Enzyme ImmunoAssay (ELISA) for the semi-quantitative determination of IgG antibodies to COVID-19 Spike antigens in human plasma and sera.
The IgG assay is intended for testing:
(a) health-care workers at risk of COVID-19 infection to verify whether or not they might be positive for potentially neutralizing anti Spike IgG;
(b) normal population for epidemiology studies on presence of
potential “protective” IgG to COVID-19 Spike antigens;
(c) PCR-negative infected individuals, successfully recovered from infection, to assure presence of potentially neutralizing antibodies;
(d) human donors, recovered from COVID-19 infection, positive for anti-Spike IgG for the generation of hyperimmune plasma, as a possible immunotherapeutic approach to the disease;
(e) vaccinated individuals to assure a reliable positive immunization with development of anti Spike IgG antibodies.
For “in vitro” diagnostic use only.