Principle
COVID-19（SARS-CoV-2）IgG/IgM Test is the colloidal gold labeled rabbit IgG
and the novel coronavirus (COVID-19) antigen, while the nitrocellulose membrane
is coated with anti-human IgG and IgM and sheep anti-rabbit IgG combined to
form a band. The principle of colloidal gold immunochromatography indirect
method is used to detect the novel coronavirus (COVID-19) IgG/IgM antibody in
human serum.
Warnings and Precautions
1. For in vitro diagnostic use only. Operation should be carried out in strict
accordance with the instructions, do not use expired or damaged products.
2. Only the diluent in the package can be used, and diluent in different batches
cannot be mixed.
3. Do not use tap water, purified water and distilled water as negative controls.
4. The test device should be used within 1 hour after unsealing. If the ambient
temperature is higher than 30°C or more humid, use immediately after tearing.
5. If there is no liquid migration in the test window within 30 seconds after adding
the detection solution, add another 1 drop of detection solution.
6. Pay attention to the possibility of virus infection when collecting specimens,
wear disposable gloves, masks, etc., after washing hands.
7. The test device is disposable. The test device and specimen after use shall be
regarded as medical waste with biological infection risk and properly disposed of
according to relevant national regulations.
8. Please use it within 1 hour after opening the inner packing.
Materials required but not provided
Timer.
Specimen collection container
Specimen collection container
Storage and Stability
The kit should be stored at room temperature (4-30°C).
Keep in a dry place away from light.
Do not freeze the test kit.
Expiry date: 24 months.
Specimen Collection and Preparation
COVID-19（SARS-CoV-2）IgG/IgM Test can be performed
used on Whole Blood/ Serum/ Plasma.
Testing should be performed immediately after specimen
collection.
Use only clear non-hemolyzed specimens.
