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Celltrion Gets FDA Emergency Use Authorization for Over-the-Counter, At-Home SARS-CoV-2 Test

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for an over-the-counter, at-home SARS-CoV-2 antigen test developed by Celltrion.

The lateral flow immunoassay is designed for the qualitative detection of the nucleocapsid protein antigen and receptor binding domain of the SARS-CoV-2 spike proteins in self-collected or adult-collected direct mid-turbinate swab samples from individuals with or without symptoms. Testing is to be performed twice over three days with at least 24 hours and no more than 48 hours between tests, according to the FDA.

About a year ago, South Korea-based Celltrion received EUA from the FDA for its Sampinute COVID-19 Antigen MIA magnetic force-assisted electrochemical sandwich SARS-CoV-2 immunoassay.

Last month, the US Department of Defense said it was awarding Celltrion's US subsidiary a $626 million contract to supply its rapid antigen test to sites across the country.