US FDA authorises 1st Covid-19 diagnostic test using breath samples
The US FDA issued an emergency use authorisation for the country's first Covid-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection
The US Food and Drug Administration (FDA) issued an emergency use authorisation 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 analysed, 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 Thursday.
The results of the test will show in less than three minutes, Xinhua news agency reported.
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 authorisation 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.