Why America’s coronavirus testing problem is so difficult to solve
After weeks of social distancing, lockdowns, and quarantines, federal and some state governments are starting to issue guidelines for reopening and getting back to something approaching normal. Testing is a key part of that, and most experts say the United States isn’t doing enough. In fact, it’s not even close.
While President Donald Trump just signed the latest relief bill, which allocates $25 billion for testing, there are many barriers preventing the country from deploying the kind of mass testing program it needs. There are shortages of supplies and, until that $25 billion is distributed, funding. There’s also no comprehensive national plan to distribute tests to the places they’re needed most. This lack of planning goes back to the pandemic’s early days, when systemic failures significantly delayed coronavirus tests from rolling out and left the US trailing in testing capacity compared with other countries. For these reasons, the number of tests performed has plateaued at about 150,000 per day in the US. Experts say we need several times that.
“We need to significantly ramp up not only the number of tests, but the capacity to perform them, so that you don’t have a situation where you have a test but it can’t be done because there isn’t a swab, or because there isn’t extraction media, or not the right vial,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told Time in late April. “I am not overly confident right now at all that we have what it takes to do that. We are doing better, and I think we are going to get there, but we are not there yet.”
So what will it will take to ramp up testing to a level that allows the US to start easing social distancing? It’s complicated. The available tests aren’t as dependable as they could be, and the labs required to process them need to increase capacity. On top of that, the country needs more public health personnel to carry out the test as well as to run the labs. Then, of course, this will all cost a lot of money. These things are not necessarily impossible tasks, though the road ahead looks tough.
Covid-19 tests, explained
There are two types of Covid-19 tests: molecular and serological. Molecular tests look for the presence of a virus’s genetic material, showing that there is an active infection. Those are the tests that require a swab to be shoved through the back of your nose and into your throat to collect a specimen (although — good news — the FDA recently authorized specimen collection by swabbing around the nostrils, and there’s a new test that uses only saliva).
Serological tests look for antibodies to the virus in the blood, the presence of which indicates there was an infection in the past. While the molecular tests for Covid-19 have been around since the beginning of February, serological tests weren’t authorized until April 1. Many people see these tests as a way to prove immunity against the virus, allowing those who test positive to resume their normal lives, free from the threat of contracting the virus again. Some countries are even using serological test results to issue “immunity passports” to citizens who test positive. Here’s some bad news on that front: Experts warn that we don’t yet know for sure that these antibodies confer immunity, nor for how long that immunity lasts if they do.
“We have no idea whether the presence of antibodies correlates with immunity,” said Dr. Gary Procop, director of clinical virology at the Cleveland Clinic and the chair of the Institute for Science, Technology and Public Policy at the American Society for Clinical Pathology.
“People are making that leap of faith, and I wouldn’t make it,” Procop added. “We don’t use serologic testing for influenza and other respiratory viruses. Why do we think we should be able to use it here?”
(If you really want to go in-depth into how these tests work, Scientific American has a great primer on reverse transcriptase polymerase chain reactions and enzyme-linked immunosorbent assays.)
Because the FDA approval process takes such a long time, coronavirus tests are instead given an Emergency Use Authorization. As of April 24, 59 molecular and 4 serological tests have received this authorization. There are also nearly 100 tests that do not yet have that authorization but which the agency is allowing to be used in order to get more tests out there sooner. In addition, the FDA has given some state health departments the right to approve tests without waiting for or needing FDA authorization.
While it’s clearly good to have tests available, the lack of strict oversight from the FDA and real-world testing that would typically occur as part of the approval process has led to some tests having significant issues with accuracy. On April 2, the Wall Street Journal said doctors were seeing about a 70 percent sensitivity rate in some molecular tests, which means 30 percent of patients were getting false negatives. Over time, these numbers should improve. No test is perfect, but ABC News reported that a similar molecular test for the flu has a 90 to 95 percent sensitivity rate.
Another issue is that not every lab can run every type of test kit — far from it. So while there may be a surplus of one company’s test kit, the only labs that can run that particular test may not have the capacity, while other labs that do have the capacity may not have the materials required to do so. The BBC compared it to expecting Chevy truck parts to fit a Prius.
