The FDA said the E25Bio Direct antigen rapid test is not reliable.
The FDA said the E25Bio COVID-19 Direct Antigen Rapid 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.”days after the FDA issued a warning
about using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test for the same reasons. The FDA said it is “concerned about the risk of false results” from the test because the company has not provided the agency with “data demonstrating the test’s performance is accurate.”
The tests were sold directly to consumers. The FDA also is concerned that the instructions may include “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 . Self-collecting nasopharyngeal or oropharyngeal samples for SARS-CoV-2 testing could result in serious injury when this is not done by trained professionals.”
France Dernières Nouvelles, France Actualités
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