COVID-19 – ELISA

ACE2-RBD Neutralization Assay – ELISA

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.

COVID-19 Spike 1&2 IgG – ELISA

INTENDED USE 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.

COVID-19 IgG Confirmation – ELISA

INTENDED USE Module-based Enzyme-Immuno-Assay (ELISA) for the confirmation of samples positive for IgG antibodies to covid-19 in first screening. The test can be used in addition to identify the specificity of antibodies to the major immunodominant covid-19 antigens. For "in vitro" diagnostic use only.      

COVID-19 IgA – ELISA

INTENDED USE Enzyme ImmunoAssay (ELISA) for the determination of IgA antibodies to COVID19 in human plasma and sera. The IgA assay is recommended, in addition to IgG and IgM, to: a) monitor the global immunological response of patients undergoing an acute infection and their follow-up to full recovery; b) and specifically for testing patients with symptoms of the gastro enteric form of COVID-19 infection. For "in vitro" diagnostic use only.  

COVID-19 IgM – ELISA

INTENDED USE Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to COVID19 in human plasma and sera. The kit is intended for the monitoring of the immune response to COVID-19 in the early stage of the infection as an additional marker to PCR. For "in vitro" diagnostic use only.  

COVID-19 IgG – ELISA

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.