the testing fiasco

“A video has emerged.”

It’s a clip from a press conference he did just a couple weeks ago, guys. https://t.co/p3HpN4iukm pic.twitter.com/x0qIVeGKQo

— Parker Molloy (@ParkerMolloy) March 17, 2020

The 4 Key Reasons the U.S. Is So Behind on Coronavirus Testing
Bureaucracy, equipment shortages, an unwillingness to share, and failed leadership doomed the American response to COVID-19.

https://www.theatlantic.com/health/archive/2020/03/why-coronavirus-testing-us-so-delayed/607954/

The COVID-19 outbreak has been a confusing time for Americans, but one thing has been glaringly clear: The U.S. is way behind when it comes to testing people for the coronavirus.

Despite the fact that last week, Vice President Mike Pence promised that “roughly 1.5 million tests” would soon be available, an ongoing Atlantic investigation can confirm only that 13,953 tests have been conducted nationally. New York, which has shut down Broadway and has at least 328 coronavirus cases, is still failing to test patients who have worrying symptoms. As late as March 6, a busy clinic in Brownsville, Texas, a border city of nearly 200,000 whose population crosses back and forth from Mexico frequently, told me they could test only three people. By comparison, South Korea, which has one of the largest outbreaks outside China, is testing nearly 20,000 people a day.

Testing is essential for identifying people who have been infected and for understanding the true scope of the outbreak. But when the initial test from the Centers for Disease Control and Prevention was rolled out to state public-health laboratories in early February, one of its components was discovered to be faulty. Since then, academic, clinical, and other laboratories have struggled to get or make new tests and diagnose patients.

Though some elements of the breakdown are by now understood, the full extent of the difficulties laboratory directors have faced has remained largely opaque. Interviews with laboratory directors and public-health experts reveal a Fyre Festival–like cascade of problems that have led to a dearth of tests at a time when America desperately needs them. The issues began with onerous requirements for the labs that make the tests, continued because of arcane hurdles that prevented researchers from getting the right supplies, and extended to a White House that seemed to lack cohesion in the pandemic’s early days. Getting out lots of tests for a new disease is a major logistical and scientific challenge, but it can be pulled off with the help of highly efficient, effective government leadership. In this case, such leadership didn’t appear to exist.

Here are the four main reasons the testing issues have been so bad:

RED TAPE

The Food and Drug Administration has a protocol called emergency use authorization, or EUA, through which it clears tests from labs around the country for use in an outbreak. Getting more of these tests up and running would greatly increase the capacity of doctors and public-health officials to screen patients for the coronavirus.

Former FDA officials I spoke with said that during past outbreaks, EUAs could be granted in just a couple of days. But this time, the requirements for getting an EUA were so complicated that it would have taken weeks to receive one, says Alex Greninger, the assistant director of the virology division at the University of Washington Medical Center, which is located right near the heart of the American outbreak. Greninger told me clinical labs were not allowed to begin testing at all before they had received the EUA, even if they had already internally made sure their tests worked. Though these regulations are in place to ensure that faulty lab tests don’t get used on patients, several microbiologists told me they felt the precautions were excessive for a fast-moving outbreak of this scale. “The speed of this virus versus the speed of the FDA and the EUA process is mismatched,” he said.

On February 28, Greninger and dozens of other clinical microbiologists wrote a letter to Congress complaining that the EUA process was slowing down the ability of their labs to deploy coronavirus tests. “Many of our clinical laboratories have already validated [tests] that we could begin testing with tomorrow, but cannot due [to] the FDA EUA process,” they wrote. The following day, the FDA changed the EUA process so that labs like Greninger’s could begin testing—they would just have to submit data for the FDA’s authorization two weeks later. But weeks had already passed during which many labs and hospitals were unable to use their tests.

“The EUA pathway … has served for Ebola and Zika, etc.,” says Mark Miller, the chief medical officer at bioMérieux, an infectious-disease diagnostic company based in France. “And then you have a situation like now with coronavirus, which I don’t think any of us have ever lived through.”

Margaret Hamburg, who served as the FDA commissioner from 2009 to 2015, told me that while she doesn’t have knowledge of what went on inside the FDA over the past few months, the agency could have proactively reached out to different national and international labs to see whether their tests could be approved for use in the U.S. For example, the FDA might ask a lab, “Would you be interested to try to redirect what you were doing for a MERS diagnostic to a novel-coronavirus diagnostic?” she says. Instead, as The New York Times reported, federal officials told one Seattle infectious-disease expert, Helen Chu, to stop testing for the coronavirus entirely. (In an email, an FDA spokesperson denied that the agency acted slowly. Ensuring the validity of tests is important, she noted, to prevent false results.)

It looks like Chu was not alone. Dozens of labs in the U.S. were eager to make tests and willing to test patients, but they were hamstrung by regulations for most of February, even as the virus crept silently across the nation.

HARD-TO-GET VIRUS SAMPLES

Labs and companies need samples of the virus itself in order to make their tests, but delays in getting access to samples further slowed down the test-development process. The coronavirus originated in China, and as several microbiologists told me, the Chinese government does not allow specimens to be shipped outside its borders.

Many researchers have had difficulty getting their hands on samples even as the virus has spread. “I was working the phones to try to get access to the virus,” Greninger said.

BioMérieux just released three versions of its coronavirus test this week, after beginning work on it on January 23. Miller says that with every viral outbreak, the company’s biggest problem by far is getting access to virus and patient specimens so that it can validate its tests. Even when working with nonauthoritarian countries, a combination of government processes, researcher reticence, complex shipping regulations, and patient-privacy concerns makes getting samples difficult for diagnostic companies like his.

Miller said it would help if researchers, governments, and companies firmed up pathogen-sharing contracts in advance of an outbreak, but so far that hasn’t happened. “The problem is that in the past, industry has been viewed as this dirty participant in all of this, and we can’t be trusted, and why would I have contracts with you?” Miller says. “But that’s ignoring the plain fact that we’re the ones that create the product in the end.”

