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FDA authorizes first COVID-19 breathalyzer test 


InspectIR Systems via CNN Newsource


The US Food and Drug Administration granted emergency use authorization for the first covid-19 test on April 14 that can detect the disease in breath samples.

According to the FDA, the InspectIR Covid-19 Breathalyzer can give results in less than three minutes and can be used in mobile testing sites and medical offices. The breathalyzer is allegedly the size of a piece of carry-on luggage.

The device separates and identifies chemical mixtures to detect up to five SARS-CoV-2 infected compounds.

Director of the FDA’s Center for Devices and Radiological Health, Dr.Jeff Shuren, referred to the device as “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”

“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,” said Shuren.

A study of the InspectIR Breathalyzer found the device to be 91.2% accurate at identifying positive samples and 99.3% at identifying negative samples. 

The FDA stated positive cases should still be confirmed with a PCR test.

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