The QuickVue SARS Antigen Test has not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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 authorization is terminated or revoked sooner.
- Dipstick test format.
- Results in 10 minutes.
- Two-color result.
- All components are included in the kit.
- Room temperature storage.
Product Specifications and Resources
|Sample type||Anterior nares swab|
|Time to results||10 minutes|
|Kit storage conditions||Room temperature (15°C to 30°C/59°F to 86°F)|
|Country of Origin||USA|
|External controls||Positive and negative included|