LACKING EQUIPMENT

The type of test Greninger is making is called a lab-developed test. To be used in other labs, his test requires special instruments that extract and then amplify the RNA that makes up the virus. However, labs across the country—like those at many county hospitals—don’t have the tools to do this. They can only run a simple type of test called a sample-to-answer test. As late as this week, several lab directors told me that no sample-to-answer versions of the coronavirus test had been approved in the U.S. “That means that the vast majority of clinical labs in this country will not be able to do in-house testing at this time,” says Susan Butler Wu, an associate professor of clinical pathology at the University of Southern California.

The U.S. health-care system is broken up into state and county public-health laboratories, which have different equipment than academic research institutions, which have different equipment than hospitals that diagnose patients. So the same test won’t necessarily work in different places. “We don’t have a nationalized health-care system where you put the same equipment in all the hospitals,” Wu says. “We have all these independent hospital systems with their own equipment in their own labs.”

Even though some hospitals actually have the new, functional CDC tests, the extraction machines and reagents that are used to perform them are in short supply. “We’ve been pleading to the research laboratories to please, if they have RNA-extraction machines, to give them to the hospital,” says Michael Mina, an associate medical director in the department of pathology at Brigham and Women’s Hospital in Boston.

LEADERSHIP AND COORDINATION PROBLEMS

For months, President Trump has made light of the coronavirus, telling attendees at a Black History Month reception, for instance, that perhaps the virus could miraculously disappear. He claimed on Twitter that the U.S. has done a “great job” handling the outbreak. Such a cavalier attitude seems unlikely to have motivated health officials to take things seriously. It also contradicted advice from most public-health experts. Even Scott Gottlieb, who recently resigned as Trump’s FDA commissioner, wrote in The Wall Street Journal on February 4 that “it’s time to start testing more people.”

Containing a new infectious disease requires a lot of close collaboration between the president, the CDC, the FDA, and other parts of the Department of Health and Human Services, several Obama-era health officials told me. “One reason we were able to move quickly [during the Ebola outbreak] was that there was a great deal of coordination and issue spotting and troubleshooting that went on,” Hamburg, the former FDA commissioner, told me.

The different arms of the sprawling health department have to feel like they’re all pulling toward the same goal. “I think you have fabulous people at CDC and FDA all doing the best they can, but we always found it was incredibly important to have all the agencies together in the same room,” says Jesse Goodman, a former FDA chief scientist who helped manage the country’s response to the 2009 H1N1 outbreak. When issues came up that merited the attention of the White House, he says, they got it.

Though Trump has proposed a payroll-tax break, as my colleague Peter Nicholas has pointed out, “Much of what he’s said publicly about the virus has been wrong, a consequence of downplaying any troubles on his watch.”

On top of that, there’s reportedly been tension and infighting between the president and his HHS secretary, Alex Azar, as well as between the FDA and the CDC. Politico reported that Vice President Mike Pence, who has no background in public health, repeatedly sidelined Azar from the coronavirus-response task force, and the White House appears to be blaming Azar for any failures in its coronavirus response. Politico also reported that an FDA scientist was “initially rebuffed”—made to wait overnight—when he attempted to visit the CDC in order to help coordinate testing. (In an email, a CDC spokesperson said this was “in full compliance with standard security processes required for all individuals whether they are federal employees or other visitors.”)

“I gather that there was a huge amount of infighting about who could or who should lead this, and there was a sense that a lot of people [inside HHS] weren’t considering it a major threat,” said a former Obama-administration official who has been in contact with current staffers and who related these private discussions under the condition of anonymity. “And why that was, I don’t know.”

It’s possible that all of these other hurdles could have been cleared if officials at the highest levels of government had been working together smoothly. Instead, we’ve seen confusion, doubt, and even more delays.

How the Coronavirus Became an American Catastrophe
The death and economic damage sweeping the United States could have been avoided—if only we had started testing for the virus sooner.

MARCH 21, 2020

https://www.theatlantic.com/health/archive/2020/03/how-many-americans-are-sick-lost-february/608521/

How many people are sick with the coronavirus in the United States, and when did they get sick?
These are crucial questions to answer, but they have never been answered well. Archived data from the Centers for Disease Control and Prevention—illustrated in the chart below—reveal that the government dramatically misunderstood what was happening in America as the outbreak began.
On the last day of February, the CDC reported that 15 Americans had tested positive for COVID-19, the disease caused by the coronavirus.

In the past week, as the country’s testing capacity has increased, officials have discovered more cases. Today, more than 17,000 people have tested positive.

That may sound like a lot. But experts believe that the United States still isn’t testing enough people to detect the outbreak’s true spread. The virologist Trevor Bedford has found evidence that the coronavirus began spreading in the United States in January. It has already infected approximately 87,000 Americans, he says.

The truth is: We don’t know how many Americans are infected with the coronavirus.
The United States is a country soon to be overrun with sick people. As the positive tests for the new coronavirus have ticked upward, so, inevitably, will the deaths.

When Wuhan began burning with infections in December, the U.S. government took only illogical, inadequate actions to stop the virus’s spread: It banned foreigners from entering from China, but inconsistently monitored Americans returning from the country. The president laughed off the virus and the Democrats’ response to it, calling it their “new hoax,” which immediately polarized the citizenry’s response to precautionary public-health information. When the sparks of this conflagration hit, Seattle was aflame before anyone at the CDC had started to reach for water.

What’s happening here, in this country, was avoidable. Nearly every flaw in America’s response to the virus has one source: America did not test enough people for COVID-19.

Testing should have told doctors how to triage patients and hospitals when to prepare their wards. It should have allowed governors to gauge the severity of a local outbreak and informed federal officials as they allocated scarce masks and ventilators. Testing should have answered the all-important question in any pandemic: How many people are sick right now? Had the nation known that, the systems that were put into place over years of pandemic planning could have powered on, protecting millions of Americans and containing the illness.

