Intended Use
The 4th Generation HCV TRI-DOT is a rapid, visual, sensitive and qualitative in vitro diagnostic test for the detection of (IgM,IgG & IgA) antibodies to Hepatitis C virus in human serum or plasma.
It has been developed and designed with increased sensitivity for core and NS3 antibodies using a unique combination of modified HCV antigen.
Salient Features
- Based on “Flow Through Technology”, which is similar to Elisa technology because of involvement of washing steps at various levels to enhance the specificity.
- Use of highly purified HCV antigens for Core, NS3, NS4, NS5 immobilized on the device.
- Detection of all the subtypes of HCV.
- Results within 3 minutes.
- In built quality control dot which validates the test.
- 100% Sensitivity & 98.9% Specificity as per WHO evaluation.
- Shelf life : 24 months at 2-8°C
Principle
- HCV antigens are immobilized on a porous immunofiltration membrane. Sample and the reagents pass through the membrane and are absorbed into the underlying absorbent pad.
- As the patient’s sample passes through the membrane, HCV antibodies if present in serum/plasma, bind to the immobilized antigens. In the subsequent washing step, unbound serum/ plasma proteins are removed.
- In the next step, the protein-A conjugate is added which binds to the Fc portion of the HCV antibodies to give distinct pinkish purple dot against a white background at the test region (“T1” &/or “T2”). At the control region (“C”) a “Built-in Quality Control Dot” has been devised to confirm the proper functioning of the device, reagent and correct procedural application.
Additional Information:
