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.

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"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.