Quidel QuickVue At-Home OTC
Based on the interim results of a clinical study where the QuickVue At-Home OTC COVID-19 Test was compared to an FDA authorized molecular SARS-CoV-2 test, QuickVue At-Home OTC COVID-19 Test correctly identified 83.5% of positive specimens and 99.2% of negative specimens.
The performance of this test is still being studied in patients without signs and symptoms of respiratory infection and for serial screening. Performance may differ in these populations.
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%)