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15
April
2022

FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

The Food and Drug Administration on Thursday issued an emergency use authorization for what it said is the first device that can detect COVID-19 in breath samples.

The test detects chemicals associated with the virus that causes the disease in a breath sample, and if it’s positive, it should be followed up by a molecular test, the agency said in a statement.

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”

The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.

“InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”

Yvonne Maldonado, an infectious disease specialist at Stanford University School of Medicine who is working on another Breathalyzer test, said that having more options to test will only help the transition to the endemic phase of the pandemic.

“If you think back from the original P.C.R., those were pretty horrible,” Ms. Maldonado said. “They were very uncomfortable and seemed to last forever — the easier we can make it, the better off we are.”

The device was tested in a study made up of 2,409 individuals both with and without symptoms of the virus. In the study, the test identified 91 percent of positive samples correctly and 99 percent of negative samples correctly.

The Breathalyzer test uses a technique called gas chromatography gas mass-spectrometry, which separates and identifies chemical mixtures to detect five compounds associated with the coronavirus in exhaled breath. If a test comes back positive on the Breathalyzer, it should be confirmed with a molecular test, such as a P.C.R. lab test.

The F.D.A. warned 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” because they do not completely rule out an infection, and noted that the device “should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.”

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