Three weeks ago, Dr. Elaine Cham, a pathologist at a large children’s hospital in California, had a sense that the nation’s coronavirus testing mess was finally getting under control.
She could send tests to a lab at Stanford University Medical Center and get the results within a day.
When backlogs grew at Stanford, Cham started sending tests to Quest Diagnostics, a major laboratory company that has been ramping up its testing capacity. But the turnaround for results could be 13 days, she said, so her hospital switched to the University of California, San Francisco, for a two- to three-day wait.
“We simply said, ‘This is ridiculous,’” said Cham, who works at UCSF Benioff Children’s Hospital in Oakland.
Testing availability remains a signature failure of the battle against the coronavirus in the United States, despite President Donald Trump’s boast last week that he got a rapid test and results within minutes. And Vice President Mike Pence has repeatedly promised that Americans will be able to get tests at their doctors’ offices, although the timeline for routine access may be months away.
More and more rapid tests are coming onto the market and private companies like Quest and LabCorp are now running thousands of tests a day. But as the virus has spread from state to state infecting hundreds of thousands of Americans, demand for testing has overwhelmed many labs and testing sites.
Doctors and officials around the country say that lengthy delays in getting results have persisted and that continued uneven access to tests has prolonged rationing and hampered patient care. In addition, swabs and chemicals needed to run the tests are in short supply in many of the nation’s hot zones.
“Many local communities are flying blind, making decisions in the absence of full information largely due to the failure of the federal government to provide sufficient testing capacity,” said Chrissie Juliano, executive director of the Big Cities Health Coalition, which represents executives in 30 urban public health departments, among them Boston, Chicago, Los Angeles, New York City and Seattle. “This testing shortage, and lack of available information about the actual burden of the virus, has set our country’s response back by an order of magnitude we will never know.”
At least 305,000 people in the U.S. have tested positive for the virus, although many public health experts say the actual number is much higher. More than 9,400 people have died.
On Monday, Trump said that the number of coronavirus tests in the U.S. now exceeds that in other countries, seeming to suggest that the country is doing a better job of monitoring the spread of the disease than those countries. But his statement, during the daily White House briefing, overlooked the fact that the U.S. has a much larger population than countries like South Korea, which has been extensively testing its residents. On a per capita basis, the U.S. had tested far fewer people than several other countries.
South Korea has tested thousands more people for every 1 million residents compared to the U.S., according to its government website as well as the COVID Tracking Project, which tracks testing in the U.S. According to the project, 1.9 million people had been tested in the U.S. as of Monday.
Adm. Brett P. Giroir, the assistant secretary of health who is overseeing the government’s testing response, said quick-response tests are being shipped around the country, and that the government is working closely with hospitals and other laboratories to ensure they have what they need. “I think testing is really in a good position right now,” he said.
Federal inquiries have begun to determine how the nation’s testing capacity turned into such a debacle. The Centers for Disease Control and Prevention had manufacturing errors with the first test it devised for public health labs around the country, and so testing in the states stalled as the virus began to spread in Washington state, New York and California. The Food and Drug Administration, charged with approving the test, was so frustrated that the agency pushed for the CDC to stop making it on site and instead send it to Integrated DNA Technologies, an outside lab.
The FDA, for its part, was slow to recognize the danger of the pandemic, and how critical testing by commercial labs and hospitals would be as the virus spread.
In early March, the nation’s two largest commercial labs, Quest Diagnostics and LabCorp, started testing, and they have acknowledged that their labs around the country were overwhelmed. Quest’s backlog is 80,000, according to the company, down from 160,000 on March 25. LabCorp says it has caught up, and now has a turnaround of four to five days from pickup.
Supplies of test swabs have gotten so low that most hospitals test only their most vulnerable patients, typically those being admitted.
Wendy Bost, a spokeswoman for Quest, which introduced its coronavirus tests on March 9, said the company had ramped up its testing and could now process more than 35,000 tests per day — over 200,000 each week — at its 12 labs around the country. Last week, Quest asked hospitals to identify health care workers and symptomatic patients for priority processing and she said the company was providing results now on an average of a day for that population.
To date, Quest has processed nearly 550,000 coronavirus tests, Bost said. The current turnaround time for other patients, she said, is now two to three days although she acknowledged there was a longer wait in the areas most affected, like Chicago, New York, New Jersey and Miami.
LabCorp has four labs running, also averaging about 35,000 to 40,000 coronavirus tests each day, the company said. Mike Geller, a LabCorp spokesman, said it had tested about 500,000 samples, and that the time for processing varied, based on demand.
