March 30, 2021—The FDA issued an emergency use authorization for the Quidel QuickVue At-Home COVID-19 test.
The test is available by prescription and authorized for people who are suspected of having COVID-19 by their health care provider within the first six days of symptom onset. The test is intended for self-use for people ages 14 and older or for an adult lay user testing another person ages eight to 14 years in a nonlaboratory setting. Results are available in 10 minutes.
Based on the interim results of a clinical study where the test was compared with an FDA-authorized molecular SARS-CoV-2 test, the QuickVue At-Home COVID-19 test correctly identified 84.8 percent of positive specimens and 99.1 percent of negative specimens.