[Intended use]
This product is used for qualitative detection of neutralizing antibody (NAb) in human serum, plasma and whole blood samples in vitro of people vaccinated with COVID-19 vaccine.
[Summary]
The novel coronavirus neutralizing antibody is protective antibody produced by the human body after inoculation with novel coronavirus vaccine or infection with novel coronavirus. The kit is used to monitor the presence of neutralizing antibody in subjects vaccinated with the novel coronavirus vaccine or in people infected with the novel coronavirus, it can be used to evaluate the immune effect after vaccination or whether neutralizing antibody are produced in human body after infection with novel coronavirus.
[Test principle]
This product is tested by colloid gold competitive inhibition method. Recombinant human receptor protein (HACE2) was used to coat nitrocellulose membrane and recombinant novel coronavirus surface receptor-binding domain (RBD) protein was used to label colloidal gold. In vitro qualitative detection of novel coronavirus antibody was performed.
When the test, drop the sample into the reagent sampling well. In the sample, the novel coronavirus antibody and the test line were coated with HACE2 to compete for binding to colloidal gold-labeled RBD protein. When the concentration of the Novel coronavirus antibody in the sample exceeded the detection limit, the colloidal gold-labeled antigen combined with the antibody in the sample to form the antibody-antigen-colloidal gold complex. During chromatography, the antigen labeled with colloidal gold binds to the novel coronavirus antibody so that part of it cannot bind to the receptor in the test line. Conversely, when the concentration of novel coronavirus antibody in the sample is lower than the detection limit concentration or the sample does not contain novel coronavirus antibody, the colloidal gold labeled antigen partially or completely binds to the receptor in the test line, and the color depth of the test line is inversely propo