For the qualitative detection of Hepatitis B surface antigen in serum or plasma.

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 suggests 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.

WARNING AND PRECAUTIONS

1.          FOR IN VITRO DIAGNOSTIC USES ONLY

2.          All patient samples should be treated as if capable of transmitting diseases.

3.          Do not interchange reagents from different lots or use test kit beyond expiration date.

4.          Icteric, lipemic, hemolysed, heat treated and ontaminated sera may cause erroneous results.

STORAGE

The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24 months).

INTERPRETATION OF RESULTS

Negative: No band in the test region (T), only one pink band appears in the control region (C). This indicates that no HBsAg have been detected.

Positive: In addition to the band in the control region (C), another pink band will appear in the test region (T). This indicates that the specimen contains HBsAg.

Invalid: If no band appears in the control region(C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.

LIMITATION OF THE PROCEDURE

1.  The test is to be used for the qualitative detection of HBsAg.

2.  A negative result does not rule out infection by Hepatitis B because the HBsAg may not be present in sufficient quality.