NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for Azure Biotech's Fastep COVID-19 Antigen Pen Home Test.
The lateral flow immunoassay device is designed to detect SARS-CoV-2 nucleocapsid protein antigen in self-collected anterior nasal swab samples and provides results in 15 minutes. It is a single test comprised of a base and test pen with an integrated sample swab and test strip.
The test is authorized for use by individuals with symptoms of COVID-19 within the first 6 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, according to the FDA. It is also authorized for use by individuals without symptoms when tested at least three times over five days with at least 48 hours between tests.
In late 2022, Houston-based Azure received EUA from the FDA for its nonprescription Fastep COVID-19 Antigen Home Test.