On 16 June 2020, the US Food and Drug Administration revoked the emergency use authorization (EUA) of the Chembio Diagnostic System, (Chembio) DPP Covid-19 IgM/IgG System, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test. Antibody tests, a type of serological test, can help provide information on a person’s and population’s exposure to Covid-19.
“Since the beginning of the Covid-19 public health emergency, the FDA has balanced the urgent need for access to diagnostic and antibody tests with providing a level of oversight that helps to ensure accurate tests are being deployed,” said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health. “By monitoring authorized tests and emerging scientific evidence, we can make changes when appropriate – including action when a test’s benefits no longer outweigh its risks. Through these efforts, we can help assure that FDA-authorized tests meet the needs of the American public.”
The Chembio antibody test was one of the first antibody tests authorized by the FDA during the Covid-19 public health emergency. At the time of authorization, based on the information that Chembio submitted to the FDA at that time, the agency concluded that the test met the statute’s “may be effective” standard for emergency use authorization and that the test’s known and potential benefits outweighed its known and potential risks.
As the FDA has learned more regarding the capability for performance of SARS-CoV-2 serology tests during the pandemic, and what performance is necessary for users to make well-informed decisions—through both the continued review and authorization of serology tests as well as through a research partnership with the National Institutes of Health’s National Cancer Institute (NCI)— the FDA was able to develop general performance expectations for these tests, which are listed in our serology templates.
Data submitted by Chembio as well as an independent evaluation of the Chembio test at NCI showed that this test generates a higher than expected rate of false results and higher than that reflected in the authorized labeling for the device. Under the current public health emergency circumstances, it is not reasonable to believe that the test may be useful in detecting antibodies against SARS-CoV-2 or that the known and potential benefits outweigh the known and potential risks of the test test, including the high rate of false results. Moreover, the risk to public health from the false test results makes EUA revocation appropriate for public health or safety. As such, the FDA decided to revoke the emergency use authorization of the Chembio test, and this test may not be distributed.
The FDA will continue to monitor the performance of tests marketed in the US and take actions, as appropriate, including modifying its policies.
The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and regulating tobacco products.