FDA authorizes first-ever breathing test for detecting COVID-19 infection
Apr 16, 2022
Washington [US], April 16 : The Food and Drug Administration (FDA) authorized the first test, InspectIR COVID-19 Breathalyzer, to detect COVID-19 through the breath for emergency use.
The InspectIR COVID-19 Breathalyzer uses a technique called gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and rapidly detect five Volatile Organic Compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath. When the InspectIR COVID-19 Breathalyzer detects the presence of VOC markers of SARS-CoV-2, a presumptive (unconfirmed) positive test result is returned and should be confirmed with a molecular test, FDA informed in a statement.
The InspectIR COVID-19 Breathalyzer which is about the size of a carry-on piece of luggage is able to identify five volatile organic compounds tied to the coronavirus in a person's breath using a technique known as gas chromatography gas mass-spectrometry, delivering results within three minutes, according to the FDA, the statement reads.
The agency said that in a study of 2,409 people, which included both people with and without symptoms, the test had a 99.3 per cent specificity rate, which measures the per cent of correctly identified negative test samples.
The FDA also noted that the InspectIR COVID-19 Breathalyzer had a 91.2 per cent sensitivity rate, which measures the per cent of correctly identified positive test samples.
However, the health agency said that a molecular test should be used to confirm positive test results returned by the COVID-19 breath test.
Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, in a statement, said, "Today's authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19," as per The Hill.
Nearly 100 of the InspectIR COVID-19 Breathalyzers, each of which the FDA said can be used to test roughly 160 samples per day, are anticipated to be made each week.
