FDA Authorizes 3-Minute COVID-19 Breath Test

By Sam Brusco, Associate Editor | 04.18.22

InspectIR breathalyzer spots chemical compounds in breath samples associated with COVID-19 infection.

The U.S. Food and Drug Administration (FDA) has awarded emergency use authorization (EUA) for the InspectIR COVID-19 breathalyzer to spot chemical compounds in breath samples associated with COVID-19 infection.
 
With an instrument the size of carry-on luggage, the test can be administered in doctor’s offices, hospitals, or mobile testing sites. The test is performed by a qualified operator under licensed healthcare provider supervision and can offer results in under three minutes.
 
InspectIR uses gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and rapidly spot volatile organic compounds related to SARS-CoV-2 infection in exhaled breath. When a positive test result is returned, it should be confirmed with a PCR test.
 
“[This] authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, MD, J.D., director of the FDA’s Center for Devices and Radiological Health told the press. “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.” 
 
A 2,409-patient study of InspectIR showed the test had 91.2% sensitivity and 99.3 percent specificity. It also showed in a population with only 4.2% of people positive for the virus that the test had a 99.6% negative predictive value, meaning those who received a negative result were likely truly negative in areas with low disease prevalence.
 
InspectIR aims to produce 100 instruments per week to evaluate about 160 samples per day.