COVID-19 test used in UK mass-screening program receives rebuke from FDA

Abstract

“Stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test.” That was the US Food and Drug Administration’s stark warning to the public on June 10 about an unapproved rapid lateral-flow test used to diagnose COVID-19. Among a litany of concerns, the FDA says that the test poses a health risk because of its potential to deliver false results. And to underscore the message, the FDA adds that users should “destroy the tests by placing them in the trash.” The antigen test, supplied by Pasadena, California–based Innova Medical Group , has not been authorized for emergency use by the FDA. In a statement, the company says it had distributed the test to customers “for evaluation purposes,” and it is not widely used in the US. But the communiqué dropped like a bombshell in the UK, where Innova’s test forms the backbone of the government’s Operation Moonshot COVID-19 screening program . The