- A rapid lateral flow immunoassay authorized for the qualitative detection of SARS-CoV and SARS-CoV-2 nucleocapsid protein antigens directly from anterior nares swab specimens
Uses
- Point-of-Care Diagnostics:
- Designed for use by trained clinical laboratory personnel or individuals operating in point-of-care (POC) settings, such as doctors' offices, urgent care clinics, and pharmacies
- Symptomatic Testing:
- Authorized for use on patients with signs and symptoms who are suspected of COVID-19 (typically within the first five days of symptom onset)
- Asymptomatic Screening:
- Can be used on asymptomatic individuals when tested serially
Features
- Rapid Turnaround:
- Results are ready in just 10 minutes, eliminating the need to send samples to an external laboratory
- Dipstick Format:
- Employs a simple, hands-free format (sample, dip, and read). No specialized instruments or readers are required
- Visual Readout:
- Delivers clear, easy-to-interpret two-color results. A blue control line confirms the test worked, and a red test line indicates a positive result
- All-Inclusive Kit:
- Contains everything needed to perform the procedure, including individually packaged test strips, reagent tubes, sterile nasal swabs, and Positive/Negative control swabs
- Room Temperature Storage:
- Requires no refrigeration, meaning no wait time for reagents to warm up before testing
Benefits
- Test and Treat Capability:
- Because results are delivered in 10 minutes, healthcare providers can assess, diagnose, and initiate appropriate treatment or isolation protocols in the same office visit
- CLIA-Waived Simplicity:
- The workflow is similar to other CLIA-waived QuickVue assays, meaning it requires minimal training and can be easily integrated into routine medical office workflows
- High Accuracy:
- Demonstrates highly accurate performance with direct anterior nares swab samples
- Workflow Efficiency:
- Requires just one reagent and very little hands-on time (approx. 30 seconds to 1 minute), reducing the administrative burden on clinical staff
