Principle

The test kit is a lateral flow immunochromatographic assay. The test uses anti-human IgM antibody (test line IgM) , anti-human IgG (test line IgG) and rabbit IgG (control line C) immobilized on a nitrocellulose strip. The burgundy colored conjugate pad contains colloidal gold conjugated to recombinant SARS-CoV-2 antigens conjugated with colloid gold (SARS-CoV-2 antigens conjugates). When a specimen followed by assay buffer is added to the sample well, IgM &/or IgG antibodies if present, will bind to SARS-CoV-2 antigens conjugates making an antigen antibodies complex. This complex migrates through nitrocellulose membrane by capillary action. When the complex meets the line of the corresponding immobilized antibody (anti-human IgM &/or anti-human IgG) the complex is trapped forming a burgundy colored band which confirms a reactive test result. Absence of a colored band in the test region indicates a non-reactive test result.To monitor the effectiveness of the test card, a quality control line (C line) is set. Regardless of whether there is a M/G line, the C line shall show color development, or the test result will be judged as invalid.