INTENDED USE

Enzyme ImmunoAssay (ELISA) for the determination of IgG antibodies to COVID19-specific Nucleocapsid (“Core”) and Spike antigens in human plasma and sera.

The kit is intended for monitoring the immune response to COVID-19. The IgG assay is recommended in particular for testing:

(a) infected individuals in follow-up serological testing and when recovered from the infection, negative for COVID-19 PCR, to assure they developed IgG antibodies to the virus, confirming a full recovery from the infection;

(b) health-care workers at risk of covid-19 infection to verify whether or not they developed IgG antibodies to the virus;

(c) individuals from normal population to study their acquired immune status against COVID-19 infection.

(d) human antibodies donors for a preliminary screening of hyper-immune sera as a possible candidate for an immunotherapeutic approach to the treatment of the disease.

For “in vitro” diagnostic use only.