| Intended Use |
One step qualitative immunochromatographic assay for detection of antibodies against HCV in human serum, plasma and whole blood |
| Principle |
Double Antigen Sandwich site Immunoassay |
| Technique |
Lateral Flow(ICT) |
| Detection |
Antibodies to HCV (IgM, IgG and IgA) |
| Capture |
Recombinant antigens – Core, NS3, NS4 and NS5 |
| Conjugate |
Recombinant antigens – Core, NS3, NS4 and NS5 coupled with colloidal gold |
| Type of Specimen required |
Serum, Plasma and Whole blood |
| Specimen Volume |
10 ml for Serum and Plasma; 20 ml for whole blood |
| Result interpretation time |
20 mintutes |
| Diagnostic Sensitivity |
> 99.5% |
| Diagnostic Specificity |
> 99% |
| Evaluations |
National Institute of Biologicals |
