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Euroimmun SARS-CoV-2 Antigen ELISA Test Receives CE Mark

NEW YORK – Euroimmun said on Wednesday it has received the CE mark for its SARS-CoV-2 Antigen ELISA test and has launched the product in countries that recognize the designation.

The laboratory-based test allows for the semi-quantitative automatable detection of SARS-CoV-2 nucleocapsid protein on a large scale. It has been validated for use with swab samples of the upper respiratory tract of patients with acute symptoms of COVID-19, or who are suspected of having been exposed to SARS-CoV-2. According to Lübeck, Germany-based Euroimmun, a subsidiary of PerkinElmer, the test has demonstrated 93.6 percent sensitivity and 100 percent specificity compared to real-time PCR for detection of the coronavirus.

It added that the SARS-CoV-2 Antigen ELISA can be used in most laboratory settings and automatically processed on all open ELISA systems. Euroimmun is currently validating the test for use with saliva samples.

In a statement, Euroimmun CEO Wolfgang Schlumberger noted that as the number of COVID-19 cases grow "there is enormous pressure to provide sufficient test capacities." While PCR testing remains the gold standard for SARS-CoV-2 testing, the availability of such tests remains challenged. "That's why a reliable and automatable antigen detection test, [such] as our new ELISA, can be a valuable supplement to help rapid identification of acutely infected individuals," Schlumberger said.