FDA authorizes first COVID breath testing device

The Food and Drug Administration (FDA) 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 device, InspectIR Covid-19 Breathalyzer, is about the size of a piece of carry-on luggage, the FDA said, and can be used in doctor's offices, hospitals and mobile testing sites. 

As per officials, the test can provide results in less than three minutes and must be carried out under the supervision of a licensed health care provider. 

Dr Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for Covid-19."

The FDA says the company will be able to produce around 100 instruments per week. 

Each test can evaluate around 160 samples every day. 

According to an FDA release, the breathalyzer correctly identified positive samples 91.2% of the time in a study of 2,409 people—in trials— and it also performed well in a subsequent study assessing its effectiveness against the virus’ omicron variant

Accuracy has been an obstacle for developers of new Covid-19 tests, but InspectIR believes its technology circumvents this problem by testing in the high part-per-trillion range, the company’s COO John Redmond said in the press release.