CORONAVIRUS

University of Iowa researchers expect their coronavirus at-home spit test to be approved within weeks

The Pentacrest on the campus of the University of Iowa including the Old Capitol Building (center), Macbride Hall (top l
The Pentacrest on the campus of the University of Iowa including the Old Capitol Building (center), Macbride Hall (top left), Jessup Hall (bottom left), Schaeffer Hall (top right), and MacLean Hall (bottom right) in an aerial photograph. (The Gazette/file photo)

IOWA CITY — Within a few weeks, University of Iowa researchers hope to begin offering a new COVID-19 at-home test they developed to improve access to testing as Iowa continues to ease emergency restrictions.

The at-home snort-and-spit coronavirus test is in its final stages of validation, with researchers seeking a few more COVID-19-positive patients to donate their saliva. Once it completes validation, the lab expects to receive a green light from the U.S. Food and Drug Administration to make the at-home test available to anyone.

People could get access to the test in a variety of ways, including home delivery or pick up from designated sites, according to Calvin Carter, a postdoctoral fellow in the UI lab.

“Really very soon we would like to ramp up statewide testing,” Carter told The Gazette.

Once researchers are able to roll out the at-home test — which eliminates the need for uncomfortable and in-demand nasal and throat swabs — the University of Iowa will become only the second academic health care enterprise to offer the spit test.

Rutgers University just weeks ago became the first in the country to land FDA approval for a coronavirus saliva test.

UI professor Val Sheffield, known for his work in the field of genetics, repurposed his lab in mid-March to pursue prompt COVID-19 testing — realizing the widespread deficiencies juxtaposed with the rising demand both locally and nationally.

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With FDA-approved swabs in short supply and trained health care workers overextended, Sheffield and his colleagues began searching for a way to test saliva collected at home — without the need for swabs or trained medical personnel.

He submitted FDA documentation April 1 to begin the novel sample-collection method and landed permission May 7 from the UI Institutional Review Board to begin the final stages of study necessary for full FDA approval, according to the UI Office of Strategic Communication.

That final study, happening now, involves testing a small number of known COVID-19 patients — fewer than a dozen — daily for five days and then once more a week later.

Should his lab receive the final approval it expects, it could further expand testing access and information across the state as more businesses reopen, events start and schools prepare for summer and fall restarts.

“We’re rationing testing, and we can’t be rationing testing,” Sheffield told UI communications. “If we’re going to reopen the economy and we don’t have the ability to test lots of people, there’s going to be a spike in cases.”

Gov. Kim Reynolds — also in pursuit of more testing in Iowa — recently launched the Test Iowa Initiative, which provided more access but initially limited testing to those with specific symptoms or who had come in contact with someone who has COVID-19.

On Friday, however, her office announced, “Testing criteria now allows any Iowan to be tested, regardless of symptoms or potential exposure to the virus.”

To be tested through the Test Iowa program, Iowans must first complete an assessment at testiowa.com and schedule an appointment at one of eight test sites.

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But while all COVID-19 sample collection in Iowa currently requires a health care worker to insert an FDA-approved swab up a patient’s nose or in a patient’s mouth and throat, the UI-crafted spit test would avoid those discomforts and risky contacts.

By cutting out the practitioner middleman, health care providers also could preserve personal protective equipment — which, like testing materials, has been in short supply.

“This method doesn’t require a health care worker to lean in close to swab a patient’s nasal cavity, which often makes the patient sneeze,” Sheffield said. “I know it makes me sneeze.”

Although details of the sample-kit pick up and drop off still are being ironed out, once a person gets a kit, the process is relatively simple.

First snort — moving cells from the nasopharynx to the back of the throat; then cough to clear the throat and move cells from the back of the throat to the mouth. Lastly, spit into a small cup.

The kit comes with a second container filled with a virus-inactivation solution that kills most — if not all — the live virus. Users are instructed to pour the solution into the cup with their saliva — so it’s not infectious when lab staff handle it — and then put it in a provided biohazard bag.

“We worked with Dr. Stanley Perlman, who is an expert on coronavirus, to test the solution, and he found that it kills 99.9 percent of the virus,” Sheffield said. “We can’t prove that it’s 100 percent, but it’s probably 100 percent.”

At the lab, researchers check the sample for pathogens. Preliminary results show the saliva method is accurate and reliable, according to Sunny Huang, a UI doctoral student.

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In touting the test’s accuracy, Sheffield said it has proved “extremely sensitive” and can make a positive detection three weeks after a person’s symptoms began and a week after he or she was cleared for work.

“That’s not to say they were still infectious, but the test could still detect RNA particles from the virus,” he said.

Although with proper funding the lab could provide the at-home testing for free, Carter said, right now researchers are looking at doing it “at cost,” which he expects will be below $100 per test. That includes the test kit, lab fees and a telehealth consultation with the results.

The UI test could be made available to anyone, but the goal is to provide widespread testing in Iowa.

Comments: (319) 339-3158; vanessa.miller@thegazette.com

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