FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

On Thursday, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor 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. The test can provide results in less than three minutes.

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 percent sensitivity and 99.3 percent specificity. The study also showed that in a population with only 4.2 percent of individuals who are positive for the virus, the test had a negative predictive value of 99.6 percent. The test performed with similar sensitivity in a follow-up clinical study focused on the omicron variant.

When the InspectIR COVID-19 Breathalyzer detects the presence of volatile organic compounds (VOCs) associated with SARS-CoV-2, a presumptive positive test result is returned and should be confirmed with a molecular test. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms associated with COVID-19.

InspectIR anticipates producing approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day. At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.

Additional information is available here.