For in vitro diagnostic use in the qualitative determination of IgM and IgG antibodies to SARS-CoV-2 virus in human serum and plasma specimens. It is intended for use only in individuals with clinical signs and symptoms consistent with SARS-CoV-2 infection as a supplementary detection indicator in conjunction with nucleic acid detection. It cannot be used as the sole basis for the confirmation or exclusion of novel coronavirus-infected pneumonia. And it is for medical institutions use only.
SARS-CoV-2 IgM/IgG Antibody Assay uses the principle of lateral flow immunochromatography. The IgG antibody or IgM antibody against the SARSCoV-2 virus in the sample will first bind to the colloidal gold-labeled coronavirus recombinant antigen on the colloidal gold. The IgG anti-viral antibody-antigencolloid gold complex will move in the mobile phase during the lateral flow chromatographic process, and captured by the anti-human IgG antibody immobilized on the detection line G. The accumulation of colloid gold containing IgG antibody-antigen-colloid gold complex at the detection line G will form a neat red band. The presence or absence of the red band is the interpretive criteria for the presence of SARS-CoV-2 IgG antibodies in the sample. By the same principle, the immuno-complex complex formed by the IgM anti-viral antibody and the colloidal gold-labeled antigen will be captured by the mouse anti-human IgM monoclonal antibody at the detection line M. This reaction will form a neat red band M. The presence or absence of the red band is the interpretive criteria for the presence of IgM anti-viral antibodies. The colloidal gold-labeled avidin continues to move forward and reacts with biotin on the quality control line C, where a neat red band C is the indication that the detection reaction system is effective.