Delays can make test result useless
No national strategy; labs struggle to keep up
Cris Julian and son Ethan emerged Friday from their two-week coronavirus quarantines in New London, Iowa.
It took less time to wait it out than it did to get their results back. As of Friday night, they were still waiting.
Youngest son Alexander was tested at the same time but got his positive test results back within 48 hours. He was exposed by another student during an open gym workout at his school. Because the state lab was closed July 3, Julian’s doctor’s office sent the tests to Quest Diagnostics.
The Centers for Disease Control and Prevention said COVID-19’s incubation period is up to 14 days, so Julian said that means her test is “worthless now.”
“We will never stop the spread if we can’t get reliable and timely results,” Julian said.
She wants the federal government to provide incentives for labs to provide a faster turnaround, and some leading public health experts agree. They said the Trump administration needs a national strategy for testing and a way to prod, penalize or otherwise enable laboratories to pick up the pace in processing.
Here’s the rub: Labs are performing more COVID-19 tests than ever, lab workers are strained and states are bidding against one another for the same, limited supplies.
“It’s the Wild, Wild West,” said Blair Holladay, CEO of American Society for Clinical Pathology. “There’s been no national testing strategy ... so states are duking it out for supply chains. That’s a problem.”
In mid-April, when labs completed about 150,000 COVID-19 tests a day, the federal government dangled a major incentive to increase testing output. Medicare would pay labs $100 for each “high-throughput” test, nearly double the $51 per test paid in the early
days of the pandemic, as a way to get labs with machines that process lots of tests to increase capacity and deliver faster results.
The labs reached an all-time high of more than 831,900 COVID-19 tests Thursday, according to the COVID Tracking Project, but the prolific expansion has led to a bottleneck, slowing results for families such as the Julians.
Quest Diagnostics said the average turnaround time for nonpriority patients was seven days or more. Patients in hospitals, those preparing for acute surgery and health care workers with symptoms get results within a day.
The laboratory giant warned it won’t be able to deliver COVID-19 test results faster as long as cases continue to rapidly escalate. The situation is “complex and not easily fixed” and affects the entire laboratory industry, Quest said in a statement.
LabCorp, citing increases in testing demand and supply and equipment constraints, said average turnaround time for non-hospital patients was four to six days, according to a company spokeswoman.
“We’ve gone way backwards” in testing, said former New York health commissioner Nirav Shah.
Shah, a senior scholar at Stanford University’s Center for Clinical Excellence, and other public health experts said the delay in results renders many of the tests irrelevant and increases the virus’s spread.
Joshua Sharfstein, a former health commissioner for Baltimore and the state of Maryland, said commercial and federal insurance programs could penalize labs that didn’t produce results within 48 hours or pay extra if they do.
“It’s the failure of a federal strategy that led us to this point,” said Sharfstein, a professor and vice dean at Johns Hopkins Bloomberg School of Public
Health. “Financial incentives would help to get more tests done quickly. Additional funding to guarantee the market would also help to grow capacity for testing over time.”
In the short term, states that can’t build more capacity should set priorities for who can be tested, he said. The “best case scenario,” Sharfstein said, would be “more timely and therefore more meaningful tests.”
“I’d rather have fewer tests that are timely than more that are too late,” he said. “It is a worthwhile trade-off.”
Former Food and Drug Administration Commissioner Scott Gottlieb favors a focus on lab capacity.
“It’s an infrastructure issue and a question of whether you’re going to undertake a huge capital investment for a business that will go away in six months,” he said.
Whatever the solution, epidemiologist Brian Castrucci called shifting testing responsibility to states the “worst misuse of federalism ever” and “a national leadership disaster.”
“When you look at that (in some places), everyone who wants a test can get a test, was that the right thing to do?” said Castrucci, CEO of the de Beaumont Foundation.
“Did we take any steps to prepare to do that? This could have been forecasted. This was never an ‘if’ but a when.”
As of Monday, Johns Hopkins University reported there have been more than 3.7 million U.S. cases of COVID-19, the disease caused by the new coronavirus, and more than 140,000 deaths.
Anthony Morelli, 21, of Winchester, Virginia, had a fever for nine days while he and his family waited for the results of his COVID-19 test this month. It took 13 days for the positive results.
His mother, Allison Lowry, had symptoms when she went through a CVS drive-thru line near her home June 30. She got her positive results back July 8.
She was sick for about three days, and the whole family self-quarantined. She would have taken Morelli to the emergency room if she was sure it was COVID-19.
“It’s really kind of a disgrace and irresponsible on the part of CVS and Quest to take on testing that they do not have the capacity to process,” Lowry said. “I can see how that would contribute to the crisis that’s going on if people don’t have symptoms anymore and they just get tired of waiting for results and just go out and infect more people.”
CVS sends test samples to third-party labs that process kits and return results, which CVS shares with customers, said Mike DeAngelis, senior director of corporate communications for the company.
“The increase in cases of COVID-19 in certain areas of the country is causing extremely high demand for tests across the board,” DeAngelis said. “This has caused backlogs for our lab partners and is delaying their processing of patient samples. Currently, during times of high demand, it may take six (to) 10 days for people to receive their results, and in some instances, our lab partners may take even longer to return results.”
Actual delivery of the results to patients further extends the process.
Ramin Bastani is CEO of Healthvana, which says it has delivered fast and private HIV results since 2015. The company contracted with cities, counties and labs in mid-April to do the same for COVID-19 tests.
He said the process of calling, then mailing printed results to thousands of people is labor-intensive. Some health departments have eight workers calling patients for up to 12 hours a day. His company can deliver results in five minutes via text message, he said.
“It can take up to a couple days, and some people fall through cracks,” Bastani said.
Assistant Secretary for Health Brett Giroir said the U.S. Department of Health and Human Services is expanding testing options at surge sites where rapid turnaround is needed and getting more tests into doctors’ offices. The federal government procures and sends testing supplies such as swabs to every state once a week, according to Giroir.
Shah blames a U.S. health system that prioritizes tests for nonemergency surgeries over people who could be spreading the virus.
“The system is perfectly designed to deliver the results it incentivized,” Shah said. “It has not incentivized public health but profit. At what point does public health ever get in ahead of the line?”
Lab industry officials said the problem is more complex than paying labs to process tests more quickly. Doctors and clinics need swabs to collect mucus samples from patients’ nasal cavities. Labs require chemical reagents to run tests on machines.
The absence of a national testing plan means there’s little federal coordination to steer pivotal supplies to regions where the virus thrives, Holladay said.
New York labs busy with the pandemic’s initial surge months ago are now well-equipped, while some labs in the Southeast and Southwest cannot turn around tests quickly enough. Labs In New York can probably finish tests in 12 hours, Holladay said, while labs elsewhere report results can take more than a week.
In Phoenix, results for three-quarters of COVID-19 tests are ready within one week, and one-quarter of tests take up to 10 days, Sonora Quest Laboratories, the metro region’s dominant lab, reported Thursday.
Further complicating matters is a mismatch of state policies on reopening restaurants, bars and gyms, as well as mask wearing.
Holladay said the lack of federal coordination and varying state reopening policies would mean less if the virus was under control and fewer Americans were dying.
“Deaths are going back up, and it’s clearly related to opening the states before this virus was under control,” Holladay said.