The FDA issued an emergency use authorization Thursday for the first-ever COVID-19 test that detects chemical compounds found in breath to determine if someone is infected with the virus.
Using an instrument about “the size of a piece of carry-on luggage,” the FDA said trained operators can perform the tests and provide results in less than three minutes.
“The test can be performed in environments where the patient specimen is both collected and analyzed, [including] doctor’s offices, hospitals and mobile testing sites,” the FDA said Thursday.
“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 device, called the “COVID-19 Breathalyzer,” was developed by InspectIR and first validated following a study of 2,409 people, including several without COVID-19 symptoms.
In the study the breathalyzer "was shown to have 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)," according to the FDA.
Similar results were found in a follow-up clinical study focused on the Omicron variant, officials added.
“Today’s authorization [of the breathalyzer] is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, 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 U.S. for the next public health emergency.”
How does it work?
The InspectIR COVID-19 Breathalyzer uses gas chromatography gas mass-spectrometry (GC-MS), to separate and identify chemical mixtures and quickly detect five Volatile Organic Compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath.
“When the [breathalyzer] detects the presence of VOC markers of SARS-CoV-2, a presumptive (unconfirmed) positive test result is returned and should be confirmed with a molecular test,” the FDA said.
“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.”
InspectIR, based in Frisco, Texas, expects to be able to produce at least 100 breathalyzer instruments per week, which the FDA said can be used to evaluate around 160 samples per day.
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