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FDA Issues Emergency Use Authorization to At-Home COVID-19 Test


The United States Food and Drug Administration (FDA) released an emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test, an at-home COVID-19 test available by prescription only. This antigen test uses self-collected nasal swab samples from individuals age 15 or older or adult-collected nasal swab samples from children age 4 and older who are suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset. This is the third at-home COVID-19 test to receive an EUA. The test is accompanied by a telehealth service that guides test-takers on how to collect the sample and provides assistance in deciphering the results.

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