EUROIMMUN 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.

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.