COVID-19 Update: FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test

Today, the U.S. Food and Drug Administration (FDA) issued a new Emergency Use Authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test for at-home use with a prescription. The BinaxNOW COVID-19 Ag Card Home Test: 

  • Is an antigen test that detects fragments of proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample. 
  • Is authorized for use at home with self-collected samples in individuals age 15 years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset. The test is also for use with individuals aged four years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset, when an adult collects the sample. 
  • Is being offered in partnership with eMed Labs, LLC., a telehealth service that will take users step-by-step through the sample collection process, explain how to perform the test, and provide assistance in reading and understanding the results. 


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