The Food and Drug Administration has issued an emergency use authorization for what it says is the first device that can detect COVID-19 in breath samples.
Technique:
The InspectIR COVID-19 Breathalyzer uses a technique called gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and five volatile organic compounds (VOCs) associated with SARS-CoV-2 infection with breath. ) is detected rapidly.
InspectIR’s performance COVID-19 The breathalyzer was validated in a large study of 2,409 individuals, including those with and without symptoms. In the study, the test showed 91.2% sensitivity (percentage of positive samples tested correctly) and 99.3% specificity (percentage of negative samples tested correctly). The study also showed that, in a population of only 4.2% of individuals who are positive for the virus, the test had a negative predictive value of 99.6%, meaning that those who received a negative test result were probably less likely to be tested. areas are really negative. disease spread.
The test can be performed in an environment where a patient sample is both collected and analyzed, such as a doctor’s office, hospital, and mobile testing sites, using a device about the size of a carry-on luggage. The test is performed by a qualified, trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe the test and can provide results in less than three minutes.