FDA approves first COVID breath test for emergency use
The instrument is the size of carry-on luggage
The Food and Drug Administration (FDA) on Thursday issued an emergency use authorization for the first COVID-19 diagnostic test that can detect SARS-CoV-2 infection in breath samples.
"Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19," Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. "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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The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage and tests can be performed in environments where the patient specimen is both collected and analyzed.
Results can be provided by a qualified, trained operator under the supervision of a licensed health care provider in less than three minutes.
The instrument utilizes a technique called gas chromatography gas mass-spectrometry (GC-MS) to "separate and identify chemical mixtures and rapidly detect five Volatile Organic Compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath."
When it detects the presence of infection, a presumptive (unconfirmed) positive test result is returned and should be confirmed with a molecular test.
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Negative results, the FDA noted, should be considered in the context of a patient's history, recent exposures and COVID-19 signs or symptoms, 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."
The device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.
"The study also showed that, in a population with only 4.2% of individuals who are positive for the virus, the test had a negative predictive value of 99.6%, meaning that people who receive a negative test result are likely truly negative in areas of low disease prevalence. The test performed with similar sensitivity in a follow-up clinical study focused on the omicron variant," the agency wrote.
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InspectIR expects to be able to produce approximately 100 instruments per week – used to evaluate around 160 samples each day.
Testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.
The Associated Press contributed to this report.