Concerns Over Open-Door Policy for COVID-19 Tests Cited in New FDA Letter

During the early stages of the coronavirus disease 2019 (COVID-19) pandemic, the U.S. Food and Drug Administration (FDA) allowed commercial diagnostic manufacturers to release their antibody COVID-19 tests into the market unreviewed.

This move may have been a mistake, with divisions within the FDA now noting flaws in this open-door policy that could have been avoided with more rigorous testing protocols.

Around the onset of the pandemic, companies around the world started to release antibody tests designed to identify COVID-19 infections. Some of these tests were mislabeled and often erroneously displayed the FDA’s official approval seal.

Others marketed their tests with unsubstantiated accuracy claims, even though independent research discovered high false result rates for these tests.

Despite these problems, governments across the globe looked to purchase millions of these antibody tests, with some agencies suggesting they could be the answer to ending lockdowns.

Even insurance coverage was provided for these tests, in spite of the fact that the claims of use were not supported by legitimate peer-reviewed evidence.

During this time, however, many scientists and government officials alike did not know which antibodies and the number of antibodies needed to identify a positive COVID-19 result and how these related to viral protection.

In an editorial letter in The New England Journal of Medicine, Jeff Shuren, M.D., the FDA’s device center director, and the agency’s in vitro diagnostics chief Timothy Stenzel, M.D., Ph.D., wrote that the agency planned to revisit their policy on antibody testing after it had authorized several serology tests. “In hindsight, however, we realized that the policy outlined in our March 16 guidance was flawed,” they wrote.

A total of 37 commercial manufacturers notified the FDA by the end of March of the release of their serology tests into the North American market. The end of April 2020 saw 164 commercial manufacturers notifying the FDA of the release of their serology tests in the U.S. market. Drs. Shuren and Stenzel wrote that this series of events differed from their experience with other commercially manufactured diagnostic tests. “In that case, very few tests were offered under notification; manufacturers generally marketed their own tests, rather than products made by other, typically non-U.S. manufacturers, as occurred with some serology tests; and false claims and data falsification were much less common,” they wrote.

In early May, the FDA their policy and increased its oversight on these tests, later naming over a dozen of products that were to be removed from the market. Ultimately, the agency decided to eliminate listings for a total of 225 COVID-19 tests from its website and handed out over a dozen warning letters.

To address epidemiologic questions about disease spread and immunity at the start of the COVID-19 outbreak, both Drs. Shuren and Stenzel suggest in their letter that the U.S. federal government should organize a public–private research plan and to establish capacity to evaluate the efficacy of tests before future outbreaks happen.

“Our collaboration with the NCI showed us the value of this approach,” wrote the FDA officials. “Combined with FDA authorization, this strategy could permit rapid independent assessment of molecular diagnostic, antigen, and serology test accuracy and minimize the need for developers to find patient specimens or other clinical samples to validate their tests, thereby expediting the availability of accurate tests.”