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What is FDA Authorizes First At-Home COVID Test about?

The FDA has authorized the first over-the-counter fully at-home diagnostic test for COVID-19 called the Ellume COVID-19 Home Test. The test detects fragments of SARS-CoV-2 proteins from a nasal swab sample and provides results on a connected smartphone in 20 minutes for individuals 2 years of age or older. While less sensitive than lab tests, the at-home nature of the test allows for expanded testing access and reduces burden on laboratories. The FDA expects Ellume to produce over 3 million tests in January

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Mfadhl

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