QuickVue® SARS Antigen Test

The QuickVue SARS Antigen Test is a rapid diagnostic tool designed for professional use in CLIA-waived settings. Authorized under FDA Emergency Use Authorization (EUA), this lateral flow immunoassay detects SARS-CoV-2 antigens from nasal swab specimens in about 10 minutes. Built on the trusted QuickVue platform, it delivers reliable, easy-to-interpret results that support timely clinical decision-making in urgent care centers, physician offices, and other point-of-care settings.

Key Features

• Results in ~10 minutes from nasal swab samples
• Based on trusted QuickVue lateral flow technology
• CLIA-waived for professional use in point-of-care settings
• Simple test procedure with clear visual results
• Compact kit includes all necessary reagents and materials

Important Information & Warnings

• For professional use only; not intended for at-home testing
• Authorized under FDA EUA; not FDA cleared or approved
• Does not differentiate between SARS-CoV and SARS-CoV-2
• Positive results: Indicate SARS-CoV-2 antigen detection; clinical correlation and confirmatory testing may be required
• Negative results: Presumptive only; do not rule out infection. Retest or confirm with molecular assays if clinically indicated
• Store test components at 59–86°F (15–30°C); do not freeze or use beyond expiration date