- Contains 300 individual test kits, making it suitable for large-scale use in settings like businesses, schools, or healthcare facilities
Applications:
- For self-testing at home or in the office by individuals aged 14 or older
- Can be used with adult-collected nasal swabs from children as young as two
- Authorized for use by individuals with or without COVID-19 symptoms
Features:
- Test type:
- Lateral flow immunoassay for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen
- Sample:
- Uses an anterior nasal swab for specimen collection
- Results:
- Delivers results in 15 minutes
- FDA authorization:
- Authorized under an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA)
Performance:
- Sensitivity:
- The test demonstrated a high degree of accuracy in clinical studies, with a positive percent agreement (PPA) of 93% and a negative percent agreement (NPA) of 100%
- Regulatory status:
- In January 2023, the FDA cleared the test for prescription and over-the-counter use
Contents:
- Each kit individually packaged
- 300 Kits per case