Why US coronavirus testing barely improved in April

America still has a big coronavirus testing problem.

In the past week, the situation seems to have improved. Daily testing numbers have gone up. President Donald Trump suggested, and then later backtracked, that the US will do 5 million Covid-19 tests a day “very soon.” The White House claimed that the US has the machines to conduct more than 2 million tests a day. Labs have claimed they have unused capacity.

These developments would be crucial to ending social distancing. All of the major plans to do so, including Trump’s, rely on much more testing to track and contain the coronavirus outbreak. On the low end, the plans call for 500,000 tests a day. On the high end, they call for tens of millions of tests.

But despite recent improvements, the country still faces a major obstacle to scaling up testing: a supply shortage. Every test requires an extensive supply line to work correctly — one that ensures a sample is collected from a patient, then shipped to a lab, then tested at that lab, and then, finally, the result is reported back to the patient. Each of these steps requires a whole host of people and materials to function.

In the past few weeks, problems have emerged every step of the way — whether it’s a shortage in personal protective equipment for the health care workers collecting a sample, in nasal swabs, in the ingredients to run the tests, or in machines to run specific kinds of tests.

It’s these blocks that keep the United States’ testing far below the 500,000 to tens of millions that experts have called for. The US averaged almost 220,000 tests a day over the last week of April, according to the Covid Tracking Project, which gathers state data. It’s an improvement from the earlier weeks in the month, when the US averaged around 150,000 tests a day — but a small improvement overall, and still far short of what experts say is needed.

The US also lags behind other countries. When accounting for population, the US testing rate is a little more than half of Italy’s, one of the countries hit hardest by the pandemic. It’s about two-thirds of Germany’s, which has been widely praised for its quick response to the crisis.

Some Trump administration officials acknowledge they have a problem: “We need to significantly ramp up not only the number of tests, but the capacity to perform them,” Dr. Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, told Time magazine on April 23. “I am not overly confident right now at all that we have what it takes to do that.”

To continue pushing the numbers up, experts say there’s a need for more federal coordination. Labs simply can’t fix these problems on their own, because many of the problems precede them, starting with how samples are collected in a clinic or hospital. States are also limited in their ability to act since the supplies they need — from swabs to reagents to machines — can originate in other parts of the US or the world.

So far, the Trump administration has been slow to act. It has taken some action, like a recent boost with the Defense Production Act to ramp up testing swab production. Congress also recently allocated $25 billion for testing and required the Department of Health and Human Services to develop a “strategic testing plan” that will, among other things, attempt to boost testing capacity.

But the administration has hesitated in taking more aggressive, proactive action. In fact, a recent “blueprint” put out by the administration mostly pinned the problem on the states, arguing that it’s up to the states to plan for, find, and fix testing-related problems with help from the private sector. The federal government will play a largely supplemental role with “guidelines,” “strategic direction,” and “technical assistance,” acting only as a “supplier of last resort.”

“They know that the federal response has been a disaster, and so now their strategy is blame 50 states,” Ashish Jha, faculty director of the Harvard Global Health Institute, told the Guardian.

So America remains stuck. Any progress on testing is coming very slowly, even as the number of coronavirus cases and deaths continues to grow. And the nation’s ability to safely reopen the economy remains out of reach.

An intricate supply chain goes into every test

A lot more goes into completing a coronavirus test than you might think.

First, a patient has to go into a clinic, hospital, pharmacy, lab, or drive-through to get a test, which requires those places to have capacity for another patient. Second, a health care worker has to be available, with both the proper training and personal protective equipment necessary, to collect a sample from the patient. Next, that sample has to be collected with the right tool, such as a nasal swab. Then, the sample needs to be stored and sent to a lab, which will need the staff and a specific set of ingredients, or reagents, to run the test. Finally, the result is reported back to the patient.

“Lab testing is a cycle that starts the second someone thinks about getting a test and ends the second the test result is acted upon,” Geoffrey Baird, a pathologist at the University of Washington, told me. “But there’s a lot of steps in between.”

Every step of this process must go smoothly to get a test done, with specific requirements and intricacies in the supply chain that fuels this process.

A single — sometimes unexpected — hitch can slow everything down. Kimberle Chapin, the lab director at Lifespan Academic Medical Centers in Rhode Island, explained how a single test manufacturer accidentally contaminated 100,000 kits nationwide during production. Since that manufacturer’s kit was needed to run tests on the manufacturer’s machine, the blunder effectively halted tests of that kind until more kits could be sent out. “That threw a major kink into testing around the country,” Chapin said. “That one little hiccup.”

In some ways, the whole country went through this kind of issue early on. The Centers for Disease Control and Prevention (CDC) originally produced and sent out the tests that labs were supposed to use to test for Covid-19. But the CDC reportedly contaminated a part of its test and took weeks to fix the mistake, causing testing to come to a complete standstill throughout most of February. Only with the CDC’s fix and the Food and Drug Administration’s move to let more private labs run their own tests did tests start to pick up in March and April.

