US FDA Approves 1st Covid Breath Diagnostic Test
LOS ANGELES, CA (IANS) – The US Food and Drug Administration (FDA) issued an emergency use authorization for the country’s first Covid-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.
The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage, according to the FDA on April 15.
The results of the test will show in less than three minutes.
The performance of the test, called InspectIR Covid-19 Breathalyser, was validated in a large study of 2,409 individuals, including those with and without symptoms. In the study, the test was shown to have 91.2 per cent sensitivity and 99.3 per cent specificity, according to the FDA.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for Covid-19,” said Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health.