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‘The system wasn’t designed to ramp up to millions.’ Here’s why U.S. is struggling with coronavirus testing

With a population of 1 million people scattered over nearly 148,000 square miles, one could argue that Montana was made for social distancing. Its sparse population has helped protect the state from a more damaging outbreak of COVID-19 so far, but its health infrastructure was not designed to handle a full-blown pandemic; no health system anywhere in the world was fully ready for novel coronavirus.

For the United States in particular, a major stumbling block has been testing, a problem that will continue to affect the United States’ ability to track potential new outbreaks as communities large and small try to resume a more normal pace of life.

Right now, there’s “increasing and incredible demand for more and more testing,” said Dr. Gary Procop, who directs laboratory work at the Cleveland Clinic in Ohio. Hospitals need fast and accurate tests to know if an incoming patient has been infected with the virus and to prevent exposing (and possibly losing) staff while they treat that person, along with other patients. But a lack of planning and coordination, along with some inherent shortfalls of the tests themselves, have hampered the ability to meet demand and monitor the outbreak across the U.S.

In Eastern Montana, roughly 6,100 people live in Sidney, a town perched along the banks of the Yellowstone River that winds for nearly 700 miles across much of the state. Almost two hours south of the border with Canada and less than 10 miles from the North Dakota state line, farmers near Sidney grow and harvest beets that workers process into sugar at a local factory, one of the town’s largest employers. Another local job generator is Sidney Health Centers, the town’s hospital, where Amber McCall has worked for a decade and where she manages the laboratory.

Unlike other parts of the U.S., Sidney is not a coronavirus hot spot. A total of 630 Montanans across the entire state have been officially diagnosed with COVID-19, an uptick in recent weeks, but still a far-cry from other states that have seen more dramatic per-capita caseloads. But health care workers in the state and across the country have still faced shortages for basic testing supplies.

When someone enters the hospital on a weekday with a suspected case of novel coronavirus, it can take up to 36 hours to get the results, McCall said, because someone must drive the sample nearly eight hours away to the state laboratory in Helena to be processed. During that time, the patient must be treated as if they are a confirmed case. It takes longer if the patient arrives Friday — they must stay through the weekend because tests can’t be transported to the state lab. McCall said she wishes the hospital could process tests locally. That way, they could process results faster, patients could know if they have been infected with the virus sooner, and hospital staff would not have to use so much personal protective equipment while waiting for pending test results to come back.This could also limit possibly unnecessary, lengthy and expensive hospital stays.

When you scrape a mucus or spit sample for a COVID-19 test, you must preserve any possible virus en route to the lab. The swab is placed in a sterile tube with transport media, which are chemicals that prevent bacteria from growing while also keeping the virus alive for up to three days. But McCall said transport media has been virtually impossible to find since March, and the backorder date has been pushed from April to May and now June 20. She has spent weeks following up with regional and national laboratory vendors and pleading for more testing supplies, she said.

That’s a big problem because transport media is essential to getting accurate test results for COVID-19 patients, but also many others. People with sexually transmitted diseases, influenza and other illnesses also require this media when they get tested.

While these testing hurdles are happening nationwide, McCall said that because Sidney is small and rural, and without many cases, her town seemed to “fall off the list.”

“For my community, it kind of felt like we were forgotten,” she said.

For months, depending on where you lived and how sick you were, if you suspected you had coronavirus, you might not have been able to get a test, despite the deadly consequences of the pandemic. At one point in mid-March, there were only 75,000 test kits for the entire country and public health officials have rallied around the need for more testing to adequately monitor the virus, so the country knows where to devote resources.

Main Street in Livingston, Montana, on March 20, 2020, amid the coronavirus pandemic. Photo by William Campbell-Corbis via Getty Images

READ MORE: The reason U.S. COVID-19 numbers aren’t higher? Not enough tests

Since late April, the White House has pledged to ramp up testing to monitor the virus’ spread, an announcement that coincided with President Donald Trump saying he would not extend federal guidelines for social distancing, which were aimed at controlling the spread in lieu of robust testing.

Two weeks later, Trump touted that the U.S. was testing approximately 300,000 people daily for COVID-19. He promised more than 12.9 million testing swabs to all 50 states, as well as more supplies needed to transport tests to labs.

“I said from the beginning that the federal government would back up the states and help them build their testing capability and capacities, and that’s exactly what’s happened,” Trump said.

