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 : 15 months at 2-8°C

Principle

1. 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.
2. 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.
3. 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.

Evaluations

WHO EVALUATION:The kit has been evaluated by WHO Collaborating Centres by using various panels from Latin America ,Asia, Europe &,African origin along with various sero -conversion panels from BBI including World wide performance panel and anti- HCV low titer performance panel. The Evaluation indicated the following results- Sensitivity 100% & Specificity 98.9%.

PATH USA:Evaluated by PATH USA,(199 reference specimens from US, Indonesia & India) indicated Sensitivity of 100 % & Specificity of 99.2 %.

AIIMS NEW DELHI:An evaluation by Department of Microbiology, All India Institute of Medical Sciences (AIIMS) New Delhi, INDIA (A national reference centre of Government of India) has indicated its Sensitivity 100% and Specificity 100%.

CMC VELLORE:An Evaluation by CMC Vellore (on reference panel of 100 Samples indicated Sensitivity 100 % & Specificity 100 %.

Approved by Drug Controller General of India( DCGI) for the usage in Blood Banks.

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