FDA issues EUA for first COVID-19 breathalyzer test, results in under 3 minutes

Editor's Note

The US Food and Drug Administration (FDA) on April 14 issued an emergency use authorization (EUA) for the first COVID-19 breathalyzer test for individuals 18 years and older. According to the agency, this new diagnostic test can detect the virus in breath samples in under three minutes.

Under the supervision of a healthcare provider licensed or authorized to prescribe tests, the test, called the InspectIR COVID-19 Breathalyzer, can be performed in doctor’s offices, hospitals, and mobile testing sites. It uses a technique called gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and detect five Volatile Organic Compounds (VOCs) associated with SARS-CoV-2 infection in the exhaled breath. According to the FDA press release, positive results should be treated as presumptive and confirmed with a molecular test.

“Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19, as they do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions,” the press release concluded.