ACON Flowflex COVID-19 Antigen Home Test
The performance of Flowflex COVID-19 Antigen Home Test was established in an all-comers clinical study conducted between March 2021 and May 2021 with 172 nasal swabs self-collected or pair-collected by another study participant from 108 individual symptomatic patients (within 7 days of onset) suspected of COVID-19 and 64 asymptomatic patients. The Flowflex COVID-19 Antigen Home Test results were compared to an FDA EUA RT-PCR COVID-19 assay to determine test performance.
Positive Percent Agreement (PPA): 93% (95% CI: 81% - 99%)
Negative Percent Agreement (NPA): 100% (95% CI: 97% - 100%)