EUROIMMUN Launches SARS-CoV-2 Antigen Test

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.

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 EUROIMMUN 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.