This single-use, lateral flow immunoassay with an integrated swab is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal samples from individuals 18 years or older when the sample is self-collected, or in individuals 2 years or older when the sample is collected by an adult. The test is authorized for individuals who are suspected of having COVID-19 by their health-care provider within 7 days of symptom onset.