RI researchers vie for FDA’s approval on new ‘bubbler’ device to detect COVID-19

Coronavirus

PROVIDENCE, R.I (WPRI) — Researchers in Rhode Island have developed a new, less invasive method to detect COVID-19.

The team of researchers from Brown University and Rhode Island Hospital created the new testing device with a name deriving from its Ocean State origins.

“It’s what we call the bubbler,” Dr. Gregory Jay, an emergency medicine physician at Lifespan, said. “Slightly Rhode Island-esque in doing so.”

Jay said the bubbler can detect COVID-19 in breath samples, which is much less invasive than the nasal swab everyone is used to.

A clinical research assistant breathes into the Bubbler device to detect COVID-19 developed and tested in Rhode Island.

For the device to work, patients are directed to breathe into the bubbler for 10 seconds to provide a sample.

Jay, who helped conduct a study of the device at Rhode Island Hospital, said the device then “reverse transcribes” the RNA from the airborne virus particles into DNA, which are then tested via PCR to determine a positive or negative result.

Brown University Professor Dr. William Fairbrother, who led the study, said the current COVID tests usually involve only samples collected from the upper respiratory tract.

Positive samples contain active virus, but Fairbrother said a viral load in the upper respiratory tract is not always correlated with symptoms in the lower respiratory tract, such as pneumonia.

“Involvement of the lower respiratory tract is often a precursor to severe COVID-19, so there is an argument for a more direct sampling focused on exhaled breath,” Fairbrother explained.

Jay said the study took place between May 2020 and January 2021 and involved 70 patients, who consented to taking part in the clinical trial in addition to receiving a traditional PCR test.

“We asked patients to collect some of their exhalation into the bubbler device by collecting two exhalations while they bubbled, that one quarter teaspoon of either mineral or canola oil, mixing their exhalation with those PCR primers,” Jay explained.

Jay says those “PCR primers” have their own molecular barcode, and results are able to be traced back to each individual patient who provided a sample. Additionally, results of a large numbers of people screened can be batched and processed together.

“That’s significant in and of itself, because that lessens the need for a full laboratory,” Jay said.

Researchers compared results from both tests, and found the sensitivity of the bubbler compared to the nasopharyngeal swab was 89% and specificity was 82%.

Jay said the test can also detect which kind of strain of the virus someone has, like the delta or omicron variant, and determine whether the person is contagious to others.

Researchers believe the bubbler could be adapted for environmental sampling, which could be useful for hotels, cruise ships, casinos and transportation hubs.

“I really think this is more meant for larger populations in large public spaces, like an auditorium, transportation stations, transportation hubs, where large [groups of] people may come and go and congregate at a given time,” Jay explained. “If there’s an opportunity to screen all those individuals, and do so rapidly, but in a parallel multiplex way, that would be more efficient.”

Currently, the research team has a patent application in the works and is looking to license the test to a partner that could help commercialize it.  Researchers are also looking to get Emergency Use Authorization from the U.S. Food & Drug Administration (FDA).

The research team believes the bubbler and its related PCR test are “comparable to or cheaper than” swab tests, since no RNA extraction or stabilization is needed.

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