QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test

The QuickFinder COVID-19/Flu Antigen Self Test and QuickFinder COVID-19/Flu Antigen Pro Test are lateral flow immunochromatographic assays for qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B antigens from anterior nasal swab samples. The Self Test variant is for non-prescription home use by individuals aged 14 and older testing themselves or adults testing individuals aged 2 and older; the Pro Test is for use by individuals aged 14 and older or adults testing individuals aged 2 and older. Results are visually interpreted within 15 minutes.

Both the proposed device and the predicate (Healgen Rapid Check COVID-19/Flu A & B Antigen Test) are lateral flow immunoassays using the same assay principle, requiring no instrumentation or mobile applications. Both detect SARS-CoV-2 nucleocapsid protein and influenza A and B nucleoprotein from anterior nasal swab specimens, produce visual results in 15 minutes, and use internal controls. The primary difference is the proposed device specifies detection within 4 days post-symptom onset versus the predicate's 5 days, and allows both lay and professional use versus lay use only.

Not stated in this summary.

The proposed device demonstrates substantial equivalence through identical intended use (OTC detection of SARS-CoV-2 and influenza A and B from anterior nasal swabs) and identical fundamental technology (lateral flow immunoassay, visually read). Comprehensive analytical testing—including limit of detection studies, inclusivity across multiple viral strains, co-spiking equivalency, cross-reactivity/microbial interference, competitive interference, and stability studies—showed performance equivalent to or better than the predicate. Clinical evaluation on 788 symptomatic subjects demonstrated clinically acceptable sensitivity and specificity (SARS-CoV-2: 90.6% PPA/99.4% NPA; Flu A: 89.7% PPA/98.8% NPA; Flu B: 86.0% PPA/99.7% NPA) comparable to molecular reference assays. Usability studies confirmed lay users could perform the test correctly and interpret results accurately, with no new safety or effectiveness concerns identified.