RevoDx HCV Genotyping qPCR Kit V01

The HCV genome exhibits significant genetic variability, which has lead to its classification into seven genotypes and multiple subtypes within each genotype. 1a and 1b genotypes are the most prevalent ones in the Western Europe and United States then 2 and 3 genotypes come next in the order. While genotype 4 is widespread in Egypt, genotype 5 is common in South Africa, and genotype 6 is in Southeast Asia. In patients from Canada and Belgium, another seventh genotype has also been identified. HCV genotype 1b is predominant in Turkey.
Hepatitis C Virus genotyping is a key component of proper clinical hepatitis C management. Genotyping, which includes at least subtyping that differentiates 1a and 1b subtypes, needs to be performed before starting antiviral therapy because choice of direct antiviral agents and treatment duration are directly influenced by HCV genotype. Treatment success and patient cure rates greatly depend on correct HCV genotype identifications. Genotyping may also provide insights into molecular epidemiology studies to know the HCV distribution across the world.

Intended Use

 RevoDx HCV Genotyping qPCR Kit is an in vitro nucleic acid amplification test for detection and differentiation of the genotypes of Hepatitis C virus (HCV) RNA in human serum or plasma. RevoDx HCV Genotyping qPCR Kit can identify HCV genotypes 1a, 1b, 2, 3, 4, 5 and 6. RevoDx HCV Genotyping qPCR Kit is intended to assist in the management of patients with chronic HCV infection and to form a strategy for anti-viral therapy in conjunction with all relevant clinical and laboratory findings. RevoDx HCV Genotyping qPCR Kit is not intended to screen blood and blood products for the presence of HCV RNA or to confirm the diagnosis of infection with HCV.