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COVID-19

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

Resource: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test
Source: U.S. Food and Drug Administration
Synopsis: The agency 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 and gives a result in 10-15 minutes without needing to send a sample to a laboratory for analysis. The test is authorized for prescription 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, within the first six days of the onset of COVID-19 symptoms.

Comment: This is one of 15 antigen tests. Remember, antigen tests are not as accurate as PCR tests. Most hospitals and surgery centers that are requiring pre-operative COVID-19 testing, are using molecular PCR tests within three days of the surgery.

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