On December 15, 2020, the U.S. Food and Drug Administration (FDA) approved the first over the counter fully at-home COVID-19 Test. The test delivers results in approximately 20 minutes and diagnoses individuals as young as two years old and is expected to be delivered to the U.S in volumes reaching 20 million in the first half of 2021. Like other antigen tests, the Ellume’s test is not as specific as those done in a lab, so positive results, of which the at-home test detected 91%, should be followed with a lab test for certainty.

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