Product Name                                             Hepacard 

Brand                                                        J MITRA & CO PVT LTD

Pack Size                                                      Catalog No.

20 Tests                                                         HB010020

100 Tests                                                       HB010100

200 Tests                                                        HB010200

Test Kit Type:                                               HBsAg Test Kit (Rapid)
Detects:                                                        All the 11 subtype of HBsAg
Sensitivity:                                                  100% by WHO Evaluation
Specificity:                                                   100% by PATH USA Evaluation

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-30 months at 2-30°C.
• WHO Evaluated with 100% Sensitivity.

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.

Evaluations

• PATH USA: Sensitivity 100% and Specificity 100% .
• DEPT. OF CLINICAL VIROLOGY, CMC VELLORE: Sensitivity 100% and Specificity 100%
• Approved By Drug Controller General Of India( DCGI) For use In Blood Banks.