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This Food and Drug Administration It authorized the first test that can detect coronavirus in a person’s breath.
InspectIR COVID-19 Breathalyzer uses technology that can detect chemical compounds in the virus in a breath sample.
Regulators said the device is the size of a piece of carry-on luggage and would likely be ideal for screening in doctor’s offices, hospitals and mobile testing sites. It received an emergency use permit as part of a process that speeds up the review of drugs and devices in a crisis situation.
“Today’s authorization is another example of the rapid innovation happening in diagnostic testing for COVID-19,” said Jeff Shuren, its director. FDADevices and Radiological Health Center. “ FDA It continues to support the development of new COVID-19 tests to develop technologies that can help address the current pandemic and better position the United States for the next public health emergency.”
The test is a notable advance due to the ease of submitting a breath test compared to nasal swabs that are oddly or invasively scanned.
However, the tests will take time to produce and FDA He said a positive test should be confirmed by a molecular test.
This FDA He said the device was validated in a study of 2,409 people, including those with and without symptoms. It had a sensitivity of 91.2%, meaning the percentage of positive samples correctly identified and a specificity of 99.3%, or the percentage of correctly identified negative samples.
This FDA InspectIR said it expects to produce around 100 instruments per week.
Each instrument can be used to evaluate approximately 160 samples per day, meaning that the breathalyzer will increase its total testing capacity by approximately 64,000 samples per month.
For more information, visit The Washington Times COVID-19 resource page.
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