For immediate release: April 14, 2022
The US Food and Drug Administration today issued an Emergency Authorization (EUA) for the first diagnostic test for COVID-19, which detects chemical compounds in breath samples associated with SARS-CoV-2 infection. The test can be performed in environments where the patient’s sample is collected and analyzed, such as doctor’s offices, hospitals and mobile test sites, using a hand luggage-sized instrument. 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 and can give results in less than three minutes.
“Today’s authorization is another example of the rapid innovation that is happening with diagnostic tests for COVID-19,” said Jeff Schuren, MD, JD, 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 effectiveness of the InspectIR COVID-19 breathalyzer was confirmed in a large study of 2,409 people, including those with and without symptoms. The study showed that the test had 91.2% sensitivity (the percentage of positive samples that the test correctly identified) and 99.3% specificity (the percentage of negative samples that the test correctly identified). The study also found that in a population of only 4.2% of people who tested positive for the virus, the test had a negative prognosis of 99.6%, which means that people who get a negative test are likely to be negative in areas with low levels. spread of the disease. The test performed with similar sensitivity in a follow-up clinical study focused on the omicron variant.
The InspectIR COVID-19 breathalyzer uses a technique 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 SARS-CoV-2 infection in exhalations. breath. When the InspectIR COVID-19 breathalyzer detects the presence of VOC markers of SARS-CoV-2, a presumed (unconfirmed) positive test result is returned, which must be confirmed by a molecular test. Negative results should be considered in the context 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 and should not be used as the sole basis. for patient treatment or management decisions, including infection control decisions.
InspectIR expects to be able to produce approximately 100 instruments per week, each of which can be used to evaluate approximately 160 samples per day. At this level of production, the test capacity with the InspectIR COVID-19 breathalyzer is expected to increase by approximately 64,000 samples per month.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human use and medical devices. The Agency is also responsible for the safety and security of supply of food, cosmetics, food additives, electronic products and the regulation of tobacco products.
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April 14, 2022
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