FDA issued three warning letters within the last week to sellers of at-home kits to test for COVID-19 antibodies, the agency flagged in a statement Wednesday.
Regulators accused the companies of offering tests directly to consumers for at-home use without its permission. The agency has yet to authorize an antibody test for at-home use.
FDA ordered the three companies to immediately fix the violations covered in the warning letters. Two of the websites were offline the day after FDA published the warning letters.
FDA in late May outlined its support for companies developing at-home sample collection kits for coronavirus diagnostics.
The agency has now allowed multiple companies to ship at-home sample collection kits, reflecting evidence that self-swabbing is reliable enough. Last week, a study by researchers at the Stanford University School of Medicine found tests yielded largely consistent results regardless of whether a physician or patient collected the sample.
But at-home sample collection differs from tests that can be carried out entirely in the home setting; no such product has been authorized by FDA, nor has the agency OK'd home-based collection for tests that detect antibodies to coronavirus.
Still, some companies have continued to sell at-home immunoassays that deliver rapid results in a similar way to pregnancy tests. FDA targeted such activities this week in warning letters to the people behind mycovidtest19.com, antibodiescheck.com and medakit.com.
The details of the tests provided through the websites varies. FDA contends mycovidtest19.com sold Cellex’s qSARS-CoV-2 IgG/IgM Rapid Test, which has emergency use authorization but is not cleared for home use. Medakit, in contrast, received the warning letter for selling a test it claims to have developed itself. Medakit is not on the list of companies with an EUA for an antibody test.
Regardless of the details, FDA said the companies violated regulations by offering at-home tests. The agency made the case that at-home testing creates risks related to “whether a lay person has the ability to collect their specimen, run the test, and interpret the test result accurately.”
The warning letters also cover other alleged violations. For example, the agency accused mycovidtest19.com of giving the “false impression that your products have been approved by FDA” by using its logo.
FDA told the companies to correct the violations and contact it within 48 hours with details of the steps they had taken. The letters were sent between May 15 and June 15. By June 18, two of the three websites were offline.
At the time of writing, Medakit’s website continues to promote what it claims is “one of the world’s first rapid point-of-care lateral flow immunoassays for the diagnosis of coronavirus infection.” The test is available to buy for €29.90 ($33.65), as it has been since at least April 13, according to an old version of its website stored by the Internet Archive. However, the U.S. is not available as a shipping location during checkout.
“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," Center for Devices and Radiological Health Director Jeff Shuren said in an FDA statement.
The action against unauthorized antibody test sellers comes as FDA also took action against an authorized test seller over accuracy concerns. The agency revoked an emergency use authorization Tuesday given to an antibody test from Chembio Diagnostics, one of the earliest companies to receive FDA's OK for that type of test.