FDA Approves EUA for First COVID Breath Test
The U.S. Food and Drug Administration issued an emergency use authorization on April 14 for the first COVID-19 diagnostic test that uses breath samples to detect positive COVID-19 infection.
The breath test, called the InspectIR COVID-19 Breathalyzer, is the size of a piece of carry-on luggage, with a tube at the top to breathe through and an attached rectangular base that resembles a walkie-talkie. The test produces results in under three minutes.
The breath test can only be performed under the supervision of a health care provider, and will soon be used by doctors’ offices, hospitals and mobile testing sites.
The device’s performance was validated by the FDA in a study of nearly 2,400 individuals who presented with and without symptoms.
The test accurately identified positive COVID-19 infection in 91.2% of cases, and showed 99.3% specificity in correctly identifying negative samples.
The study also showed that those who received a negative test result were likely to be truly negative in areas of low disease prevalence, as only 4.2% of individuals who tested positive for the virus had a negative predictive value of 99.6%.
A follow-up, omicron-specific study revealed similar sensitivity findings.
InspectIR makes approximately 100 instruments per week that can be used to evaluate 160 samples per day.
The FDA’s decision to grant EUA for the InspectIR test comes after the accuracy of the rapid antigen test and the ability of those tests to detect the omicron strain compared with other COVID-19 strains was drawn into question.
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