The U.S. Food and Drug Administration has issued warning letters to three companies for marketing adulterated and misbranded COVID-19 antibody tests. Generally, antibody tests, also called serological tests, detect antibodies to SARS-CoV-2, which can help identify individuals who have developed an adaptive immune response to the virus, as part of either an active infection or a prior infection. These tests may be important in the fight against this pandemic, as they may provide information on disease prevalence and the frequency of asymptomatic infection. Today’s warning letters are the first set of letters the agency has issued for marketing adulterated or misbranded COVID-19 test kits.
“Providing regulatory flexibility during this public health emergency never meant we would allow fraud,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “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. 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.”
Warning letters were issued to...
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