Our product portfolio for SARS-CoV-2 provides you with the appropriate tools to answer all your diagnostic questions. It comprises two PCR tests, an antigen ELISA for acute diagnostics, several serological tests for differentiated detection of antibodies (IgA, IgM, IgG) against different SARS-CoV-2 antigens, a surrogate virus neutralisation test and an interferon-gamma release assay. The detection of specific anti-SARS-CoV-2 IgG using ELISA can be performed using not only venous blood samples, but also dried capillary blood (dried blood spots – DBS).
All tests are CE-marked. Moreover, the Anti-SARS-CoV-2 ELISA (IgG) and the EURORealTime SARS-CoV-2 have been approved for use in authorised laboratories by the U.S. Food and Drug Administration (FDA) via an Emergency Use Authorization (EUA)
Please consider the current US-specific instruction for use of the respective test system for validity of the FDA EUA.
Update on the Omicron virus variant and the Quan-T-Cell: We do not yet have the experimental data to make statements on the possible effects of the Omicron variant on our Quan-T-Cell for the detection of SARS-CoV-2-specific T-cell activity. However, a variety of publications already confirm that T-cell reactivity against virus variants including Omicron is very stable and that it offers a certain level of variant-independent immune protection.
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Detection of antibody response after vaccination: All COVID-19 vaccines currently used and approved in the EU are based on the wild type version of the spike protein (Wuhan-Hu-1). This means that antibodies formed after such vaccination can definitely be detected by the S1-based antibody assays from EUROIMMUN.
Using antibody tests based on the nucleocapsid protein (NCP), antibody reactions after vaccination can be distinguished after those formed after a contact with SARS-CoV-2 (does not apply for the use of vaccines which also contain an N component). A positive result in the Anti-SARS-CoV-2 NCP ELISA (IgG) indicates a past contact with the pathogen. However, even with a negative result a past SARS-CoV-2 infection cannot be excluded.
With our cooperation partner Homed-IQ, EUROIMMUN offers companies and individuals a simple and well-organised option for vaccination titer determination. You would like to learn more?
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Update on the Omicron virus variant and S1-based antibody detection: We do not yet have the experimental data to make statements on the possible effects of the Omicron variant on our serological test systems for the detection of antibodies against the S1 domain.
The acquisition of the serum samples required from patients positive for the Omicron variant but immunologically naive to other SARS-CoV-2 variants (i.e. who have never been in contact with the wild type form or other variants and were not vaccinated against SARS-CoV-2) proves very challenging.
Although it cannot generally be excluded that an infection with the SARS-CoV-2 variant Omicron leads to formation of antibodies which are not or only poorly detectable by the S1 wild type isolate (Wuhan-Hu-1) used by us, our in silico analyses do show that the amino acid sequence of the S1 domain and the RBD within the S1 domain of the Omicron variant and the wild type are highly homologous. Therefore, we do not expect a negative effect of the Omicron mutations on the performance of our test systems for antibodies against the S1 domain at this stage.
More information in our FAQ
Information on Omicron variant: According to in silico analysis, the new SARS-CoV-2 variant, called Omicron, is expected to be reliably detected by our EURORealTime SARS-CoV-2 and EURORealTime SARS-CoV-2/Influenza A/B tests systems. This also applies to the virus variants Alpha, Beta, Gamma, Delta, Lambda and Mu.
At this early stage it is not yet possible to make a statement about the possible effects of the Omicron variant on the performance of the EUROIMMUN antibody test systems or the interferon-gamma release assay Quan-T-Cell SARS-CoV-2.
EUROIMMUN carefully follows all reports and official information on the new SARS-CoV-2 variant from sources like the ECDC, WHO or FDA and immediately investigates possible effects on the test systems as soon as corresponding data is available.
More information in our FAQ
Efficient combination: one test for COVID-19 and flu - By using the EURORealTime SARS-CoV-2/Influenza A/B it is possible to keep an eye not only on the spread of COVID-19 but also of the upcoming flu in an efficient and resource-saving way.
NOW! with CE mark! The interferon-gamma release assay from EUROIMMUN is already established in research and allows determination of the activity of SARS-CoV-2-reactive T cells to support the evaluation of the cellular immune response after infection or vaccination.
Direct detection of the virus via RNA (RT-PCR) or viral antigens (ELISA) allow reliable identification of acute SARS-CoV-2 infections. With the EURORealTime SARS-CoV-2 and the EURORealTime SARS-CoV-2/Influenza A/B, EUROIMMUN offers a single-parameter test for detection of the virus as well as a combination test for parallel detection of SARS-CoV-2 and influenza virus types A and B as well as for differentiation between these viruses. Additionally, the antigen ELISA enables detection of the viral nucleocapsid protein in swabs from patients with acute infections.
The portfolio contains several ELISAs and one immunoblot for the detection of antibodies against modified nucleocapsid protein (IgM and IgG) and against the domains S1 and S2 of the spike protein (IgA and IgG). The S1-based ELISA is available as Anti-SARS-CoV-2 QuantiVac ELISA (IgG), including 6 calibrators for quantification of the antibody concentration. It is the first test that also allows issuing of the results in standardised units (BAU/ml). The serological product range is supplemented by the SARS-CoV-2 NeutraLISA, a surrogate virus neutralisation test for the detection of neutralising anti-S1/RBD antibodies, and the interferon-gamma release assay Quan-T-Cell for determination of the activity of SARS-CoV-2-reactive T cells. Both test systems are useful tools for evaluation of the immune response after infection with SARS-CoV-2 or vaccination with vaccines based on the spike protein. With the IgG ELISAs, dried capillary blood (dried blood spots, DBS) can be used as sample material, besides venous blood.
The ELISAs are used worldwide by renowned diagnostic laboratories, reference institutes, clinics and research institutions in order to diagnose and investigate COVID-19.
The Blood collection set contains all materials that are required for sample collection and mailing of dried capillary blood samples (dried blood spots – DBS). It is suitable either for personal use in a home environment or for blood collection performed by a healthcare professional. The subsequent investigation of the samples for specific IgG antibodies against SARS-CoV-2 is performed in a laboratory.
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EUROIMMUN develops and produces test systems for doctors and laboratories that cannot be performed by private individuals.