FDA warns against E25Bio COVID-19 tests

The Food and Drug Administration is warning against the use of a certain COVID-19 test.

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The FDA advised consumers not to use the E25Bio COVID-19 Direct Antigen Rapid Test.

The administration said the test has not been “authorized, cleared or approved” to be distributed or used in the U.S.

The agency said the tests could have false labeling that said it has been FDA-approved.

The test may also be sold under the name E25Bio SARS-CoV-2 Antigen Test Kit.

>>Related: FDA: Stop using LuSys Laboratories COVID-19 tests due to potential false results

If the test is used, the FDA said it could come back with a false result. The test, which was sold direct to consumers, may also cause injury as the testing procedures involve sticking the probe deep inside the nose or mouth and reaching the back of the throat. That type of test should be done by a trained professional, the FDA said. There have been no reports of injuries or worse from the use of the E25Bio COVID-19 Direct Antigen Rapid Test.

If you have used the E25Bio COVID-19 Direct Antigen Rapid Test, talk to your medical provider if you think you have had false test results or if you were injured by the swab.

Health care professionals are being instructed to retest patients if they used the E25Bio test and if they suspect the results were not accurate.

For more information, visit the FDA’s website.

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