And the US Food and Drug Administration stated that its recent studies, in cooperation with the National Institutes of Health, showed that despite the detection of antigen tests for the “Omicron” mutant, this was done with a lower sensitivity, which means that it detects infection to a lesser degree.
The agency said it could not share any information about how weak any of the tests were to detect omicron, but was working to get more details.
“Studies are underway to confirm the cause of the apparent decrease in sensitivity,” the FDA said in a statement to CNN. “Once these are found, modifications to existing tests can be made by each developer, with FDA support if appropriate.”
Antigen tests are less sensitive than laboratory polymerase chain reaction (PCR) tests, but they are quick, affordable, and easy to use at home.
The FDA suggests that people continue to use these tests and make sure they follow directions exactly.
If a person gets a negative antigen test result, but suspects they have COVID-19 because they have symptoms, or have been exposed to the coronavirus, they should get a PCR (or molecular test) test.
And Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in America, encouraged people to continue to use rapid “Covid-19” tests.
“The tests are still feasible,” Fauci told CNN on Tuesday. “Don’t let anyone think the FDA said the tests were futile. They said they’re currently less sensitive. These tests have never been 100 percent sensitive.”
“What the FDA is saying today is that some tests are less sensitive to omicron, that is, their ability to detect it is low, but they still say the tests are useful and should be used,” Fauci added.
At a press conference on the White House’s response to “Covid-19” Wednesday, the Director of the US Centers for Disease Control and Control (CDC), Dr. Rochelle Walinsky, stressed the importance of antigen testing in “survival places and to keep children in schools, at higher education levels, And maintaining the safety of our university campus.”
Fauci noted Wednesday that the Food and Drug Administration was intended to be “completely transparent in saying that the sensitivity may be reduced a little, but it emphasized that its use remained important.”
The lack of detail has drawn criticism from some scientists and test experts.
On Twitter, eMed’s chief scientific officer, Dr. Michael Mina, criticized the Food and Drug Administration’s “extremely vague” statement that did not provide “any explanation or data.”
He also noted that the rapid tests are no less sensitive, “but simply, omicron is more contagious.”
In its announcement Tuesday, the agency did not mention specific tests whose sensitivity had decreased.
Abbott, the manufacturer of popular home antigen tests, confirmed to CNN that it is closely monitoring the situation with the omicron mutant and has not seen any change in the performance of the BinaxNOW test, so far.
“We know that our tests are an important tool in controlling the spread of the virus, and we will remain vigilant during our analysis and closely monitor test performance,” the company said in a statement to CNN.
US President Joe Biden acknowledged this week that the United States had not pushed enough to increase the number of “Covid-19” tests, which is currently causing a huge demand for it due to the holidays and the fast-moving “Omicron” and “Delta” variants, to empty store shelves. Long queues at test sites.
The administration is distributing half a billion free home tests, but it’s not clear when the tests will reach Americans who want them.
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