Coronavirus variants popping up across the US are beginning to affect tests for the virus, the US Food and Drug Administration said Wednesday.
The agency said it is asking test developers to ensure their tests can detect the virus as it continues to mutate, an FDA official said.
“We are starting to see mutations to impact tests,” Dr. Timothy Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said during a briefing.
“There may be a performance difference going forward,” he added.
Stenzel said that Covid-19 tests are being developed that will consider new variants.
“We are going to start beginning to ask developers how they think they can monitor for variants of concern,” he said.
“At least for key variants, we're going to start wanting to know if there's any loss of sensitivity with those variants,” he added.
Stenzel said the FDA will stay vigilant in monitoring how variants impact the performance of Covid-19 tests and encouraged test developers to do the same.
Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said Wednesday that 308 cases of a variant first identified in Britain and known as B.1.1.7 have been seen in 26 states so far.
