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Press Release/Announcement

Potential for false positive results with antigen tests for rapid detection of SARS-CoV-2--letter to clinical laboratory staff and health care providers.

US Food and Drug Administration: November 3, 2020.

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November 11, 2020

US Food and Drug Administration: November 3, 2020.

False-positive results contribute to patient and family discomfort and harm. This announcement shares information for clinicians to improve the reliability of the COVID-19 testing process and highlights government- and staff-level actions to support effective testing.