Intended Use:

Test for detection of Hepatitis B (HBsAg) in human serum and plasma samples.

Introduction:

Hepatitis B surface antigen (“Australis Antigen”) consists of lipid, carbohydrate and protein elements; the protein moiety provides a marker for identification of chronic, infectious HBV infections. Hepatitis B is transmitted sexually or intravenously and has an incubation period of six months. If not diagnosed properly and in time, it can develop into acute or chronic infection, liver cirrhosis and fulminant Hepatitis. This test is very useful for screening blood donors, to find out whether they are HBsAg positive before collection of blood.

Method Principal:

HBsAg card test utilizes the principle of immunochromatography, a unique assay based on antigen capture or sandwich principle. The method uses monoclonal antibody conjugated to colloidal gold and polyclonal antibodies immobilized on nitrocellulose strip in thin line. As the test sample flows through the membrane assembly of the test device, the coloured monoclonal anti-HBsAg-colloidal gold conjugate complexes with the HBsAg in the sample. This complex moves further on the membrane to the test region where it is immobilized by a polyclonal anti-HBsAg antiserum coated on the membrane leading to formation of a pink-purple coloured band. The formation of first purple band (T zone) confirms a positive test result. Absence of this coloured band in the test region indicates a negative test result. The unreacted conjugate and unbound complex, if any, move further on the membrane and are subsequently immobilized by the anti-rabbit IgG coated on the membrane at the control region, forming a pink-purple band. This control band serves to validate the test results.