FDA Issues Safety Letter about Genetic Variants of SARS-CoV-2 and False Negative Results with Molecular Tests

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 on the FDA-issued safety letter about genetic variants of SARS-CoV-2 and false negative results with molecular tests.

FDA Issues Safety Letter about Genetic Variants of SARS-CoV-2 and False Negative Results with Molecular Tests

On January 8, 2021, the U.S. Food and Drug Administration (FDA) issued a Letter to Clinical Laboratory Staff and Health Care Providers to clarify that genetic variants of SARS-CoV-2 may lead to false negative results when using molecular tests to detect SARS-CoV-2.