U.S. Food and Drug Administration (FDA) regulators have moved against dozens of supposed COVID-19 antibody tests that have never been shown to work, publishing a list of those that failed to file applications or have already pulled their products voluntarily.
There are 28 on that list so far, from Artron BioResearch Inc. and Artron Laboratories Inc.’s COVID-19 lgM/lgG antibody test to the SARS-CoV-2 IgM/IgG (GICA) produced by Zhongshan Bio-Tech Co Ltd. All have been removed from the official notification list of tests being offered through the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. As a result, the agency stated that it expects these tests will neither be marketed or distributed.
Companies are required to provide paperwork demonstrating their tests’ performance capabilities. The FDA expects to add more names to the removal list as time goes on.
“Our action today is an important step the agency has taken to ensure that Americans have access to trustworthy tests,” FDA Commissioner Stephen Hahn said. “We have seen a high level of collaboration and engagement from developers who want to get this right, and we continue to be available to work extensively with industry to help them with developing accurate tests for the public.”
Antibody tests work differently from the more commonly known nasal swab tests. Nasal swab tests focus on active infections, whereas antibody tests rely on proteins in the blood that arise from fighting off infections — antibodies. They can show if someone had COVID-19 and recovered. New antibody tests are rolling out all the time.