“LabCorp, along with other laboratories, is experiencing unprecedented and rapidly increasing demand for COVID-19 testing in the midst of this national health emergency,” Geller said.
The latest test approvals by the FDA include one by Abbott Laboratories, called ID Now, which can provide results in just a few minutes; and others, like Roche and Hologic, which perform automated, high-volume testing in commercial and hospital labs.
These tests work by finding fragments of genetic material from the virus to indicate a current infection.
But these tests will take weeks, if not months, to be manufactured on a scale that can be widely shipped to most institutions. For many hospitals, however, the cost of the instruments needed to run those tests will be prohibitive. And even the nation’s top hospitals have reported that they are very low on the materials needed to run the tests.
Darcy Ross, a spokeswoman for Abbott, said the company had shipped its new, fast-turnaround test to 18 states, including those with the highest number of infections like New York, New Jersey, Michigan and California. In addition, the federal government is buying the Abbott test instruments for state public labs. Mia Heck, a spokeswoman for the Department of Health and Human Services, said it was sending 15 machines each to public health labs in all 50 states and the Pacific islands, and 250 to the Indian Health Service. Alaska will get 50. Twenty will go to the CDC and 50 to the Strategic National Stockpile.
Heck said the department had purchased 30,000 test cartridges, to be used in the ID Now devices, to leave a sufficient supply for private hospitals and clinics. As of Friday, Abbott had already shipped 190,000 test cartridges, and planned to produce 50,000 more each day.
On Monday, CVS Health announced it would open drive-thru test sites, using the ID Now test, in Georgia and Rhode Island.
The University of California, San Francisco announced Monday that it would provide free COVID-19 testing for the next 30 days to health departments in nine surrounding Northern California counties. UCSF built out an empty biopharmaceutical space near downtown, using $5 million from the Chan Zuckerberg Initiative, after the federal and state governments loosened regulations on where testing labs could be built and who could staff them.
At UC Davis Health in Sacramento, California, Dr. David Lubarsky, the health system’s chief executive, said the health system had a large testing instrument from Roche that could run more than 1,000 tests a day, but the company had been sending enough supplies to run only a few hundred tests per day.
“Every single person should be tested who presents with symptoms that suggests they have COVID-19,” Lubarsky said. “But the reason we are not suggesting that is the lack of available test kits.”
Lubarsky said UC Davis was working on developing new tests that could be run on the Roche machine, which he said were expected to be approved in a couple of weeks.
Michael Weist, a spokesman for Roche, said the demand for materials needed to run its 3 1/2-hour test was outpacing the supply. There are now 60 sites that have it.
“It’s a difficult decision because everybody wants to run the test,” he said.
At another hospital in California, an emergency room doctor, who asked not to be named for fear of losing her job, said she had to send home a patient who most likely had a bad case of COVID-19. The hospital has so few test swabs that doctors are permitted to use them only for patients who are admitted, who are over 65 with diabetes or other medical problems, or who are pregnant. Reluctantly, the doctor sent her home, with a face mask and instructions on hand-washing, which can provide only limited protection in her tight, multifamily living quarters.
The long wait time for hospitals to obtain coronavirus test results can cripple a hospital, said Dr. Steven Choi, chief quality officer and associate dean at Yale New Haven Health System and Yale University School of Medicine.
“Number one, you don’t know what kind of disease or illness you are dealing with in a severely sick patent,” he said, “and until you know if they are positive or negative, you are going to be using potentially unnecessary personal protective equipment, which is already at a shortage. The people who come into your room use face shields, goggles, mask and gloves — and it could turn out you have a cold.”
Dr. Julio E. Figueroa, chief of infectious diseases at Louisiana State University School of Medicine in New Orleans, said drive-thru and tent testing sites had helped ease a backlog.
Figueroa said his hospital was sending fewer to LabCorp, which he said had an average return of four to five days. Instead, they are relying on the Roche diagnostic test, which they can do in-house. But, like Lubarsky in Sacramento, he lacks sufficient supplies to do as many of the tests as he would like.
“That’s another bottleneck in terms of testing,” Figueroa said.
Most of the current tests use a sample taken with a nasal swab. The swab is pushed through the nose to the spot where it meets the throat, and a sample is taken.
Some doctors favor an alternative sampling method, using a nasal wash, which flushes saline into the nose and then collects it coming out of the nostrils.
Dr. David Persing, executive vice president of Cepheid, which received FDA authorization for a coronavirus test that analyzes samples in about 45 minutes, said its test could work with samples taken by swab or nasal wash.
“For an emergency room that has run out of swabs, that would be a good option,” he said.