FDA OKs First Breath Test for COVID-19

The FDA granted an emergency use authorization (EUA) to the first COVID-19 test that can detect the virus in breath samples, the agency announced on Thursday.

Dubbed the InspectIR COVID-19 Breathalyzer, the test uses gas chromatography-mass spectrometry to rapidly detect volatile organic compounds associated with SARS-CoV-2. Patients breathe into a disposable straw on the device — which is about the size of a piece of carry-on luggage, according to the agency — and results are returned in less than 3 minutes. The test is intended for healthcare settings where samples can be collected and analyzed, such as mobile testing sites, doctor’s offices, and hospitals.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a statement. “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 its news release, the FDA noted that positive test results with the breathalyzer should be considered presumptive and confirmed with a molecular test.

“Negative results 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, as they do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions,” the agency said.

Primary support for the EUA came from a study of 2,409 individuals with and without symptoms, conducted in four U.S. states. The breathalyzer test was found to have a sensitivity of 91.2% (90% CI 85.4-94.8) and specificity of 99.3% (95% CI 98.8-99.5) when compared with a PCR test. This yielded a negative predictive value of 99.6%, the agency noted, “meaning that people who receive a negative test result are likely truly negative in areas of low disease prevalence.”

A follow-up trial of 12 symptomatic individuals in Texas, conducted in February when Omicron accounted for nearly all cases there, showed a similar sensitivity of 90.9% (90% CI 67.7-98.0).

The company expects to produce 100 units each week, with each unit estimated to be able to analyze 160 samples each day, according to the FDA.