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.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
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