The U.S. Food and Drug Administration (FDA) said the Revogene SARS-CoV-2 test from Meridian Bioscience is unlikely to detect Omicron, the new coronavirus variant now circulating around the world.
The reason: the Revogene SARS-CoV-2 test is a single-target assay that focuses on a portion of the N-gene where deletions occur with the Omicron (B.1.1.529) variant. As a result, the test will return false negative results in patients infected with Omicron, the FDA said, adding that the performance of the test is not expected to be impacted for other known SARS-CoV-2 variants.
“Meridian Biosciences has not yet distributed this test and does not intend to distribute this test, within or outside the United States, until this issue is resolved,” the FDA said.
The agency said it included the information about the test on its new web page, the “SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.”
