Don’t Use These Rapid COVID-19 Tests, FDA Warns

On Jan. 28, the US Food and Drug Administration issued a letter warning people not to use two different tests produced by Empowered Diagnostics:

• The CovClear COVID-19 Rapid Antigen Test; and
• The ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.

The Empowered situation is the latest in a string of recent Class 1 recalls of COVID-19 rapid tests.

The FDA’s Empower Warning

The letter notes that both tests were distributed with labeling suggesting that they’ve been authorized by the FDA. But neither test has received FDA authorization, clearance, or approval for distribution or use in the US. The agency says that both tests pose high risk of false results. Meanwhile, Pompano Beach, Florida-based Empowered is recalling both tests, in what the FDA has classified as a Class 1 recall, the most serious type. The CovClear COVID-19 Rapid Antigen Test uses a nasal swab sample to detect SARS-CoV-2 antigens. The FDA’s recommendations:

• Test users and caregivers: Talk to your health care provider if you were tested with the test and have concerns about your test results; and
• Health care providers and testing program organizers: If the antigen test was given less than two weeks ago and you suspect the result is inaccurate, consider retesting using an FDA authorized SARS-CoV-2 test; retesting isn’t necessary for tests done more than two weeks ago and where’s there’s no reason to suspect current SARS-CoV-2 infection.

The ImmunoPass COVID-19 Neutralizing Antibody Rapid Test uses a fingerstick blood sample to detect antibodies produced by the immune system in response to SARS-CoV-2. The FDA’s recommendations:

• Test users and caregivers: Talk to your health care provider if you were tested with the test and have concerns about your test results; and
• Health care providers and testing program organizers: Consider retesting using an FDA authorized SARS-CoV-2 antibody test if you suspect a recent or prior SARS-CoV-2 infection.

The letter also advises that any person who suspects false results or experiences any problems with either of the tests report this to the FDA. The agency says that it’s working with Empower to resolve the issues.

Takeaway

Class 1 recalls of rapid COVID-19 tests have become a fairly regular occurrence in recent months. Although the Empowered tests involved in this case weren’t authorized by the FDA, many of the COVID-19 tests targeted for Class 1 recall have received Emergency Use Authorization, including Ellume’s COVID-19 Home Test (the first fully at-home SARS-CoV-2 testing kit to receive EUA for over-the-counter sale), Abbott’s Alinity m SARS-CoV-2 AMP Kit, and the Quidel Lyra PCR assay for COVID-19.