To detect COVID-19 through the breath the Food and Drug Administration(FDA) in the United States authorized Inspect IR, a COVID 19 Breathalyzer for emergency use.
This Breathalyzer is based on a technique called gas chromatography gas mass spectrometry (GC-MS). This technique separates and identifies chemical mixtures and rapidly detects 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.
( With agency inputs)