INTENDED USE

SARS CoV-2 Neutralizing Antibody Rapid Test Kit（Colloidal Gold）is a lateral flow chromatographic immunoassay for the semi-qualitative detection of neutralizing Antibody after vaccination or after the infection with SARS-CoV-2 virus. in human serum, plasma and whole blood. The SARS-CoV-2 neutralizing antibodies are the protective antibodies which produced by the human body after vaccination or infection with SARS-CoV-2 virus. Not all the antibody which produced by human body are the neutralizing antibody. Only the antibody have protective function can be named neutralizing antibody. So this kit use the SARS-COV-2 ACE2 antigen to competitively combine to RBD antigen with RBD antibody. This kit is used to monitor the presence of neutralizing antibody in the bodies. It is suitable for checking the immune effect after vaccination or after the infection with SARS-CoV-2 virus. It will be used to determine the infection rate, herd immunity and predicted humoral protection, and vaccine efficacy during clinical trials and after large-scale-vaccination.

PRINCIPLE

The SARS CoV-2 Neutralizing Antibody Rapid Test（Colloidal Gold） is a lateral flow chromatographic immunoassay. The test cassette consists of: 1)a burgundy colored conjugate pad containing SARS-COV-2 S-RBD antigen conjugated with colloidal gold (SARS CoV-2 conjugates) and mouse IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (test band) and a control band (C band). The test band is pre-coated with SARS-COV-2 ACE2 antigen for competitively bind to RBD with neutralizing antibody, in order to detection the neutralizing antibody in serum, plasma and whole blood. The C band is pre-coated with goat anti mouse IgG.

When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. If there is antibody producing after vaccine or infection with SARS-COV-2 virus, the RBD antibody will be conjugated with RBD antigen, thus the ACE2 antigen can not bind to RBD antigen. So the test line will not be colored. If no antibody produced, the ACE2 antigen will bind to RBD antigen, the test line will be colored. This kit can be monitor the presence of neutralizing antibody in the body.