WASHINGTON: The US Food and Drug Administration announced Thursday that the first Covid-19 test, which detects chemical components linked to the coronavirus in breath, has been given emergency use authorization.
Medical offices and mobile testing locations can utilise the InspectIR Covid-19 Breathalyzer.
The InspectIR Covid-19 Breathalyzer, which is about the size of a carry-on suitcase, can be used in medical offices and mobile testing sites, according to the FDA. It may produce findings in just three minutes.
To detect five molecules linked to SARS-CoV-2 illness, the technology separates and detects chemical combinations.
The InspectIR Breathalyzer was reported to correctly identify over 91 percent of positive samples and over 100 percent of negative samples in a study. Another study focused on the Omicron coronavirus subtype and showed similar sensitivity. According to the FDA, a positive result should be validated with a PCR test.
Dr. Emily Volk, president of the College of American Pathologists and a board-certified anatomic and clinical pathologist, said Friday, “It’s another tool, and the FDA announcement suggests it’s reasonably accurate and a relatively user-friendly tool.”
“It will be interesting to watch how extensively this is accepted,” Volk added. “It might depend on how much it costs.”
InspectIR Systems said in an email to CNN on Friday that it would not reveal the machine’s pricing or when it will be available.
The FDA’s approval is “yet another example of the rapid innovation occurring with COVID-19 diagnostic tests,” according to Dr. According to Jeff Shuren, head of the FDA’s Center for Devices and Radiological Health, “The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency.”
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