NEW YORK — InBios International last week received Emergency Use Authorization from the US Food and Drug Administration for its point-of-care SCoV-2 Ag Detect Rapid Test for SARS-CoV-2 antigens.
The lateral flow immunoassay is designed to detect the SARS-CoV-2 nucleoprotein antigen in direct anterior nasal swab specimens collected by healthcare providers. It is for use with individuals suspected of COVID-19 within five days of the onset of symptoms and with individuals without symptoms when used twice over two or three days with at least 24 hours and no more than 48 hours between tests.
The test may be used by any lab CLIA-certified to perform moderate-, high- or waived- complexity tests, as well as at the point of care.
In mid-2020, Seattle-based InBios received FDA EUAs for two SARS-CoV-2 antibody tests. Last year, the company also received FDA EUA for a PCR-based test for the virus.