But testing remains far from where it should be, public health experts say, and cases are continuing to go undetected. According to analysis from the Harvard Global Health Institute, the U.S. needed to test at least 900,000 people daily by May 15 to get an accurate picture of the outbreak, which would help communities know where to devote resources. By that date, one estimate suggested the U.S. had administered more than 360,000 tests daily.

States have universally struggled to get enough tests, but while some states are doing better with testing, some are resorting to unusual methods in the absence of more help from the federal government. In April, Maryland bought 500,000 tests from a South Korean company and flew them into the state on board a passenger airplane, but the Baltimore Sun reported it remains unclear if the tests were ever distributed.

To reopen, states need to see a downward trajectory of positive cases for 14 days, according to the White House’s May 14 Opening Up America Again guidelines.

In remarks before Congress, Dr. Ashish Jha, director of the Harvard Global Health Institute, testified on May 13 about the state of testing, calling the nation’s initial response to the pandemic “inadequate.” Despite the White House’s pronouncements, Jha told PBS NewsHour’s William Brangham that he still thinks “we’re missing a vast majority of the cases that are out there.”

By mid-June, U.S. testing capacity is still a far cry from what it should be, Jha said. Reopening across states appears to have left many people with the mistaken impression that the worst of the virus is over, and Jha said, “We are early in this pandemic.”

President Donald Trump tours the Puritan Medical Products manufacturing facility in Guilford, Maine, where swabs for coronavirus tests are made, on June 5, 2020. Photo by REUTERS/Tom Brenner

Testing options and accuracy problems

Testing is one of the three essential pillars of reopening the country safely and keeping it open, public health experts say, and different kinds of tests have different functions, drawbacks and levels of accuracy.

Diagnostic tests rely on polymerase chain reactions to identify a virus’ ribonucleaic acids, or RNA, and determine if it is active in a person. This type of test is highly adaptable to do different things, but is not meant to be processed at a high-capacity or in mass quantities, according to Jim Flanigan, executive vice president for the American Society for Clinical Laboratory Science. In April, the FDA approved its first at-home diagnostic kit where people use a cotton swab to collect a nasal sample they then place in an insulated package and mail it in for laboratory testing.

Antigen tests are a type of diagnostic tests that look for a protein on the virus, but take fewer resources and less time than conventional tests and could help scale up COVID-19 testing. But they are not yet in wide production or distribution.

Antibody tests pick up on whether someone has previously been exposed to the virus, which is useful if someone suspects they were infected, but hadn’t gotten a diagnostic test while they were sick. These tests, also called serology tests, are not useful for diagnosing a person currently sick and showing symptoms. These include highly sensitive laboratory-based tests, as well as home-administered kits.

Antibody tests also cannot be used to determine if a person is immune to COVID-19 because researchers don’t yet know enough about the body’s immune response to the virus to confirm either way, according to the Centers for Disease Control and Prevention.

On March 16, the Food and Drug Administration granted emergency use authorization to companies to produce and market antibody tests. Test makers flooded the market, many priced at more than $100 each. But, Flanigan said, many tests had no proof that they actually worked or could accurately detect the presence of antibodies, so it’s likely that ineffective versions are being marketed to consumers. As a result, the FDA revoked authorization for unproven antibody tests two months later.

WATCH: Why antibody tests, a crucial step toward overcoming COVID-19, are still unreliable

Many of these tests produce a margin of false results, both the FDA and CDC have reported, meaning people could think they have been exposed to the virus, when in fact, they have not been.

“It’s problematic because it gives people a false sense of confidence that they are immune when in fact they are not,” Flanigan said.

Fast-forward to May 4, when the FDA altered its policy on antibody tests, requiring companies to present data that proved their tests actually worked. That move cut down on the number of tests, but “unfortunately, this is one of those things where the horse is out of the barn already,” Flanigan said. Many people are unaware that they need to check the FDA website to see if a specific test is up to snuff before using the results to decide how to live their lives.

The FDA notes that “all tests can provide at least some false results,” which doesn’t make them bad, but underscores the limitations of testing. “That is why antibody tests should only be used as part of a well-conceived testing plan and why the results should always be interpreted by appropriate experts,” the agency’s guidelines read.

