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  • Our data demonstrate that cobas HCV s performance characteri

    2022-05-23

    Our data demonstrate that cobas HCV’s performance characteristics meet these requirements, making the assay useful in the management of therapy for chronic hepatitis C. We documented that cobas HCV has the requisite LOD, measureable range (15 − 1.0E + 08 IU/mL) and precision allowing for baseline HCV RNA determination, therapeutic response monitoring, and SVR documentation with a single test. To demonstrate cobas HCV’s utility as a monitoring tool in GT 1 therapy, our study incorporated testing of samples drawn during treatment of previously refractory subjects with DAA regimens that are pharmacologically analogous to [14], but less effective than drugs that are currently approved and recommended for treatment. Likewise, for GT 2 and GT 3, we characterized VR to pegIFN/RBV, which is inferior in efficacy to currently recommended DAAs for these genotypes. This design allowed for characterization of a range of on-treatment PPVs and NPVs, which followed expected trends. Inclusion of currently recommended, highly potent regimens likely would have yielded PPV’s of 100% and NPV’s that were either incalculable or 0%. The lack of available samples from patients undergoing treatment for GT 4–6 precluded determination of therapeutic monitoring efficacy for these less common genotypes. In summary, the cobas HCV test is a state-of-the-art quantitative HCV RNA test with performance characteristics suitable for the diagnosis and therapeutic management of chronic hepatitis C in the DAA era. The test is performed on cobas 6800 or 8800 systems, new generation, high throughput instrumentation with operational characteristics (primary tube testing, multiple validated tube types, and sample-to-result total automation) that can maximize laboratory operational efficiency and service [15].
    Funding This study was supported and funded by Roche Molecular Systems.
    Competing interests
    Ethical approval
    Author contributions
    Acknowledgments
    Introduction Hepatitis C PH-797804 (HCV) infection is an important health problem both in Brazil and worldwide because a considerable number of infected patients progresses to chronic liver diseases (cirrhosis and hepatocellular carcinoma) and require liver transplantation. In Brazil, mandatory notification of HCV infection has been implemented since 1998. From 1999 to 2015, the Brazilian Ministry of Health (MH) recorded 289,459 cases, 64.2% of which occurred in the southeast region. In addition, a cross-sectional population-based survey conducted in Brazil from 2005 to 2009 revealed an overall prevalence of 1.38% and estimated 1.3 million HCV-infected individuals in the country. Associations between HCV infection and old age, injected-drug use, sniffed-drug use, hospitalization, lack of sewage disposal, and injection with glass syringes have been described, and these associations depend on the socio-demographic characteristics of patients and regions. Located in the southeast region, São Paulo is the most populous and wealthy state in Brazil, where HCV has been detected in 0.9% of individuals aged 10–19 years, and in 1.63% of those aged 20–69 years. HCV-infected patients are reported to the Brazilian MH, which provides free universal access to treatment, HCV genotyping and viral load determination. Furthermore, the Brazilian MH recommends that HCV loads be measured for diagnosis confirmation and after six months of follow-up. Moreover, in patients without spontaneous HCV clearance and/or in those who have started treatment, genotyping and subsequent viral load measurements are recommended four times a year. Human T-cell lymphotropic virus types 1 and 2 (HTLV-1 and HTLV-2) are endemic in Brazil, with an estimated 2.5 million individuals infected with HTLV. HTLV-1 is associated with at least two diseases of high morbidity and mortality: adult T-cell leukemia/lymphoma (ATLL) and HTLV-1-associated myelopathy/tropical spastic paraparesis (HAM/TSP). Despite their endemicity and high morbidity, HTLV-1 or HTLV-2 notification is not compulsory in Brazil.