Why America can’t get its act together on coronavirus testing
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It didn’t have to be this way.
A pandemic that emerged globally more than six months ago has now engulfed every part of our lives. The first reported case of COVID-19 in the U.S. occurred on Jan. 20. And yet, well into the summer of 2020, the United States can’t seem to get its act together on one of the most basic processes that can help control an outbreak: letting Americans know, in a timely manner, whether or not they actually have the coronavirus. Some have had to wait days, or even weeks, to receive a coronavirus test result.
There’s no single party at fault for our current diagnostic dilemma and the devastating toll this virus has wrought on American life. The Centers for Disease Control (CDC) botched the job at the earliest stages with a COVID test that just didn’t work. Many individuals in the U.S. have fumbled their responsibility to wear masks and socially distance, exacerbating the problem. Political leaders have given the nation wildly divergent advice on the best way to approach the kind of pandemic we have not seen in more than 100 years.
These various failures are inextricably linked and feed a vicious cycle. If you’re looking for someone to blame, it’s not so much a straight line as it is a constellation of culprits.
“We’ve had six months, and we haven’t built the infrastructure necessary, and I think a large part of the reason is because there hasn’t been a true interest in running a national infrastructure, and a belief that the pandemic was over in May,” says Ashish Jha, director of the Harvard Global Health Institute.
Experts from companies, laboratories, and hospitals, along with top government officials, tell Fortune they are trying their best to cut down how long it takes to get a COVID test result back, including prioritizing tests for certain people and promoting technologies that can deliver results within 15 minutes.
But it’s still a difficult circumstance for many workers, high-risk patients, and others who absolutely need tests with a quick turnaround time, yet may not have access to them.
The good news is that public health officials say testing capacity is growing. The bad news is that it’s still very inconsistent.
Stories from the pandemic
Danny Houk moved to New York City at the worst possible time. A Chicago transplant, he’s been in Brooklyn for nearly a year. The 33-year-old was laid off from a tech company during the pandemic. Houk is also a working actor—and that presents its own challenges. He got a gig from a production company slated to resume filming at the end of July.
But the results of the first coronavirus test he took on July 9, a requirement for being on set, hadn’t come back by late July. He took a second test from a different site on July 20 and received results within two days.
Antoinette, a 58-year-old schoolteacher in the Bronx who lives in New York’s Westchester County, had a similarly frustrating experience before a medically necessary colonoscopy. She had a polyp removed in early 2019 and was required to get a checkup a year later. That necessitated a COVID test, as is typical with procedures right now, and she received one on the morning of July 10. On July 15, two days before her procedure, Antoinette’s doctor called to say the test results still hadn’t come through. She took a rapid response test at 6 p.m. on July 16, the night before her colonoscopy, and received results within 15 minutes at White Plains Hospital. “I heard that for some other patients it was a 10-day turnaround time,” says Antoinette, who asked to use only her first name for privacy.
These aren’t unique tales. Delays and bizarre discrepancies in coronavirus testing times are hitting workers across industries such as Houk, everyday people who have mild symptoms or may have been exposed to the pathogen, and even patients who are most at risk for COVID-19 or waiting for medical procedures like Antoinette.
Testing companies and the federal government say they are doing their best to grapple with an impossible circumstance. And while experts who spoke with Fortune largely agree, they lament the failures that have built to this moment.
Trump administration officials at the Department of Health and Human Services (HHS) tell Fortune that testing capacity, as well as turnaround time, will improve significantly in the coming weeks.
“We have increased testing since March 12, when I took over in my position, by 32,000% in ACLA [American Clinical Laboratory Association] labs,” says Adm. Brett Giroir, assistant HHS secretary and one of the department’s previous coronavirus diagnostics czars.
Among commercial laboratories such as LabCorp and Quest Diagnostics, Giroir says that technologies such as “pooled testing” will decrease turnaround times significantly. “This will improve their efficiency by 20% or 30%,” adding that nursing homes, some of the highest-risk facilities, will also benefit from these investments.
But that may prove cold comfort to Americans facing a labyrinth of confusion and disparate results in getting a lab result returned. A COVID diagnostic taken at one facility may return results in mere days; another may take two weeks. But the interval between those days could spell the difference between protection and widespread infection, since people with the coronavirus may not have active symptoms.
