It was only a matter of time before a COVID-19 breathalyzer reached the US market. On April 14, the FDA announced that for the first time it has granted Emergency Use Authorization (EUA) for a COVID-19 breathalyzer test.
Breathalyzer tests rely on a different biomarker for virus detection: volatile organic compounds (VOCs) expelled by the lungs. In addition to offering greater accuracy and speed, breathalyzer tests are less invasive than current SARS-CoV-2 rapid tests that rely on tissue samples collected by swabs.
InspectIR, a Texas-based developer of portable opioid and cannabis detection devices, will be remembered as the Edmund Hillary of COVID-19 breathalyzers. Dubbed the InspectIR COVID-19, the device uses a technique called gas chromatography gas-mass spectrometry to separate and identify five VOCs associated with SARS-CoV-2 in exhaled breath. Patients breathe into a disposable straw on the device, which is roughly the same size as a piece of carry-on luggage, with results provided in less than three minutes.
Caveat: A test that does detect SARS-CoV-2 VOCs should be considered a presumptive positive test result that needs to be confirmed with a molecular test, the FDA says. Negative results don’t rule out SARS-CoV-2 infection and shouldn’t be used as the sole basis for treatment or patient management decisions, including infection control decisions.