The US Food and Drug Administration (FDA) yesterday, 14 April, issued an emergency use authorization (EUA) for the first diagnostic test for COVID-19 that detects chemical compounds in breath samples associated with SARS-CoV-2 infection.
The test can be performed in environments where a patient sample can be properly collected and analysed, such as indoctors' offices, hospitals and mobile COVID-19 testing units. The test is performed by qualified, trained personnel under healthcare provider supervision and can yield results in less than three minutes.
"Today's authorization is another example of the rapid innovation happening with diagnostic tests for COVID-19," said Jeff Shuren, M.D, J.D., director of the FDA's Center for Devices and Radiological Health. "FDA continues to support the development of new tests for COVID-19 to advance technologies that can help address the current pandemic and better prepare the U.S. for the next public health emergency."
The study that led to the approval of the coronavirus test
The performance of the InspectIR COVID-19 device, which is the size of a carry-on bag, was validated in a large study 2.409 subjects, with or without symptoms, in which the test was shown to have 91.2% sensitivity (the percentage of positive specimens correctly identified in the test) and 99.3% specificity (the percentage of negative specimens correctly identified).
The study also showed that, in a population where only 4.2% of people are virus positive, the test had a negative predictive value of 99.6%, meaning that people who tested negative are likely to be truly negative in areas of low disease prevalence. The test was performed with similar sensitivity in a clinical follow-up study focused on the Omicron variant.
Source: iefimerida.gr
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