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BioWorld - Thursday, July 16, 2026
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Home » FDA’s Stenzel highlights sensitivity, specificity for COVID-19 antibody testing
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FDA’s Stenzel highlights sensitivity, specificity for COVID-19 antibody testing

May 6, 2020
By Mark McCarty
The U.S. FDA continues to modify its emergency use authorization (EUA) policy for testing for the SARS-CoV-2 virus, although workplace testing is still on the agency’s to-do list. The FDA’s Tim Stenzel noted on a May 6 briefing that serological tests for antibodies must now demonstrate an overall sensitivity of 90% and overall specificity of 95%, a set of standards that might challenge some tests that are available under the EUA policy.
Medical technology Regulatory Diagnostics Coronavirus FDA

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