For the most part, molecular tests must be performed in a laboratory, with — and this is a very simplified summary of the process — a medical technologist preparing the specimen, running it through a machine, and then manually reading and interpreting the results. Just the machine part of the process takes several hours. Factor in the time it takes to get the test to the lab, and you’re likely looking at a one or two day turnaround (if there’s a lab on-site that can do the test, obviously, it would be much less). If the lab has a backlog, the turnaround will be a lot longer.
That’s what makes “point of care” tests so appealing. These can be done in a matter of minutes at the same place where the specimen is collected — for instance, at a drive-in testing site or at an urgent care center. Abbott Lab’s ID NOW machine can get a positive result in five minutes, while the Cepheid GeneXpert can do it in 45. These tests are molecular tests but use a different method than the PCR tests performed in laboratories. They’re also generally less accurate.
Trump introduced the ID NOW machine to the country in a March 29 press conference, where he displayed the toaster-sized, 6.6 pound machine upside down. Eager to anoint the newest immediate solution to this massive and complex worldwide problem, the president called the test a “whole new ballgame.” But there have been issues with the test, such as accuracy and availability falling far short of what the administration initially promised.
“These tests are performing terribly,” Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, bluntly stated in a recent Project on Government Oversight panel discussion.
For its part, Abbott Labs told the Wall Street Journal that it has distributed 600,000 test cartridges as of April 19, adding “we’ve been clear from the outset on what we could initially provide, and we’ve met every commitment.” The company is currently manufacturing 50,000 test cartridges a day, but the number of test cartridges does not mean that many tests can be run. As the machines can only do one test at a time, point-of-care testing capacity really depends on how many machines there are. (Laboratory PCR tests, on the other hand, take longer to run but can test many specimens simultaneously.) According to NPR, there are 18,000 ID NOW machines in the country. Cepheid says there are 23,000 GeneXpert machines globally. So having a point-of-care machine, say, at the entrance to every workplace, school, or airport across the country — not to mention a trained person to run the rest, wearing the necessary PPE — simply isn’t realistic yet.
At-home tests could make things even easier, but taking the collection and testing process out of the hands of trained professionals introduces another set of problems. Many people can’t even put on masks correctly. Expecting them to properly collect a specimen, pack it, and ship it to a lab might be too much. For these reasons, the FDA has been slow to authorize any test kits with any at-home element, only doing so for one kit so far. This test, the LabCorp COVID-19 RT-PCR, allows people to collect their own specimens, which they then send to the lab to be processed.
“Any at-home test, there’s always an issue of specimen acquisition,” Procop told Recode. “Did the person get the swab up their nose far enough? … There may be issues of people who only do the front part of their nose where the virus doesn’t really live, and that may decrease the sensitivity a little bit. But, for the most part, it’ll probably be okay.”
A test that can be performed entirely at home, no trained clinicians or expensive lab equipment needed, sounds great, too. It’s a goal some researchers think they can achieve. MIT Technology Review recently wrote about efforts to create such tests. A completely at-home test for a virus isn’t unheard of. You can buy at-home HIV tests at the drug store, but that test detects antibodies and antigens, which take a while to form so early cases would be missed. Also, it was more than 30 years from the time HIV was first widely known to the point when this test got approved by the FDA.
“I think that’ll be a long way off,” Procop said of the possibility of a completely at-home Covid-19 test.
Why the US isn’t testing enough
Creating a coronavirus diagnostic test is only the first step of a long process that might lead to widespread use. The test still has to be manufactured, distributed, and administered at the mass scale required. Here is where we are really seeing the impact of the delays and a lack of funding and guidance from the federal government.
Some of these problems were unavoidable. For example, when the coronavirus outbreak started earlier this year, the supply chain for these tests simply didn’t exist at the scale needed, so many testing companies faced shortages of everything from swabs to reagents (chemicals used to create the reaction needed to detect the virus in molecular tests). The FDA has tried to help by authorizing other materials to be used for swabs, but again, there are only so many materials that can collect specimens, and the FDA warns that its substitute swab material recommendations “are based on limited available evidence.”
