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# EUA for Covid-19 Breathalyzer
- URL: https://www.fdaweb.com/eua-for-covid-19-breathalyzer/
- Published: 2022-04-14T12:00:00.000Z
- Updated: 2026-09-14T17:40:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151606

FDA has granted InspectIR an emergency use authorization for the first Covid-19 diagnostic test that detects Covid-19 chemical compounds in breath samples. “The 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,” an [agency release](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-diagnostic-test-using-breath-samples?ref=fdaweb.com) says.

FDA says the InspectIR COVID-19 Breathalyzer’s performance was validated in a study of 2,409 individuals, including those with and without symptoms. “In the study, 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),” it says. The test performed similarly well in a follow-up clinical study focused on the omicron variant.

The Breathalyzer uses 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, FDA says. Positive test results should be confirmed with a molecular test, it says.