NEW YORK — The US Food and Drug Administration on Monday granted Emergency Use Authorization for InBios International's SCoV-2 Ag Detect Rapid Self-Test, an over-the-counter SARS-CoV-2 antigen test designed for use at home.
The test is for single use as well as for serial use.
For single use, the lateral flow immunoassay is intended for the qualitative detection of SARS-CoV-2 nucleoprotein antigen in self-collected or adult-collected anterior nasal swab specimens from individuals as young as 2 years old with COVID-19 symptoms within the first five days of symptom onset.
The test is also authorized for use in individuals, with or without COVID-19 symptoms, when tested twice over three days with at least 24 hours and no more than 48 hours between tests.
Test results are available in about 20 minutes, according to the FDA.
About a month ago, Seattle-based InBios received FDA EUA for a SARS-CoV-2 total antibody test.