FDA Warns Companies Over COVID-19 Antibody Tests

Companies under fire for selling misbranded COVID-19 antibody test kits

(RxWiki News) The US Food and Drug Administration (FDA) has sent warning letters to three companies for marketing COVID-19 antibody test kits with inaccurate or misleading claims.

Serological tests, also called antibody tests, detect antibodies to SARS-CoV-2. This helps identify those who have an active infection or who have had COVID-19 before.

The companies the FDA recently warned were either falsely claiming that their tests were “FDA approved” or including the FDA logo (which is only allowed for official FDA use) on the product label.

These antibody tests were being sold for at-home use without approval or clearance by the FDA.

The FDA sent letters to Medakit Ltd. of Sheung Wan, Hong Kong; Antibodiescheck.com and Yama Group; and Dr. Jason Korkus, DDS and Sonrisa Family Dental d/b/a My COVID19 Club of Chicago, Illinois.

“When tests are marketed inappropriately, with inaccurate or misleading claims – such as the ability to perform the test completely at home, or that the test is authorized, cleared, or approved when it is not – they put the health of Americans at risk," said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a press release. "Such conduct will not be tolerated by the FDA, and we will continue to monitor tests marketed in the U.S., taking appropriate action as warranted.”

Currently, there are no COVID-19 antibody test kits that are approved or cleared by the FDA to be used completely at home, the FDA noted.

There are, however, FDA-approved at-home tests that require the collection of samples at home. In these cases, the individual collects samples from the nose or saliva and then sends samples in the provided packaging to a lab for processing and testing.

The FDA said it was aware of many companies that were marketing and selling fraudulent COVID-19 products that claim to prevent, mitigate, treat, diagnose or cure COVID-19. In fact, the agency said it had sent at least 75 warning letters as of the publication date.

Some of these fraudulent products included essential oils, patches, gels, CBD products, teas and tinctures, colloidal silver and dietary supplements.

The FDA strongly encouraged consumers to remain cautious of companies selling products, including test kits, that say they prevent, mitigate, treat, diagnose or cure COVID-19. The FDA said it continues to take steps to find and stop companies from selling unapproved COVID-19-related products.

The agency asked consumers to report adverse events related to COVID-19 products to the FDA’s MedWatch Adverse Event Reporting program.

The FDA’s COVID-19 Health Fraud website provides a complete list of the companies and websites the FDA has sent warning letters to regarding their COVID-19-related products.

A few things the FDA wants the public to know when trying to judge whether a product is legitimate:

  • If it seems too good to be true, it probably is.
  • “Miracle cures” that claim a scientific breakthrough or contain a secret ingredient are likely a scam.

If you have symptoms related to COVID-19, follow the guidelines set by the Centers for Disease Control and Prevention and call your health care provider.

Last Updated:
June 30, 2020