A more recent hold-up has been nasal swabs. These are actually more technical than might seem at first. Given that they’re stuck deep into a person’s nasal cavity, they have to be high quality — to make sure they don’t break off while they’re in there. Manufacturers can’t just use any materials either; some components can fail to pick up enough of a sample, or even ruin or dilute a sample.

Chapin gave an example of a cotton swab on a wooden stick: “It ends up that the cotton swab is inhibitory to some [kinds of tests], and then the wooden stick has some fluorescent components to it, which is the same fluorescence that we use to detect the virus. So in one sense, you may get a false negative, because the swab material inhibits being able to detect the virus, and in one sense you may get a false positive, because of the components of the stick.”

Only a few manufacturers can produce the necessary swabs, and they were set up to make only so many — certainly not enough to meet rising global demand as the coronavirus spreads. As Baird said, “Do you think the factory right now that makes 10,000 of those a day can all of a sudden make 10 million of them?”

Swabs are only one example, with problems also popping up with other tools needed to collect samples, personal protective equipment for staff, vials and other equipment to store the samples as they’re transported and tested, some testing platforms (particularly for rapid testing), and the reagents used to isolate, amplify, and otherwise probe a sample for the coronavirus. Which supply shortage is a bottleneck in the chain in a given moment can vary depending on the time and place.

It’s these issues, along with sometimes strict rules over who can get tested, that have led to unused capacity in some labs, including Baird’s. When a lab says it has unused capacity, it’s typically speaking to how many tests its machines and platforms could theoretically process each day. But to actually conduct those tests, the lab first needs the staff, samples, reagents to run those samples, and everything in-between.

Testing is necessary to ease social distancing

It has been stated thousands of times throughout the pandemic, but it remains as true as ever: More testing is needed to fight the coronavirus and ease social distancing. Every major proposal for ending the pandemic puts testing at the center.

It’s not just about learning the scope of the pandemic, but about using that knowledge to take specific actions. Testing gives officials the means to isolate sick people, track, and quarantine the people whom those verified to be sick came into close contact with (a.k.a. contact tracing), and deploy community-wide efforts if a new cluster of cases is too large and uncontrolled otherwise.

Contact tracing is a big part of that. A report from the Johns Hopkins Center for Health Security and Association of State and Territorial Health estimates the US will need to hire 100,000 contact tracers — far above what states and federal officials have so far said they’re hiring. A phone app could help mitigate the need for quite as many tracers, but Americans may not have the appetite for an app that will effectively track their every move.

If done correctly, countries like South Korea and Germany have shown that testing and contact tracing can help control the spread of Covid-19.

It’s not a cure-all. All the major plans still acknowledge that some level of social distancing will be necessary until a vaccine or other major medical breakthrough is available, perhaps a year or more from now; maybe expect that you’ll be able to visit friends and family in their homes, but not pack movie theaters, concerts, sports stadiums, or some restaurants. And places will likely have to tighten social distancing here and there as outbreaks flare up again, as Germany is considering despite its success so far.

But testing would allow a better situation than our current one — and it’s a necessary bridge to really diminish the danger of the coronavirus.

The labs that have been able to overcome many of these problems acted early on in the outbreak and diversified their tests. According to Chapin, her lab in Rhode Island, which currently conducts more tests per person than any other state, was able to scale up testing in part because it started to stock up on supplies in February. It also maintains a diversity in testing platforms, so it can still run other tests if, for example, one platform breaks down or faces supply issues due to a manufacturing glitch (as already happened).

But individual labs can only go so far. They can’t do much about a nasal swab factory not having the employees it needs to manufacture enough swabs, a reagent producer not having the materials it needs, or a hospital not having the protective equipment to safely collect samples. All of these actors — and more — have to simultaneously work together on their own.

It’s this level of fragmentation, experts say, that necessitates proactive coordination from the federal government to predict, detect, and fix supply problems that can pop up across the US and the globe. Besides the federal government, no other entity — not manufacturers, labs, or cities and states — can properly oversee the full line of production that’s needed.

The good news is that the work of addressing supply bottlenecks should be relatively straightforward. “This is supply chain 101. This is operations 101,” Nada Sanders, a supply chain management expert at Northeastern University, told me. “It’s so simple. And it’s just not happening.”

So far, though, there’s little sign of that changing — and Trump has suggested that it’s on the states and the private sector instead. That leaves the fragmentation along the supply chain in place, making it unclear how, when, or if testing problems will get fixed and when the US will be able to safely relax social distancing.

“The whole point of this social distancing is to buy us time to build up capacity to do the types of public health interventions we know work,” Natalie Dean, a biostatistics professor at the University of Florida, previously told me. “If we’re not using this time to scale up testing to the level that we need it to be … we don’t have an exit strategy. And then when we lift things, we’re no better equipped than we were before.”

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