Early in the pandemic, when the numbers of asymptomatic COVID-19 cases were mounting, officials at the FDA decided to authorize the use of serology tests that laboratories had validated but that the agency hadn’t actually reviewed.
Now two FDA officials are admitting that this was a mistake, but one the agency has learned from. In an article published in the New England Journal of Medicine, two top officials of the FDA’s Center for Devices and Radiological Health (CDRH) said that the agency was trying to slow the spread of SARS-CoV-2, the virus that causes COVID-19, by using the results of serology tests to screen for antibodies for the virus.
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