INTENDED USE

Enzyme ImmunoAssay (ELISA) for the semi-quantitative determination of inhibition activity of RBD-ACE2 binding induced by antibodies to SARS-CoV-2 in human plasma and sera.

The assay is intended for:

• Confirmation of anti RBD antibodies neutralizing activity in patients positively recovered from covid-19 showing antibodies to Spike/RBD;
• human donors, recovered from COVID-19 infection, positive for anti-Spike/RBD antibodies for the generation of hyperimmune plasma, as a possible immunotherapeutic approach to the disease;
• vaccinated individuals to assure a reliable positive immunization with development of neutralizing anti Spike/RBD IgG antibodies.

For “in vitro” diagnostic use only.