On Sept. 1, 2021, Quidel announced it will make Quidel’s non-prescription QuickVue® At-Home OTC COVID-19 Test available to consumers at more than 7,000 CVS Pharmacy locations across the United States and online. The shelf-stable packages each contain two self-administered rapid antigen tests.

The QuickVue® At-Home OTC COVID-19 Test allows consumers to easily perform the test themselves without a doctor’s prescription and get results in 10 minutes from nasal swab samples. The QuickVue® At-Home COVID-19 Test shows excellent performance, with positive results agreeing with PCR 83.5% of the time, and negative results agreeing 99.2% of the time, delivering confidence to individuals running the test and helping to prevent asymptomatic virus spread.

The QuickVue^® At-Home OTC COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. The QuickVue^® At-Home OTC Covid-19 Test has not been FDA cleared or approved. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.