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FDA approves first COVID-19 breath test for emergency use

(The Hill) – The Food and Drug Administration (FDA) announced Thursday that it has authorized the first test to detect COVID-19 by breath for emergency use.

The InspectIR COVID-19 Breathalyzer is capable of identifying five coronavirus-related volatile organic compounds in a person’s breath using a technique known as gas chromatography-gas mass spectrometry, providing results in less than three minutes, according to the FDA.

The agency said that in a study of 2,409 people, including both people with and without symptoms, the test had a specificity rate of 99.3%, which measures the percentage of negative test samples correctly identified.

The FDA also noted that the InspectIR COVID-19 breathalyzer had a sensitivity rating of 91.2%, which measures the percentage of correctly identified positive test samples.

Still, the health agency said a molecular test should be used to confirm positive test results returned from the COVID-19 breath test.

“Today’s clearance is another example of the rapid innovation that is occurring with diagnostic tests for COVID-19,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement.

“The FDA continues to support the development of new COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the United States for the next public health emergency.”

The InspectIR COVID-19 breathalyzer, which the FDA said was about the size of a carry-on, will be able to be used in places like mobile testing sites, hospitals and doctor’s offices, the agency said. ‘agency.

About 100 of the InspectIR COVID-19 breathalyzers, each of which the FDA says can be used to test about 160 samples per day, are expected to be manufactured each week.


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