BinaxNOW COVID-19 Ag Card

The BinaxNOW COVID-19 Ag Card is a lateral flow immunochromatographic test that detects SARS-CoV-2 nucleocapsid protein antigen directly from anterior nasal swab specimens. It is intended for rapid, qualitative diagnosis of COVID-19 in symptomatic individuals within five days of symptom onset, either through serial testing (twice over three days with 48 hours between tests) or single testing followed by molecular confirmation if negative.

Both the BinaxNOW COVID-19 Ag Card and predicate device (Nano-Check COVID-19 Antigen Test) are visually read lateral flow immunoassays that detect nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab samples. The proposed device uses SARS-CoV-2 specific antibodies immobilized on a membrane support as two distinct lines mounted on a cardboard, book-shaped hinged test card.

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The device demonstrates substantial equivalence through identical intended use (rapid qualitative detection of SARS-CoV-2 in nasal swabs for near-patient diagnosis) and identical technological platform (lateral flow immunoassay detecting nucleocapsid protein). The clinical data from 604 symptomatic patients show positive agreement of 86.9% and negative agreement of 98.5% against RT-PCR comparator, with strong performance across variant strains (Delta, Omicron). The only difference from the predicate is the extended window from four to five days post-symptom onset, which does not affect the fundamental safety and effectiveness profile, supported by analytical studies demonstrating broad variant reactivity, no cross-reactivity with 28 commensal and pathogenic organisms, and reproducibility across multiple sites.