A new COVID-19 test method would let patients swab their own noses for specimens at designated testing sites — an approach that could help with swab shortages and conserve dwindling supplies of protective gear for health care workers.
Minnetonka-based UnitedHealth Group announced study results Wednesday that support the new approach, which was developed by doctors at one of the company’s clinics near Seattle.
A testing expert at the Mayo Clinic, which was not involved with the study, called the Wednesday announcement “a significant step in our fight against COVID-19” because UnitedHealth Group says the results prompted the Food and Drug Administration to update guidance to health care providers.
“The FDA has moved forward with allowing COVID-19 samples to be collected from the lower nostrils using a simple swabbing procedure that can be self-administered by people experiencing coronavirus symptoms,” the Seattle-based Bill & Melinda Gates Foundation said in a statement. “This will reduce the need for health care workers to use gowns, masks, and gloves to collect samples.”
UnitedHealth and the Gates Foundation collaborated on the research with the University of Washington and lab-testing giant Quest Diagnostics.
The study found that tests using self-administered swabs accurately detected COVID-19 in more than 90% of positive patients. That rate is “consistent with the clinician-administered test,” UnitedHealth Group said in a news release.
The study was conducted in nearly 500 patients at UnitedHealth’s network of clinics in Seattle, a city that for some time was “the epicenter of this epidemic” in the U.S., Dr. Deneen Vojta, the company’s chief medical officer for research and development, said in an online video posted Wednesday.
The idea for self-administered tests came from Dr. Yuan-Po Tu, an infectious disease physician at Everett Clinic, one of UnitedHealth’s large medical groups in Seattle. The novel coronavirus is so “hot,” Vojta said, that Tu speculated health care workers could easily direct patients to use shorter swabs to collect specimens from the front part of the nostril and mid-nose.
With most specimen collections right now, health care workers use very long swabs that go deep into the nose, Vojta said, and often cause patients to sneeze or even vomit.
“He called me and he said, ‘You know, Deneen, our front-line workers are going through the protective equipment 2 ½ gear per patient,’ ” Vojta said in the video. “What we found was, in fact, this [new method] worked just as well. ... This is still self-collection in a health care environment.”
A UnitedHealth Group spokesman said the FDA’s website describes the new approach as “acceptable” when the standard route for collecting specimens is not available. He said the company’s study prompted the change.
Dr. Dan Wattendorf of the Bill & Melinda Gates Foundation wrote in a blog post Wednesday: “We’re hopeful that it could be a game changer at a time when we will need to find ways to relieve stress on our health care system.”
Right now, health care providers are required to collect all samples and must first put on personal protective equipment in all cases. It takes a minute or two to get gowned up, Wattendorf said, but that step in a pandemic “may need to be repeated dozens of times a day.”
“The introduction of a simple swab could have a big impact on protecting health care providers and health care supplies over the next few weeks at a time when we expect a surge in cases,” Wattendorf wrote. “There is also an ample supply of these swabs at this time.”
Health care providers have reported shortages of the long swabs currently being used — one of many problems that has limited the supply of COVID-19 tests in the U.S.
Vojta of UnitedHealth Group stressed in the video that the company is not calling this an in-home test, since currently no such tests have been backed by federal regulators.
Matthew Binnicker, director of the clinical virology lab at Mayo Clinic in Rochester, said in a statement to the Star Tribune that study data are not yet available for public review, but the FDA’s updated guidance is an important change.
“Allowing patients to collect their own nasal swab, rather than requiring a provider-collected nasopharyngeal swab, will allow for broader COVID-19 testing, reduce exposures to health care workers, and conserve much needed personal protective equipment,” Binnicker said in a statement.