The US Food and Drug Administration (FDA) has granted emergency use authorization to a Covid diagnostic test that utilizes breath samples to generate a positive or negative result. The ‘InspectIR’ breath analyzer Covid test identifies chemical components related to coronavirus in breath samples. In a statement regarding the test, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, stated that ‘today’s authorization is just another example of the fast innovation occurring with diagnostic tests for COVID-19.’
‘The FDA continues to support the development of innovative COVID-19 tests with the objective of developing technologies that can assist address the present epidemic and better position the US for the next public health disaster,’ he said. According to Xinhua news agency, the test, which is the size of carry-on luggage, may produce results in less than three minutes.
‘The FDA continues to support the development of novel COVID-19 tests with the goal of creating technologies that can help address the current pandemic and better prepare the United States for the next public health calamity,’ he added. The test, which is the size of carry-on luggage, may yield findings in less than three minutes, according to Xinhua.
The performance of the InspectIR COVID-19 Breathalyzer was evaluated and verified in a large sample of 2,409 persons. Individuals in the research were both sick and asymptomatic. According to the FDA website, the test showed a sensitivity of 91.2 percent (the percentage of positive samples correctly identified) and a specificity of 99.3 percent (the percentage of negative samples correctly identified) in the experiment.
‘InspectIR anticipates being able to create roughly 100 instruments each week, each of which may be used to examine approximately 160 samples per day,’ the agency stated. ‘At this rate of manufacturing, testing capacity for the InspectIR COVID-19 Breathalyzer will rise by roughly 64,000 samples per month.’
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