FDA warns against using rapid test from E25 Bio

Feb. 9, 2022

The U.S. Food and Drug Administration (FDA) issued a safety communication to tell people not to use the E25Bio COVID-19 Direct Antigen Rapid Test, a product that may have been sold directly to consumers.

The agency said it has not approved the test for distribution in the United States. The FDA said the test may also be sold under the trade name E25Bio SARS-CoV-2 Antigen Test Kit.

The FDA said it 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.”

However, the FDA said it “has not received reports of injuries, adverse health consequences, or death associated with use of the E25Bio COVID-19 Direct Antigen Rapid Test.”

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