Intended Use:
This product is used for the qualitative detection of Hepatitis B Surface Antigen (HBsAg) in
serum/plasma samples. It can be used to screen for HBsAg in the scene for blood donation and
detect HBsAg before clinical emergency operation.
Principle of the Procedure:
This product uses colloidal gold immunochromatography to detect HBsAg in serum/plasma
samples qualitatively.The antigens HBsAg in the blood sample combine with colloidal gold-labeled
recombinant antibodies (Au-sAb1), and then form antigen-antibody complexes. The sample
passes through the detection zone, in which the sandwich complexes gather along a line,
appearing as a purplish red streak (the test or signal line). Excess gold-labeled antibodies gather
along the control line, signaling visually that the test is valid.
Warnings and Precautions:
1. Use for in vitro diagnostics.
2. Use by healthcare professionals.
3. Do not use the strip beyond the expiration date printed on the outside of the box.
4. The strip must be used within 1 hour once its foil pouch has been opened.
5. Patient specimens and used strip may be potentially infectious. Proper handling and disposal methods should be established by the laboratory direction in accordance with local regulations.
6. Proper laboratory safety techniques should be followed at all times when working with potentially infectious blood specimens.
