For use under the Emergency Use Authorization (EUA) only
The QuickVue SARS Antigen Test detects SARS-CoV-2 antigens directly from anterior nares swab specimens. The QuickVue SARS Antigen Test provides accurate and reliable results in 10 minutes, allowing for testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments.
Features and Benefits:
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.
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.
Product Specifications:
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)
Internal controls:
Included
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:
24 months from date of manufacture
CLIA complexity:
Waived*
How Does the QuickVue OTC COVID-19 Test Work?
The test uses a gentle self-collected anterior nasal (nares) swab sample to determine a positive or negative COVID-19 result. The swab is swirled in a tube of reagent solution, then removed, before a test strip is inserted. After ten minutes, you can take the strip out of the tube and see your results.
Quick Reference Instructions
SWAB SWIRL
DIP SEE RESULTS
Product Documentation:
Fact Sheet for Healcare Providers
Quick Reference Instructions
Safety Data Sheet
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