Getting a COVID test hasn’t always been easy. People have waited in lines, camped out at test locations and paid exorbitant prices.
But your next COVID test could be as easy as exhaling a sigh of relief.
The U.S. Food and Drug Administration (FDA) has approved a new COVID breathalyzer test. Earlier this month, the FDA issued emergency use authorization (EUA) for the first diagnostic test that detects chemical compounds in breath samples associated with COVID-19.
The InspectIR COVID-19 Breathalyzer yields results in about three minutes and has an impressive accuracy rate. According to the FDA, its performance was validated in a study of 2,409 individuals, including those with and without symptoms. In the study, the test had a 91.2 percent sensitivity (the percent of positive samples the test correctly identified) and 99.3 percent specificity (the percent of negative samples the test correctly identified).
The downsides are that the device is about the size of a piece of carry-on luggage and the person administering the test will need to be trained and supervised by an authorized healthcare provider, so widespread use of the breathalyzer outside of a medical setting does not seem likely at this point. Each machine can only process about 20 samples per hour. Ulysses Wu, MD, chief epidemiologist and infectious disease medical director at Hartford HealthCare, says this new testing may not be practical at sites that already have existing diagnostic tests.
“I do think it will be beneficial in areas that do not yet have testing in place,” he added. “Mobile testing sites, particularly in underserved areas, could certainly benefit.”
InspectR Systems, the Texas company that developed this technology, says they aim to produce about 100 testing devices per week. Those yielding positive results via the breathalyzer will need to have those results confirmed with a PCR test.
Dr. Wu also added that ongoing research for this technology will be necessary to validate its accuracy in detecting future variants.