Advaite announced today that it received FDA emergency use authorization for its RapCov point-of-care COVID-19 antibody test.
Malvern, Penn.-based Advaite’s rapid response IgG antibody test uses fingerstick whole blood in point-of-care settings and is touted as capable of providing results in 15 minutes, according to a news release.
All RapCov rapid COVID-19 test kits are manufactured and assembled at FDA-registered facilities in southeastern Pennsylvania, Advaite said.
The company plans on immediately supplying the market with its testing kits on a national scale following the FDA authorization, it said.
“This is a watershed moment in the fight against this pandemic,” Advaite CEO Karthik Musunuri said in the release. “The RapCov rapid COVID-19 test offers unique advantages in containing the virus. Advaite’s test is simple to use, provides accurate results from a drop of fingertip blood and can detect IgG antibodies to the COVID-19 virus. Perhaps most critically, our tests provide results in 15 minutes at the point-of-care.
“Fifteen-minute testing can mean peace of mind and workforce readiness. Unlike conventional tests that require offsite blood specimen lab work, the RapCov rapid COVID-19 test analysis can be done on the spot at the point of care, such as at a physician’s office, making this an ideal solution for screening mass populations.”