Instead, the CDC botched its own test development. It sent testing kits to state public-health labs with a nonfunctioning ingredient. And by then, the virus was already spreading. It was already spreading as the Food and Drug Administration held up independent labs that had made their own tests. It was spreading as samples piled up, as the world’s top virology researchers pleaded to be permitted to test them and as the FDA denied their requests.

The virus was spreading as a delay in test kits became a national shortage. When community transmission in the United States was discovered, and states and hospitals lacked the supplies to diagnose even a dangerously ill patient, it was spreading. When a week passed, and the market began to collapse, and the country had barely tested 1,000 people, it was still spreading. Even as kits started to trickle out, the CDC and many state officials clung to restrictive rules that allowed only patients who had traveled internationally or been exposed to a known case to be tested, even though the coronavirus was already clearly spreading in American offices, day cares, and movie theaters. Doctors and nurses with all the symptoms of COVID-19 were denied tests because they could not prove exposure. The virus was still spreading.

Every six days that the country did not test, every six days that it did not act, the number of infected Americans doubled.

“The way no one expected how this response would fail in the U.S. is the testing,” Nahid Bhadelia, the medical director of the Special Pathogen Unit at Boston University School of Medicine, told us. She is an expert in infectious diseases and pandemics, and oversees the medical-response program at one of the few labs in the country permitted to handle the pathogens that cause Ebola, anthrax, and the bubonic plague.

“If you don’t know where the disease is early in the epidemic, you have no hope of containing it,” Bhadelia said. “Even now, [testing is] that Achilles’ heel; it’s the crack that is making its way throughout our entire response.”

Without testing, there was only one way to know the severity of the outbreak: counting the dead. On February 29, Washington State confirmed that a man who had been at the Life Care Center outside Seattle had died, the first American death officially attributed to the virus. According to a now-archived version of the CDC’s website, the United States had, by then, tested 472 total people.

The death came at the end of a month that was America’s last chance at containing COVID-19. But it was too late. February had been lost.

On the last day of January, Trevor Bedford, a scientist at the Fred Hutchinson Cancer Research Center, in Seattle, hit Publish on a 484-word blog post that should have shaken the nation.

Bedford is one of the country’s experts on the evolution and infectiousness of viruses. Virus genomes are like tree rings: They provide clues to where a virus came from and how many times it’s been passed from person to person. With the outbreak raging in Wuhan, Bedford had been studying the genetic sequences of the new coronavirus that Chinese researchers had posted. By January 11, six were in the record, which allowed him to reconstruct the relationships between the individual strains. Though the World Health Organization insisted that this new coronavirus had “limited human-to-human transmission,” the genomes told Bedford otherwise. Whatever this virus was, he suspected it could spread easily among strangers, like the common cold or the flu.

Six days later, when a pair of travelers in Thailand came down with a similar illness, and researchers published the genome of the virus that had infected them, Bedford’s worst fears were confirmed. An epidemic had already begun. The new coronavirus had slipped the cordon in Wuhan, and was out in the world.

“As this became clear to me, I spent the week of Jan 20 alerting every public health official I know,” Bedford wrote that month. On January 23, the Chinese government, which had spent weeks trying to cover up the virus, swung into action. It locked down the city of Wuhan and by mid-February had restricted the movement of 700 million people. On January 24, the CDC announced it had developed a test for the disease. The FDA wouldn’t approve it for another week and a half.

This was the moment that epidemiologists had spent years dreading and anticipating. Almost every city and state in America had a pandemic-preparedness plan, reams of paper ready to put into action.

King County, in which Seattle and Kirkland sit, had a plan, of course. The last revision, dated October 2013, forecast the consequences of a pandemic flu in now-eerie detail. The country, they predicted, would be faced with deaths that could range into the millions. The pandemic “has the potential to suddenly cause illness in a very large number of people, who could easily overwhelm the healthcare system throughout the nation.” No vaccines would be available at first. Community services could break down. Everything could become disrupted “for several weeks, if not months.” So many of the steps that then seemed unthinkable to regular people—closing schools for months, social distancing, curfews, and more—were not only contemplated but gamed out.

Except for one thing. The plan took as a given that a functional testing apparatus would catch diseases on the way in, or at least before the fire started raging. Under its “Planning Assumptions” section, the second bullet point read, “There will be a need for heightened global, national and local surveillance.” Surveillance is public-health jargon for testing and the system that surrounds it. The planners knew there would be a need; they barely considered that it would not be met.

“A heightened local surveillance system … serves as an early warning system for potential pandemics and a critical component of pandemic response plans,” they wrote in another section of the report. “Local surveillance during a pandemic outbreak provides important information regarding the severity of disease, characteristics of the affected population, and impacts on the healthcare system.”

For every contingency that was considered, every difficulty and problem was assumed to be downstream of the high-quality information that would flow from the testing system. Without data about American cases in hand, how to handle the virus would become a matter of guesswork, not judgment.

In late January, as Bedford began to warn public-health officials, there remained, according to the president, nothing to worry about. “We have it totally under control,” President Donald Trump said at Davos. “It’s one person coming in from China, and we have it under control. It’s going to be just fine.”

On or about January 15, someone infected by the coronavirus arrived in the Seattle area, Bedford’s research would later show. The virus began to silently spread in the region. It would not be detected for another six weeks.

If there is one thing about the novel coronavirus that you must understand, it’s that it is a firecracker with a long fuse. Here is what the explosion looks like: Every six days, the number of people infected by the disease doubles, according to estimates from Bedford and other epidemiologists. At the start of February, Bedford now believes, the United States had something like 430 infections; if American interventions have done nothing to slow the disease’s spread, then his simple calculations show that more than 120,000 people could be infected by this weekend. Because of the great uncertainty, it’s probably most appropriate to give Bedford’s range: About 60,000 to 245,000 people are now infected with COVID-19 in the United States.

An invisible fuse sets off this burst of disease. If someone is infected with the coronavirus on Monday, she may start being contagious and infecting other people by Wednesday. But she may not start showing symptoms until Friday—meaning that she was spreading the virus before she even knew she had it. And in some cases, infected people take 14 days to start showing symptoms.

