The Food and Drug Administration announced Thursday that Americans will be able to find out if they have COVID-19 with a ventilator test.
The FDA has granted emergency use authorization for a test conducted by the Medical Examination System to collect breath samples and analyze chemical compounds associated with the coronavirus, the first of its kind. allowed to use.
In a study of 2,409 people, the test correctly identified positive COVID infections in 91.2% of cases and correctly identified negative samples in 99.3%, the FDA said in a statement. A similar result was seen in a follow-up study that focused on the contagious omicron variant of the coronavirus.
According to the test, the test is performed by exhaling into the tube in a manner similar to blowing up a balloon and gives results within three minutes.
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The FDA says the test device is about the size of a piece of hand luggage, and breath testing can be performed at doctors’ offices, hospitals, and other testing sites.
“Today’s authorization is yet another example of the rapid innovation happening with diagnostic tests for COVID-19,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “FDA continues to support the development of new COVID-19 tests with the goal of improving technologies that can help address the current pandemic and better position the United States for the next public health emergency.” according to.”
The FDA says a positive result obtained from a breath-reducing device that tests for COVID-19 must be confirmed with a molecular test.