FDA has issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home Covid-19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis.
The QuickVue At-Home Covid-19 Test is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult. The test is authorized for individuals suspected of covid-19 by their healthcare provider within the first six days of symptom onset.
“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” says Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “The QuickVue At-Home Covid-19 Test is another example of the FDA working with test developers to bring important diagnostics to the public.”
For more information, visit Quidel.