New Antigen Template Urges Studies For Asymptomatic COVID-19 Screens

FDA updated its COVID-19 antigen test template Monday (Oct. 26) to recommend certain test developers seeking emergency use authorization include studies to support claims for screening asymptomatic patients, point-of-care testing and tests measuring multiple infections. The agency recommends test developers looking to validate an antigen test for asymptomatic patients include data supporting the use of the test from clinical validation studies. The clinical studies should enroll at least 20 asymptomatic patients and the specimens should ideally be collected in a...