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By Jim Carlton
Health-services giant UnitedHealth Group Inc. is rolling out a coronavirus test that patients can self-administer, potentially reducing the risk to health-care workers as testing quickly expands around the nation.
The Food and Drug Administration on Monday included the new methodology in its guidance to the nation's medical workers. A UnitedHealth clinic in the hard-hit Seattle area began using it that day, and the company said it plans to implement the test nationwide.
In most tests now used, nurses and other staff have to extend a swab through people's noses to the back of their throats to get a specimen, potentially exposing themselves to a sneeze or cough, said Dr. Yuan-Po Tu, the director of infectious diseases at UnitedHealth's Everett Clinic in the Seattle region, who led the research team.
Under the new method, the swab can be administered by a patient at the front of the nose, dropped into a test tube and handed back to a health-care worker. The patient can even do it from inside a vehicle. "This is groundbreaking, because it will radically change how the samples are obtained and make the health-care worker much safer," Dr. Tu said.
It is one of several coronavirus tests and methods health companies have rolled out recently, including the rapid expansion of drive-through testing and a regimen that provides results in 45 minutes from California company Cepheid.
Dr. Tu said UnitedHealth's new method went into use Monday at several of Everett's clinics in the Seattle region.
Ken Ehlert, chief scientific officer for UnitedHealth, said the new protocol would be put in place as quickly as possible at the company's OptumCare network of more than 48,000 physicians.
FDA officials declined to comment. A doctor not involved in the study called the test method promising but cautioned it probably wouldn't be as accurate in identifying Covid-19, the disease caused by the new coronavirus, as swabs administered by a professional.
"You're going to miss diagnosing Covid-19 in some people because they will inadequately swab themselves," said Dr. Michael McCullough, an assistant clinical professor of emergency medicine at the University of California, San Francisco campus in Fresno, Calif. "But if you use a much simpler test which is a little less perfect, you can test exponentially more people and catch more of the disease."
Officials of UnitedHealth said the study accurately detected Covid-19 in more than 90% of patients confirmed as infected, a result they said was consistent with the test administered by a clinician. The study included nearly 500 patients at UnitedHealth's OptumCare facilities. The Bill & Melinda Gates Foundation, among others, assisted with the research.
Dr. Tu said he came up with the idea for a new way to administer the test two weeks ago when Everett's clinics were being inundated with patients complaining of Covid-19 symptoms and the clinic was running out of protective gear. "I said the only way we can get out of this situation is to change the way we collect specimens," he said.
He teamed with other medical experts from UnitedHealth and elsewhere to conduct a weeklong study, in which nurses and other workers could use much less protective gear to collect test-tube samples. The team reported its findings last Sunday night to the FDA, which updated its guidance to include it the next day.
Peter Loftus contributed to this article.
Write to Jim Carlton at firstname.lastname@example.org
(END) Dow Jones Newswires
March 26, 2020 05:44 ET (09:44 GMT)
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