The omicron variant may not show up in rapid COVID-19 antigen tests, raising questions about how accurate tests will be during the upcoming winter COVID-19 surge.
The Food and Drug Administration said Tuesday that rapid COVID-19 antigen tests have struggled to detect the omicron variant compared to earlier COVID-19 strains.
- This was based off early studies from the FDA and the National Institutes of Health’s RADx program.
The FDA said that the data suggests the tests “do detect the omicron variant but may have reduced sensitivity” at detecting positive COVID-19 cases.
- “The FDA and RADx are continuing to further evaluate the performance of antigen tests using patient samples with live virus,” the FDA’s statement said.
However, the FDA said it still recommends people use the rapid COVID-19 antigen tests for determining potential positive cases.
- “The FDA continues to authorize the use of these tests as directed in the authorized labeling and individuals should continue to use them in accordance with the instructions included with the tests,” the FDA added. “Antigen tests are generally less sensitive and less likely to pick up very early infections compared to molecular tests.”
The FDA’s announcement comes amid a shortage of COVID-19 tests. As I wrote for the Deseret News, people are struggling to find at-home COVID-19 tests and available testing sites because there’s been such an increased demand due to the holiday season.
- “You know, testing has always been an issue. ... That has been problematic. It has been compounded by the situation of the high demands,” Dr. Anthony Fauci told CNN’s Kaitlan Collins in an interview Monday morning.
- “Obviously, not making any excuses for it: We should have had more tests available. But hopefully now as we get into the first couple of weeks in January, that’ll get much better,” he said.