FDA grants emergency use authorization to COVID breath test

Coronavirus

(NewsNation) — The U.S. Food and Drug Administration on Thursday issued an emergency use authorization for the first COVID-19 breath test.

According to the FDA, the diagnostic test detects chemical compounds associated with the virus from breath samples.

Officials say the test can be performed in places such as doctors’ offices, hospitals and mobile testing sites using a device about the size of a piece of carry-on luggage. Results from the InspectIR COVID-19 Breathalyzer are reportedly ready in less than three minutes.

In a study of 2,409 subjects, the FDA said the breath analyzer was shown to have 91.2% sensitivity (the percent of positive samples the test correctly identified) and 99.3% specificity (the percent of negative samples the test correctly identified). The study’s test focused on the omicron variant.

The FDA said in the event the InspectIR COVID-19 Breathalyzer test comes back with a positive result, the diagnosis should be confirmed with a molecular test. The agency insisted negative results should be considered in the context of the patient’s recent exposure and symptoms.

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

At this time, InspectIR expects to be able to produce around 100 of the devices per week, which each can be used to test approximately 160 samples per day, thus increasing testing capability by 64,000 samples each month.

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