FDA Rescinds Emergency Use Authorization for COVID-19 Antibody Test

FDA recently revoked the emergency use authorization (EUA) for the SARS-CoV-2 antibody test, Chembio Diagnostic System (Chembio), due to performance concerns, according to an official press release.

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The Chembio antibody test was one of the first antibody tests authorized by FDA during the COVID-19 public health emergency. 

FDA based its EUA on information that Chembio submitted to the agency. At the time, the agency believed that the test met the statute’s “may be effective” standard for EUA approval and that the test’s known and potential benefits outweighed its potential risks.

FDA noted that it revokes EUAs when the criteria under 564(c) of the Act for issuance of such authorizations are no longer met, or other circumstances that make revisions or revocation appropriate to protect the public health or safety.

The agency concluded that after learning more regarding the capability for performance of SARS-CoV-2 serology tests during the pandemic and what was necessary to create an accurate and successful test, Chembio did not meet the criteria. 

Through its partnership with the National Institutes of Health’s National Cancer Institute (NCI), and after review of the authorization, FDA created general performance expectations for antibody tests.

“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,” FDA said.

“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.” 

Antibody tests are a type of serological test that can provide information on an individual’s exposure to COVID-19. 

Unlike vaccines, antibody treatments don’t produce lasting protection against a disease. Instead, these treatments are meant to equip bodies with tools to immediately fight off an infection or prevent an imminent contagion. 

“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,” Jeff Shuren, MD, director of FDA’s center for devices and radiological health, said in the press 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.”

This is the second COVID-19 EUA to be reversed this week but the first of a COVID-19 antibody test. On Monday, FDA revoked an EUA for chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ). 

FDA stated that the decision to reverse the EUA is based on newly gathered information including clinical trial data results that led the agency to conclude that the drug may not be effective to treat COVID-19.

“FDA has concluded that, based on new information and other information in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks,” the press release stated.