The Food and Drug Administration on Thursday issued an emergency use authorization for InspectIR Systems’ “Covid-19 Breath Analyzer,” the first government-approved device capable of detecting coronavirus infections in patients’ breath.
In one study of 2,409 people, the breath analyzer correctly identified positive samples 91.2% of the time, and it also did well in a subsequent study assessing its effectiveness against the Omicron version of the virus, according to an FDA release. .
The breath test provides results in less than three minutes, and can be administered using a carry-on luggage-sized device at healthcare facilities or mobile testing sites, the agency said.
The FDA said the InspectIR projects will eventually be able to produce about 100 COVID-19 respirators per week, each of which can conduct about 160 tests per day.
The agency said that at InspectIR’s current levels of production, the COVID-19 respirator should boost the US’s testing capacity to about 64,000 samples each month.
InspectIR’s breath analyzer detects compounds linked to COVID-19 infection using gas chromatography-mass spectrometry, a chemical analysis technique used in everything from monitoring food contamination to measuring Venus’s atmosphere. goes. The company’s breath test technology could also be used to detect chemical markers for influenza infection, said CEO Tim C. Wing said in a 2020 press release. The company’s COO John Redmond said in a press release that accuracy has been an obstacle for developers of new COVID-19 tests, but Inspector believes its technology can solve this problem by testing in the high parts-per-trillion range. removes it. Test results published by the FDA seem to bear this out, reporting 99.6% accuracy in identifying COVID-negative samples.
“Covid-19 Breath Analyzer being tested at the University of Miami” (Forbes)