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April 14, 2022 – FDA Authorizes the InspectIR COVID-19 Breathalyzer

On April 14, 2022, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to the InspectIR COVID-19 Breathalyzer test. This new diagnostic tool uses a technique called gas chromatography gas mass-spectrometry (GC-MS) to identify whether the SARS-CoV-2 virus is present in a person’s breath. The COVID-19 Breathalyzer must be administered by a licensed health care professional and provides results in less than three minutes. The COVID-19 Breathalyzer can correctly identify a positive COVID-19 infection with 91.2 percent sensitivity and negative results are reliable 99.3 percent of the time. Notably, the test performs similarly well when testing for the omicron coronavirus variant. The COVID-19 Breathalyzer test is much less invasive than a nose or saliva swab test and delivers results quicker and more accurately.

The InspectIR COVID-19 Breathalyzer is a mobile diagnostic unit that does not store any biological samples and sanitizes itself between uses. To use the COVID-19 Breathalyzer, the user inserts a disposable straw into the device and blows into it for approximately ten seconds. Results are displayed on a digital screen This new diagnostic tool will be particularly useful in high-traffic transportation settings like airports and train stations to quickly screen individuals for COVID-19 under the supervision of a health care professional. Ideally, individuals will find the Breathalyzer more comfortable to use, which should boost public health surveillance efforts to curb the spread of COVID-19.

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