Euroimmun launches novel ELISA for detection of SARS-CoV-2 antigen in acutely infected patients

Automatable and reliable COVID-19 test rounds out company's menu of offerings for acute diagnostics of the virus

18 Dec 2020
Ellen Simms
Product and Reviews Editor

Product news

Euroimmun, a PerkinElmer, Inc. Company, has 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.

The Antigen ELISA is a laboratory test able to be applied in semi quantitative automatable detection of the SARS-CoV-2 nucleocapsid protein on a large scale. It is validated for swab sample material from the upper respiratory tract and is useful for testing individuals with acute symptoms that point to COVID-19 or who have had suspected contact with SARS-CoV-2. Validation data revealed 93.6% positive agreement (sensitivity) and 100% negative agreement (specificity) between results obtained with the Antigen ELISA and those obtained with a real time PCR test for detecting the virus. Based on the well-known ELISA technology, the SARS-CoV-2 Antigen assay can be performed in most diagnostic laboratory settings and automatically processed on all open ELISA platforms.

“Infection numbers are continuously increasing, and there is enormous pressure to provide sufficient test capacities. The availability of gold-standard PCR testing, however, is often challenged in acute COVID-19 outbreak situations. That’s why a reliable and automatable antigen detection test as our new ELISA can be a valuable supplement to help rapid identification of acutely infected individuals,” says Dr. Wolfgang Schlumberger, CEO of Euroimmun.

The SARS-CoV-2 Antigen ELISA is available in countries that recognize CE marking. Validation of saliva specimens for use with this assay is currently in process.

The assay is the latest of the comprehensive EUROIEuroimmun MMUN COVID-19 product portfolio and the third test to support acute COVID-19 diagnostics following the two molecular diagnostic systems: EURORealTime SARS-CoV-2 and EURORealTime SARS-CoV-2/Influenza A/B.

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ELISAEnzyme-linked immunosorbent assays (ELISA), also known as enzyme immunoassays (EIA), are used for the detection and quantification of proteins, peptides and antibodies in a sample. ELISA often comes in kit format, with pre-selected antibody pairs to detect specific proteins or biomarkers of diseases such as diabetes and obesity, or cardiovascular and neurological disorders. Detection is made possible with chemiluminescent, fluorescent or colorimetric substrates and detection instruments such as microplate / ELISA readers. Other kits available include: Enzyme-linked immunospot (ELISPOT) assays for the quantification of protein-producing cells and chemiluminescent immunoassays (CLIA) kits. Find the best ELISA kits and products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Covid-19COVID-19, caused by the SARS-CoV-2 virus, has led to a global health crisis with profound impacts on societies and economies. Research into diagnostics, vaccines, treatments, and understanding viral mechanisms continues to evolve. The pandemic has accelerated innovations in healthcare and biopharmaceuticals, including novel vaccine platforms and rapid testing technologies. Browse our peer-reviewed product directory to find top COVID-19 testing kits, research tools, vaccines, and treatments, compare products, read reviews, and receive direct pricing from manufacturers.
Euroimmun launches novel ELISA for detection of SARS-CoV-2 antigen in acutely infected patients