The US FDA is warning people not to use the E25Bio COVID tests (Direct Antigen Rapid Test, or DART), according to an agency alert.
According to the FDA, 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 . The E25Bio COVID tests (DART) may also be sold under the trade name E25Bio SARS-CoV-2 Antigen Test Kit.
The FDA is concerned about the risk of false results when using this test because E25Bio has not provided the FDA with adequate data demonstrating that the test’s performance is accurate. In addition, the FDA is aware that the E25Bio COVID-19 Direct Antigen Rapid Test (DART) was 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.
The FDA has not received reports of injuries, adverse health consequences, or death associated with use of E25Bio COVID tests.
Do not use E25Bio COVID-19 Direct Antigen Rapid Test.
- Test users and caregivers: Talk to your healthcare provider if you were tested with the E25Bio COVID-19 Direct Antigen Rapid Test and you have concerns about your test results, or if you believe you may have been harmed when collecting your own nasopharyngeal and oropharyngeal swab sample.
- Health care providers: If your patient was tested with the E25Bio DART in the last 2 weeks and you suspect an inaccurate result, consider retesting your patients using an FDA authorized SARS-CoV-2 diagnostic test. If testing was performed more than two weeks ago, and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.
- Testing program organizers: Notify participants in your testing program to stop using the E25Bio COVID-19 Direct Antigen Rapid Test and to use an FDA-authorized test. For listings of FDA-authorized tests, see:
- Report any problems you have with the E25Bio COVID-19 Direct Antigen Rapid Test to the FDA, including suspected false results or injuries from self-swabbed nasopharyngeal or oropharyngeal samples.