On April 3, the FDA issued an emergency use authorization (EUA) for OSANG LLC’s QuickFinder COVID-19/Flu Antigen Self Test, a single use test intended to detect and differentiate influenza A and B (commonly known as flu) and SARS-CoV-2 (the virus that causes COVID-19), in individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first four days of symptom onset when tested at least twice over three days with at least 48 hours between tests.
Validation data to support the EUA of this test was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. The test can be used for people aged 14 years or older with a self-collected nasal swab specimen and aged 2 years or older when an adult collects the nasal swab specimens.
NIH has the Independent Test Assentment Program.
