【Product Name】

Generic name:
New Coronavirus COVID-19 IgM/IgG Test Strip (Colloidal Gold)

【Package Size】
20 tests/kit

【Intended Use】
The New Coronavirus COVID-19 IgM/IgG Test Strip (Colloidal Gold) is intended to qualitative detect the IgG and IgM of COVID-19 in
human serum, plasma, whole blood or finger-prick blood.

【Test Principle】
The New Coronavirus COVID-19 IgM/IgG Test is based on immunochromatography assay. The test strip is composed of:
1） Conjugate pad: colloidal gold marked recombinant COVID-19 antigen and colloidal gold marked antibody used as control material.
2） NC membrane: contents two test lines (G and M) and one control line (C). Mouse anti-human IgM monoclonal antibody is coated in
the test line M to detect the existence of IgM of COVID-19; Mouse anti-human IgG monoclonal antibody is coated in the test line G to
detect the existence of IgG of COVID-19; Antibody used as control material is coated in the control line C.
Add certain amount of sample into the sample loading area on the test strip. The sample flows through the membrane. The IgM in the
sample can combine with colloidal gold marked antigen and form immune complex, which then combines with the coated anti-human
IgM monoclonal antibody and form sandwich compound, causing the red-purple test line M to appear, indicating the existence of IgM of
COVID-19 (IgM positive).
The IgG in the sample can combine with colloidal gold marked antigen and form immune complex, which then combines with the coated
mouse anti-human IgG monoclonal antibody and form sandwich compound, causing the red-purple test line G to appear, indicating the
existence of IgG of COVID-19 (IgG positive).
If neither test line G nor test line M is visible, the test result will be negative.
A red-purple control line C shall appear whether the test lines are visible or not. The absence of control line C suggests the invalidity of
current test, and a new test shall be carried out.