Warning letters have been issued to 3 companies marketing adulterated and misbranded serological tests that claim to detect antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), according to the Food and Drug Administration (FDA).
The Agency sent these letters 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. These tests, which were labeled falsely as FDA-approved and also contained the FDA logo, were being sold directly to consumers for at-home use. At this time, the FDA has not authorized any type of test for coronavirus disease 2019 (COVID-19) that has the ability to be completely done at home.
Additionally, the FDA has revoked the emergency use authorization (EUA) for the Chembio Diagnostic System, Inc. (Chembio) DPP COVID-19 IgM/IgG System, a SARS-CoV-2 serology test. The antibody test was one of the first to receive an EUA, however as more data regarding performance expectations were made available, the accuracy of the test was called into question. Specifically, the Agency noted that the test generates a higher than expected rate of false results.
“Under the current circumstances of the public health emergency, it is not reasonable to believe that the test may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the test outweigh the known and potential risks of the test, including the high rate of false results,” the FDA stated in a press statement.
For more information visit fda.gov.