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This is the first Emergency Use Authorization (EUA) issued by the FDA to diagnose COVID-19 by detecting compounds associated with COVID-19 infection in breath samples
People only need to blow air through a disposable straw under the guidance of a trained operator, and the device can complete the collection and detection of breath samples, and the test results can be obtained in less than 3 minutes
Developed by InspectIR, the Covid-19 breath analyzer uses gas chromatography-mass spectrometry (GC-MS) to separate and identify compounds in exhaled breath and quickly detect 5 volatile species associated with Covid-19 infection.
The effectiveness of the new crown breath analyzer was previously confirmed in a large study of 2,409 people (including symptomatic, asymptomatic, and uninfected people), and the results showed that the analyzer had a detection sensitivity of 91.
The FDA also reminded that samples tested positive by the new crown breath analyzer should be further confirmed by nucleic acid testing
Dr.
InspectIR previously focused on developing portable breath analyzers for opioid and cannabis detection
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