Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Rapid Test
Package Insert
【PRODUCT NAME】
Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Rapid (Colloid
Gold Method) Test
【PACKING SPECIFICATION】
25 tests/box, 50 tests/box.
【INTENDED USE】
Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Rapid Test is used for detection of new coronavirus (2019-nCoV) IgM/IgG antibodies in human whole blood, serum, and plasma in vitro.
It can be used as a supplement to nucleic acid test results or in combination with nucleic acid, and cannot be used as the basis for the diagnosis and exclusion of new coronavirus (2019-nCoV) infection.
【TEST PRINCIPLE】
This kit uses immunochromatography to add the blood sample to the test card. If novel coronavirus (2019-nCoV) antibody IgM/IgG is present in the sample, it will bind to colloidal gold-labeled anti human 2019-nCoV IgM/IgG .The immune complex moves forward along the detection card under the action of capillaries. If the sample contains the novel coronavirus 2019-nCoV antibody IgM/IgG , it will bind to the novel coronavirus 2019-nCoV recombinant protein coated on the detection area on the membrane to form a purple-red stripe. The colloidal gold-labeled biotin was captured in the streptavidin-coated quality control region, forming a red stripe, showing 2019-nCoV-antibody positive.