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State Coronavirus Response Hurt by Faulty Tests, Restrictive Guidelines

Besides the delay in getting functioning kits to labs, coronavirus testing has had restrictive guidelines for who can be tested under the FDA’s "emergency use authorization" for labs allowed to conduct the assessments.

by Lewis Kamb, The Seattle Times / March 4, 2020

(TNS) — The recent surge in positive coronavirus cases and deaths that has made the Seattle area the epicenter for the burgeoning disease in the United States partly stems from "unique epidemiology going on in Washington" -- an outbreak at a Kirkland nursing home where the virus spread among a particularly vulnerable population, the state's epidemiologist for infectious diseases said Tuesday.

But that's only part of the story, Dr. Scott Lindquist, of Washington's Department of Health (DOH), acknowledged Tuesday. A problem with the federally approved testing kits initially supplied to state public health laboratories across the nation last month didn't work well and stymied testing for -- and recognition of -- the virus' spread in Washington.

"That really did set us back, there's no denying that," Lindquist said.

The poorly functioning kits to test for SARS-CoV2 -- the virus that causes the disease known as COVID-19 -- required the Centers for Disease Control and Prevention (CDC) to manufacture new kits that only began arriving in labs late last week. The delay meant that novel coronavirus and its spread largely went undetected for weeks until new kits became available, public health officials and infectious disease experts said.

"I think it's fair to say that the American response has been slow in terms of rolling out testing," said Dr. Caroline Buckee, an epidemiologist and associate director of the Center for Communicable Disease Dynamics at Harvard University.

Aside from the delay in getting functioning kits to labs, coronavirus testing has been saddled with restrictive guidelines for who can be tested under the Food and Drug Administration's (FDA) "emergency use authorization" for labs allowed to conduct the assessments. The restrictions mean only those patients who meet specific criteria as a "person under investigation" can be tested, such as those who recently traveled to Wuhan, China, where the epidemic started, or those with certain symptoms who came into close contact with someone confirmed to have been exposed to the virus.

Such testing delays and restrictions have masked the extent of the disease, including "quite a lot of community transmission" among patients who otherwise don't fit high-risk categories, Buckee said.

"From the genetic data we're seeing in the Washington state area, it seems likely there has been ongoing transmission of the virus for six weeks," Buckee said. "The fact that they've only sent out these new test kits in the last week means we've been missing a lot of cases."

The CDC did not respond to a request for an interview about testing issues Tuesday, and the FDA declined an interview request.

Since Friday, after the new test kits arrived in Washington and the DOH lab in Shoreline has ramped up testing, the state as of Tuesday evening has confirmed nine coronavirus deaths -- the only fatalities so far confirmed in the nation. It's also confirmed an additional 18 cases, all of which are in King and Snohomish counties. Public health workers are monitoring an additional 231 people who could have been exposed to the virus. Seven of the nine deaths, and seven other confirmed cases, are tied to Life Care Center of Kirkland, a long-term care facility.

Until last week, the DOH had been sending potential coronavirus samples to the CDC in Atlanta as part of a cumbersome testing process that took up to five days to yield results. Now, the state lab has the capacity to run 200 tests a day and can get test results back in a day or two, Lindquist said. The University of Washington also has started coronavirus testing under the FDA's emergency use authorization, with capacity of up to 400 tests per day.

Another university lab and other private labs in the area also are seeking the federal authorization to conduct testing, Lindquist said.

Following a closed-door briefing with senators Tuesday, Vice President Mike Pence said the CDC has lifted all restrictions on coronavirus testing and would be releasing new guidelines to fast-track testing for people who fear they have the virus, even if they are only displaying mild symptoms.

Previously, some of the restrictions for testing in recent days had been eased somewhat to allow public health officers some leeway in deciding who should be tested. However, no testing previously had been available for those with only mild symptoms, public health officials said. As more testing capacity becomes available, "people who might be in the community who aren't sick enough to require hospitalization" also likely could get tested, said Dr. Jeff Duchin, health officer for Public Health -- Seattle & King County.

But, even with Pence's announcement, that hadn't happened as of Tuesday, rankling some people wracked with worry and experiencing flulike symptoms.

Heather Segars, 44, a Shoreline mother and preschool teacher who recently returned home from a trip to Disneyland with a cough and shortness of breath, said her efforts to get tested have been roundly rejected after repeated calls, a visit to area clinics and an hourlong wait on a coronavirus hotline.

"I'm a very healthy person, and so from what I understand, I'm not in the risk population," Segars said. "But I have a kid with an autoimmune disease ... If they're just testing the people who have to be hospitalized ... that makes me nervous."

Officials at local hospitals say they recognize that people with mild symptoms want to get tested, but that could put a strain on clinical health resources.

"There are many people in the community who are very worried, whether they traveled somewhere or know someone who is ill," said Dr. Chris Baliga, section head of the infectious disease unit at Virginia Mason Seattle Medical Center, which is treating a coronavirus patient. "But we appreciate the difficulty in approving testing when there's very limited capacity. We don't want to not have the ability to test someone we really need to test because our system is so full of people who are worried but don't really need testing."

