Intended Use:
This test is used for the qualitative detection of Antibody to Hepatitis B Surface
Antigen (HBsAb )in serum/plasma samples. It can be used to screen for HBsAb in
the scene for blood donation and for in vitro diagnostic use.
Principle of the Procedure:
This product uses colloidal gold immunochromatography to detect HBsAb in
serum/plasma samples qualitatively. During the detection, HBsAb in the samples
combine with colloidal gold-labeled recombinant antigens (Au-sAg) and then form
antigen-antibody complexes (Au-sAg-sAb). 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 antigens 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
