FDA 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,” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement. “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: 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. Violations outlined in the warning letters include: offering test kits for sale in the United States directly to consumers for at-home use without marketing approval, clearance, or authorization from the FDA; misbranding products with labeling that falsely claims products are “FDA approved”; and labeling that bears the FDA logo, which is only for the official use by the FDA and not for use on private sector materials.
There are no diagnostic or antibody COVID-19 test kits that are authorized, cleared or approved to be used completely at home. Testing in the home can present unique and potentially serious public health risks, including whether a lay user has the ability to collect their specimen, run the test, and interpret their results accurately. However, the FDA has authorized several diagnostic COVID-19 tests for use with at-home collection of samples—such as from the nose or saliva—that can then be sent to a lab for processing and test reporting. However, there are not any serology tests that are authorized for use with at-home collection of samples.
The FDA has requested that the companies take immediate steps to correct violations, such as ceasing the sale of the products or preventing future sales. Failure to immediately correct the violations cited in the warning letters may result in legal action, including possible seizure and injunction.
The FDA reminds consumers to be cautious of websites and stores selling products, including test kits, that claim to prevent, mitigate, treat, diagnose or cure COVID-19. Fraudulent COVID-19 products defraud consumers of money and can place consumers at risk for serious harm. Using these products may lead to delays in getting proper diagnosis and treatment of COVID-19 and other potentially serious diseases and conditions.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of COVID-19 products to the FDA’s MedWatch Adverse Event Reporting program.
