InBios Receives FDA’s Emergency Use Authorization for Home COVID-19 Test
Seattle, Wash.-based InBios International has received Emergency Use Authorization from the FDA for its over-the counter COVID-19 diagnostic test for home use.
The company’s SCoV-2 Ag Detect rapid self-test is can detect antigen from the SARS-CoV-2 coronavirus that causes COVID-19 infections.
The test uses anterior nasal swab samples from people age 14 years and up with symptoms of COVID-19, within the first five days after symptom onset, or from adult-collected anterior nasal (nares) swab samples in children age two to 13.
It may also be used for individuals who are asymptomatic, provided they are tested twice over three days with at least 24 hours and no more than 48 hours between tests.