At the Cleveland Clinic, one of the nation’s largest and most esteemed hospitals, Procop and his team evaluated the Abbott ID Now, a COVID-19 diagnostic test that was widely promoted for turning around results in a few minutes, and has been used at the White House to screen staff members and other visitors. But a study by Procop’s team released earlier this month raised questions about how accurate those tests were and said the tests appeared to produce false negatives.

On May 14, the FDA issued a statement that it was investigating data suggesting accuracy problems, which Abbott disputed. “No diagnostic test will be 100% accurate due to performance characteristics, specimen handling, or user error,” the FDA statement read, “which is why it is important to study patterns and identify the cause of suspected false results so any significant issues can be addressed quickly.”

A well plate used in the early stages of development of a coronavirus disease antibody test at the Laboratory for Human Biology Research, Department of Anthropology at Northwestern University in Evanston, Illinois, on April 19, 2020. File photo by Thomas McDade/Handout via REUTERS

Capacity and supply chain breakdowns

Few manufacturers around the world produce the components that are vital to testing so many people, at a time when states and the country are desperate to safely return to normal life. Widespread shortages in testing supplies were thus reported across the country, from rural hospitals to major health care systems alike, by late March, Flanigan said. Swabs and transport media quickly ran out, along with reagents used to extract the RNA from the sample to see if the virus was present.

“The system wasn’t designed to ramp up to millions of tests a day,” Flanigan said.

On April 14, several groups that represent clinical laboratories sent a letter to Congress asking for a diagnostic testing strategy.

“Supply chain issues are absolutely the single largest thing preventing us from increasing capacity of testing,” Flanigan said.

Another holdup can occur when the test goes to be analyzed. During the early weeks of the pandemic, a patient’s sample would be analyzed manually, which could take between 12 and 24 hours to find the presence of the virus. Since then, drug companies have developed more high-capacity analyzers that can complete thousands of samples each day.

But each test kit corresponds only to the testing analyzer made by the same brand. For example, an Abbott test kit cannot be processed by a Roche analyzer. This lack of interchangeable parts creates bottlenecks for processing people’s tests and for providing a steady supply chain. One lesson the U.S. health system may take from this pandemic is that there is a need for standards to create interchangeable parts for laboratory tests, but “there aren’t any now,” Flanigan said.

All of these issues have underscored the need for a national coordinated strategy to mend broken supply chains and get testing where it needs to go, he said.

Right now, “There’s no way to get what we need,” Procop said. “We have to figure out how to work with what we can get.”

A sign lists menu items on the day restaurants and stores reopened on Main Street on May 04, 2020 in Bozeman, Montana. Photo by William Campbell/Getty Images

In Sidney, people have resumed normal clinic and laboratory visits, but efforts tied to ramping up testing for the virus still takes up the bulk of McCall’s time, she said. Last week, the hospital administered more antibody tests than diagnostic tests. When she shops at the local grocery store, McCall said the only people she sees wearing masks are her coworkers from the hospital. She fears a second wave, and that it might be worse because of “the mindset that ‘It didn’t happen last time,’ so people are not as compliant with any orders.”

On Wednesday, two tests came back positive, the first in Sidney since early April, McCall said.

The state further relaxed quarantine measures on June 1, just in time for the start of summer tourism. While tourism spending nationwide is expected to plunge by 45 percent this year, Montana is bracing for an influx of domestic sightseers in the coming months, drawn to open-air natural wonders like Glacier National Park, even as the state stresses gradual reopening to tourists. Montana officials “have no idea what the summer is going to be like,” said Jim Murphy, who oversees the Communicable Disease Bureau for the state’s Department of Health and Human Services. Murphy said he was particularly concerned about the communities that dot the outskirts of the state’s parklands with year-round residents of roughly 1,000 people.

This year, those visitors could bring or spread the virus, potentially overwhelming local health care systems and the state has no way of tracking every person who enters or leaves, said Dr. Gregory Holzman, who serves as Montana’s chief medical officer.

“It’s much more on the honor system,” he said. But that’s not fool-proof. Sometimes, people forget or are not motivated to be forthcoming about where they’ve been, if they are symptomatic or even aware that they are carrying the virus.

Even after tourists go home, public health officials in his state and elsewhere need “thoughtful guidance on how to get folks back to work safely,” Holzman said. Universities have suggested testing all students, faculty and staff when they return to college campuses in the fall, but Holzman said, “You’d have to test everybody every day, which is untenable.”

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