As healthcare giants across the world try to speed up the coronavirus testing capability, a new antigen test in the U.S. is expected to be a game-changer in the field.
The U.S. Food and Drug Administration (FDA) has given emergency use authorization to San Diego-based Quidel Corp. for its rapid coronavirus antigen test that could practically be done in the doctor’s office. This is the first-ever emergency use authorization given by the FDA for a COVID-19 antigen test.
The former head of the FDA believes that this new coronavirus test can lead to a new breakthrough in COVID-19 testing, especially considering the fact that now more and more states are lifting movement restrictions and lockdown to restart the economy.
However, the health experts continue to remain worried about the missing testing capabilities, which may lead to a new wave of infections due to insufficient screening of suspected cases.
“It’s a very rapid test that could be used in a doctor’s office,” said former FDA Commissioner Scott Gottlieb. “Doctors now have about 40,000 of these Sophia machines already installed in their offices” where they are used to test for strep throat and flu, he said.
Gottlieb, who is now a special partner at New Enterprise Associates, says that the test can be done in $5 in the U.S. and the results are available within a few minutes while waiting at the doctor’s office.
However, he believes that it is important to ensure that doctors are guided properly by the U.S. authorities on the use and further processing if the case turns out to be positive.
He fears that doctors may not be using this highly-affordable test for screening if a positive case means they have to clean the entire set-up, close the office and quarantine the staff.
If the test is implemented properly and made widely available to the doctors to test the coronavirus suspects in the U.S., the Trump administration will be better equipped to reopen the U.S. economy by lifting off several restrictions on people and businesses across the country.
The PCR tests currently available in the U.S. for COVID-19 diagnosis take time to give results. The one provided by Quidel rapidly delivers results of COVID-19 testing by detecting antigens on the surface of the coronavirus.
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