www.fdanews.com/articles/203340-diabetomicss-saliva-based-covid-19-test-gets-fda-emergency-use-authorization
Diabetomics’s Saliva-Based COVID-19 Test Gets FDA Emergency Use Authorization
June 28, 2021
The FDA has granted Diabetomics an Emergency Use Authorization for its COVID-19 antibody test, CovAb.
The test assesses saliva samples, delivers results within 15 minutes and detects all three COVID-19 antibody classes—IgA, IgG and IgM—that are present at different stages of infection.
The highly accurate test has 97.6 percent sensitivity and 98.8 percent specificity, according to the Hillsboro, Ore.-based company.