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    About EUROIMMUN's product range for COVID-19 diagnostics

Anti-SARS-CoV-2 ELISA (IgG) approved under the "COVID-19 Convalescent Plasma" Emergency Use Authorisation

18th February 2021

Already in May 2020, the FDA has provided Emergency Use Authorization (EUA) for EUROIMMUN’s Anti-SARS-CoV-2 ELISA (IgG) serology test. Now we are happy to announce that the S1-based Anti-SARS-CoV-2 ELISA (IgG) is also included in the COVID-19 convalescent plasma emergency use authorization granted to the U.S Department of Health and Human Services. FDA Registered or licensed blood establishments can now test plasma donations for anti-SARS-CoV-2 antibodies using the EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) for the purpose of qualifying high titer COVID-19 convalescent plasma in the manufacture of COVID-19 convalescent plasma.

More information on the EUA can be found here


EUROIMMUN Launches SARS-CoV-2 Test System to Detect T-Cell Response

14th January 2021

PerkinElmer today announced that its EUROIMMUN business has launched a SARS-CoV-2 Interferon Gamma Release Assay (IGRA) for Research Use Only (RUO) to determine the activity of T-cells reactive to SARS-CoV-2, the pathogen causing COVID-19.

Press release


EUROIMMUN Launches Novel ELISA for Detection of SARS-CoV-2 Antigen in Acutely Infected Patients

16th December 2020

EUROIMMUN, a PerkinElmer, Inc. Company, today announced the launch of the CE marked SARS-CoV-2 Antigen ELISA for specific determination of the SARS-CoV-2 protein. The assay adds to the Company’s broad product portfolio for COVID-19 diagnostics and supports the molecular PCR tests to aid in diagnosing acute SARS-CoV-2 infections.

Press release


EUROIMMUN expands testing portfolio for acute diagnostics of COVID-19

14th November 2020

EUROIMMUN, a PerkinElmer, Inc. Company, today announced the launch of the CE marked EURORealTime SARS-CoV-2/Influenza A/B for direct detection of SARS-CoV-2, influenza virus type A and influenza virus type B. It expands the testing portfolio for acute COVID-19 diagnostics by supporting differential diagnostics between SARS-CoV-2 infections and the common flu. It is available in countries accepting the CE mark.

Press release


EUROIMMUN Launches Quantitative ELISA to Measure SARS-CoV-2 Antibodies Against Viral S1 Protein

09th November 2020

PerkinElmer, Inc. (NYSE: PKI) announced today that EUROIMMUN, a PerkinElmer company, has launched the Anti-SARS-CoV-2 QuantiVac ELISA (IgG) to quantify IgG antibodies against the SARS-CoV-2 S1 antigen. This quantitative test kit applies a recombinant S1 subunit of the SARS-CoV-2 spike protein, enabling detection of IgG antibodies. Antibodies of class IgG against S1 have been the focus of vaccine development programs as well as discussions about possible immunity in previously infected individuals.

Press release


High sensitivity of EURORealTime SARS-CoV-2 proven by FDA SARS-CoV-2 Reference Panel Comparative Data

15th September 2020

The U.S. Food and Drug Administration published comparative performance data (Limit of Detection, LoD) for more than 55 authorized SARS-CoV-2 molecular diagnostic tests which have been tested against a standardized sample panel provided by the FDA. We are happy to announce that the EURORealTime SARS-CoV-2 was under the top 5 ranking assays with the lowest LoDs reported, as of today. The EURORealTime SARS-CoV-2 LoD is comparable to Roche cobas SARS-CoV-2 or Quest SARS-CoV-2 rRT-PCR. Please find the complete SARS-CoV-2 reference panel comparative data on the FDA website.


EURORealTime SARS-CoV-2 approved by the FDA via an Emergency Use Authorization

08th June 2020

Subsequent to the EUROIMMUN-Anti-SARS-CoV-2 ELISA (IgG), the EURORealTime SARS-CoV-2 for direct pathogen detection has now also been approved for use in authorised laboratories by the U.S. American Food and Drugs Administration (FDA) within the framework of an Emergency Use Authorization (EUA).

Press release

FDA fact sheet for laboratories

FDA fact sheet for patients


SARS-CoV-2 Testing From EUROIMMUN

12th May 2020

EUROIMMUN UK, a subsidiary of EUROIMMUN AG, is based in London and has supported Public Health England (PHE) in establishing a serology assay for use in the National Testing Strategy since March with tens of thousands of tests delivered. The EUROIMMUN tests are being used in a serosurveillance study, the results of which will inform the UK Government’s strategy to combat the pandemic.

Press release EUROIMMUN UK


Important update to the EUROIMMUN product portfolio for serological diagnostics of COVID-19

06th May 2020

Dear EUROIMMUN customer,
Yesterday, ourAnti-SARS-CoV-2 ELISA (IgG) was approved by the US-American Food and Drug Administration (FDA) by an emergency use authorization(EUA). The results of a new independent validation effort by the U.S. Government provided the scientific evidence used to support the authorization. We are delighted that the excellent performance and reliability of our test system was therewith also officially acknowledged in the US.

Customer letter EUROIMMUN AG


FDA Provides Emergency Use Authorization to PerkinElmer for Serological Test to Identify COVID-19 Antibodies

05th May 2020

WALTHAM, Mass.--(BUSINESS WIRE)--May 5, 2020-- PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, announced today that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for EUROIMMUN’s (a PerkinElmer company) Anti-SARS-CoV-2 ELISA (IgG) serology test. Clinical laboratories certified to perform high complexity tests under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using this ELISA for the detection of antibodies of the immunoglobulin class G.

Press release PerkinElmer, Inc.