FDA grants emergency use authorization to first breath-based COVID-19 diagnostic test

A new avenue of testing for COVID-19 opened last week, with emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the InspectIR COVID-19 Breathalyzer, a diagnostic capable of detecting SARS-CoV-2 infection from breath samples.

In less than three minutes, the InspectIR test has been shown capable of delivering results in doctor’s offices, hospitals, and mobile testing sites alike. However, it is not self-applicable: it must be issued by a trained operator under the supervision of a licensed/authorized health care provider. Still, in a study of 2,409 participants both with and without symptoms, the test offered a 91.2 percent sensitivity – or percent of positive samples correctly identified – and 99.3 percent specificity – the percent of negative samples correctly identified.

It also performed similarly on the omicron variant as it did on the original strain.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Dr. Jeff Shuren, 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 U.S. for the next public health emergency.”

InspectIR is expected to produce about 100 breathalyzers per week, each capable of evaluating approximately 160 samples per day. This means the company could increase testing capacity by about 64,000 samples per month.

The test works through gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and quickly detect certain compounds associated with SARS-CoV-2 infection in each exhaled breath. Once detected, the test provides a presumptive positive result, and users are encouraged to confirm with a molecular test.