How can you gird yourself and others against a pathogen if it takes that long to even realize you’re carrying it? While experts emphasize the importance of personal responsibility, not everyone, including essential employees in health care and multiple other fields, have the luxury of working from home during these times. Others in more niche industries face their own set of barriers.
Houk’s and Antoinette’s experiences encapsulate what Americans across the nation, especially those who can’t work or receive health care services without taking precautions, have had to tackle. Where he’s working, “they’re being super safe about all the requirements to make sure everyone’s tested,” Houk says. “And so they want to do a test two weeks out to see if you were positive for COVID.” Antoinette has a whole different set of problems as a teacher.
Two weeks is a generous time frame when it comes to testing. For travel purposes, you may have to prove you don’t have COVID-19 within just three days of flying to certain states.
Testing giants LabCorp and Quest Diagnostics, alongside public health experts, hospital laboratory directors, government officials, and industry groups, tell Fortune that a surge in recent cases and a lack of access to the machines and basic materials required to conduct these tests have brought us to a moment when coronavirus testing turnaround times can take five or more days on average.
A common theme among government officials, corporate leaders, and medical professionals is the efforts are moot if people don’t take personal responsibility and wear a mask, socially distance, and limit travel while more treatments and effective vaccines can be developed.
This gets at the heart of the problem: demand. As many cities and states have reopened, and only 67% of people report wearing a mask, coronavirus cases are surging across the country. It certainly doesn’t help that public officials have been playing a tug-of-war among one other, and sometimes with themselves, on advice to the public. States such as Florida and Arizona, which downplayed the risks of the pandemic in favor of reopening economies, have since retrenched, leaving their residents in a bind. And there’s only so much that companies and public facilities can do to meet the urgency of the moment.
“It really doesn’t matter if they wait five days, seven days, or 10 days” to get a test result, Giroir says, referring to those who are at low risk of COVID. He says the priority should be to test those who are most at risk—to triage, as multiple experts told Fortune.
“There is infinite demand and limited supply” for testing, Giroir says.
Giroir also points to another critical issue: The country needs to ramp up “point-of-care testing,” where swabs can be tested on site—whether that’s at a drive-thru location, hospital, or retail outlet like Walgreens—and results are delivered much faster. The American system is too reliant on tests that must be shipped off to a commercial laboratory that requires more complex machinery. And certain molecular diagnostic tests, including some which rely on “polymerase chain reaction,” or PCR technology, just take longer. Some types of PCR tests must cycle through multiple temperatures, heating up and then cooling down the sample. So the timeline for results depends on a lot of factors, most of which the patient doesn’t know at the time of the test.
“Commercial labs do about half of the overall testing, and the other half is done at a point-of-care site that can return results within 15 minutes or a local hospital with about a 24-hour turnaround time,” Giroir says. HHS has expanded partnerships with companies such as Hologic that produce machines that can do automated testing, which requires less manpower and less turnaround time.
Giroir says such efforts will contribute to lower turnaround times for test results. “Point-of-care will be an increasing share of the market,” he says. “In August, it should be a dominant share of the market. By September, we expect at least 15 million point-of-care tests.”
Why you haven’t received your test results
There are currently 36 molecular coronavirus diagnostic tests that have Food and Drug Administration (FDA) emergency authorization. These are the kinds of tests that can sniff out someone with an active case of COVID-19, as opposed to a blood test that senses whether or not you’ve developed COVID antibodies from a previous infection that may offer some immunity.
Taking these tests isn’t fun. A professional has to shove a swab up your nose, and perhaps also down your throat, depending on which test you’re given. Then those biological samples have to travel down links in the testing supply chain.
It’s a complicated system that requires the use of chemical reagents (essential components that induce a reaction telling you what’s happening on a biological level and what’s going on with a sample collected from a swab); testing kits that may include swabs, vials, and other clinical materials; and, critically, the availability of the machines that can conduct all of these tests, whether a point-of-care test or a more complex one.
And when the companies making all of those materials have to serve the entire world, that can be a big problem. Representatives from LabCorp, Quest Diagnostics, and the ACLA admit that the battle between supply and demand has brought them to their knees despite their best efforts.
“The most significant gating factor we currently face is limits to the testing platforms, the complex machines that perform the technical analysis, as well as reagents, or chemicals, required to perform testing,” says a spokesperson for Quest Diagnostics.
