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News From the Food and Drug Administration
May 17, 2022

First Breathalyzer Test to Diagnose COVID-19

JAMA. 2022;327(19):1860. doi:10.1001/jama.2022.7700

The first test that uses breath samples to diagnose COVID-19 recently received Emergency Use Authorization from the FDA.

The InspectIR COVID-19 Breathalyzer, which uses an instrument about the size of a piece of carry-on luggage—a “chemical-lab-in-a-box,” as its developer describes it—can provide results within 3 minutes, according to the FDA. Testing with the device is performed by specially trained operators under the supervision of a health care professional licensed to prescribe tests in physicians’ offices, hospitals, and mobile testing sites.

A study involving 2409 people, only some with COVID-19 symptoms, validated the performance of the testing device. In the study, the breathalyzer correctly identified 91.2% of positive samples and 99.3% of negative samples, according to the FDA, which noted that a follow-up clinical study found the test performed with similar sensitivity with the Omicron variant.

The breathalyzer uses gas chromatography–mass spectrometry to detect 5 volatile organic compounds (VOCs) in exhaled breath that are associated with SARS-CoV-2 infection, according to the FDA. When those VOCs are detected, the test result should be confirmed with a molecular test. Negative test results from the breathalyzer don’t rule out SARS-CoV-2 infection and should be considered in the context of the patient’s recent exposures, history, and symptoms consistent with COVID-19, FDA officials noted.

Developer InspectIR Systems, located in Frisco, Texas, expects to produce 100 instruments per week, each of which can evaluate 160 breath samples per day, according to the FDA.