The onset of symptoms starts another awful clock. Many people will recover in a few weeks. But if someone’s case is severe, he may not recover for a month. And even if someone’s case is fatal, she may still survive for three weeks. This means that, first, cases discovered now may not become deaths for weeks; second, some people who will die in early April may only start showing symptoms today.

Mitigation efforts must burn through the same fuse. Even the decision to lock down the Bay Area, the country’s richest region, will not relieve pressure on the medical system for weeks.

Both of these factors mean that time is of the essence. This virus hides effectively and doubles quickly, but it kills slowly and painfully, and it kills most effectively when medical care isn’t available. This makes the coronavirus a particular disaster for the American hospital system, which after decades of streamlining has little spare capacity.

If the coronavirus was in the United States, it had to be found early, before too many explosions could go off.

Helen Y. Chu, an infectious-disease specialist at the University of Washington, thought she had a way to detect COVID-19’s arrival. She directed a monitoring program called the Seattle Flu Study, which studied the spread of the seasonal flu and collected samples from sick people on an ongoing basis. What if some of those patients didn’t have the flu at all, but COVID-19? In January, she and her colleagues began asking federal and state officials for permission to repurpose specimens to test for this other, similar respiratory disease, according to The New York Times. They turned her down then—and they kept rejecting her requests as the weeks wore on. There were legitimate privacy concerns, and government officials were not ready to authorize Chu to look.

On the last day of January, roughly 380 people were already infected with the coronavirus, most of them in the Seattle area, according to Bedford’s estimate. (Bedford is also part of the Seattle Flu Study.)

But then the CDC hit a disastrous roadblock, as it began to send test kits to public-health labs across the country. Two of the test’s reagents were fine, in most cases, but a third chemical initially deemed necessary for the test simply did not work. For the time being, every test for COVID-19 would have to be conducted by the CDC.

As the CDC struggled to find a solution, other laboratories tried to bring their own tests online. They found themselves hamstrung by the FDA, which, though it repeatedly loosened the rules, could not move as fast as the coronavirus.

Alex Greninger, the assistant director of the clinical virology laboratory at the University of Washington, wanted to run a test of the lab’s own design. His lab would end up being one of the fastest to set up testing, and become the most important early source of information about the growth of the outbreak. But initially he, too, found himself caught up in the bureaucratic gears. On February 14, he sent a frustrated email to other clinical laboratories. The obstacles to setting up a test were unbelievable, he wrote: The FDA was asking him to show test results for more specimens than there were confirmed coronavirus cases in the United States—and the FDA wasn’t even making samples from those cases available to him. (The FDA did not immediately respond to The Atlantic’s request for comment.)

No one at the federal level was moving fast enough to actually deal with the looming disaster. “The most pernicious effect of the current regulatory environment is that it kneecaps our ability for preparedness should a true emergency emerge,” Greninger wrote to other laboratory directors. “Why bother getting ready as a clinical lab if you think that you won’t ever be allowed to do anything until May or June?” Even after his lab got FDA approval, another two to three weeks would pass before it could actually test a large number of samples. In coronavirus time, three weeks is about how long it takes for 100 cases to become more than 1,000. “We’ve been exceptionally fortunate to have so few positive cases,” he wrote. “Should that change in the coming weeks, this month will have been the time when we could have expanded our capacity for testing by including clinical labs.”

But the entire American testing effort, which would provide the crucial surveillance capability to understand any incipient outbreak, had stalled. The days ticked by; the virus spread. American public-health labs—which generally have far more capacity than the CDC—had completed only 16 tests, maybe a handful of people, by mid-February. All the way to February 26, only 102 specimens, or perhaps 50 people, had been tested by those labs. Overall, the CDC had tested fewer than 500 people. If the U.S. had a small number of cases, it was only because no one was looking for them. “We just twiddled our thumbs as the coronavirus waltzed in,” William Hanage, a Harvard epidemiologist, wrote in The Washington Post.

Perhaps because of the wildly constrained supply of tests, the criteria to get one were strict. You basically had to go to Wuhan, lick someone, and then develop pneumonia. No one from the federal government even tried to look for community transmission in the United States. In late February, the president voiced his hopes that “the numbers are going to get progressively better as we go along.”

They would not. In fact, as Trump spoke, the virus had reached a nursing home in the Seattle suburb of Kirkland, where it has so far killed 35 residents. The staff knew a mysterious virus was circulating, but life went on as normal. A concerned visitor who had gone to a Mardi Gras party at the center reached out to King County Public Health, the Los Angeles Times reported, and got the runaround.

On February 26, the CDC confirmed what should have been clear much earlier: Community transmission in the United States had begun. The coronavirus was now spreading among Americans who had not traveled abroad or known a confirmed case. At least 60 people in the country now had the virus, according to the CDC’s totals at the time—and, as researchers and analysts soon realized, the true number was almost certainly much higher.

The CDC’s website now says that there were already 268 cases in the United States by that date. When Japan had nearly as many confirmed cases, it closed every school in the country. But because of the testing backlog, the United States remained unaware of its infection rate. And the president encouraged happy thinking. As CDC officials warned that the number of cases could soon quickly rise, Trump disagreed. “Within a couple of days,” he said, the number of cases “is going to be down to close to zero. That’s a pretty good job we’ve done.”

Bedford now estimates that roughly 7,640 people in the United States were already infected.

Chu, the Seattle infectious-disease specialist, decided not to wait for government officials any longer. As the United States declared the first cases of community transmission, she tested through Greninger’s lab without official approval and got a positive. The meaning was obvious to her. “It’s just everywhere already,” she later told The New York Times.

Under pressure to get tests out, the most important fix that our national agencies could make was to simply allow labs to start testing people. In a description that has now been removed from the CDC’s website, the agency gave labs simple instructions: They should use the two working reagents in the old kits. These instructions could have gone out weeks before they actually did, Greninger says, because they relied on the supplies that the CDC had already sent.