A spokesperson from the ACLA agrees: “We have seen a huge surge of demand over the last several weeks among our member groups. And while our labs are doing everything we can to continue to build capacity, I think the problem is that there are days where a lab is receiving more specimens than they can process in a day.”
LabCorp CEO Adam Schechter says the company is buying everything it can get its hands on. “We have bought every piece of equipment we can buy. I’ve even bought used equipment that I could find in the marketplace,” he says. “And we’re buying every reagent and test that we can find. We’re focused on testing in the U.S. because, you know, we’re a U.S. diagnostics testing company.”
How we can fix the situation
Schechter says one way LabCorp has dealt with this backlog is by incorporating as many platforms as possible. A COVID test created by, say, Roche, may be different from one created by LabCorp itself, or Abbott, or any of the dozens of other companies requiring various ingredients for their diagnostic potions. Roche’s test may require one kind of reagent or machine; Abbott’s may require another. But even having multiple machines at hand can’t make up for constantly surging demand.
Giroir from HHS says the federal government has done everything it can to buy up supplies in order to deliver them to local sites. The CDC declined to comment on its efforts to deploy reagents through an agency called the International Reagent Resource.
On July 21, Schechter said that LabCorp’s testing capacity had risen from about 2,000 to 3,000 tests per week to 165,000 tests per day across 14 laboratories in America working constant seven-day shifts including weekends and holidays.
Just five days later, LabCorp updated its numbers based on what the company said was a higher capacity, which had cut down on test delivery times: “With this additional capacity, we have reduced the average time to deliver results to two to three days from specimen pickup. For hospitalized patients, the average time for results is faster.”
In late July, Quest’s turnaround times were more than two days for priority 1 patients and seven or more days for nonpriority patients. Priority 1 patients are people who are actively sick in the hospital, health care workers showing COVID symptoms, or patients who are about to have certain procedures.
“Demand for our molecular diagnostic testing remains high as the virus has spread across much of the United States, particularly the South, Southwest, and West,” the company says in an emailed statement to Fortune in late July. “Persistent high demand has strained our testing capacity and extended delays for test results.”
But on August 3, the company noted a shift saying the situation has improved thanks to technologies such as pooled testing. The company said that average turnaround times had gone down to five or more days for nonpriority patients. It’s still at two days on average for priority 1 patients, but Quest expects that to go down to one day within the next week, along with three days for nonpriority patients.
“We expect this week to be the third consecutive week in which our capacity will exceed test orders, a pattern we have not seen since early June,” the company wrote in a press release. “The combination of growing capacity coupled with plateauing demand is translating into faster turnaround times for our COVID-19 molecular diagnostic testing.”
That’s still a pretty significant lag time.
Gary Procop, the head of clinical virology at the Cleveland Clinic who has direct oversight over the renowned institution’s COVID-19 testing, paints a bleak picture of what has led to this crisis. “It’s kind of everything,” he says. “Platforms that run the tests have been unavailable or on long waiting lists. Fortunately we’re a large laboratory; we’ve repurposed some machines. I don’t think we’ve stolen any yet.”
This is a problem that will only get worse, according to Procop, as flu season rears its head. Many of the same materials will be needed to conduct those tests.
He adds that the latest problem is “plastics”—the literal plastic plates and pipettes that you need to administer COVID tests. And that’s a problem he feels could be solved by the government through the Defense Production Act (DPA). “You could use that to get a General Motors or a Ford Motor Company to manufacture those parts,” he says.
Jha, Giroir, and other experts Fortune spoke with say that a production process is essential, but Giroir warns that the DPA isn’t a “magic wand.”
“We constantly do that,” says Giroir, referring to the DPA. “And yes, we’re working a lot with the supply chain, including on everything from test tubes to pipette tips, on everything. And not everything is known, because there are confidentiality issues, but you will see these things rolling out.”
Supply-chain issues are practical dilemmas. Policy issues and personal behavior are a different nightmare that have already dictated the course of this pandemic and will continue to do so.
“There’s a whole different set of national strategies or individual state strategies around the coronavirus,” says Jha. “The trouble is, if you build up local strategies in Arizona or Texas, that can hurt turnaround times for testing in Rhode Island or Massachusetts.”
“I think it’s just going to get worse in the coming weeks or months.”