The Food and Drug Administration on Tuesday issued an emergency use authorization for the first over-the-counter, fully at-home COVID-19 test for emergency use. Previously, the agency authorized the first prescription COVID-19 test for home use, and the first non-prescription test system that allows people to take their own samples before sending it to a lab for analysis. The latest news appears to combine the best of the worlds.
The Ellume COVID-19 Home Test will likely be sold at pharmacies, and it won't require a prescription. FDA Commissioner Stephen Hahn said patients can buy the rapid antigen kit, take it home, conduct their own nasal swab, and get their results "in as little as 20 minutes." As is the case with most tests, the FDA cautions there is a risk of false positive and negative results.
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