The FDA said Tuesday that rapid Covid home tests are more likely to give a false negative with the heavily-mutated Omicron variant.
The country is facing a massive surge in cases that experts say is being under-captured as a result of a testing crunch, with long wait times for the more accurate PCR tests, and home kits in extremely short supply.
The FDA said it was collaborating with the National Institutes of Health to study the performance of home tests against patient samples containing live versions of the Omicron variant.
The agency said that early data suggests that the Omicron variant may have reduced sensitivity.
A test's sensitivity is how likely it is to detect a positive.
The statement said that previous testing had focused on heat-inactivated virus samples, rather than live virus which is better.
The FDA said that it would allow the use of antigen tests, which work by detecting the surface of the coronaviruses, and that individuals should use them according to instructions.
In order to confirm a negative, some rapid tests require users to take two tests in a certain amount of time.
If a person tests negative for Covid with a rapid test but is thought likely to have it, they should still get a gold standard test such as the PCR.
The genetic material of the virus can be detected. They are more accurate because they can make millions of copies of the virus.
Agence France-Presse.
