Yesterday, the FDA published a document (here) detailing potential impact on the performance of specific COVID-19 detection tests for the Omicron variant as well as other variants of SARS-CoV-2. The FDA listed tests that may have reduced ability to detect the SARS-CoV-2 Omicron variant and provided a list of thirty‑three sites at which this test is primarily used.
The Agency further explains other issues that impact why these specific tests may not be able to detect the Omicron variant as well as other tests for which performance could be impacted by other variants. False-negative tests are the biggest concern; therefore, healthcare providers and labs should be certain that the tests employed are appropriate for the job at hand. This may be easier said than done. It may be possible that multiple tests will have to be used to cover the potential for identifying COVID‑19‑positive patients as the number of mutations increases.
The FDA will continue to update this information as more details are available and as different variants are identified and studied.
