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Help CenterOne Step Test for Hepatitis B Surface Antibody
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One Step Test for Hepatitis B Surface Antibody
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.
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