QuickVue SARS Antigen Test

1.800.874.1517

English | Chinese

FDA Emergency Use Authorization

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.

Healthcare professionals can purchase the QuickVue SARS Antigen Test through select authorized distributors.

Features & Benefits

Feature	Benefit
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

Product Spec Name	Product Spec Data
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	12 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.