Cyril C Y Yip1, Siddharth Sridhar2,3,4,5, John H N Lau1, Andrew K W Cheng1, Kit-Hang Leung2, Jonathan H K Chen1, Kwok-Hung Chan2, Vincent C C Cheng1, Kwok-Yung Yuen1,2,3,4,5,6. 1. Department of Microbiology, Queen Mary Hospital , Hong Kong Special Administrative Region, China. 2. Department of Microbiology, The University of Hong Kong , Hong Kong Special Administrative Region, China. 3. State Key Laboratory of Emerging Infectious Diseases, The University of Hong Kong , Hong Kong Special Administrative Region, China. 4. Research Centre of Infection and Immunology, The University of Hong Kong , Hong Kong Special Administrative Region, China. 5. Carol Yu Centre for Infection, The University of Hong Kong , Hong Kong Special Administrative Region, China. 6. Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Li Ka Shing Faculty of Medicine, The University of Hong Kong , Hong Kong Special Administrative Region, China.
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.
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.
Entities:
Keywords:
Hepatitis C virus; diagnostic test evaluation; genotype 6; genotyping; real-time RT-PCR