First COVID-19 Diagnostic Test Using Breath Samples Approved

The FDA granted emergency use authorization (EUA) for the first COVID-19 diagnostic test to use breath samples to detect chemical compounds in breath associated with a SARS-CoV-2 infection (InspectIR COVID-19 Breathalyzer). The test provides results in less than 3 minutes.

The new breathalyzer COVID-19 breath diagnostic test can be performed in environments where the patient specimen is both collected and analyzed, such as healthcare providers’ offices, hospitals, and mobile testing sites, using an instrument approximately the size of a piece of carry-on luggage. The test uses gas chromatography to separate and identify chemical mixtures and rapidly detect five volatile organic compounds (VOCs) associated with SAS-CoV-2 infection in inhaled breath.

When the COVID-19 Breathalyzer test detects the presence of VOC markers of 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 consistent with COVID-19, as they do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions, the FDA notes.

The performance of the new COVID-19 breath diagnostic test was shown in a clinical trial that enrolled 2,409 individuals, including those with and without symptoms, to have 91.2% sensitivity and 99.3% specificity. 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% (people who receive a negative test result are likely truly negative in areas of low disease prevalence). The test performed with similar sensitivity in a follow-up clinical study focused on the omicron variant, according to the FDA.

The InspectIR COVID-19 Breathalyzer is a product of InspectIR Systems.