FDA Warning on E25Bio Covid Tests

FDA has issued a warning to not use the E25Bio Covid-19 Direct Antigen Rapid Test (DART). “This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it may include false labeling representing that the test is authorized by the FDA,” an agency notice says. FDA is concerned about the risk of false results because E25Bio has not provided the FDA with adequate data demonstrating its performance is accurate.

Additionally, the agency says the tests have been sold directly to consumers and may have been accompanied by labeling with instructions for collecting a sample from deep inside the nose, reaching the back of the throat (nasopharyngeal) or from the middle part of the throat (pharynx) just beyond the mouth (oropharyngeal), “which could result in serious injury when this is not done by trained professionals.”