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The Food and Drug Administration has issued an emergency use authorization for what it said 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 rapidly detect five Volatile Organic Compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath.
The performance of the InspectIR COVID-19 Breathalyzer was validated in a large study of 2,409 individuals, including those with and without symptoms. In the study, the test was shown to have 91.2% sensitivity (the percent of positive samples the test correctly identified) and 99.3% specificity (the percent of negative samples the test correctly identified). The study also showed that, in a population with only 4.2% of individuals who are positive for the virus, the test had a negative predictive value of 99.6%, meaning that people who receive a negative test result are likely truly negative in areas of low disease prevalence.
The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of 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 tests and can provide results in less than three minutes.