FDA Warns Against Unauthorized E25Bio COVID-19 Tests

The FDA has issued a warning about the potential for false results from the E25Bio COVID-19 Direct antigen rapid test, which the agency has not authorized for distribution or use in the U.S.

Sold directly to consumers, the test may include instructions for collecting a sample from deep inside the nose, reaching the back of the throat or from the middle part of the throat, just beyond the mouth, which may result in serious injury if done by nonprofessionals, the agency said.

The test, which may also be sold under the trade name E25Bio SARS-CoV-2 antigen test kit, may include false labeling claiming that it is authorized by the FDA, the agency said.