Chemi-Luminescence ImmunoAssay (CLIA) for the quantitative determination of antibodies to COVID-19 Virus (SARS-CoV-2) Spike/RBD in human plasma and sera. The Antibody 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/RBD antibodies. (b) normal population for epidemiology studies on presence of potential “protective” Antibodies to SARS-CoV-2 Spike/RBD; (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/RBD antibodies 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/RBD antibodies.

Chemi-Luminescence ImmunoAssay (CLIA) for the serological determination of the neutralization activity of antibodies to SARS-CoV-2, induced by natural infection and/or vaccination, able to block the interaction of Receptor Binding Domain (RBD) and ACE2 and thus the virus infection. The assay is intended for testing sera and plasma collected from: (a) PCR-negative Covid-19 individuals successfully recovered from infection, to assure presence of anti RBD neutralizing antibodies; (b) human donors, recovered from COVID-19 infection, positive for anti-RBD antibodies for the generation of hyperimmune plasma, as a possible immunotherapeutic approach to the disease; (c) vaccinated individuals to assure a reliable and efficient immunization with development of neutralizing antibodies able to block ACE2-RBD binding.

Chemi-Luminescence ImmunoAssay (CLIA) for the semi-quantitative determination of IgG antibodies to SARS-CoV-2 Nucleocapsid protein (NCP) in human plasma and sera. The kit is intended for monitoring of infected patients. In addition the kit may be used when testing the population and health-care workers looking for potentially infective “pauci” or a-symptomatic individuals in the early phase of infection, in combination with SARS-COV-2 molecular tests. The device has been adapted for the use in exclusive combination with the Dia.Pro CLIA random access instrument named SARA.

Chemi-Luminescence ImmunoAssay (CLIA) for the quantitative determination of IgA antibodies to SARS-CoV-2 Nucleocapsid protein (NCP) in human plasma and sera. The kit is intended for monitoring of infected patients. In addition, the kit may be used when testing the population and health-care workers looking for potentially infective “pauci” or a-symptomatic individuals in the early phase of infection, in combination with SARS-COV-2 molecular tests. The device has been adapted for the use in exclusive combination with the Dia.Pro CLIA random access instrument named SARA.

Chemi-Luminescence ImmunoAssay (CLIA) for the semi-quantitative determination of IgM antibodies to SARS-CoV-2 Nucleocapsid protein (NCP) in human plasma and sera. The kit is intended for monitoring of infected patients. In addition the kit may be used when testing the population and health-care workers looking for potentially infective “pauci” or a-symptomatic individuals in the early phase of infection, in combination with SARS-COV-2 molecular tests. The device has been adapted for the use in exclusive combination with the Dia.Pro CLIA random access instrument named SARA.