Scaling up the production of reagents is even more complicated. These compounds include DNA components, enzymes, and saline solutions.
“Pretty complicated biochemistry,” Procop said. “And, of course, the companies have to make these under certain conditions. … They have to make very complicated products in a very controlled manner.”
There are signs that testing capacity is starting to improve. According to the COVID Tracking Project, over 311,000 were run on April 22. This is the most tests performed so far in a single day and represents more than twice the average number of daily tests during the month of April, when the average floated around 150,000. That said, the number of daily tests dropped back down to around 190,000 on April 23, so it remains unclear if the US can maintain a high level of capacity.
Quest Diagnostics, one of the largest lab companies in America, told Recode that it is now running 50,000 coronavirus diagnostic tests per day, and has eliminated the backlog that once caused significant delays in reporting results.
“That capacity meets demand,” Quest told Recode. “If the demand were higher, we would explore way to accommodate that. We may very well be able to accommodate increased demand (depending on the amount) with our current setup. To increase capacity, we may explore bringing up test capabilities in additional labs or other means.”
The demand for testing right now does not necessarily line up with the level of testing that experts believe we need to ease social distancing. Some plans call for 1 to 2 million tests a day for this to happen; one calls for 100 million per day. Scott Gottlieb, a former FDA director for Trump who wrote a roadmap to reopening the economy for the American Enterprise Institute, told Vox that these shortages were not simple to fix, as the materials come from other countries — all of which need these supplies for their own tests — and manufacturers would have to take the time to set up a new source in America:
Getting to the point where you have a 2-3 million test capacity per week — which is probably where you need to be initially as you do this transition — is going to be very hard. We’ve tapped out the available platforms and now we’re dependent upon creating new platforms and new supply chains to fuel those platforms. We’re approaching an upper limit in spare capacity. The question is how fast can Abbott and other companies build new testing platforms? And how fast can LabCorp and Quest scale up new labs that didn’t exist before?
Then there’s the issue of having enough trained personnel to run those labs and machines.
“If we’re talking about doubling or tripling our capacity, that would require, for some of our members, retraining staff specifically for these tests,” Louise Serio, spokesperson for the American Clinical Laboratory Association (ACLA), which represents commercial labs, told Recode. “It may mean hiring more staff. That would be a piece that is necessary to significantly expand the capacity — in addition to obviously having access to those very high-throughput platforms [machines that can run many samples at once].”
One medical laboratory scientist and teaching specialist told ACLA that she is now working 50 to 70 hours to train medical technologists who work in departments to run molecular tests.
But say we do manage to get all the supplies, machines, and people needed to do the number of tests that will let the country ease social distancing without endangering more lives. Then, those tests have to be given to the people and places that need them. That’s a massive undertaking, too.
How the US compares to other countries
Until recently, the US lagged behind many other countries in its testing. Though President Trump famously said in the beginning of March that “anybody who wants a test gets a test,” this has never been true. Trump has made big promises that companies like Google, Walmart, Target, Walgreens, Rite-Aid, and CVS would work with the administration to facilitate access to testing, but the reality has fallen far short of expectations.
As of April 23, the US has performed about 4.6 million tests, currently completing an average of about 150,000 tests per day. But the testing rate has plateaued there, rather than steadily scaling up to reach the level experts say that’s needed. This might indicate that America has reached its testing capacity, and tests still aren’t readily available in many areas, or have been restricted only to people who fit certain criteria.
There’s also a problem with how the US is testing. America currently has a test positivity rate — the percentage of positive tests in all tests conducted — of 20 percent. For perspective, that’s 10 times higher than South Korea’s. Harvard epidemiologist William Hanage told NPR that a 10 percent positivity rate or lower is a good benchmark for an adequate testing program. A high positivity rate, like the 20 percent number in the US, could indicate that tests are only being done on the people most likely to have the virus, which means many people still aren’t being tested.