Meanwhile, Bedford began examining the new coronavirus strains from patients in Washington State, just as he had, six weeks earlier, analyzed the Asian samples. The Seattle-area specimens led him to a devastating conclusion: The viral genomes were too similar to have arrived in the United States at different times, from different people, but they were also too varied to have arrived recently. By the end of February, the disease had not only established itself in the United States. It had been circulating for close to six weeks. Seattle, on March 1, found itself in the same position as Wuhan did on January 1, with a growing coronavirus outbreak that was on the verge of exploding.

If Seattle went the route of Wuhan, the nation had three weeks before being set on a track in which hundreds or even thousands of people might die in Washington State alone. If a fire was raging in Seattle, it would throw off sparks across the country, hitting many more.

The clock required urgent action. On March 2, Bedford pressed Seattle officials to implement social-distancing policies immediately. If the epidemic grew any further … well, the CDC knew what might happen.

“Widespread transmission of COVID-19 in the United States would translate into large numbers of people needing medical care at the same time,” the agency warned in a passage titled “What May Happen” on the coronavirus page of its website. “Public health and healthcare systems may become overloaded, with elevated rates of hospitalizations and deaths.”

One day after Bedford published his warning, the CDC announced that it would stop reporting how many people in the United States had been tested for the coronavirus. Donald Trump shared his views on Fox News the following night. “A lot of people will have this, and it’s very mild,” he said. “They’ll get better very rapidly. They don’t even see a doctor. They don’t even call a doctor.”

The virus was now clearly spreading, but the CDC still seemed stuck in neutral. On March 10, CDC Director Robert Redfield described his agency’s strategy to The New York Times. “It’s going to take rigorous, aggressive public health—what I like to say, block and tackle, block and tackle, block and tackle, block and tackle,” he said. “That means if you find a new case, you isolate it.”

Redfield’s advice would have sounded reasonable back on Planet A, where the U.S. surveillance apparatus had not failed so spectacularly, but it was almost nonsensical on Planet B, where we all now live. Almost no one was getting tested, so how could anyone find a new case? A few days earlier, a state-by-state investigation by The Atlantic found little evidence that more than 2,000 people had been tested nationwide. We also found that many states had effectively no ability to test for COVID-19, and the few that did—Washington and California—were already deep into their local outbreaks. After we published the story, reports flooded in from across the country from people who had been denied tests, or doctors who couldn’t get one for patients who they believed needed them. In some cases, even doctors who had treated COVID-19 patients were not able to get tested.

As we heard from dozens of frightened and frustrated people across the country, President Trump told reporters, “Anyone who wants a test can get a test.” This was and is still not true.

The scarcity of tests forced officials to ration them. States, counties, and hospitals implemented strict rules about who could qualify for a test. The rules, while based on CDC guidance, were often too limited, given how widely the virus had already spread: They asked about foreign travel and confirmed exposure to a COVID-19–positive patient, weeks after it was clear that the virus was in the United States and that many cases were going undetected. At least 19 states have used a version of the rules that made it effectively impossible to detect the first signs of community spread in a state or city.

In the few places where officials have tested people without known exposure to COVID-19, they have found the virus. In Sonoma County, California, the public-health department asked four hospitals to test the first 20 patients who walked in the door each day with any coronavirus symptoms—even if the patient had not traveled abroad or been exposed to another known case. They started the project on a Friday. They had found a positive by Saturday. “All we needed was one case to say: Yes, we have community transmission,” Jennifer Larocque, a spokesperson for the county, told us.

In other places, the criteria have prevented residents from understanding the true extent of community spread. Nebraska, which hewed closely to the rules, insisted it had only one case of community spread, even as suspicious cases filled ICUs, according to a 35-year-old doctor who asked not to be named, because she was not authorized to speak with the press. Nebraska announced its second case of community spread on Wednesday. The state has tested 800 people, total, for the coronavirus, the chief medical officer said.

The federal government’s reliance on CDC data about the severity of the outbreak froze efforts to stop it. Even after Bedford’s warning, the government published no studies of viral mutation. The void forced leaders to act on the basis of risk, not solid information. How could a mayor shut down her city if it had only 10 for-sure cases? How could a CEO tell employees to call off their trips—and not to Western Europe or central China, but to Seattle?

American cities, blinded by the lack of testing data, did little as crucial days went by. On March 7, as the severity of the local outbreak was becoming known, huge events were allowed to go on. More than 30,000 people attended a Seattle Sounders game that night. No one wanted to say what has now become clear: February was our chance to get this right. We lost that entire month. And we now live in a new era of work stoppages, overwhelmed hospitals, dead elders, and a wrecked economy.

No one had the guts to say what needed to be said over the past month: To save our people, we will have to keep our cities in a chokehold and decimate our economy. It would have taken guts and the full-throated backing of every level of government and agency, as well as irrefutable data, for local officials to do something like that. No one told them to, and the data did not exist for them to come to that conclusion on their own.

Without strong federal leadership, each state has been going after its own solutions and running its own show, as if its residents would stay neatly within their own state lines. Despite the rising number of cases and hospitalizations, President Trump tried to use partisan rhetorical tactics to fight the virus, and in so doing, encouraged Americans to ignore legitimate, dire warnings. Now, though Trump has begun to mobilize a response to the pandemic, his base has been slow to acknowledge that precautions are necessary. This dangerous remove from reality was possible for too long because of the absence of data showing how bad things already were.

Ironically, given that the debacle started with testing, it may end there as well. South Korea, which on March 1 was the site of the largest confirmed coronavirus outbreak outside of China, has aggressively tested a huge percentage of its population, and continues to screen massive numbers of people. Now, just three weeks later, new COVID-19 cases are declining, and only 102 people have died as of Friday. Washington State, with one-seventh the population of South Korea, already has 83 fatalities. The U.S. caseload has ballooned to almost 20,000, more than twice South Korea’s total. Bedford and other experts believe that Korean-style massive-scale testing will be essential to restoring normal economic conditions. “This is the Apollo program of our times,” he said this week. “Let’s get to it.”

wv wrote:

…is what the Fox News folks and rightwing-propaganda will focus on. Donald Trump valiantly tried to lead the nation, but the big-gubmunt-bureaucracy failed us….