But even some people in seemingly high-risk groups for coronavirus have reported troubles in getting tested.

Gina Norton's 72-year-old mother shared a room with two other residents at Life Care of Kirkland until one was taken to the hospital with pneumonialike symptoms last week, according to the families of both residents. Norton said her mom had also developed a cough and trouble breathing while in the shared room at Life Care. She's since been moved into isolation and is receiving nebulizer treatments and cough syrup, Norton said.

Her family has begged the facility to take the woman to get tested, but was told she did not meet the criteria for testing because she did not have a fever.

"We just want her tested," Norton said. "We don't want to wait until she's so sick that she can't fight the virus. We want to know."

Officials for Life Care didn't respond to requests for comment.

"They want to be tested"

The way the process generally works now, potential coronavirus patients seek treatment from their health care providers, who in turn assess whether the patients meet the criteria for testing. Health care providers send requests for tests to their local or county health departments, which must approve those requests for processing and send them to the state lab for testing.

"Because this is a brand-new test under emergency use authorization, we can use it as long as we follow these very strict guidelines," Lindquist said.

That generally means a patient approved for a test must have a fever and signs of lower respiratory illness with recent travel to an affected area; or have the same symptoms and recent exposure as someone confirmed with coronavirus; or have an unexplained fever or pneumonialike symptoms that require hospitalization.

With the recently eased restrictions, some exceptions have been made to test patients with "unexplained respiratory illnesses who've been hospitalized," or if local health officers see other high-risk signs that warrant testing, Lindquist said.

"Unfortunately, there is no licensed use of this test for people who have mild illnesses or symptoms," he added. "And I know that's really frustrating for people, because they want to be tested and they want to know."

Facing pressure from Congress and public criticism, Dr. Stephen Hahn, the FDA chief, said the CDC is working with private manufacturers to drastically increase testing capacity and make 2,500 test kits available by the end of the week, with each kit capable of 500 tests. Pence repeated those numbers Tuesday, saying the kits amounted to 1.5 million tests.

Democratic Sen. Maria Cantwell of Washington said in a statement she pressed Pence and other officials during Tuesday's closed-door hearing. "They keep throwing out numbers, like millions of tests, and we're saying, 'that's not right.' Millions of tests aren't available right this second. People are calling their doctors and they're not being able to get tests."

Regardless, the testing capacity likely will change as the UW and private labs with pending authorization ramp up testing, public health officials say. The UW lab performed 70 tests under the restrictive FDA guidelines during its first day of testing on Monday, Lindquist said, adding it "would like to get up to 1,000 [tests] per day."

Back for new kits

Such aggressive testing will come far later than what was initially anticipated, however.

Since shortly after a Snohomish County man who'd recently traveled to China got sick, sought treatment and became the first confirmed case of coronavirus in the U.S., Washington's public health agencies have been prepared to aggressively test for the virus, said Patty Hayes, director of Public Health -- Seattle & King County, on Friday.

"They've been ready for almost a month to start these tests," Hayes said. "They just didn't have the CDC-approved reagents and the packets that they need."

The problems began shortly after the CDC rolled out its newly developed testing kits to about 100 public health labs nationwide about three-and-a-half weeks ago, said Kelly Wroblewski, director of the infectious disease program for the Association of Public Health Laboratories, based in Silver Spring, Maryland.

The diagnostic test kits, which use a genetic testing method called polymerase chain reaction (PCR) to look for the virus in material taken from saliva or nasal swabs, were able to sidestep a more rigorous approval process, receiving the expedited approval under the FDA's "emergency use authorization" permit, Wroblewski noted.

"We've done that several times now, and it's always worked pretty well," Wroblewski said. "But this time, a number of public health laboratories noticed some problems with the negative control [a component of the PCR tests] and reported that."

The problems forced CDC to manufacture new testing kits and go back to the FDA for approval, she said."The delay has not been ideal" for recognizing community spread of the disease, Wroblewski added.

Seeking to ramp up testing further, the FDA on Saturday issued expanded allowances for certain labs seeking to develop diagnostic tests under its emergency use authorization policy.

Duchin said he expects the added capacity eventually will allow private and public labs to test "someone [who] goes into the doctor with a cough or a cold [and] gets tested on the premises."

In the meantime, those with mild symptoms are advised to do what they should normally do: Stay home.

"Let's be honest, if you have mild symptoms and you get a test, what are you going to do differently because you get that test result?" Linquist asked. "You're going to stay home and limit your contact and exposure with other people. There's no cure for this virus and there's no vaccine to prevent it, so that's all you can do."


Seattle Times staff writer Scott Greenstone contributed to this report, which contains information from The New York Times.

Lewis Kamb: 206-464-2932 or lkamb@seattletimes.com; on Twitter: @lewiskamb.

Asia Fields: afields@seattletimes.com; on Twitter: @asiakmfields.

 

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