Today, the US Food and Drug Administration issued an emergency authorization (EUA) for the first COVID-19 diagnostic test to detect chemicals 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 clinics, hospitals, and mobile test sites, using an instrument about the size of a hand luggage. The test is performed by a qualified, trained operator under the supervision of a health care provider who is 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 in COVID-19 diagnostic testing,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Apparatus and Radiology Health. “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 performance of the InspectIR COVID-19 ventilator was validated in a large study of 2,409 people, including those with and without symptoms. In the study, the test was found to have 91.2% sensitivity (percentage of positive samples correctly identified by the test) and 99.3% specificity (percentage of negative samples correctly identified). The study also showed that, in a population with only 4.2% of those who tested positive for the virus, the test had a negative prognostic value of 99.6%, meaning that those who tested negative were likely to be actually negative in some areas. low prevalence of the disease. The test was performed with similar sensitivity in a clinical follow-up study focusing on the micron variant. The InspectIR COVID-19 Breathalyzer uses a technique called gas chromatography-mass spectrometry (GC-MS) to separate and identify chemicals and to quickly detect five volatile organic compounds (VOCs) associated with SARS-CoV-2 infection. on exhaled breath. When the InspectIR COVID-19 Breathalyzer detects the presence of SARS-CoV-2 VOC markers, a hypothetical (unconfirmed) positive test result is returned and should be confirmed by molecular testing. Adverse events should be considered in the context of recent reports, 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 the sole basis. for treatment or patient management decisions, including infection control decisions. InspectIR expects to be able to produce about 100 instruments per week, which can be used to evaluate about 160 samples per day. At this level of production, the test capacity using the InspectIR COVID-19 respirator is expected to increase by approximately 64,000 samples per month.

Boilerplate The FDA, an agency of the US 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 organization is also responsible for the safety and security of food supply, cosmetics, food supplements, products that emit electronic radiation and for the regulation of tobacco products in our country.

Content currently from: 14/04/2022 Controlled products Health issues