FDA revokes one of the first antibody tests it authorised amid coronavirus pandemic

The United States Food and Drug Administration (FDA) on June 16 revoked the use of one of the first antibody tests it authorised during the coronavirus public health emergency. The FDA in a release on Tuesday said that it is revoking the emergency use authorization (EUA) of the Chembio Diagnostic System, Inc. (Chembio) antibody test due to performance concerns with the accuracy of the test. Antibody tests are a type of serological test that helps in providing information about a person's or a population's COVID-19 exposure. 

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Revocation appropriate 

According to FDA, data submitted by Chembio as well as an independent evaluation of the Chembio test at the National Cancer Institute (NCI) showed that this test generates a higher than expected rate of false results and higher than that reflected in the authorised labeling for the device. The FDA further said that the revocation of the Chembio test is appropriate because it puts the health and safety of the American public at risk from false results. 

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"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. 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," said Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health. 

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According to figures by Johns Hopkins University, the United States has recorded over 2 million confirmed coronavirus cases and more than 1,16,000 deaths so far, which is the highest in the world, both in terms of infections and fatalities. Meanwhile, the world has logged in 8.1 million cases and over 4,43,000 deaths as of June 17. 

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