The Rapid Response COVID-19 Antigen Rapid Test Cassette - At Home is an in vitro immunochromatographic assay intended to detect nucleocapsid protein antigen from SARS-CoV-2 virus that causes COVID-19 in nasal swab samples from individuals suspected of COVID-19 within 7 days of symptom onset and from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection. This device is authorized for home-use in a nonlaboratory setting with direct anterior nasal (nares) swab samples for:
- Unobserved self-collection for individuals aged 18 years or older
- Adult supervised self-collection for individuals for ages 14 or older
- Adult collecting from individuals aged 2 years or older