That won’t fly. A president is in a position to streamline all that and get it running to face a crisis.

As it stands he’s still insisting that states buy their own supplies even while the Feds bid against them.

wv wrote:

Did Shake-speare have anything to say
about plagues?

w
v

“Tis the times’ plague, when madmen lead the blind.” From King Lear.

Actually he wrote Lear during a plague.

The Lost Month: How a Failure to Test Blinded the U.S. to Covid-19
Aggressive screening might have helped contain the coronavirus in the United States. But technical flaws, regulatory hurdles and lapses in leadership let it spread undetected for weeks.

link https://www.nytimes.com/2020/03/28/us/testing-coronavirus-pandemic.html

WASHINGTON — Early on, the dozen federal officials charged with defending America against the coronavirus gathered day after day in the White House Situation Room, consumed by crises. They grappled with how to evacuate the United States consulate in Wuhan, China, ban Chinese travelers and extract Americans from the Diamond Princess and other cruise ships.

The members of the coronavirus task force typically devoted only five or 10 minutes, often at the end of contentious meetings, to talk about testing, several participants recalled. The Centers for Disease Control and Prevention, its leaders assured the others, had developed a diagnostic model that would be rolled out quickly as a first step.

But as the deadly virus from China spread with ferocity across the United States between late January and early March, large-scale testing of people who might have been infected did not happen — because of technical flaws, regulatory hurdles, business-as-usual bureaucracies and lack of leadership at multiple levels, according to interviews with more than 50 current and former public health officials, administration officials, senior scientists and company executives.

The result was a lost month, when the world’s richest country — armed with some of the most highly trained scientists and infectious disease specialists — squandered its best chance of containing the virus’s spread. Instead, Americans were left largely blind to the scale of a looming public health catastrophe.

The absence of robust screening until it was “far too late” revealed failures across the government, said Dr. Thomas Frieden, the former C.D.C. director. Jennifer Nuzzo, an epidemiologist at Johns Hopkins, said the Trump administration had “incredibly limited” views of the pathogen’s potential impact. Dr. Margaret Hamburg, the former commissioner of the Food and Drug Administration, said the lapse enabled “exponential growth of cases.”

And Dr. Anthony S. Fauci, a top government scientist involved in the fight against the virus, told members of Congress that the early inability to test was “a failing” of the administration’s response to a deadly, global pandemic. “Why,” he asked later in a magazine interview, “were we not able to mobilize on a broader scale?”

Across the government, they said, three agencies responsible for detecting and combating threats like the coronavirus failed to prepare quickly enough. Even as scientists looked at China and sounded alarms, none of the agencies’ directors conveyed the urgency required to spur a no-holds-barred defense.

Dr. Robert R. Redfield, 68, a former military doctor and prominent AIDS researcher who directs the C.D.C., trusted his veteran scientists to create the world’s most precise test for the coronavirus and share it with state laboratories. When flaws in the test became apparent in February, he promised a quick fix, though it took weeks to settle on a solution.

The C.D.C. also tightly restricted who could get tested and was slow to conduct “community-based surveillance,” a standard screening practice to detect the virus’s reach. Had the United States been able to track its earliest movements and identify hidden hot spots, local quarantines might have confined the disease.

Dr. Stephen Hahn, 60, the commissioner of the Food and Drug Administration, enforced regulations that paradoxically made it tougher for hospitals, private clinics and companies to deploy diagnostic tests in an emergency. Other countries that had mobilized businesses were performing tens of thousands of tests daily, compared with fewer than 100 on average in the United States, frustrating local health officials, lawmakers and desperate Americans.

Alex M. Azar II, who led the Department of Health and Human Services, oversaw the two other agencies and coordinated the government’s public health response to the pandemic. While he grew frustrated as public criticism over the testing issues intensified, he was unable to push either agency to speed up or change course.

Mr. Azar, 52, who chaired the coronavirus task force until late February, when Vice President Mike Pence took charge, had been at odds for months with the White House over other issues. The task force’s chief liaison to the president was Mick Mulvaney, the acting White House chief of staff, who was being forced out by Mr. Trump. Without high-level interest — or demands for action — the testing issue festered.

At the start of that crucial lost month, when his government could have rallied, the president was distracted by impeachment and dismissive of the threat to the public’s health or the nation’s economy. By the end of the month, Mr. Trump claimed the virus was about to dissipate in the United States, saying: “It’s going to disappear. One day — it’s like a miracle — it will disappear.”

By early March, after federal officials finally announced changes to expand testing, it was too late. With the early lapses, containment was no longer an option. The tool kit of epidemiology would shift — lockdowns, social disruption, intensive medical treatment — in hopes of mitigating the harm.

Now, the United States has more than 100,000 coronavirus cases, the most of any country in the world. Deaths are rising, cities are shuttered, the economy is sputtering and everyday life is upended. And still, many Americans sickened by the virus cannot get tested.

In a statement, Judd Deere, a White House spokesman, said that “any suggestion that President Trump did not take the threat of Covid-19 seriously or that the United States was not prepared is false.” He added that at Mr. Trump’s direction, the administration had “expanded testing capacities.”

Dr. Bruce Aylward, a senior adviser at the World Health Organization, led an expert team to China last month to research the mysterious new virus. Testing, he said, was “absolutely vital” for understanding how to defeat a disease — what distinguishes it from others, the spectrum of illness and, most important, its path through populations.

“You want to know whether or not you have it,” Dr. Aylward said. “You want to know whether the people around you have it. Because you know what? Then you could stop it.”

“You can’t stop it,” he warned, “if you can’t see it.”

A Startling Setback

The first time Dr. Robert Redfield heard about the severity of the virus from his Chinese counterparts was around New Year’s Day, when he was on vacation with his family. He spent so much time on the phone that they barely saw him. And what he heard rattled him; in one grim conversation about the virus days later, George F. Gao, the director of the Chinese Center for Disease Control and Prevention, burst into tears.

