Filenews 15 April 2022
The new coronavirus test approved Thursday by the FDA provides results in less than three minutes.
The U.S. Food and Drug Administration (FDA) issued yesterday, April 14, an emergency permit (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 the patient sample can be collected and analyzed correctly, such as dispensaries, hospitals and mobile COVID-19 control units. The test is performed by qualified, trained staff under the supervision of a healthcare provider 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 Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "The FDA continues to support the development of new tests for COVID-19 with the aim of promoting technologies that can help tackle 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 COVID-19 InspectIR device, which is the size of a hand luggage, was validated in a large study of 2,409 people, with or without symptoms, in which it was shown that the test had 91.2% sensitivity (the percentage of positive samples correctly identified in the test) and 99.3% specificity (the percentage of negative samples correctly determined).
The study also showed that, in a population where only 4.2% of people are positive to the virus, the test had a negative predictive value of 99.6%, meaning that people who received a negative result are most likely actually negative in areas with a low prevalence of the disease. The trial was conducted with similar sensitivity in a clinical follow-up study that focused on the Omikron variant.
