Stuart Palmer; Chin Shiou Huang

doi:10.1016/j.diagmicrobio.2019.02.020

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

Jia Horng Kao, Chun Yen Lin, Wan Long Chuang, Yao Yun Cheng, Jui Yu Hu, Wen Kai Liang, P. Friebe^*, Stuart Palmer, Chin Shiou Huang

^*Corresponding author for this work

Research output: Contribution to journal › Journal Article › peer-review

5 Scopus citations

Abstract

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^TM 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.

Original language	English
Pages (from-to)	344-348
Number of pages	5
Journal	Diagnostic Microbiology and Infectious Disease
Volume	94
Issue number	4
DOIs	https://doi.org/10.1016/j.diagmicrobio.2019.02.020
State	Published - 08 2019
Externally published	Yes

Bibliographical note

Publisher Copyright:
© 2019 Elsevier Inc.

Keywords

Genotype
HCV
IntelliPlex HCV genotyping kit
PlexBio
Sensitivity
Specificity

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.diagmicrobio.2019.02.020

Cite this

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title = "Clinical evaluation of IntelliPlexTM HCV genotyping kit for hepatitis C virus genotyping",

abstract = "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.",

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author = "Kao, {Jia Horng} and Lin, {Chun Yen} and Chuang, {Wan Long} and Cheng, {Yao Yun} and Hu, {Jui Yu} and Liang, {Wen Kai} and P. Friebe and Stuart Palmer and Huang, {Chin Shiou}",

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year = "2019",

month = aug,

doi = "10.1016/j.diagmicrobio.2019.02.020",

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AU - Kao, Jia Horng

AU - Lin, Chun Yen

AU - Chuang, Wan Long

AU - Cheng, Yao Yun

AU - Hu, Jui Yu

AU - Liang, Wen Kai

AU - Friebe, P.

AU - Palmer, Stuart

AU - Huang, Chin Shiou

PY - 2019/8

Y1 - 2019/8

N2 - 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.

AB - 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.

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KW - HCV

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