An in vitro solid-phase immunochromatographic test for the rapid and qualitative detection of Functional Active Antibodies against SARS-COV-2 virus (able to neutralize Spike viral protein by preventing its binding to the cell receptor on the host cell) in whole blood/serum/plasma.
COVID-19 is an infectious disease caused by SARS-COV-2 virus. SARS-COV-2 infection, as well as vaccination, stimulates an immune response that includes the production of antibodies in the blood. The antibodies thus produced provide protection against future infections by the virus as, by remaining within the circulatory system for a period of time, they will quickly and strongly bind the pathogen in order to prevent its entry into the host cell, as well as its replication. These specific antibodies are called neutralizing antibodies.
In order to detect neutralizing antibodies that are functionally active against SARS-COV-2 virus, Spikey Immuno Test provides (i) a pre-incubation of the sample with the Spike protein supplied in the kit (functional test) and (ii) an immuno-chromatographic test of the sample for the detection of Spike itself. If the sample contains functionally active neutralizing antibodies, the binding sites of the viral protein will be masked by them and the protein will not be visible to the test (it will not bind the monoclonal antibodies related to its capture and detection present in the test box, therefore a visible line will not appear.)
If the sample does not contain functionally active neutralizing antibodies, the protein binding sites will be accessible and the protein will be visible to the test (it will be able to bind the monoclonal antibodies related to its capture and detection present in the test box, and a visible line will appear.) This possible blocking of the interaction between the viral protein and its ligand (the monoclonal antibody), mediated by antibodies neutralizing the SARS-COV-2 virus of the sample, simulates the interaction that takes place in vivo between the virus and its receptor in the host cell.
The test can determine the presence of antibodies neutralizing SARS-COV-2 virus in low/no concentration, medium concentration and high (optimal) concentration.