These single-use, lateral flow immunoassays with integrated swabs are 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 or for use serially from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over 2 or 3 days with at least 24 hours and no more than 48 hours between tests.