FDA Authorizes Breathalyzer Test for COVID-19
Newly granted diagnostic can provide results in 3 minutes
4 minute read
On April 14, 2022, the U.S. Food and Drug Administration released a new COVID-19 update by issuing an emergency use authorization (EUA) for a COVID-19 diagnostic tool detecting chemical compounds in breath samples associated with SARS-CoV-2 infection. The InspectIR COVID-19 Breathalyzer was produced by InspectIR Systems, and is authorized for those 18 and older. It was used in a large study of 2409 individuals, including those with and without symptoms. The results of the study are as follows:
91.2% sensitivity (The percent positive samples the test correctly identifies)
99.3% specificity (The percent negative samples the test correctly identifies)
The study 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%
People who receive a negative test result are likely truly negative in areas of low disease prevalence
One of the limitations with PCR-based testing is that there are steps within the process where errors can occur. These include sampling quality, sample handling, and time consuming sample processing. While not common, false negative tests can occur with PCR-based methods, so additional and orthogonal analytical methods are appealing.
This newly FDA-approved testing product uses an analytical chemistry approach called gas chromatography gas mass-spectrometry (GC/MS) to isolate chemicals within our breath that have been identified to be associated with SARS-CoV-2 infection.
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