FDA Greenlights the First COVID-19 Breath Test

The U.S. Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for InspectIR’s COVID-19 Breathalyzer as the first government-approved COVID-19 diagnostic test using breath samples.

The InspectIR’s COVID-19 Breathalyzer was designed to be the size of a piece of carry-on luggage, allowing the trained operators to collect and analyze patients’ specimens in the hospitals, doctor’s offices, and even mobile testing sites.

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

The instruments are able to test approximately 160 samples per day, allowing the testing capacity to be increased by 64,0000 samples per month.

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Rapid and Sensitive Workflow

With the gas chromatography gas mass-spectrometry (GC-MS)  technique, the instruments are able to separate and identify five different Volatile Organic Compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath, and provide the results in under three minutes.

The instrument’s clinical trial was first started in May 2020 according to the company’s press release, and it has validated the performance of 91.2% sensitivity and 99.3% specificity. In addition, the study also provides a negative predictive value of 99.6%, demonstrating that people who receive a negative test result are likely truly negative in areas of low disease prevalence.

FDA suggests that the positive test results provided by InspectIR’s COVID-19 Breathalyzer still require confirmatory testing with a molecular test, and they should not be used as the sole basis for treatment, or infection control decisions.

Novel COVID-19 Tests Are More Than Welcome

This is not the first time FDA granted an alternative rapid COVID-19 test besides the most common but also unpleasant at-home-swabs COVID-19 test. It has issued EUA to SalivaDirect, a COVID-19 test using saliva samples, along with ADEXUSDx, a COVID-19 antibody test using a finger prick.

“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,” Shuren added. 

Author

Aurora Mau