BinaxNOW™ COVID-19 Antigen Self Test

The BinaxNOW COVID-19 Antigen Self Test is a rapid, visually read lateral flow immunoassay for qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in anterior nasal swab specimens. It is intended for non-prescription home use by individuals aged 15 years or older testing themselves, or adults testing individuals aged 2 years or older who have signs and symptoms of COVID-19. Negative results are presumptive and symptomatic individuals with initial negative results must be retested within 48–72 hours.

Both the BinaxNOW COVID-19 Antigen Self Test and the predicate device (QuickVue COVID-19 Test, K231795) are visually read lateral flow immunoassays detecting SARS-CoV-2 nucleocapsid protein antigen from nasal swabs. The BinaxNOW uses a book-shaped hinged card with a test strip and swab well; SARS-CoV-2 specific antibodies and a control antibody are immobilized on a membrane as two distinct lines. Results are interpreted visually at 15 minutes based on presence or absence of pink/purple lines.

Not stated in this summary.

The devices share identical intended use (rapid, qualitative detection of SARS-CoV-2 from anterior nasal swabs) and identical technological approach (lateral flow immunoassay detecting nucleocapsid protein). The only difference is the intended use age population (15+ years versus 14+ years), which does not affect technological similarity, safety, or effectiveness. Analytical studies demonstrate high sensitivity and specificity (positive agreement 86.9%, negative agreement 98.5% overall) across two clinical studies covering Delta and Omicron variants. Performance with serial testing shows strong detection capability. The device meets special controls for over-the-counter SARS-CoV-2 tests, establishing substantial equivalence despite the minor age indication change.