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COVID-19 Breathalyzer Test Receives FDA Approval

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By Josh Piers - - 5 Mins Read
Sending a swab up the nose to swirl about and test for COVID-19 has become a familiar but unsettling feature of living through the epidemic, whether it's a PCR test or an at-home version. But what if there was another option? For the first time, health officials in the United States have approved the COVID-19 breathalyzer, a device that promises results in under three minutes. As new sub-variants drive up case numbers, some experts anticipate that this will be the first of many new techniques to identify the virus and, as a result, improve how we live with it. There's even a chance that breath testing could one day be used to detect and monitor other diseases like cancer. So, how far has technology progressed? And, more importantly, could it truly replace the nasal swabs we've come to despise?

Breath test with a catch

The US Food and Drug Administration (FDA) has given the first COVID-19 diagnostic test, which detects chemical components in breath samples linked to SARS-CoV-2 infection, an emergency use authorization (EUA). The test can be done in places where the patient's samples is both collected and analyzed, such as doctor's offices, hospitals, and mobile testing sites, with a device roughly the size of a carry-on bag. It is carried out by a qualified, trained operator under the supervision of a health care physician who is licensed or permitted by state law to prescribe tests, and findings are available in less than three minutes. "Today's approval exemplifies the rapid innovation that is occurring with COVID-19 diagnostic tests," says Jeff Shuren, M.D., J.D., head of the FDA's Center for Devices and Radiological Health. "With the goal of advancing technology that can assist address the present pandemic and better prepare the United States for the next public health emergency, the FDA continues to support the development of innovative COVID-19 tests."

How does InspectIR COVID-19 Breathalyzer Work?

When the InspectIR COVID-19 Breathalyzer identifies SARS-CoV-2 VOC markers, it returns a presumptive (unconfirmed) positive test result, which needs to be proved by a molecular test.  Negative results should be interpreted in light of a patient's recent exposures, medical history, and the presence of clinical signs and symptoms consistent with COVID-19, 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, including infection control. InspectIR aims to be able to create around 100 instruments per week, each capable of evaluating around 160 samples per day. The COVID-19 Breathalyzer's testing capacity is estimated to increase by roughly 64,000 samples per month.

Breath tests could be used to detect the flu, cancer, and COVID-19.

The epidemic has helped to focus attention and funds on breath research, much as it has for other discoveries like mRNA vaccines and telehealth. When COVID-19 began, Perena Gouma, a materials science and engineering professor, was working on a breath test to identify the flu. Professor Gouma says he received a phone call from the White House after they read his flu breathalyzer article and asked, "Can you produce a test for COVID-19?" She and her Ohio State University colleagues have subsequently devised a test that can be self-administered and returns a result in under 30 seconds. Her test looks at the composition of several substances in someone's breath to see if they have COVID-19 and how severe it is. Professor Gouma claims that the test has a high accuracy rate and that if extensively used, it might "revolutionize" COVID-19 screening. Her attempts to acquire an emergency use authorization from the FDA, however, have so far failed. "I'm a little bit enraged because after spending two years working on this technology day and night and making everything so open and transparent - we ended up with this," she says. According to the FDA, it does not comment on the status of pending applications. Professor Davis said scientists are barely scraping the surface of the field's possibilities. She hopes that one day, breath testing can be used to diagnose and monitor diseases like cancer. Breath research doesn't have to just be about the lung, interestingly, because what we're measuring from the exhaled breath is really representative of the entire body," Professor Davis says.