The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the InspectIR COVID-19 Breathalyzer, the first COVID-19 diagnostic test to detect SARS-CoV-2 infection through breath samples.
The InspectIR COVID-19 Breathalyzer is designed to detect chemical compounds associated with a SARS-CoV-2 infection using gas chromatography gas mass-spectrometry, which separates and identifies chemical mixtures to rapidly detect 5 volatile organic compounds associated with a SARS-CoV-2 infection in exhaled breath.
The test is performed by exhaling into a tube that is connected to the test kit. The device analyzes the sample and determines a positive or negative test result in less than 3 minutes. A positive test result should be confirmed with a molecular test. A negative result should be viewed in the context of other factors (eg, recent exposure, presence of symptoms) and should not be used as the sole basis for treatment or patient management.
The test is intended for use in hospitals, doctor’s offices and mobile testing sites and should be performed by a qualified, trained operator under the supervision of a health care provider.
The authorization was based on a clinical trial evaluating the performance of the InspectIR COVID-19 Breathalyzer in 2409 individuals with or without symptoms. Findings demonstrated that the test had 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).
Moreover, in a population with only 4.2% of individuals who were positive for the virus, the test had a negative predictive value of 99.6%. In a follow-up clinical study focused on the Omicron variant, the test was found to have similar sensitivity.
The Company expects to be able to produce approximately 100 instruments per week, which can evaluate approximately 160 samples per day.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the US for the next public health emergency.”
- Coronavirus (COVID-19) update: FDA authorizes first COVID-19 diagnostic test using breath samples. News release. US Food and Drug Administration. Accessed April 14, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-diagnostic-test-using-breath-samples
- InspectIR Systems, LLC. Accessed April 15, 2022. https://inspect-ir.com/