Diagnos HCV BI-DOT

Intended Use

The 4th Generation DIAGNOS HCV BI-DOT is a visual, rapid, sensitive and qualitative in vitro diagnostic test for the detection of (IgM,IgG & IgA) antibodies to Hepatitis C Virus in human serum or plasma. The 4th Generation DIAGNOS HCV BI-DOT has been developed and designed with increased sensitivity for core and NS3 antibodies using a unique combination of modified HCV antigens.

Salient Features

• Rapid ,visual 4th generation test.
• Based on Flow Through Technology.
• Use of unique combination of Core, NS3, NS4, NS5 antigen.
• Detects all the subtypes of HCV.
• Result with in 3 min.
• Shelf life : 24 months at 2-8°C.
• Sensitivity- 100 %.
• Specificity- 99.8 %.

Principle

HCV antigens are immobilized on a porous immunofilteration membrane. Sample and 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 immoobilized 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 “T”. At the control region (“C”) a built- in Quality Control dot” has been devised to confirm the proper function of the device, reagent and correct procedural application.

Ordering Information

Evaluations

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