The FDA today published information to help developers of tests to screen asymptomatic people for COVID-19.
Agency officials said they want to streamline the emergency use authorization (EUA) process for screening tests that could help asymptomatic individuals decide whether they should participate in an activity, based on the test results.
As part of the effort, the FDA issued a new supplemental template for test developers seeking EUAs of serial molecular, antigen and at-home tests. Serial tests are used to test the same individual multiple times within a few days to detect an asymptomatic infection that might not show up with a single test. The CDC recommends serial testing at least once per week for people who may have been exposed to the virus.
“We believe this effort will pave the way for further expanding the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs and increase consumer access to testing,” said FDA Center for Devices and Radiological Health (CDRH) director Jeff Shuren and Tim Stenzel, director of CDRH’s Office of In Vitro Diagnostics, in a news release.
As part of the streamlining process, the agency said it might authorize a POC test or an over-the-counter (OTC) at-home test without validating its use in asymptomatic individuals. The agency also issued a fact sheet to help schools, workplaces, communities and other locations select a screening test.
“The FDA believes that evidence of a test’s strong performance in symptomatic patients combined with serial testing can mitigate the risk of false results when testing asymptomatic individuals,” Shuren and Stenzel said. “We believe these combined efforts will further expand the availability of tests authorized for screening asymptomatic individuals, including OTC use, help bolster existing and new testing programs and increase consumer access to testing.”
