FDA Authorizes QuickVue At-Home COVID-19 Test

U.S. Food and Drug Administration sent this bulletin at 03/01/2021 09:34 AM EST

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US Food and Drug Administration

COVID-19 Update: FDA Issues Authorization for the Quidel QuickVue At-Home COVID-19 Test  

Today, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to Quidel for its QuickVue At-Home COVID-19 Test for at-home use with a prescription. The Quidel QuickVue At-Home COVID-19 Test:

  • Is an antigen test that detects proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample.
  • Gives a result in 10-15 minutes without needing to send a sample to a laboratory for analysis.

The Quidel QuickVue At-Home COVID-19 Test is authorized for:

  • Prescription use within the first six days of onset of COVID-19 symptoms.
  • At-home use with a self-collected nasal swab sample by people age 14 years and older or people age 8 years and older when the nasal swab sample is collected by an adult.

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