Tech & Innovation in Healthcare
Using Breathalyzers to Diagnose COVID-19
On April 14, 2022, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a diagnostic test that can detect compounds associated with COVID-19 in breath samples. The InspectIR COVID-19 Breathalyzer showed to have 91.2 percent sensitivity (percentage of correctly identified positive samples) and 99.3 percent specificity (percentage of correctly identified negative samples) in a study of more than 2,400 individuals, which included those with and without symptoms. The breathalyzer test detects five volatile organic compounds (VOCs) related to a COVID-19 infection in the patient’s breath via a gas chromatography gas mass-spectrometry (GC-MS) technique. Healthcare providers can perform the test in doctor’s offices, mobile testing sites, hospitals, and other facilities where the patient’s specimen is collected and analyzed. The testing equipment is about the size of a small suitcase, and the test can be performed by a trained, qualified professional under the supervision of a licensed and authorized healthcare provider. “Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health in a statement.
Tech & Innovation in Healthcare
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Using Breathalyzers to Diagnose COVID-19
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