This lateral flow immunoassay is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals with symptoms of COVID-19 within the first seven days of symptom onset, or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult-collected anterior nasal swab samples from individuals aged 2 years or older. Each kit box contains 2 tests cards to enable for testing twice over 3 days, with at least 24 hours apart.