Intended Use:
This test is used for the qualitative detection of Human Immunodeficiency Virus in
serum/plasma samples. It can be used to screen for HIV in the scene for blood
donation and for in vitro diagnostic use.
Principle of the Procedure:
This product uses colloidal gold immunochromatography to detect HIV1/2
antibodies in serum/plasma samples qualitatively.During the detection,HIV
antibodies in the samples combine with colloidal gold-labeled antigens 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 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. The transfer pipette should be used for one specimen only. Discard it after used.
6. Patient specimens, used strip and transfer pipettes may be potentially infectious. Proper handling and disposal methods should be established by the laboratory direction in accordance with local regulations.
7. Proper laboratory safety techniques should be followed at all times when working with potentially infectious blood specimens
