NEW YORK – The US Food and Drug Administration on Friday issued a warning not to use the E25Bio COVID-19 Direct Antigen Rapid Test because it has not received proper regulatory vetting.
The test has not been authorized, cleared, or approved for distribution or use in the US, though it may include false labeling saying the test has been authorized by the FDA, the agency said. The test may also be sold under the trade name E25Bio SARS-CoV-2 Antigen Test Kit.
The FDA said it has not received any reports of injuries, adverse health consequences, or death associated with use of the test, but it recommends that individuals who have used the test to talk to their healthcare providers. Providers whose patients have used the test in the past two weeks should consider retesting them with an FDA-authorized test if the provider suspects an inaccurate result. Individuals who have used the test more than two weeks ago need not retest if there is no indication of a SARS-CoV-2 infection, the FDA said.
Last week, the agency warned consumers not to use two COVID-19 tests from Empowered Diagnostics, also because neither had been authorized, cleared, or approved by the FDA. The company is recalling both tests. This week, SD Biosensor voluntarily recalled its COVID-19 rapid antigen test amid reports that the test kits, which were not authorized, cleared, or approved by the FDA, had been illegally imported.