Dr. Redfield, a longtime AIDS researcher, had never run a government agency before his appointment to lead the C.D.C. in 2018. Until then, his biggest priorities had been fighting the opioid epidemic and the spread of H.I.V. Suddenly, a man who preferred treating patients in Haiti or Africa to being in the public glare was facing a new pandemic threat.

At first, Dr. Redfield’s agency moved quickly.

On Jan. 7, the C.D.C. created an “incident management system” for the coronavirus and advised travelers to Wuhan to take precautions. By Jan. 20, just two weeks after Chinese scientists shared the genetic sequence of the virus, the C.D.C. had developed its own test, as usual, and deployed it to detect the country’s first coronavirus case.

“That’s our prime mission,” Dr. Redfield said later in an interview, “to get eyes on this thing.”

Assessing the virus would prove challenging. It was so new that scientists had little information to work with. China provided limited data, and rebuffed an early attempt by Mr. Azar and Dr. Redfield to send C.D.C. experts there to learn more. That the virus could cause no symptoms and still spread — something not initially known — made it all the more difficult to understand.

To identify the virus, the C.D.C. test used three small genetic sequences to match up with portions of a virus’s genome extracted from a swab. A German-developed test that the W.H.O. was distributing to other countries used just two, potentially making it less precise.

But soon after the F.D.A. cleared the C.D.C. to share its test kits with state health department labs, some discovered a problem. The third sequence, or “probe,” gave inconclusive results. While the C.D.C. explored the cause — contamination or a design issue — it told those state labs to stop testing.

The startling setback stalled the C.D.C.’s efforts to track the virus when it mattered most. By mid-February, the nation was testing only about 100 samples per day, according to the C.D.C.’s website.

Dr. Redfield played down the problem in task force meetings and conversations with Mr. Azar, assuring him it would be fixed quickly, several administration officials said.

With capacity so limited, the C.D.C.’s criteria for who was tested remained extremely narrow for weeks to come: only people who had recently traveled to China or had been in contact with someone who had the virus.

A string of critical errors.

The lack of tests in the states also meant local public health officials could not use another essential epidemiological tool: surveillance testing. To see where the virus might be hiding, nasal swab samples from people screened for the common flu would also be checked for the coronavirus.

The C.D.C. announced a plan on Feb. 14 to perform the screening in five high-risk cities: New York, Chicago, Los Angeles, San Francisco and Seattle. An agency official said it could provide “an early warning signal to trigger a change in our response strategy.” But most of the cities could not carry it out.

“Had we had done more testing from the very beginning and caught cases earlier,” said Dr. Nuzzo, of Johns Hopkins, “we would be in a far different place.”

The consequences became clear by the end of February. For the first time, someone with no known exposure to the virus or history of travel tested positive, in the Seattle area, where the U.S.’s first case had been detected more than a month earlier. The virus had probably been spreading there and elsewhere for weeks, researchers later concluded. Without a more complete picture of who had been infected, public health workers could not do “contact tracing” — finding all those with whom any contagious people had interacted and then quarantining them to stop further transmission.

The C.D.C. gave little thought to adopting the test being used by the W.H.O. The C.D.C.’s test was working in its own lab — still processing samples from states — which gave agency officials confidence. Dr. Anne Schuchat, the agency’s principal deputy director, would later say that the C.D.C. did not think “we needed somebody else’s test.”

And the German-designed W.H.O. test had not been through the American regulatory approval process, which would take time.

Throughout February, Dr. Redfield shuttled between Atlanta, where the C.D.C. is based, and Washington, holding multiple calls every day with Mr. Azar and participating in the coronavirus task force.

Mr. Azar’s take-charge style contrasted with the more deliberative manner of Dr. Redfield, who lacked the kind of commanding television presence that impressed Mr. Trump. He was “a consensus person,” as one colleague described him, who sought to avoid conflict. He relied heavily on some of the C.D.C.’s career scientists, like Dr. Schuchat and Dr. Nancy Messonnier, the director of the agency’s National Center for Immunization and Respiratory Diseases.

Under scrutiny from Congress, Dr. Redfield offered reassurances. Responding on Feb. 24 to a letter from 49 members of Congress about the need for testing in the states, he wrote, “CDC’s aggressive response enables us to identify potential cases early and make sure that they are properly handled.”

Days later, his agency provided a workaround, telling state and local health department labs that they could finally begin testing. Rather than awaiting replacements, they should use their C.D.C. test kits and leave out the problematic third probe.

Meanwhile, the agency’s epidemiologists were growing more concerned as the virus spread in South Korea and Italy. On Feb. 25, Dr. Messonnier gave a briefing with a much blunter warning than usual. “Disruption to everyday life might be severe,” she said.

Mr. Trump, returning from a trip to India, was furious, according to senior administration officials. Later that day, Mr. Azar seemed to be tamping down the level of concern. All Dr. Messonnier had meant, he said at a news conference, was that people should “start thinking about, in their own lives, what that might involve.”

“Might,” Mr. Azar repeated emphatically. “Might involve.”

Barriers to Testing

Dr. Stephen Hahn’s first day as F.D.A. commissioner came just six weeks before Mr. Azar declared a public health emergency on Jan. 31. A radiation oncologist and researcher who helped turn around MD Anderson in Houston, one of the nation’s leading cancer centers, Dr. Hahn had come to Washington to oversee a sprawling federal agency that regulates everything from lifesaving therapies to dog food.

But overnight, his mission — to manage 15,000 employees in a culture defined by precision and caution — was upended. A pathogen that Mr. Trump would later call the “invisible enemy” was hurtling toward the United States. It would fall to the newly arrived Dr. Hahn to help build a huge national capacity for testing by academic and private labs.

Instead, under his leadership, the F.D.A. became a significant roadblock, according to current and former officials as well as researchers and doctors at laboratories around the country.

