Thanks to a green light from the U.S. Food and Drug Administration, the UW Medicine Clinical Virology Lab has begun testing hundreds of patient samples each day to detect the coronavirus, helping to break a logjam in diagnostic testing amid a serious outbreak in the Seattle region.
Long-established and certified to conduct complex tests for microbes, the lab eventually could have the capacity to screen up to 5,000 samples per day, a process that takes about eight hours for each sample. For the Seattle area — the epicenter of the coronavirus outbreak in the United States — that could ease a severe shortage in coronavirus tests that has slowed the ability of doctors to identify cases, provide treatment and trace contacts.
“Research and clinical care go hand-in-hand when it comes to dealing with viruses,” said Dr. Keith Jerome, a virologist at Fred Hutchinson Cancer Research Center who also heads the Virology Division of the University of Washington School of Medicine. “And the fact that we have a long research history in how these viruses work is why we were ready to go as soon as we got the green light.”
Due to a shortage of tests to date, testing of patient nasal swabs had been limited only to the sickest patients who had a history of travel or contact with other coronavirus patients. That created a serious gap in detecting patients who may have contracted the virus through silent, community spread, as appears to have happened in the outbreak at a Kirkland, Washington, nursing home.
As tests become more widely available, a sick patient can be referred for testing by a qualified physician. People who simply want to know their status for reassurance will still have to wait until those at highest risk are tested.
Within 48 hours of receiving permission from the FDA to conduct tests on Feb. 29, the UW laboratory began processing 100 tests a day, and it expects soon to reach more than 1,000 a day.
“Things are happening in a matter of hours or days that normally take weeks or months,” Jerome said today at a Seattle press conference. “It is going to help change the trajectory of this epidemic in the United States.”
With no vaccine to prevent COVID-19, and no antiviral drugs to treat it, “testing is the main weapon we have against the virus,” Jerome said.
The breakthrough will begin to provide relief to Seattle-area residents who live at the center of the largest U.S. outbreak of COVID-19, which began in early December in Wuhan, China, and is rapidly spreading around the globe.
As of March 4, according to the Washington State Department of Health, there are 31 confirmed cases of COVID-19, and nine deaths, in King County, which includes Seattle; and eight cases and one death in nearby Snohomish County.
Dr. Alex Greninger, assistant director of UW Medicine Clinical Virology Laboratories, heads the team that developed the new test. It uses a technique known as PCR to spot telltale gene sequences of the SARS-CoV-2 virus on samples taken from patients.
“Seattle and the West Coast are the front lines for this virus,” Greninger said. “So, we are doing what we can to protect the rest of the United States.”
One difficulty posed by this virus is that it has a long incubation time before it starts to cause lower respiratory tract systems. It can be two weeks from transmission before symptoms show.
“Every virus is different,” Greninger said. “This one is certainly one of the most challenging I’ve ever seen in my lifetime.”
Researchers at sophisticated labs like UW’s are routinely able to produce diagnostic tests for viruses, but when the COVID-19 outbreak occurred, patient tests were limited to those provided by the federal Centers for Disease Control and Prevention. However, after those tests proved to be faulty, there was a shortage of diagnostics needed for patients across the country.
The FDA resolved the mounting crisis when it decided that laboratories like UW Medicine’s could use their assays to diagnose patients, and the CDC has meanwhile corrected the quality control problem with its test.
Jerome said that, despite that glitch, academic and government researchers are working cooperatively.
“We are sharing everything,” he said. “There is a huge spirit of collaboration. This is a major emergency, and we all understand that.”
Sabin Russell is a staff writer at Fred Hutchinson Cancer Research Center. For two decades he covered medical science, global health and health care economics for the San Francisco Chronicle, and wrote extensively about infectious diseases, including HIV/AIDS. He was a Knight Science Journalism Fellow at MIT, and a freelance writer for the New York Times and Health Affairs. Reach him at firstname.lastname@example.org.
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