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FDA Warns Against More Unauthorized COVID Tests

Image courtesy of Amanda Pedersen / MD+DI COVID test with warning tape.png
Unauthorized COVID-19 tests continue to plague the regulatory agency. FDA flagged three such tests on Tuesday.

FDA continues to warn the public against the use of unauthorized COVID tests.

Most recently, the agency said people should not to use the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white packaging, the SD Biosensor Standard Q COVID-19 Ag Home Test packaged in a white and magenta box, or the Flowflex SARS-CoV-2 Antigen Rapid Test from ACON Laboratories packaged in a dark blue box. Images of each of these tests can be found by clicking on the respective links above. These COVID tests have not been authorized, cleared, or approved by FDA for distribution or use in the United States, therefore the agency is concerned about the risk of false results when using them.

Last month FDA warned consumers against the use of COVID tests sold by E25Bio without authorization. That test was particularly alarming as it included 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 agency warned.

In a separate update, FDA noted that it has revoked Abbott's emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card 2 Home Test. Abbott's COVID test is still available under a separate EUA, however, so the previous EUA is no longer necessary.

Understanding COVID testing is key to making an informed decision that meets your needs, FDA said. The agency encourages the public to learn more by visiting its consumer update: Coronavirus Disease 2019 Testing Basics.

COVID tests by the numbers

As of March 1, 420 tests and sample collection devices are authorized by FDA under EUAs. These include 290 molecular tests and sample collection devices, 85 antibody and other immune response tests, and 45 antigen tests. There are 70 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 14 EUAs for antigen over-the-counter (OTC) at-home tests, and three EUAs for molecular OTC at-home tests. FDA has authorized 25 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 850 revisions to test EUA authorizations.

TAGS: IVD COVID-19
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