FDA Authorizes 3-Minute COVID-19 Breath Test
By Sam Brusco, Associate Editor | 04.18.22
InspectIR breathalyzer spots chemical compounds in breath samples associated with COVID-19 infection.
The U.S. Food and Drug Administration (FDA) has awarded emergency use authorization (EUA) for the InspectIR COVID-19 breathalyzer to spot chemical compounds in breath samples associated with COVID-19 infection.
With an instrument the size of carry-on luggage, the test can be administered in doctor’s offices, hospitals, or mobile testing sites. The test is performed by a qualified operator under licensed healthcare provider supervision and can offer results in under three minutes.
InspectIR uses gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and rapidly spot volatile organic compounds related to SARS-CoV-2 infection in exhaled breath. When a positive test result is returned, it should be confirmed with a PCR test.
“[This] authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, MD, J.D., director of the FDA’s Center for Devices and Radiological Health told the press. “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 U.S. for the next public health emergency.”
A 2,409-patient study of InspectIR showed the test had 91.2% sensitivity and 99.3 percent specificity. It also showed in a population with only 4.2% of people positive for the virus that the test had a 99.6% negative predictive value, meaning those who received a negative result were likely truly negative in areas with low disease prevalence.
InspectIR aims to produce 100 instruments per week to evaluate about 160 samples per day.
With an instrument the size of carry-on luggage, the test can be administered in doctor’s offices, hospitals, or mobile testing sites. The test is performed by a qualified operator under licensed healthcare provider supervision and can offer results in under three minutes.
InspectIR uses gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and rapidly spot volatile organic compounds related to SARS-CoV-2 infection in exhaled breath. When a positive test result is returned, it should be confirmed with a PCR test.
“[This] authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, MD, J.D., director of the FDA’s Center for Devices and Radiological Health told the press. “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 U.S. for the next public health emergency.”
A 2,409-patient study of InspectIR showed the test had 91.2% sensitivity and 99.3 percent specificity. It also showed in a population with only 4.2% of people positive for the virus that the test had a 99.6% negative predictive value, meaning those who received a negative result were likely truly negative in areas with low disease prevalence.
InspectIR aims to produce 100 instruments per week to evaluate about 160 samples per day.