Unauthorized home COVID test kits targeted by FDA
Several companies marketing a variety of home tests for COVID-19 were warned by the US Food and Drug Administration (FDA) for misbranding and impermissible marketing. The letters, issued this week, gave the firms 48 hours to take corrective action.The FDA warned US-based AkivaMed on 23 July for offering a “COVID-19 Antibody Rapid Test Kit” to consumers for at-home blood test collection and analysis.
“We remind you that, to date, FDA has not approved, cleared, or authorized any COVID-19 serology test for at-home testing. Different and potentially serious public health risks are presented with testing in the home versus a healthcare setting,” said FDA in the warning letter. AkivaMed’s website, said the agency, made claims that “This test is certified and recommended by the FDA.”
Akivamed’s product was still available on their website at the time of publication of this article.
In another warning dated 24 July, Missouri-based CoreMedica Laboratories was warned for marketing an at-home blood sample collection kit for COVID-19/SARS-CoV-2 antibody screening. This company marketed a kit both through its own website and through a firm called TestMyDrop’s website for home collection of blood samples to be sent for serology testing without receiving FDA marketing approval, clearance or authorization.
In its marketing materials, said the agency, the test claimed also to offer “protection to our first responders. (Eliminates PPE [personal protective equipment]) changes…” The marketing materials also claimed that the test “reduces the risk of exposure to yourself and others.”
A separate warning letter was sent on the same date to FairPriceMD, a Tennessee firm that also marketed a home COVID-19 serology test that it claimed was manufactured by CoreMedica. The marketing material on the FairPriceLabs website made similar claims about reducing the risk of exposure and protecting first responders. Social media posts made by the firm claimed that the test was the “first COVID-19 Home Collection Kit- FDA Approved,” according to the warning letter.
The FairPriceLabs home collection test kit was still marketed on the firm’s website at the time of publication of this article.
A 23 July warning letter went to Diagnostic Solutions Laboratory. The Florida-based firm was offering at-home stool sample collection kits through the website holisticheal.com, and through Amazon. The stool test offered claimed to test for SARS-CoV-2 in stool samples through reverse transcriptase – polymerase chain reaction (RT-PCR) technology. FDA had not issued marketing approval, clearance or authorization for the test, according to the warning letter.
The warning letter also cited posts on a forum on the ch3nutrigenomics.com website made by “Dr. Amy.” In part, the post stated: “I would like to announce that we finally have access to a coronavirus stool test (the lab has labeled this stool test as: SARS-CoV-2). This is an at home stool test.” This post, said FDA, directed consumers to the Holistic Heal website as well.
The Amazon webpage cited by the agency is no longer active, and the stool testing kit marketing material could not be found on either website at the time this article was published.