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.
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.
NEW! EURORealTime SARS-CoV-2 now also validated for use with saliva as sample material.
NEW! Surrogate Virus Neutralisation Test for semiquantitative determination of neutralising antibodies to support the evaluation of the immune response to SARS-CoV-2 after infection or vaccination with a S1/RBD-based vaccine.
NEW! Line blot for the determination of IgG antibodies against SARS-CoV-2 and seasonal coronaviruses (HCoV)*
NOW! S1-based Anti-SARS-CoV-2 ELISA (IgG) is now also included in the COVID-19 convalescent plasma emergency use authorization granted to the U.S Department of Health and Human Services.
Soon available! A powerful trio from EUROIMMUN! - The new SARS-CoV-2 NeutraLISA will soon supplement the product range of quantitative antibody (QuantiVac ELISA) and T cell (IGRA) tests for the complete analysis of the immune response after SARS-COV-2 infection or vaccination.
Updated information on the new SARS-CoV-2 variants! Just as with the variants VOC*202012/01 (lineage B.1.1.7) and 501.V2 (lineage B.1.351), the variant 501Y.V3 first identified in Brazil (lineage P.1) is expected to be reliably detected using the EURORealTime SARS-CoV-2 and EURORealTime SARS-CoV-2/Influenza A/B. With respect to the ELISAs, we do not expect the new mutations to have any effect either on the performance of the test systems.
Please find further information here.
Information on the new SARS-CoV-2 variants! According to in silico analysis, it is expected that the new SARS-CoV-2 variants VOC*202012/01 (B.1.1.7 lineage) and 501.V2 (B.1.351 lineage) are reliably detected by our EURORealTime tests for the COVID-19 diagnostics. Here, you can find more information on the new variants and test possibilities with our assays.
NEW! SARS-CoV-2 Interferon Gamma Release Assay to determine activity of SARS-CoV-2 reactive T-cells now available for research use only*.
*For research use only, not for in vitro diagnostics in the sense of EU Directive 98/79/EC
First antibody test for quantification in BAU/ml! Excellent correlation of the Anti-SARS-CoV-2 QuantiVac ELISA with the recently approved independent WHO reference material “First WHO International Standard Anti-SARS-CoV-2 Immunoglobulin. The ELISA is the first test which also allows issuing the IgG antibody concentration in standardised units (BAU/ml).
NEW! ELISA for the detection of SARS-CoV-2 antigen is available from now on. The laboratory diagnostic product supports acute COVID-19 diagnostics, especially during an outbreak. It enables reliable pathogen detection and can be processed fully automatically.
NEW! On time for the flu season: With the EURORealTime SARS-CoV-2/Influenza A/B EUROIMMUN offers a new combination test for differential diagnostic clarification of symptoms that can be associated with influenza as well as COVID-19.
NEW! ELISA for quantitative determination of antibodies against viral S1 antigen is now available: the Anti-SARS-Cov-2 QuantiVac ELISA (IgG). The quantification of antibodies against viral S1 can support the assessment of the individual immune response to SARS-CoV-2 after infection or vaccination.
High sensitivity of EURORealTime SARS-CoV-2 proven by FDA SARS-CoV-2 Reference Panel Comparative Data
The Blood collection set from EUROIMMUN for the collection and mailing of dried capillary blood samples for the use in in vitro diagnostic analysis is now available
New ELISA for the detection of IgM antibodies against NCP of SARS-CoV-2 now available
ELISA for detection of IgG antibodies against S1 and NCP of SARS-CoV-2 are now validated for the use of dried capillary blood (dried blood spots – DBS) as an alternative sample material.
EURORealTime SARS-CoV-2 approved by FDA via EUA
Now available: New ELISA format, optimized for automatic processing with the EUROLabWorkstation ELISA
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.
Download flyers and further information material here.
EUROIMMUN develops and produces test systems for doctors and laboratories that cannot be performed by private individuals.