“The high positivity rates on #COVID19 testing would suggest our testing capacity is still too low,” Gottlieb tweeted. “At the current levels of infection, to achieve a positivity rate of 1%, we would need to have conducted 70+ million covid tests.”
That said, where America was once embarrassingly behind on testing, it has recently caught up to some of its peers. It now tests more people per capita than South Korea, to which its testing rate was once unfavorably compared. In both the US and South Korea, the first coronavirus case was diagnosed on the same day: January 21. The initial response could not have been more different. While South Korea ramped up testing quickly and was able to minimize the spread of the virus, the United States took its time, rejecting the World Health Organization’s test protocol to develop its own through the Centers for Disease Control and Prevention (CDC). In the meantime, the Trump administration and some health agencies repeatedly downplayed the virus’s threat to the American public.
When the CDC’s tests were released, they were flawed. The tests were also only given to people who fit strict guidelines, and could only be performed by a few CDC-approved labs. It wasn’t until the end of February that the FDA allowed commercial labs to test for the coronavirus and use their own tests, which greatly expanded testing capacity. At this point, however, the virus was already widespread. By the end of March, the per capita testing rate in South Korea was six times that of the US. Even with its progress, America still lags behind countries including Germany, Canada, Spain, and Italy in per capita testing.
“The idea of anybody getting [a test] easily the way people in other countries are doing it, we’re not set up for that,” Fauci said in a March 12 hearing. “Do I think we should be? Yes, but we’re not.”
South Korea and Germany, by contrast, were prepared. South Korea learned from its mistakes in the 2015 MERS (Middle East Respiratory Syndrome) outbreak, and therefore had a better response system in place, including an invasive contact tracing system that likely wouldn’t be accepted by the American public. Germany thought ahead and got test kits together before the virus ever hit the country. As of April 24, Germany had just over 150,000 coronavirus cases and about 5,500 deaths. On the same day, the US had over 870,000 cases and just over 50,000 deaths. Germany and South Korea also have effective systems to keep track of infected people and centralized public health care systems. The United States does not.
The population of the US is several times larger than Germany’s and South Korea’s combined, which obviously makes testing and supply shortages a bigger issue. That’s an excuse, but not a complete one. If anything, South Korea may have a surplus of tests, as it is now sending some to America. Maryland’s Republican Gov. Larry Hogan was able to secure 500,000 test kits from the country after a frustrating and futile effort to get them from American suppliers (he then thanked the federal government for “generously offering” the use of labs to run those tests), and the Federal Emergency Management Agency (FEMA) purchased 750,000 tests from South Korea in mid-April.
All that said, America has still managed to keep its death rate lower than many of Germany’s peers, including the United Kingdom, Belgium, Spain, France, and Italy. This is assuming that countries are accurately tracking and reporting all of their cases and deaths. As the New York Times recently reported, coronavirus death tolls have likely been undercounted worldwide, and the lack of testing makes it impossible to truly know how many cases there are.
But while the US isn’t the only country to face dire consequences for failing to adequately prepare and respond to the pandemic, it does have the most known cases of and deaths from the virus than any other country.
The big mass testing hurdle laboratories can’t solve: money
How many tests do we really need? As noted above, the number of tests experts believe the US should perform varies quite a bit. The higher estimates call for testing the entire US population every three to four days in order to catch the virus before an infected person can spread it to someone else.
Still, many plans call for millions of tests per day. Dr. Brett Giroir, the Trump administration’s testing czar, has called for a number on the lower end of those estimates, saying he thinks the country will need 4.5 million tests per month. And the Harvard Global Health Institute’s director Ashish Jha told the New York Times that at least 152 tests per 100,000 people should be performed daily (that’s about three times more than the current average). A recently released Harvard report, “Roadmap to Pandemic Resilience,” put the number at 5 million per day by early June (for a “safe social reopening”), scaled up to 20 million per day by late July (to “fully mobilize the economy”). Even that, the report says, may not be enough.
In any case, experts do agree that testing must be accompanied by contact tracing and people continuing to practice things like good hygiene, social distancing, and quarantine if they suspect they are sick.
