- Demand for Covid-19 tests far outstrips supply in the U.S.
- "The wheels have fallen off the wagon," said Susan Butler-Wu, an Associate Professor of Clinical Pathology at the University of Southern California's Keck School of Medicine.
- As the calendar moves toward flu season, the problem is poised to get worse.
Across much of the U.S., concerned citizens are lining up to get tested for the coronavirus, only to wait a week or longer for their results to arrive.
With the country mired in its worst pandemic in a century, health experts are apoplectic about the length of the testing delays. In addition to the anxiety it causes patients, the lag time is disastrous for public health, because infected people aren't being quarantined in a timely fashion and it's impossible to retrace their steps to find others who have been exposed.
The inability for the U.S. to establish an efficient testing system, five months into the crisis, is one reason why numerous states continue to hit record infection rates and why the nation as a whole has far more cases than any other country.
"The wheels have fallen off the wagon," said Susan Butler-Wu, an associate professor of clinical pathology at the University of Southern California's Keck School of Medicine.
What's gone wrong?
A lot. At the highest level, demand for Covid-19 tests is outstripping supplies. The polymerase chain reaction, or PCR, tests are considered the most accurate on the market but, like with all tests, labs across the country can't access them fast enough.
Butler-Wu, who has a clinical microbiology lab in Los Angeles, said there's huge pressure to "test, test, test" for the virus without a coherent strategy to ensure that clinical and commercial labs have sufficient supplies.
A survey from June shared by the College of American Pathologists found that 64% of labs reported difficulty in acquiring reagents — a mixture that's used in chemical analysis — for their platforms and test kits. Among respondents, 60% were struggling to get nasopharyngeal swabs to collect and transport patient samples, and more than half found it a challenge to get viral transport media to conduct the tests.
"At this point, I think testing delays are happening all over the U.S.," said Steven Pergam, an associate professor in the vaccine and infectious disease division at Fred Hutchinson Cancer Research Center. "But it depends on where patients seek care, how well funded the public health organizations are in that state and where the tests go."
Basic needs are also in short supply. Labs say they don't have enough plastic disposables, like tips and tubes. Staffing is a major problem, with lab techs already taking increased shifts and too few trained engineers available to service the instruments when they break down.
Facilities can't forecast how many tests they'll be able to perform because they don't know when or if they'll be getting the supplies they need.
"I'd be happy to get three-quarters of what our suppliers tell us we'll receive," said Karen Kaul, chair of the Department of Pathology and Laboratory Medicine at NorthShore University Health System. "It might be different for the big commercial labs but right now, at the hospital level, we are often getting 10%."
Fred Turner, CEO of Curative, a company working on Covid-19 tests, said even the large commercial labs like Quest Diagnostics are struggling to keep up because they aren't built for rapid scaling. That's particularly true in parts of the country where Covid-19 is spiking, like the South.
"They are built for driving down margins with roughly stable volumes," Turner said.
At the heart of the failure to date is the lack of a national strategy to address the need for rapid and widespread testing. Ideally, we'd be able to open locations as needed in areas with outbreaks and to source products that could be manufactured and shipped to those locations. The government would also be funding new technology and providing grants for institutions to expand their resources.
"It would be great to put more money into diagnostics, and that's really important," said Butler-Wu. "But real money needs to go to a plan, meaning a nationalized response."
The problem is evolving. The more infection rates extend into smaller, less urban communities, the less prepared we are, because the top medical institutions tend to be centered around big cities and universities.
"The next concern for us is that rural communities won't have access to the same testing strategies and are relying more on industry and places like LabCorp," said Pergam. "Many aren't getting quick results."
Some infectious disease experts and technologists are calling for new approaches. To ramp up to millions of tests per day, as more people look to get a clean bill of health and return to work or school, companies are developing rapid, at-home tests that can return a result in a matter of minutes.
Such tests could, in theory, be self-administered.
Whether they'll be sufficiently accurate remains a big question, but some experts say that for people who just need frequent tests so they can comfortably go to work, this method could still be useful.
"We could have a slightly less accurate test that emphasizes frequency and turnaround time," said Jeff Huber, a former Google executive who's now helping fund companies that are developing such tests.
Others say there may be a path forward for these new tests, but it could be challenging to convince the industry to adopt them.
"One of the reasons people may be slow to move in that direction is because we want every test to perform as well as the best test," said Rich Davis, a clinical microbiology lab director at Providence Sacred Heart Medical Center. "But that's not always possible, and adoption of a new approach requires the adoption of a new way of thinking about what the test does."
Adding to the pressures surrounding the rapidly spreading coronavius is the rapidly moving calendar. Flu season is just around the corner, and many states are preparing to reopen schools in a matter of weeks.
That means more stress on a testing infrastructure that's already suffering from extreme backlogs.
"It's very worrisome," said Kaul. "What happens when the companies making influenza reagents switch to Covid? We'd have to choose which test we perform."
Butler-Wu agrees that this could become a major problem unless things change.
"There will be a knock-on effect when it comes to testing for other conditions," she said. "Many of us are going to be made to prioritize."