FDA Authorizes First COVID-19 Diagnostic Breath Test

The InspectIR COVID-19 Breathalyzer test detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.

The FDA announced yesterday that it had provided an Emergency Use Authorization to the InspectIR COVID-19 Breathalyzer. This test is the first such to detect the virus from people’s breath.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, MD, JD, director of the FDA’s 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 US for the next public health emergency.”

The breathalyzer was part of a large study of 2409 people, including those with and without symptoms. The breathalyzer was shown to have a 91.2% sensitivity (the percent of positive samples the test correctly identified) and a 99.3% specificity (the percent of negative samples the test correctly identified).

The study also showed that, in a population with only 4.2% of individuals who are positive for the virus, the test had a negative predictive value of 99.6%, meaning that people who receive a negative test result are likely truly negative in areas of low disease prevalence. The test performed with similar sensitivity in a follow-up clinical study focused on the Omicron variant.

The InspectIR breathalyzer uses gas chromatography gas mass-spectrometry to separate and identify chemical mixtures and rapidly detect 5 volatile organic compounds associated with SARS-CoV-2 infection in exhaled breath. When the breathalyzer detects the presence of VOC markers of SARS-CoV-2, a presumptive (unconfirmed) positive test result is returned and should be confirmed with a molecular test.

The company that produces the breathalyzer, InspectIR Systems, expects to be able to produce approximately 100 instruments per week, which they say can each be used to evaluate approximately 160 samples per day. The company is expecting to increase its sample capacity to eventually 64,000 per month.