Advisor 465

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

FDA revokes emergency authorisation for coronavirus antibody test

On 14 June 2020 the FDA revoked the Emergency Use Authorization (EUA) for one of the first antibody tests for coronavirus, due to performance concerns with the test’s accuracy.

In the USA, legislation permits the FDA to use EUA for medical countermeasures needed during public health emergencies. The FDA Commissioner may thus allow the use of unapproved medical products or unapproved uses of approved medical products in an emergency, to diagnose, treat or prevent serious or life- threatening diseases or conditions caused by chemical, biological, radiological nuclear or emerging infectious disease threats when there are no adequate approved and available alternatives. Chembio test Antibody tests (types of serological tests) can help to provide information on a person’s and population’s exposure to COVID-19. On 14 April 2020, Chembio Diagnostic Systems’ (Chembio’s) DPP COVID-19 IgM/IgG System – a SARS-CoV-2 antibody test – became one of the first antibody tests authorised by the FDA in response to the pandemic. At the time of the authorisation, based on the information that Chembio submitted to the FDA, the agency concluded that the test met the statute’s “may be efective” standard for EUA, and that the test’s known and potential benefits outweighed its known and potential risks. However, as the FDA learned more about the capability for performance of SARS-CoV-2 serology tests, and about the level of performance needed to allow users to make well-informed decisions – through both the continued review and authorisation of serology tests as well as through a research partnership with the National Institutes of Health’s National Cancer Institute (NCI) – the FDA developed general performance expectations for these tests.

Data submitted by Chembio, as well as an independent evaluation of the Chembio test at the NCI, showed that the test generates a higher than expected rate of false results, which is also higher than the rate reflected in the authorised labelling for the device. In the context of the current pandemic, the FDA considers that it is not reasonable to believe that the test may be efective in detecting antibodies against SARS-CoV-2, or that the known and potential benefits of the test still outweigh its known and potential risks, including the high rate of false results. In view of these considerations and the risk to public health from false test results, the FDA concluded that it was appropriate to revoke the EUA, and as a result the test may no longer be distributed. Speaking as the revocation was announced, Jef Shuren (Director of the FDA’s Center for Devices and Radiological Health) said, “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 eforts, we are able to help assure that FDA-authorized tests meet the needs of the American public.” Source: ; a copy of the revocation letter issued on 14 June 2020, which reviews the performance data in more detail, is available at . Don’t miss out on the latest news and bulletins between issues. Follow us on Twitter @gcpadvisor

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Issue 465, 2020

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