INTENDED USE

This product is used for qualitative detection of novel coronavirus (SARS-CoV-2) IgM/IgG antibodies in human serum, plasma and venous whole blood specimen in vitro. It is only used as a supplementary for the negative cases of novel coronavirus nucleic acid test, or in conjunction with it in diagnosis of suspected cases. Neither can this test kit be used as a decisive or exclusive evidence for the diagnosis of COVID-19, nor for the screening purpose; this product should only be used in medical institutions.

PRINCIPLE

2019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method) adopts the indirect immunochromatography technology for the detection. The specimen loaded on the pad will move forward along the nitrocellulose membrane to the detection region as a chromatographic process, with the formation of complexes of SARS-CoV-2 IgM/IgG antibody and colloidal gold labeled SARS-CoV-2 antigen if present. The complexes are captured by anti-human IgG/IgM antibody conjugated in the G and M lines of the nitrocellulose membrane to exhibit the color of purple. In the case of the absence of SARS-CoV-2 IgM/IgG antibody in a specimen, no purple line would be observed in G or M region, while a purple line should always be observed in C region due to the binding of rabbit IgG in the gold label cushion to the goat anti-rabbit antibody in C region, in regardless of the existence of SARS-CoV-2 IgM/IgG antibody in a specimen.