COVID-19Infectious DiseasesMedical DevicesPreventive MedicineRespiratory


Here’s an exciting piece of news! 

The FDA has just issued an Emergency Use Authorization (EUA) for a breathalyzer test for COVID-19. Yes, there’s now a test for COVID-19 that doesn’t require a nose or throat swab. 

InspectIR Systems in Frisco, Texas has developed an instrument to test for COVID-19 that uses breath samples to detect the presence of SARS-CoV-2 in symptomatic individuals. “The breathalyzer uses gas chromatography-mass spectrometry to detect 5 volatile organic compounds in exhaled breath that are associated with SARS-CoV-2 infection.” When these organic compounds are detected, a molecular test is done to confirm the presence of the virus. A negative breathalyzer test does not rule out COVID-19, however. 

A study involving 2409 people, some of whom were symptomatic for COVID-19, showed 91.2% accuracy at detecting positive individuals. In other words, the study participants were first tested for COVID-19 in the conventional manner. Then, these folks also underwent a breathalyzer test. Of the patients whose standard test was positive, 91.2% also had a positive breathalyzer test. Of those whose standard test was negative, 99.3% also had a negative breath test. That’s a very good outcome.

Results from the COVID-19 breathalyzer test are available in 3 minutes, and “the instrument can evaluate 160 breath samples per day” and is “about the size of a piece of carry-on luggage.”

This device sounds like a good thing to me. Breathalyzer tests for alcohol detection on site are widely used and reliable. The portability of this device and the speed of obtaining results are beneficial for large-scale screening programs and drive-through testing kiosks. Positive tests require additional confirmation at this point, but if the test continues to be accurate and reliable, as shown in the recent study, confirmation will not be necessary. 

It is anticipated the InspectIR COVID-19 Breathalyzer will be in use before too much longer.

Reference: NEWS From the FDA. “First Breathalyzer test to diagnose COVID-19” JAMA 2022 May 17;327(19):1860.

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