Intended Use

Hepacard is visual, rapid, sensitive and accurate one step immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg) in Human serum or plasma.The assay is intended to be used as an aid in the recognition and diagnosis of acute infections and chronic infectious carriers of the Hepatitis B Virus(HBV).

Salient Features

• Detects all the 11 subtype of HBsAg.
• Antigen Sensitivity- 0.5 ng/ml.
• No sample preparation required.
• See through Device for easy result interpretation.
• Shelf life-24 months at 2-30°C.
• 100% Sensitivity & 98.0% Specificity by WHO Evaluation.

Principle

HEPACARD is a one-step immunoassay based on the antigen capture, or “sandwich” principle. The method uses monoclonal antibodies conjugated to colloidal gold and polyclonal antibodies immobilized on a nitrocellulose strip in a thin line. The test sample is introduced to and flows laterally through an absorbent pad where it mixes with the signal reagent. If the sample contains HBsAg, the collodial gold-antibody conjugate binds to the antigen, forming an antigen-antibody-collodial gold complex. The complex then migrates through the nitrocellulose strip by capillary action. When the complex meets the line of immobilized antibody(Test line) “T”, the complex is trapped forming an antibody-antigen-antibody colldial gold complex.

This forms a pink band indicating the sample is reactive for HBsAg. To serve as a procedural control, an additional line of anti-mouse antibody (Control line) “C”, has been immobilized at a distance from the test line on the strip. If the test is performed correctly, this will result in the formation of a pink band upon contact with the conjugate.

valuations

• WHO Evaluation: Sensitivity 100% And Specificity 99.4% .
• PATH 8USA: Sensitivity 100% And Specificity 100% .
• DEPT. OF CLINICAL VIROLOGY, CMC VELLORE: In This Evaluation Of 90 Samples The
• Sensitivity Obtained Was 100% And Specificity 100% .
• University Of Madras: In This Evaluation The Sensitivity Obtained Was 100% And Specificity 100% .
• Approved By Drug Controller General Of India( DCGI) For The Usage In Blood Banks.