FDA Issues Safety Letter about Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2

COLA is engaged with the CDC’s Laboratory Outreach Communication System (LOCS) in the Division of Laboratory Systems (DLS) to transmit their public health messages to our laboratories and affiliates. Below is a link to the most recent message about an FDA-issued safety letter about the potential for false positive results with antigen tests for rapid detection of SARS-CoV-2.

FDA Issues Safety Letter about Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2

On November 3, 2020, the U.S. Food and Drug Administration (FDA) issued a Letter to Clinical Laboratory Staff and Health Care Providers to alert clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2.

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