According to the FDA, the test takes less than three minutes to get results and can be performed by a certified, trained operator under the supervision of a licensed health care practitioner or authorized by state law.
The test can be performed in clinics, hospitals and mobile test sites. where a patient’s samples can be collected and analyzed.
The InspectIR COVID-19 Breathalyzer is about the size of a hand luggage 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 found to have 91.2 percent sensitivity (the percentage of positive samples accurately identified by the test) and 99.3 percent specificity in the research (the percentage of negative samples that the test correctly identified).
The study also found that the test had a negative prognostic value of 99.6 percent in a community with only 4.2 percent of people who tested positive for the virus, suggesting that those who tested negative were more likely to be really negative in low-incidence sites.
In a follow-up clinical study focusing on the Omicron variant, the test was found to have the same sensitivity.
“Today’s authorization is another example of the rapid innovation in COVID-19 diagnostic testing,” said Dr. Jeff Suren, director of the FDA’s Center for Apparatus and Radiology Health, in a statement.
“The FDA continues to support the development of new COVID-19 tests aimed at promoting technologies that can help address the current pandemic and better position the United States for the next public health emergency.”
The InspectIR COVID-19 Breathalyzer uses an instrument called gas chromatography-mass spectrometry (GC-MS) to separate and identify chemical compounds and to rapidly detect five volatile organic compounds (VOCs) associated with COVID-19 infection in breathing.
According to the Center for Public Environmental Surveillance, GC-MS is one of the most accurate tools for analyzing environmental samples.
When VOCs are detected by the InspectIR COVID-19 ventilator, a probable positive test result is returned, which should be confirmed by molecular testing.
The FDA notes, however, that adverse effects should be interpreted in the light of a patient’s recent reports, medical history, and the presence of COVID-19-consistent clinical signs and symptoms, as they do not rule out SARS-CoV infection. -2.
“(Results) should not be used as the sole basis for treatment or patient management decisions, including infection control decisions,” the FDA said in a statement.
InspectIR aims to be able to generate about 100 instruments each week, each capable of evaluating approximately 160 samples per day.
A 2021 study by researchers at Wexner University Medical Center The Ohio State University concluded that the use of breathalyzer technology for the rapid diagnosis of patients with respiratory infections has the potential to significantly improve the ability to quickly examine both patients and asymptomatic patients. people.
