Date Issued: February 4, 2022
The U.S. Food and Drug Administration (FDA) is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test. 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-19 Direct Antigen Rapid Test 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 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). Self-collecting nasopharyngeal or oropharyngeal samples for SARS-CoV-2 testing 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 the E25Bio COVID-19 Direct Antigen Rapid Test.
Recommendations
Do not use E25Bio COVID-19 Direct Antigen Rapid Test.
- Test users and caregivers: Talk to your health care 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 COVID-19 Direct Antigen Rapid Test 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.
Device Description
The E25Bio COVID-19 Direct Antigen Rapid Test uses a nasal (anterior nares), nasopharyngeal, or oropharyngeal swab sample to detect proteins called antigens from the SARS-CoV-2 virus.
Risk of False Results or Injury
- A false-negative antigen test result means that the test does not detect the SARS-CoV-2 virus but the person is actually infected. A false-negative result may lead to delayed diagnosis or inappropriate treatment of COVID-19, which may cause people harm including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when people are housed together in health care, long-term care, and other facilities based on these false test results. When false negative test results are received, actions to limit exposure to an infected person might not be taken, such as isolating people, limiting contact with family and friends, or limiting access to places of employment.
- A false-positive antigen test result means that the test says the person has SARS-CoV-2 virus present but they are actually not infected. A false-positive result may lead to a delay in both the correct diagnosis and appropriate treatment for the actual cause of a person’s illness, which could be another life-threatening disease that is not COVID-19. False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive people are housed together.
- Risk of injury when self-collecting nasopharyngeal or oropharyngeal samples. Only trained health care providers should collect nasopharyngeal or oropharyngeal swab samples. People who were instructed to collect their own nasopharyngeal or oropharyngeal swab samples are at risk of serious injury including:
- Injury to the tonsils/throat from use of the swab
- Potentially inducing vomiting
- Pieces of the swab breaking off, as they may be more fragile and are not designed for throat swabbing, nasopharyngeal swabbing, or self-collection
FDA Actions
The FDA regularly monitors the marketing of unauthorized, unapproved, or uncleared tests, including reports of problems with test performance or results. The FDA is providing this information to help inform test users, caregivers, health care personnel, and the public and to reduce the risk of false test results that could lead to serious illness and death.
The FDA will continue to keep the public informed of significant new information.
Reporting Problems with Your Test
If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
Questions?
If you have questions about this Safety Communication, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.
