Comparative performance of two commercial sample-to-result systems for hepatitis C virus quantitation and genotyping. (1st December 2020)

• Record Type: Journal Article
• Authors: Yip, Cyril C. Y.; Sridhar, Siddharth; Lau, John H. N.; Cheng, Andrew K. W.; Leung, Kit-Hang; Chen, Jonathan H. K.; Chan, Kwok-Hung; Cheng, Vincent C. C.; Yuen, Kwok-Yung
• Is Part Of: Expert review of molecular diagnostics. Volume 20:Number 12(2020)
• Page Start: 1253
• Page End: 1258
• Publication Date: 2020-12-01
• Subjects: Hepatitis C virus -- real-time RT-PCR -- genotyping -- diagnostic test evaluation -- genotype 6; Molecular diagnosis -- Periodicals; 616.0758205
• DOI: 10.1080/14737159.2020.1820327
• Languages: English
• ISSNs: 1473-7159

Abstract

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 m 2000) 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 RealTi m e HCV assay (Abbott). For genotyping, the cobas HCV GT assay only showed moderate agreement with the RealTi m e HCV Genotype II assay (kappa = 0.550). The cobas assay outperformed the RealTi m e 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 RealTi m e HCV Genotype II assay.