Intended Use:

Test for detection of Hepatitis C virus in human serum and plasma samples.

Introduction:

Hepatitis C Virus (HCV) is a small, enveloped positive-sense, single-stranded RNA Virus. HCV is now known to be the major cause of parenterally transmitted non-A, non-B hepatitis. Antibody to HCV is found in over 80% of patients with well-documented non-A, non-B hepatitis. On the basis of Phylogenetic analysis, HCV has been grouped into six major genotypes each of which contains one or more subtypes. The first-generation HCV antibody test became in early 1990s and was widely used more recombinant antigen. Third generation assays were introduced recombinant NS5 antigen in the late 1990s. The first, second and third generation HCV antibodies assays still lack sensitivity in seroconversion or show inexplicable discrepancies with confirmatory assay. To solve this problem, fourth generation assays using antigen from multiple HCV genotype that includes genotypes 2 & 3 apart from Genotype 1 containing universal conserved epitopes, are been developed ad evaluated.

Method Principal:

Card test for HCV utilizes the principle of immunochromatography. The method uses multiple epitope HCV recombinant peptide conjugated to colloidal gold and immobilized on nitrocellulose strip in thin line. As the test sample flows through the membrane assembly of the test device, the coloured multiple epitope HCV recombinant peptide gold conjugate complexes with the HCV Ab in the sample. This complex moves further on the membrane to the test region where it is immobilized by a multiple epitope HCV recombinant peptide coated on the membrane leading to formation of a pink-purple coloured band. The formation of first purple band (T zone) confirms a positive test result. Absence of this coloured band in the test region indicates a negative test result. To serve as a procedural control, a coloured line will always appear at the control line region if the test has been performed properly.