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'rapid innovation'

FDA authorizes COVID-19 breath test that provides results in less than 3 minutes

A test that can detect COVID-19 via breath is on the way in the United States. 

The Food and Drug Administration says it has issued an emergency use authorization for the InspectIR COVID-19 Breathalyzer, which can detect COVID-19 using breath samples and return results in less than three minutes.

The test uses an instrument "about the size of a piece of carry-on luggage," and it must be performed in "environments where the patient specimen is both collected and analyzed," such as doctor's offices, hospitals, and testing sites, the FDA says. 

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

In a study consisting of over 2,400 people, this breath test correctly identified 91.2 percent of positive samples. Additionally, the FDA says the study indicated that those who receive a negative test result via the test "are likely truly negative in areas of low disease prevalence," as its "negative predictive value" was 99.6 percent. Those who receive a positive test result should have it confirmed via a molecular test, though. 

According to the FDA, InspectIR will be able to produce about 100 instruments a week, each of which can evaluate about 160 samples a day, and expects to increase testing capacity by about 64,000 samples a month.