Comparative performance of two commercial sample-to-result systems for hepatitis C virus quantitation and genotyping

Cyril C.Y. Yip; Siddharth Sridhar; John H.N. Lau; Andrew K.W. Cheng; Kit Hang Leung; Jonathan H.K. Chen; Kwok Hung Chan; Vincent C.C. Cheng; Kwok Yung Yuen

doi:10.1080/14737159.2020.1820327

Comparative performance of two commercial sample-to-result systems for hepatitis C virus quantitation and genotyping

Cyril C.Y. Yip, Siddharth Sridhar, John H.N. Lau, Andrew K.W. Cheng, Kit Hang Leung, Jonathan H.K. Chen, Kwok Hung Chan, Vincent C.C. Cheng, Kwok Yung Yuen

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

5 Citations (Scopus)

Abstract

Objectives: Accurate assays for hepatitis C virus (HCV) quantitation and genotyping are important for the management of HCV infection. In this study, we evaluated the performance of cobas HCV and cobas HCV GT assays (Roche) for HCV quantitation and genotyping on the cobas 4800 System. Methods: We compared the performance of the cobas HCV assays with another commercial system (Abbott m2000) using a panel of well-characterized patient samples and proficiency testing samples. Results: The limit-of-detection of the cobas HCV assay in our center was higher (15 IU/mL) than the manufacturer claim (9.2 IU/mL). The assay showed high analytical specificity, accuracy, precision, and linearity. Performance was congruent with the RealTime HCV assay (Abbott). For genotyping, the cobas HCV GT assay only showed moderate agreement with the RealTime HCV Genotype II assay (kappa = 0.550). The cobas assay outperformed the RealTime assay for typing HCV genotypes 1b and 6 (p = 0.033). Conclusion: Our results confirm that the cobas 4800 System is a reliable platform for HCV quantitation and genotyping. The cobas HCV GT assay is a good choice for genotype 1b/6 endemic areas in east Asia, clearly outperforming the RealTime HCV Genotype II assay.

Original language	English
Pages (from-to)	1253-1258
Number of pages	6
Journal	Expert Review of Molecular Diagnostics
Volume	20
Issue number	12
DOIs	https://doi.org/10.1080/14737159.2020.1820327
Publication status	Published - 2020
Externally published	Yes

Bibliographical note

Publisher Copyright:
© 2020 Informa UK Limited, trading as Taylor & Francis Group.

ASJC Scopus Subject Areas

Pathology and Forensic Medicine
Molecular Medicine
Molecular Biology
Genetics

Keywords

diagnostic test evaluation
genotype 6
genotyping
Hepatitis C virus
real-time RT-PCR

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10.1080/14737159.2020.1820327

Cite this

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title = "Comparative performance of two commercial sample-to-result systems for hepatitis C virus quantitation and genotyping",

abstract = "Objectives: Accurate assays for hepatitis C virus (HCV) quantitation and genotyping are important for the management of HCV infection. In this study, we evaluated the performance of cobas HCV and cobas HCV GT assays (Roche) for HCV quantitation and genotyping on the cobas 4800 System. Methods: We compared the performance of the cobas HCV assays with another commercial system (Abbott m2000) using a panel of well-characterized patient samples and proficiency testing samples. Results: The limit-of-detection of the cobas HCV assay in our center was higher (15 IU/mL) than the manufacturer claim (9.2 IU/mL). The assay showed high analytical specificity, accuracy, precision, and linearity. Performance was congruent with the RealTime HCV assay (Abbott). For genotyping, the cobas HCV GT assay only showed moderate agreement with the RealTime HCV Genotype II assay (kappa = 0.550). The cobas assay outperformed the RealTime assay for typing HCV genotypes 1b and 6 (p = 0.033). Conclusion: Our results confirm that the cobas 4800 System is a reliable platform for HCV quantitation and genotyping. The cobas HCV GT assay is a good choice for genotype 1b/6 endemic areas in east Asia, clearly outperforming the RealTime HCV Genotype II assay.",

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author = "Yip, {Cyril C.Y.} and Siddharth Sridhar and Lau, {John H.N.} and Cheng, {Andrew K.W.} and Leung, {Kit Hang} and Chen, {Jonathan H.K.} and Chan, {Kwok Hung} and Cheng, {Vincent C.C.} and Yuen, {Kwok Yung}",

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doi = "10.1080/14737159.2020.1820327",

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AU - Yip, Cyril C.Y.

AU - Sridhar, Siddharth

AU - Lau, John H.N.

AU - Cheng, Andrew K.W.

AU - Leung, Kit Hang

AU - Chen, Jonathan H.K.

AU - Chan, Kwok Hung

AU - Cheng, Vincent C.C.

AU - Yuen, Kwok Yung

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AB - Objectives: Accurate assays for hepatitis C virus (HCV) quantitation and genotyping are important for the management of HCV infection. In this study, we evaluated the performance of cobas HCV and cobas HCV GT assays (Roche) for HCV quantitation and genotyping on the cobas 4800 System. Methods: We compared the performance of the cobas HCV assays with another commercial system (Abbott m2000) using a panel of well-characterized patient samples and proficiency testing samples. Results: The limit-of-detection of the cobas HCV assay in our center was higher (15 IU/mL) than the manufacturer claim (9.2 IU/mL). The assay showed high analytical specificity, accuracy, precision, and linearity. Performance was congruent with the RealTime HCV assay (Abbott). For genotyping, the cobas HCV GT assay only showed moderate agreement with the RealTime HCV Genotype II assay (kappa = 0.550). The cobas assay outperformed the RealTime assay for typing HCV genotypes 1b and 6 (p = 0.033). Conclusion: Our results confirm that the cobas 4800 System is a reliable platform for HCV quantitation and genotyping. The cobas HCV GT assay is a good choice for genotype 1b/6 endemic areas in east Asia, clearly outperforming the RealTime HCV Genotype II assay.

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Comparative performance of two commercial sample-to-result systems for hepatitis C virus quantitation and genotyping

Abstract

Bibliographical note

ASJC Scopus Subject Areas

Keywords

Access to Document

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