Rapid COVID-19 tests not accurate with Omicron- FDA

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Rapid COVID-19 antigen tests may be less effective at detecting Omicron than earlier strains on the virus, the Food and Drug Administration said Tuesday.

READ ALSO: OMICRON overtakes Delta, more contagious, less severe

The development was gleaned from preliminary studies conducted by the FDA in collaboration with National Institutes of Health’s RADx program into the performance of the at-home tests on the heavily-mutated Omicron variant.

Early data suggest that antigen tests do detect the Omicron variant but may have reduced sensitivity,” the agency said.

Sensitivity is a measure of how likely a test is able to detect a positive.

Previous testing had focused on heat-inactivated virus samples, rather than a live virus which is better, and a drop-off in performance hadn’t been spotted until now, the statement added.

The FDA said it would continue to authorize the use of antigen tests – which work by detecting surface proteins of the coronavirus – and that individuals should continue to use them in accordance with the instructions. 

For instance, some rapid tests instruct users to take two tests, a certain amount of time apart, to confirm a negative.

If a person tests negative with a rapid test but is thought likely to have Covid, either because of symptoms or their exposures, they are still recommended to get a “gold standard” molecular test – such as PCR. 

These detect the genetic material of the virus. They are more accurate because they can make millions of copies of the virus’ RNA, so even tiny amounts become detectable.

MTO/Punch

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