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 Simple workflow follows a similar format to CLIA-waived QuickVue assays. No instrument necessary.
- Results in 10 minutes Test and treat in the same office visit.
- Two-color result Easy to read and interpret. Blue control line and red test line.
- All components included in kit Ready to use, no need for additional equipment.
- Room temperature storage No refrigerator space needed. No need to wait for reagents to warm up.
- Rapid SARS-CoV-2 tests can be run immediately as needed.
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)|
|External controls||Positive and negative included|
|PPA (Reference Extracted SARS-CoV-2 RT-PCR Assay)||96.6%|
|NPA (Reference Extracted SARS-CoV-2 RT-PCR Assay)||99.3%|
|Shelf life||12 months from date of manufacture|