U.S. FDA Issues Authorization for At-Home COVID-19 Test

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization on March 1, 2021, for the Quidel QuickVue At-Home COVID-19 Test.

This is another antigen test where certain individuals can rapidly collect and test their sample at home without sending a sample to a laboratory for analysis, says the FDA.

The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal swabs from individuals ages 14 and older or individuals ages 8 and older 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,” commented Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, in a press statement.

In addition to this new prescription home test, Quidel also was issued emergency authorization in December 2020 for their QuickVue SARS Antigen Test for use in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high, moderate, or waived complexity tests, as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver.

The FDA is an agency within the U.S. Department of Health and Human Services. It protects public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, other biological products for human use, and medical devices.