Rapid antigen tests less sensitive for detecting Omicron variant infections: US Food and Drug Administration
Dec 29, 2021
Washington [US], December 29 : The Food and Drug Administration in the US has said that rapid antigen tests are less sensitive for detecting Omicron variant infections.
"Early data suggest that antigen tests do detect the omicron variant but may have reduced sensitivity," FDA said in a statement on Tuesday (local time).
The FDA provided information based on preliminary study results of some antigen tests using patient samples containing live viruses.
The FDA has said that it will continue to collaborate with the National Institutes of Health's (NIH) RADx program to further evaluate the performance of antigen tests using patient samples with live viruses.
The SARS-CoV-2 virus has mutated over time, resulting in genetic variation in the population of circulating viral strains over the course of the COVID-19 pandemic. Molecular, antigen, and serology tests are affected by viral mutations differently due to the inherent design differences of each test, the statement added.