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PKI Gets FDA Emergency Nod For Serological Test To Identify COVID-19 Antibodies

PerkinElmer Inc. (PKI) said that the U.S. Food and Drug Administration has issued Emergency Use Authorization for EUROIMMUN's, a PerkinElmer company, Anti-SARS-CoV-2 ELISA (IgG) serology test.

Serological tests detect antibodies in the blood and are detected when an immune reaction to the pathogen has already taken place. These tests can determine who had previously been infected with COVID-19 (2-4 weeks or more prior to testing) and may have developed immunity.

The EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

According to the company, the EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) has 99% specificity and 100% sensitivity after 21 days following the onset of symptoms.

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