FDA revokes EUA for Chembio serology test

June 17, 2020

The U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) for the Chembio Diagnostic System’s DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, the agency said in a press release.

The FDA said it revoked the EUA due to performance concerns with the accuracy of the test.

Antibody tests, a type of serology test, can help provide information on whether a person has been exposed to SARS-CoV-2. 

“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,” said Jeff Shuren, MD., director of FDA’s Center for Devices and Radiological Health.

Officials at Chembio were not immediately available for comment on deadline. 

The Chembio antibody test was one of the first antibody tests granted an EUA by the FDA, which was based on information on performance that Chembio submitted to the FDA at that time. Since then, the agency has been working with the National Institutes of Health’s National Cancer Institute (NCI), which has been performing independent validation of the tests.

In explaining its decision to revoke the EUA for Chembio’s test, the FDA said that “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,” the agency said in a news release. “The risk to public health from the false test results makes EUA revocation appropriate to protect the 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 said.

In May, the FDA revised its policy on serology tests and now requires commercial developers to apply for an EUA within 10 business days of the date they notify the FDA that they have completed their validation testing on an antibody assay and are marketing the product.

Visit the FDA for more news