SHINJIN MEDICS INC.

The Hepatitis B Surface Antigen Test (Whole Blood/Serum/Plasma) is a rapid detection of Hepatitis B Surface Antigen in whole blood, serum or plasma.
For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

INTRODUCTION

Hepatitis B Surface Antigen is the coat protein of Hepatitis B,it does not have infectivity. It is often associated with the presence of hepatitis b virus, so it is a sign of infected with hepatitis B virus. In a typical Hepatitis B infection, HBsAg will be detected 2 to 4 weeks before the ALT level becomes abnormal and 3 to 5 weeks before symptoms or jaundice develop. HBsAg has four principal subtypes: adw, ayw, adr and ayr. Because of antigenic heterogeneity of the determinant, there are 10 major serotypes of Hepatitis B virus. The test utilizes acombination of monoclonal antibodies to selectively detect elevated levels of HBsAg in whole blood, serum or plasma.

PRINCIPLE OF THE ASSAY

The Hepatitis B Surface Antigen Test (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay based on the principle of the double antibody–sandwich technique. The membrane is pre-coated with anti-HBsAg antibodies on the test line region of the test.While detecting a positive sample, HBsAg in the specimen (whole blood, serum or plasma) reacts with the particle coated with anti-HBsAg antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-HBsAg antibodies on the membrane and generate a coloured line. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result.To serve as a procedural control, a colored line will always appear in the control line region indicating that the proper volume of specimen has been added and membrane wicking has occurred.