With New Variant Comes Potential New Testing Issue

FDA warns that rapid antigen tests may not pick up on omicron that well
By Jenn Gidman,  Newser Staff
Posted Dec 29, 2021 8:44 AM CST
FDA: Omicron May Prove More Elusive in Rapid Home Tests
A medical staff member conducts a COVID-19 rapid test on a woman in Athens, Greece, on Wednesday.   (AP Photo/Thanassis Stavrakis)

(Newser) – Not all news regarding the latest COVID-19 variant is gloomy, with very early signs pointing to less severe illness overall—meaning fewer hospitalizations and deaths—with omicron. When it comes to testing, however, the latest development doesn't bode well, per a warning issued by the Food and Drug Administration on Tuesday. "Early data suggests that antigen tests do detect the omicron variant but may have reduced sensitivity," the FDA noted Tuesday in a release. What that means in layman's terms, per Politico: Those rapid at-home tests available at local drugstores or online may not be terribly capable of picking up on omicron.

The FDA teamed up with scientists from the National Institutes of Health for this preliminary research using live-virus samples, early results of which suggest that rapid tests could possibly miss omicron infections and spit out "false negatives," per NBC News. The agency's announcement comes during a current surge in COVID cases that have led to more people seeking out the rapid tests, which offers results in minutes, over what CBS News calls the "gold standard" in testing: molecular PCRs, which have to be analyzed in a lab and therefore take longer to process, but which are more accurate.

The development also comes on the heels of the Biden administration announcing that it plans on distributing 500 million at-home tests to American households. The FDA says further clinical studies are needed, and that it's not advocating people stay away from antigen tests altogether. Instead, the agency recommends that individuals who test negative using a rapid test, yet still have COVID symptoms or were exposed to a person with COVID, get a follow-up PCR test. Politico also notes that people should be taking antigen tests on two separate days for further confirmation, which is why these tests usually come two to a box. (The CDC modified its isolation protocols this week.)

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