FDA authorizes the first COVID-19 breath test

The Food and Drug Administration granted emergency-use authorization to the first COVID-19 test that can detect the coronavirus in a breath sample, within minutes and with a high degree of accuracy, the agency said Thursday.

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

The InspectIR COVID-19 Breathalyzer, which is about the size of a piece of carry-on luggage, can produce results in less than 3 minutes and can be used in doctor’s offices, hospitals and mobile testing sites by trained operators. A single machine can analyze about 160 samples per day.

The device was tested in a study made up of 2,409 individuals both with and without symptoms of the virus. In the study, the test identified 91% of positive samples correctly and 99% of negative samples correctly.

The Breathalyzer test uses a technique called gas chromatography-mass spectrometry, which separates and identifies chemical mixtures to detect five compounds associated with the coronavirus in exhaled breath. If a test comes back positive on the Breathalyzer, it should be confirmed with a molecular test, such as a PCR lab test.

The FDA warned that negative tests “should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19” because they do not completely rule out an infection, and noted that the device “should not be used as the sole basis for treatment or patient management decisions, including infection-control decisions.

InspectIR, the company that produces the Breathalyzer, expects to be able to produce about 100 machines per week.