Posted on Apr 17, 2022
FDA authorizes breath test that can detect COVID-19 in three minutes
515
9
1
7
7
0
The Food and Drug Administration has granted emergency use authorization to a new COVID-19 test that can detect infections with only a sample of a patient's breath, using a device that can yield results in less than three minutes.
The agency says the InspectIR COVID-19 Breathalyzer will only be available for tests "by a qualified, trained operator under the supervision of a health care provider."
"The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency," Dr. Jeff Shuren, the FDA's top COVID-19 testing official, said in a statement announcing the authorization.
The agency says the InspectIR COVID-19 Breathalyzer will only be available for tests "by a qualified, trained operator under the supervision of a health care provider."
"The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency," Dr. Jeff Shuren, the FDA's top COVID-19 testing official, said in a statement announcing the authorization.
FDA authorizes breath test that can detect COVID-19 in three minutes
Posted from cbsnews.com
Medical
Health
Posted 2 y ago
Responses: 1
2
2
0
PO1 William "Chip" Nagel
..."Like with the rapid at-home COVID-19 tests that have surged in popularity over recent months, the FDA says positive results from the newly authorized breathalyzer "should be confirmed with a molecular test."
While most COVID-19 tests rely on swabs, the FDA has greenlighted other alternatives to look for signs of the virus. Back in August 2020, the agency authorized a test from Yale that looked for infection using saliva samples. Last year, an antibody test earned the FDA's emergency authorization using a finger prick.
The federal government has also backed the development of an array of new types of COVID-19 tests, including at-home kits that might one day be able to test for flu and COVID-19 infections with a single swab.
"Today's authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19," said Shuren."
..."Like with the rapid at-home COVID-19 tests that have surged in popularity over recent months, the FDA says positive results from the newly authorized breathalyzer "should be confirmed with a molecular test."
While most COVID-19 tests rely on swabs, the FDA has greenlighted other alternatives to look for signs of the virus. Back in August 2020, the agency authorized a test from Yale that looked for infection using saliva samples. Last year, an antibody test earned the FDA's emergency authorization using a finger prick.
The federal government has also backed the development of an array of new types of COVID-19 tests, including at-home kits that might one day be able to test for flu and COVID-19 infections with a single swab.
"Today's authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19," said Shuren."
(2)
(0)
Read This Next
Continue with Facebook 
Continue with Google