Summary :
- Food and Drug Administration on Apr 14 issued an emergency use authorization
- It said is the first device that can detect COVID-19 in breath samples
- The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage
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.
The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.
“InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”