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April 27, 2020

Health Law Daily

FDA Considers Changing Policy On COVID-19 Antibody Tests As Inaccurate Tests Flood The Market

  • April 27, 2020

Politico (4/27, Brennan, Lim) reports the FDA “is dealing with a flood of inaccurate coronavirus antibody tests after it allowed more than 120 manufacturers and labs to bring the tests to market without an agency review.” Antibody tests “have been eyed as a tool to help reopen the country by identifying people who may have immunity,” since the data they provide could “help determine the true size of the U.S. outbreak by finding cases that were never formally diagnosed.” However, “many of the tests available now aren’t accurate enough for such purposes,” with some giving “too many false positive results, which could mislead some people into thinking they have already been infected.” FDA Commissioner Stephen Hahn “told POLITICO that the agency has discussed changing the current policy, which allows manufacturers to validate the quality of their own products as long as they include a disclaimer with test results.”