So, how do we scale up from about 150,000 tests a day to millions of tests per day? And why aren’t we doing that many already? A lot of it comes down to money — and not just money so that patients can afford the tests. We’ve seen the government provide funding for this already. The country’s health system needs money for the tremendous additional upfront cost for the machines, equipment, supplies, and personnel.
“There’s been a disconnect between everyone agreeing that testing is essential to our way out of this and the government’s willingness to invest in the large commercial laboratories who are performing the majority of the testing in the US to have this national network,” said Serio, from the ACLA.
Keep in mind that many of these items will no longer be needed once the pandemic passes, making them a bad investment for labs. Even the biggest labs are already under financial strain. And while the larger commercial labs might be able to absorb the additional cost of more machines, smaller ones can’t. While the demand for coronavirus tests is clearly there, testing overall has actually declined — people aren’t having elective surgeries or getting routine bloodwork done for their annual physicals these days. Quest recently furloughed 4,000 employees and issued pay cuts after it saw a 40 percent decrease in overall testing volume.
So, who will pay for it? For some context, let’s look at the ventilator shortage, where there was a similar issue: Hospitals couldn’t afford to buy the expensive machines they likely wouldn’t need once the pandemic was over. The federal government eventually spent $3 billion to purchase hundreds of thousands of them for the Strategic National Stockpile, which can then be distributed as needed across the country.
The Trump administration has been reluctant to pay for a testing program, even though the need for tests was apparent even before the need for ventilators. Trump himself dismissed the notion of the federal government being involved in testing as “ridiculous,” tweeting that it is “the States” that “have to step up their TESTING!” Earlier this month, the federal government stopped funding testing sites, saying they would be left to states to manage instead.
States, on the other hand, have appealed to the federal government for the funding they say they need to set up testing programs, including in an April 21 letter to Congress from the National Governors Association. Most states have balanced budget requirements, which makes it extremely difficult or even impossible for them to suddenly spend huge amounts of money on a testing system whilst simultaneously taking in far less tax revenue than anticipated, due to businesses shutting down and people being laid off. The federal government, on the other hand, routinely spends more money than it takes in — hence America’s ballooning national debt.
The good news is that the Centers for Medicare and Medicaid Services increased its reimbursement amount for coronavirus tests from $51 to $100 in the hopes that getting more money per test would encourage labs to invest in what they need to run more tests (Medicare and Medicaid typically reimburse providers far less than the market rate, meaning providers sometimes lose money on those patients). The first relief bill, signed in March, paid for testing for uninsured patients. The $25 billion in the relief bill for coronavirus testing includes funding for items needed to increase capacity. Once the funding is there, the federal and states government will have to decide where and how to distribute it. How much labs will actually get, then, is still in question.
“ACLA urges HHS to quickly provide clarity on how the funding will be allocated to support hotspots and high-risk populations, as well as broader efforts to increase high throughput testing nationwide,” ACLA President Julie Khani said in a statement. “Continued support and funding for high throughput testing from commercial, hospital, and academic laboratories is essential to achieve both of these goals.”
But this $25 billion provision wasn’t in initial versions of the bill and was only the result of a week of negotiations to add it — Democrats wanted it, Republicans didn’t — indicating that, even now, with the federal government desperate to re-open the country, getting the funds necessary to safely do so from it is still a struggle.
The fault lies at the top. Trump once said he’d rather keep sick people on a cruise ship, potentially infecting the rest of the passengers, than let them on American land because it would increase the number of coronavirus cases. The president is reportedly far more concerned with keeping the number of confirmed cases down than he is with minimizing the actual number of cases. In that case, mass testing is not in Trump’s best interests, even if it is in his country’s.
Which is tough. After all the issues America has had so far with its Covid-19 testing system — developing new tests, fixing supply chains, getting them to the people who need them, allowing more labs to perform them, and scaling up the capacity of those labs to run these complicated molecular tests at an unprecedented rate — securing the funds to make it all work requires support from the federal government. That means the decision to ramp up testing in the United States likely depends on the whims of President Trump. This is the same man who, when he declared a national emergency over the coronavirus outbreak, said about testing, “I don’t take responsibility at all.”
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