Hep C point of care test.
New Hep C point of care test launched.
INTENDED USE
The MHS HCV test is a rapid, fourth generation, qualitative Immuno-assay for detection of antibodies to Hepatitis C virus (HCV) in human serum / plasma. The test employs a cocktail of genotype cross-reactive recombinant antigens derived from the core, NS3, NS4, and NS5 regions of multiple HCV genotypes.
HCV test summary and explanation.
HCV is a single-stranded RNA virus containing a linear genome with a length of about 9,600 nucleotides with positive polarity. It is now recognized that HCV Infection is the major etiological agent of post transfusion hepatitis type non-A, non-B. HCV Infection frequently progresses to chronic liver disease. On the basis of phylogenetic analysis, HCV has been grouped into six major genotypes, each of which contains one or more subtypes. The distribution of HCV genotypes varies in different geographical areas.
The first and second generation HCVtest
The first generation antibody test became commercially available in early 1990s and was widely used. As more reactive recombinant antigens were identified from conserved regions of the HCV genome, newer serologic assays were introduced.
Third generation HCV Test
Third-generation assays were introduced in the late 1990s. In these assays, a recombinant NS5 antigen has been added to the antigens used in the second-generation assays. These third-generation assays have higher sensitivities and specificities than second-generation assays and are much less strongly influenced by the Infecting genotype.
The first, second and third generation HCV antibody assays still lack sensitivity in seroconversions or show inexplicable discrepancies with confirmatory assays. This is primarily due to poor cross-reactivity with the current HCV genotype 1 antigen-based assays. To solve this problem fourth generation assays using antigens from multiple HCV genotypes that includes genotypes 2 & 3 apart from genotype 1, containing universally conserved epitopes, are been developed and evaluated.
Fourth generation HCV Test
The MHS Hep C test is a fourth generation assay that uses a cocktail of recombinant antigens that is broadly cross-reactive to all major HCV genotypes. The antigens are derived from multiple HCV genotypes apart from genotype -1.
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