Access Bio Gets EUA for COVID-19 Test
An antigen test for COVID-19 made by Access Bio has received an Emergency Use Authorization (EUA) from the FDA.
Somerset, N.J.-based Access Bio's CareStart COVID-19 Antigen Home Test is a chromatographic, digital immunoassay intended for the qualitative detection of the SARS-CoV-2 coronavirus’ protein antigens.
The test kit does this by analyzing anterior nasal swab specimens in individuals with or without symptoms, who must be tested twice over two or three days with at least 24 hours and not more than 48 hours between tests. It gives results in 10 minutes.