The first diagnostic test for COVID-19, which identifies chemical components in respiratory samples unique to the coronavirus, was approved by the US Food and Drug Administration (FDA) on Thursday.
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 health care provider who is licensed or authorized by state law to prescribe tests.
The test can be performed in doctors’ offices, hospitals and mobile testing sites; where patient samples can be both collected and analyzed.
The InspectIR COVID-19 breathalyzer is approximately the size of a handbag and has been used in an extensive study of 2,409 people, with and without symptoms of COVID-19, to confirm its effectiveness.
The test was shown to have 91.2% sensitivity (the percentage of positive samples accurately recognized by the test) and 99.3% specificity in the study (the percentage of negative samples that the test correctly identified).
The study also found that the test had a negative prognosis of 99.6% in a community with only 4.2% of people positive for the virus, which shows that those who tested negative were most likely to have negative in places with low incidence.
Subsequent clinical trials focused on the Omicron variant found that the test had the same sensitivity.
“Today’s authorization is another example of the rapid innovation that is happening with diagnostic tests for COVID-19,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
“The FDA continues to support the development of new tests for COVID-19 to improve technologies that can help tackle 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 mass spectrometry with gas chromatography (GC-MS) to separate and identify chemical mixtures and quickly detect five volatile organic compounds (VOCs) associated with COVID-19 infection in exhaled breath.
According to the Center for Public Environmental Supervision, the GC-MS is one of the most accurate tools for analyzing environmental samples.
When VOC markers are detected by the InspectIR COVID-19 breathalyzer, a presumed positive test result is returned, which must be confirmed by a molecular test.
However, the FDA notes that negative results should be interpreted in the light of recent patient exposures, medical history, and the presence of COVID-19-compliant clinical signs and symptoms, as they do not rule out SARS-CoV-2 infection.
“The results should not be used as the sole basis for treatment or management decisions, including infection control decisions,” the FDA said in a statement.
InspectIR aims to be able to create about 100 instruments each week, each of which can evaluate about 160 samples per day.
A 2021 study conducted by researchers at Ohio State University’s Wexner Medical Center concluded that the use of breathalyzer technology to quickly diagnose patients with respiratory infections has the potential to significantly improve the rapid screening ability of both patients and patients. asymptomatic people.
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