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PerkinElmer's Euroimmun ELISA Coronavirus Tests Get CE Mark

NEW YORK – PerkinElmer said on Wednesday that the Anti-SARS-CoV-2 ELISA tests for immunoglobulin classes A and G from its Euroimmun business have been CE marked.

Euroimmun's PCR-based EuroRealTime SARS-CoV-2 has also been submitted for CE marking.

Waltham, Massachusetts-based PerkinElmer noted that the anti-SARS-CoV-2 antibodies for classes IgA and IgG are two of the first antibody detection tests to receive CE making and be made available for SARS-CoV-2 testing.

Earlier this week, PerkinElmer said that its RT-PCR test received Emergency Use Authorization from the US Food and Drug Administration. While PCR-based tests allow for the direct detection of the coronavirus in patient samples, serologic tests such as Euroimmun's detect antibodies against SARS-CoV-2 in blood to tell if an individual has been exposed to the virus and possibly developed immunity, even if the person never developed any symptoms.