FDA Issues EUA for First COVID-19 Breath Test


The InspectIR Systems Breathalyzer test can provide results in three minutes.

The FDA has issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.

Developed by the device company InspectIR Systems, the COVID-19 Breathalyzer test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage, the FDA said in a news release.

The test can provide results in less than three minutes.

Jeff Shuren, M.D.

Jeff Shuren, M.D.

“This authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “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 United States for the next public health emergency.”

InspectIR expects to be able to produce about 100 instruments per week, which can each be used to evaluate around 160 samples per day. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by about 64,000 samples per month,” according to the FDA.

The performance of the InspectIR COVID-19 Breathalyzer was validated in a large study of 2,409 people, including those with and without symptoms.

The test was shown to have 91.2% sensitivity (the percent of positive samples the test correctly identified) and 99.3% specificity (the percent of negative samples the test correctly identified), the FDA said.

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 COVID-19 Breathalyzer uses a technique called gas chromatography gas mass-spectrometry to separate and identify chemical mixtures and rapidly detect five volatile organic compounds associated with SARS-CoV-2 infection in exhaled breath.

When the InspectIR COVID-19 Breathalyzer detects the presence of these compound markers of SARS-CoV-2, a presumptive (unconfirmed) positive test result is returned and should be confirmed with a molecular test, according to the FDA.

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