INTENDED USE

The HBsAg Rapid Test is a Chromatographic immunoassay (CIA) for direct qualitative detection of Hepatitis B type virus surface antigen (HBsAg) in human serum or plasma.

PRINCIPLE

The HBsAg RST is a chromatographic immunoassay (CIA) for the detection of surface antigens of Hepatitis B in human serum or plasma. Specific antibody against HBsAg is pre-coated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with other specific antibodies. If HBsAg present, a pink colored band will develop on the membrane in proportion to the amount of HBsAg presented in the specimen. Absence of this pink colored band in the test region s ests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence of HBsAg.

REAGENTS AND MATERIALS PROVIDED

1.One pouched cassette with desiccant.

2.One piece of operating instruction.