The FDA announced that it revoked the emergency use authorization (EUA) of the Chembio DPP COVID-19 antibody test due to accuracy concerns.
Chembio’s IgM/IgG SARS-CoV-2 serological antibody test received EUA in March as a fingerstick-style test designed to use the company’s MicroReader 1 and MicroReader 2 analyzers to detect IgM and IgG antibodies and offer results within 15 minutes.
As it was one of the first antibody tests authorized by the FDA during the COVID-19 pandemic, the agency concluded at the time that it met the statute’s “may be effective” standard for EUA, with the test’s known and potential benefits outweighing its known and potential risks.
However, the agency has since learned more regarding performance capabilities for SARS-CoV-2 serology tests, according to a news release, and developed general performance expectations for these tests.
Data submitted by Chembio showed that its test generates a higher than expected rate of false results and higher than that reflected in the authorized labeling for the device, leading the FDA to conclude that, under the current circumstances of the public health emergency, it is not reasonable to believe the test may be effective in detecting antibodies against SARS-CoV-2, or that its known and potential benefits outweigh the risks.
Chembio’s test may not be distributed now that it has been revoked, and the FDA said it will continue to monitor the performance of tests marketed in the U.S. and take actions as appropriate.
“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,” FDA Center for Devices & Radiological Health director Dr. Jeff Shuren said in the release. “By continuing to monitor authorized tests and emerging scientific evidence, we are able to make changes when appropriate – including taking action when a test’s benefits no longer outweigh its risks. Through these efforts, we are able to help assure that FDA-authorized tests meet the needs of the American public.”
