FDA: At-home antigen tests may have ‘reduced sensitivity’ to Omicron variant


AMARILLO, Texas (KAMR/KCIT) — The Food and Drug Administration (FDA) has released early research on the potential impact the Omicron variant has when it comes to at-home rapid antigen tests.

The agency released its preliminary research Tuesday, showing at-home rapid antigen tests may be less sensitive at detecting Omicron.

The FDA and the National Institutes of Health (NIH) RADx program said they used samples from Omicron-positive patients which contained the live virus. They said this, “represents the best way to evaluate true test performance in the short-term.”

“Early data suggests that antigen tests do detect the omicron variant but may have reduced sensitivity,” said the FDA’s report.

This means it is possible the tests could not detect an infection, resulting in a false negative.

If you take an at-home test and get a negative result but still feel like you have COVID-like symptoms, the FDA recommends you take a molecular, or PCR, test. They have longer turn-around times but are done in labs.

The FDA said antigen tests are generally less sensitive and less likely to pick up very early infections compared to molecular tests.

“It is important to note that these laboratory data are not a replacement for clinical study evaluations using patient samples with live virus, which are ongoing,” said the FDA. “The FDA and RADx are continuing to further evaluate the performance of antigen tests using patient samples with live virus.”

All of this comes as case numbers are surging across the country, promoting the demand for rapid at-home tests.

“The FDA, our partners, and test developers continue to evaluate test sensitivity, when tests should be performed, and the frequency of testing,” said the FDA. “The agency is also coordinating with our international regulatory counterparts who are also evaluating the impact of omicron on antigen tests used in their countries.”

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