US FDA approves emergency use of first Covid test that uses breath samples
US Food and Drug Administration (FDA) has given emergency use authorisation to a Covid diagnostic test that uses breath samples to provide a positive or a negative result.
Called the ‘InspectIR’, this breath analyser Covid test detects chemical compounds associated with coronavirus in breath samples.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health said, “today’s authorisation is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”
“The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the US for the next public health emergency,” he added.
The test, which is the size of carry-on luggage, can show the result in less than three minutes.
The FDA explained how the test is to be used. It must be carried out under the supervision of a licensed health care provider and can be performed in settings where the patient samples are both collected and analysed, such as doctor's offices, hospitals, and mobile testing locations.
InspectIR COVID-19 Breathalyser's performance was tested and validated in a comprehensive study of 2,409 people. The study included both symptomatic and asymptomatic individuals. As per the FDA website, the test had 91.2 per cent sensitivity (the percentage of positive samples correctly identified) and 99.3 per cent specificity (the percentage of negative samples correctly identified) in the trial.
“InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” said the agency.
“At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”