evidence: This page provides information about tests authorized by the U.S. Food and Drug Administration (FDA) for the identification and differentiation of specific SARS-CoV-2 mutations and lineages as well as the impact of viral mutations on COVID-19 tests. Recommendations for clinical laboratory staff and health care providers and information about certain tests for which the FDA has identified potential impacts on performance due to SARS-CoV-2 genetic mutations are also included on this page. The FDA will update this page when significant new information becomes available, including when the FDA's analyses identify tests for which performance may be impacted for known SARS-CoV-2 variants. [...] Clinical laboratory staff and health care providers should be aware that COVID-19 diagnostic tests are generally designed to detect all known variants. However, they are typically not able to identify the specific type of SARS-CoV-2 variant (such as delta or omicron) present in a patient sample. The FDA continues to conduct analyses to identify tests for which performance may be impacted for known SARS-CoV-2 variants. [...] - Test Name (Link to EUA): DTPM COVID-19 RT-PCR test - Manufacturer: Tide Laboratories, LLC - The FDA's Analysis:This test is now expected to detect the SARS-CoV-2 omicron variant (B.1.1.529). The original test was a single target test that was expected to fail to detect the SARS-CoV-2 omicron variant (B.1.1.529) due to a nine-nucleotide deletion in the N-gene, spanning positions 28370-28362, which is within the portion of the N-gene that the single target covered. The test has been modified and is now a multiplex test with an added reverse primer to detect the omicron variant.