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FDA Warns Against Use of Three SARS-CoV-2 Rapid Antigen Tests

The story has been updated to clarify that the FDA noted Acon Biotech, not Acon Laboratories, is selling an unauthorized test.

NEW YORK – The US Food and Drug Administration on Tuesday issued a warning to consumers not to use certain Celltrion USA DiaTrust COVID-19 Ag Rapid Tests or the SD Biosensor Standard Q COVID-19 Ag Home Test.

Additionally, the agency told consumers not to use certain Acon Biotech's Flowflex SARS-CoV-2 Antigen Rapid Test.

Certain Celltrion tests, the SD Biosensor test, and certain Acon tests have not been authorized, cleared, or approved by the FDA for distribution or use in the US, and the agency is concerned they may provide false results. The FDA noted it has not received any reports of injuries, adverse health consequences, or deaths resulting from the use of the unauthorized tests.

In the case of Celltrion, the FDA warned against use of the firm's test if it comes in green and white packaging. The unauthorized test uses a mid-turbinate nasal swab sample to detect SARS-CoV-2 antigens, and while it has the same name as a Celltrion test which received Emergency Use Authorization from the FDA in April, the two tests are not the same — the authorized test does not come in a green and white box.

Celltrion also received FDA EUA for an over-the-counter, at-home SARS-CoV-2 test in October.

The unauthorized SD Biosensor test uses a nasal swab to detect SARS-CoV-2 antigens. In January the FDA issued an EUA for the SD Biosensor COVID-19 At-Home Test, which is different from the test that the agency is telling consumers not to use.

Meantime, the FDA told consumers to stop using the Acon Flowflex SARS-CoV-2 Antigen Rapid test if it is packaged in a dark blue box because it is unauthorized by the agency. The unauthorized test uses a nasal swab sample to detect SARS-CoV-2 antigens. The FDA granted EUA to another similarly named Acon test, the Flowflex COVID-19 Antigen Home test, in October. 

The FDA noted that the unauthorized test is from Acon Biotech, not Acon Laboratories, the developer and manufacturer of the test which received EUA.

The FDA recommends individuals who have used the unauthorized tests and are concerned about the results to speak with their healthcare providers. For healthcare providers and testing program organizers, if the tests were used less than two weeks ago, the FDA recommends retesting the patient with a test that has received EUA from the agency. If testing was performed more than two weeks ago and there is no suspicion of a SAR-CoV-2 infection, no retesting is necessary.