specificity in identifying HCV genotype - not less than 99%
subtype specificity in identifying HCV - not less than 95%
analytical sensitivity - 500 genome equivalents of HCV RNA.
Reagent kit for the determination of genotype and subtype of hepatitis C virus by hybridization on a biological microchip (HCV-Biochip) designed to identify six genotypes (1-6) and 36 subtypes (1a, 1b, 1c, 1d, 1e, 2a, 2b, 2c, 2d, 2i, 2j, 2k, 2l, 2m, 3a, 3b, 3k, 4a, 4c, 4d, 4f, 4h, 4i, 4k, 4n, 4o, 4p, 4r, 4t, 5a, 6a, 6b, 6d, 6g, 6h, 6k) of hepatitis C virus
An important feature of hepatitis C virus (HCV) is its extremely high variability due to the formation of a large number of different genotypes and subtypes, which are not always distinguishable immunological methods and are characterized by different degree of virulence and resistance to the therapeutic drug (ribavirin, interferon) that necessitates selective individual approach to the choice of therapy. According to a modern classification, the reflecting clinical features of the disease, HCV proposed differentiate into 6 main genotypes subdivided into more than 70 subtypes, designated Latin letters in the order of their opening (1a, 1b, 2a, 2b, 2c, 3a, 4a, etc. ).
Identification of genotype and subtype of HCV is a clinically important problem and is used for direct determination of the duration and type of antiviral therapy. Adequacy and duration of therapy, and hence the cost of treatment, are directly dependent on the HCV species determined.
Work test system is based on the analysis of the nucleotide sequence of NS5B region of the HCV genome.