The Anti-SARS-CoV-2 ELISAs for immunoglobulin classes A and G from EUROIMMUN, a PerkinElmer, Inc. company has received CE-marking and can now be applied to COVID-19 diagnostics.

They have also developed a PCR test, 'EURORealTime SARS-CoV-2'. A CE-IVD application has been submitted for this product and is currently available for Research Use Only (RUO) in the EEA and has received FDA-EUA.

While IgG antibodies indicate a persisting or even past infection, IgA antibodies are described as early markers of acute respiratory tract infections. In a recent study (doi: 10.1101/2020.03.18.20038059; March 2020), the additional value of specific IgA detection for early diagnostics of acute SARS-CoV-2 infections was confirmed.

The good sensitivity and specificity of the ELISAs have also been proven. The developers underline that the antigen used in the EUROIMMUN Anti-SARS-CoV-2 ELISAs (IgA and IgG), the spike protein S1 domain, is more specific for the serological detection of SARS-CoV-2 antibodies than the more highly conserved N- or full-length S-proteins.

ELISAs are suited for screening on a large scale to identify persons who may have had contact with the virus even without noticing, have had an immune response, and have probably developed an immunity. They can also be applied to collect epidemiological data.

Like almost all other ELISAs from EUROIMMUN, the Anti-SARS-CoV-2 ELISAs can be processed automatically using laboratory instruments.