The first COVID-19 diagnostic test, which identifies chemical components in breath samples unique to the coronavirus, received emergency use permission from the U.S. Food and Drug Administration (FDA) on Thursday.
According to the FDA, the test takes less than three minutes to get results and can be administered by a certified, trained operator under the supervision of a health-care physician who is licenced or permitted by state law to prescribe tests.
The test can be carried out at doctor’s offices, hospitals, and mobile testing sites; where a patient’s samples can be both collected and analysed.
The InspectIR COVID-19 Breathalyzer is roughly the size of a carry-on bag and was used in an extensive study of 2,409 people, both with and without COVID-19 symptoms, to validate its performance.
The test was shown to have 91.2 per cent sensitivity (the per cent of positive samples accurately recognized by the test) and 99.3 per cent specificity in the research (the per cent of negative samples the test correctly identified).
The study also found that the test had a negative predictive value of 99.6 per cent in a community with just 4.2 per cent of people positive for the virus, indicating that those who obtain a negative test result are most likely really negative in locations with low disease incidence.
In follow-up clinical research focused on the Omicron variant it was found that the test had equal sensitivity.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a release.
“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.”
The InspectIR COVID-19 Breathalyzer employs an instrument called gas chromatography gas mass spectrometry (GC-MS) to separate and identify chemical mixtures and quickly detect five Volatile Organic Compounds (VOCs) linked with the COVID-19 infection in exhaled breath.
According to the Centre of Public Environmental Oversight, the GC-MS is one of the most accurate tools for analyzing environmental samples.
When the VOC markers are detected by the InspectIR COVID-19 Breathalyzer, a presumptive positive test result is returned, which should be confirmed with a molecular test.
The FDA notes, however, that negative results should be interpreted in light of a patient’s recent exposures, medical history, and the presence of clinical signs and symptoms consistent with COVID-19, as they do not rule out SARS-CoV-2 infection.
“(Results) should not be used as the sole basis for treatment or patient management decisions, including infection control decisions,” the FDA said in a release.
InspectIR aims to be able to create around 100 instruments each week, each capable of evaluating around 160 samples per day.
A 2021 study by researchers at The Ohio State University Wexner Medical Center concluded that the use of breathalyzer technology to rapidly diagnose patients with respiratory infections has the potential to greatly improve the ability to rapidly screen both patients and asymptomatic people.