COVID-19 Tests May Be Impacted by Variants

12/7/21 — As the SARS-CoV-2 virus continues to mutate over time, genetic variations could impact the performance of some COVID-19 molecular, antigen, and serology tests. The FDA website “SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests” provides information regarding the impact of viral mutations on COVID-19 tests, recommendations for clinical laboratory staff and healthcare providers, and information about certain tests for which the FDA has identified potential impacts on performance due to SARS-CoV-2 genetic mutations. One such test is the Tide Laboratories DTPM COVID-19 RT-PCR Test, which may fail to detect the omicron variant. Please see the website for a list of labs using this test and for FDA’s assessment of how variants are impacting other COVID-19 tests.