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November 09, 2020

Health Law Daily

FDA Authorizes First Serology Test To Screen For Coronavirus Antibodies

  • November 09, 2020

CNBC (11/6, Feuer) reported that the FDA “announced on Friday that it has authorized the first serology test that screens for neutralizing antibodies caused by a previous coronavirus infection.” The new test “will help researchers study the neutralizing antibodies, said Dr. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.” However, patients and health providers “should not interpret the positive results of the test to mean that patients are protected against [COVID-19], the agency said.”