FDA moves to pull certain Covid-19 antibody tests

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With the accuracy of antibody tests for Covid-19 under close scrutiny, the FDA is making good on its promise to ensure high standards are maintained. The agency has named 28 antibody, or serological, tests it says will no longer be marketed in the US. The makers of these products, many of whom are based in China, had either failed to seek emergency use authorisation for their tests or had “significant problems” identified with them, according to the FDA. Some manufacturers voluntarily withdrew antibody tests; one such is the Biomedomics assay sold by Becton Dickinson under a distribution agreement. This is just the beginning: the FDA said it would update the list, which can be found under the eighth drop-down FAQ on this page, on an ongoing basis. None of the tests yet named for removal have received emergency use authorisation – though interestingly the agency has not granted EUAs to any new antibody tests in the past two weeks.

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