ALL COVID TESTS ARE NON-RETURNABLE.
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.
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:
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
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.
