There is a new date of April 14, 2022.
The first government-approved device that can detect coronaviruses in patients' breath was granted an emergency use authorization by the Food and Drug Administration.
The first Covid-19 breath test has been approved by the FDA.
In a study of 2,409 people, the breathalyzer correctly identified positive samples 91.2% of the time, and it also performed well in a subsequent study assessing its effectiveness against the omicron variant.
The breath test can be administered at either a healthcare facility or a mobile testing site using an instrument roughly the size of a carry-on luggage.
Each of the 100 Covid-19 breathalyzers that InspectIR will eventually be able to produce could perform 160 tests per day, according to the FDA.
The Covid-19 breathalyzer should increase the U.S.'s testing capacity by about 64,000 samples each month, the agency said.
A technique for analyzing chemicals used in everything from monitoring for food contamination to measuring the atmosphere of Venus is used by InspectIR. Tim C. Wing said in a 2020 press release that the company's breath-testing technology can also be used to detect chemical markers for the flu. John Redmond, the company's COO, said in the press release that the company believes it can circumvent the problem of accuracy by testing in the high part-per-trillion range. The FDA published trial results that reported 99.6% accuracy at identifying Covid-negative samples.
The University of Miami is testing a Breath Analyzer.
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