People who suspect they may have COVID-19 could soon find out with a simple breath test that returns results in three minutes.
On Thursday, the U.S. Food and Drug Administration granted emergency use authorization for a device called the InspectIR Covid-19 Breathalyzer . The test, which must be administered by a trained operator, demonstrates a high degree of accuracy and takes up no more space than a piece of carry-on luggage.
"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 statement . agency press announcing the approval. "The FDA continues to support the development of new COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the US for the next public health emergency."
InspectIR can process 160 samples per day and can be used at mobile testing sites, hospitals and doctors’ offices. The company can produce about 100 of the machines per week, The New York Times reported .
The test uses gas chromatography and gas mass spectrometry, a technique that separates and identifies chemical mixtures, to detect the presence of five compounds associated with the coronavirus.
Its accuracy was confirmed in a large study of just over 2,400 people, including those with and without symptoms. In the end, the test was shown to have a sensitivity of 91.2% (the percentage of positive samples that the test correctly identified) and a specificity of 99.3% (the percentage of negative samples that the test correctly identified). The test worked just as well in a follow-up study focused on the Omicron variant .
InspectIR COVID-19 Breathalyzer: 91.2% sensitivity, 99.3% specificity.
The test’s approval comes as Omicron’s BA.2 subvariant takes over the country and now accounts for nearly 86% of all COVID cases, according to data from the US Centers for Disease Control and Prevention. The Northeast have seen cases rise recently as the subvariant rises, and Philadelphia even brought back its indoor mask mandate this week to try to stop the spread of BA.2.
A positive test must be confirmed through another testing method, such as a PCR laboratory test, the FDA emphasized.
The agency cautioned that negative tests "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" and "should not be used as the sole basis for testing decisions." treatment or management of the patient, including infection control decisions.
The performance of the InspectIR COVID-19 breathalyzer was validated in a large study of 2,409 people, including those with and without symptoms. In the study, the test was shown to have a sensitivity of 91.2% (the percentage of positive samples that the test correctly identified) and a specificity of 99.3% (the percentage of negative samples that the test correctly identified). The study also showed that in a population with only 4.2% of people testing positive for the virus, the test had a negative predictive value of 99.6%, meaning that people who receive a negative result in the test are probably actually negative in areas of low prevalence of the disease. The test was 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 chromatography-gas mass spectrometry (GC-MS) to separate and identify chemical mixtures and rapidly detect five volatile organic compounds (VOCs) associated with SARS-CoV-2 infection in the exhaled breath. When the InspectIR COVID-19 Breathalyzer detects the presence of SARS-CoV-2 VOC markers, a presumptive (unconfirmed) positive test result is returned and must be confirmed with a molecular test. Negative results should be considered in the context of the 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 a guideline. the only 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 test approximately 160 samples per day. At this level of production, testing capacity with the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month. |
