QUIDEL® QuickVue® SARS Antigen Test – 25 Test Kit
Rapid COVID-19 test for detecting SARS-CoV-2 antigens in nasal swab specimens.
The QuickVue® SARS Antigen Test is a rapid chromatographic immunoassay intended to detect active SARS-CoV-2 infection from direct anterior nasal swab specimens. This CLIA-waived test delivers reliable results in just 10 minutes and is designed for use in point-of-care settings such as urgent care clinics, health centers, and schools. The dipstick format simplifies workflow and includes all necessary reagents and controls.
Key Benefits
• Results in 10 minutes
• Easy-to-use dipstick format
• CLIA-waived for use in moderate and waived settings
• Designed for anterior nasal swab collection
• Helps identify active COVID-19 infections
• Includes positive and negative controls
• Room temperature storage
Performance Characteristics
• Sensitivity: 96.6% (within 5 days of symptom onset)
• Specificity: 99.3%
• Overall Agreement: 98%
Intended Use
For the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swab specimens from individuals suspected of COVID-19.
Kit Contents
• 25 dipstick test strips
• 25 reagent tubes
• 25 sterile nasal swabs
• Positive and negative external controls
• Tube holder
• Instructions for use
Packaging Details
• 25 tests per kit
• CLIA-waived classification
• For use with direct anterior nasal swab specimens
• Room temperature storage (59–86°F)