Private-sector tests were supposed to be the next tier after the C.D.C. fulfilled its obligation to jump-start screening at public labs. In other countries hit hard by the coronavirus, governments acted quickly to speed tests to their populations. In South Korea, for example, regulators in early February summoned executives from 20 medical manufacturers, easing rules as they demanded tests.

But Dr. Hahn took a cautious approach. He was not proactive in reaching out to manufacturers, and instead deferred to his scientists, following the F.D.A.’s often cumbersome methods for approving medical screening.

Even the nation’s public health labs were looking for the F.D.A.’s help. “We are now many weeks into the response with still no diagnostic or surveillance test available outside of C.D.C. for the vast majority of our member laboratories,” Scott Becker, chief executive of the Association of Public Health Laboratories, wrote to Mr. Hahn in late February. “We believe a more expeditious route is needed at this time.”

Ironically, it was Mr. Azar’s emergency declaration that established the rules Dr. Hahn insisted on following. Designed to make it easier for drugmakers to pursue vaccines and other therapies during a crisis, such a declaration lets the F.D.A. speed approvals that could otherwise take a year or more.

But the emergency announcement created a new barrier for hospitals and laboratories that wanted to create their own tests to diagnose the coronavirus. Usually, they faced minimal federal regulation. But once Mr. Azar took action, they were subject to an F.D.A. process called an “emergency use authorization.”

Even though researchers around the country quickly began creating tests that could diagnose Covid-19, many said they were hindered by the F.D.A.’s approval process. The new tests sat unused at labs around the country.

Stanford was one of them. Researchers at the world-renowned university had a working test by February, based on protocols published by the W.H.O. The organization had already delivered more than 250,000 of the German-designed tests to 70 laboratories around the world, and doctors at the Stanford lab wanted to be prepared for a pandemic.

“Even if it didn’t come, it would be better to be ready than not to be ready,” said Dr. Benjamin Pinsky, the lab’s medical director.

But in the face of what he called “relatively tight” rules at the F.D.A., Dr. Pinsky and his colleagues decided against even trying to win permission. The Stanford clinical lab would not begin testing coronavirus samples until early March, when Dr. Hahn finally relaxed the rules.

Executives at bioMérieux, a French diagnostics company, had a similar experience. The company makes a countertop testing system, BioFire, that is routinely used to check for the flu and other respiratory illnesses in 1,700 hospitals around the country. It can provide results in about 45 minutes.

“A lot of us said, you know, your typical E.U.A. is just much too demanding,” said Dr. Mark Miller, the company’s chief medical officer, referring to the emergency approval. “It’s going to take much too much time. And can’t you do something to shorten that?”

Officials at the F.D.A. tried to be responsive, Dr. Miller said. But rather than throw out the rules, the agency only modified the regulatory requirements, still requiring weeks of discussions and negotiations.

After conversations with the F.D.A. in mid-February, the company received emergency approval for its BioFire test on March 24. (The company also began talking to the F.D.A. in January about another type of test, but decided not to pursue it in the United States for now.) Dr. Miller said that while he was ultimately satisfied with the F.D.A.’s actions, the overall response by the government was too slow, especially when it came to logistical questions like getting enough testing supplies to those who needed them.

“You’ve got other countries — and I’m sorry, unfortunately, the U.S. is one of those — where they’ve been slow, disorganized,” he said. “There are still not enough tests available there to test everybody who needs it.”

In an emailed statement, Dr. Hahn maintained that his agency had moved as quickly as it safely could to ensure that tests would be accurate. “Since the early days of this pandemic,” he said, “the F.D.A.’s doors have always been and still remain open to test developers.”

A Lack of Trust

Alex Azar had sounded confident at the end of January. At a news conference in the hulking H.H.S. headquarters in Washington, he said he had the government’s response to the new coronavirus under control, pointing out high-ranking jobs he had held in the department during the 2003 SARS outbreak and other infectious threats.

“I know this playbook well,” he told reporters.

A Yale-trained lawyer who once served as the top attorney at the health department, Mr. Azar had spent a decade as a top executive at Eli Lilly, one of the world’s largest drug companies. But he caught Mr. Trump’s attention in part because of other credentials: After law school, Mr. Azar was a clerk for some of the nation’s most conservative judges, including Justice Antonin Scalia of the Supreme Court. And for two years, he worked as Ken Starr’s deputy on the Clinton Whitewater investigation.

As Mr. Trump’s second health secretary, confirmed at the beginning of 2018, Mr. Azar has been quick to compliment the president and focus on the issues he cares about: lowering drug prices and fighting opioid addiction. On Feb. 6 — even as the W.H.O. announced that there were more than 28,000 coronavirus cases around the globe — Mr. Azar was in the second row in the White House’s East Room, demonstrating his loyalty to the president as Mr. Trump claimed vindication from his impeachment acquittal the day before and lashed out at “evil” lawmakers and the F.B.I.’s “top scum.”

As public attention on the virus threat intensified in January and February, Mr. Azar grew increasingly frustrated about the harsh spotlight on his department and the leaders of agencies who reported to him, according to people familiar with the response to the virus inside the agencies.

Described as a prickly boss by some administration officials, Mr. Azar has had a longstanding feud with Seema Verma, the Medicare and Medicaid chief, who recently became a regular presence at Mr. Trump’s televised briefings on the pandemic. Mr. Azar did not include Dr. Hahn on the virus task force he led, though some of the F.D.A. commissioner’s aides participated in H.H.S. meetings on the subject.

And tensions grew between the secretary and Dr. Redfield as the testing issue persisted. Mr. Azar and Dr. Redfield have been on the phone as often as a half-dozen times a day. But throughout February, as the C.D.C. test faltered, Mr. Azar became convinced that Dr. Redfield’s agency was providing him with inaccurate information about testing that the secretary repeated publicly, according to several administration officials.

In one instance, Mr. Azar appeared on Sunday morning news programs and said that more than 3,600 people had been tested for the virus. In fact, the real number was much smaller because many patients were tested multiple times, an error the C.D.C. had to correct in congressional testimony that week. One health department official said Mr. Azar was repeatedly assured that the C.D.C.’s test would be widely available within a week or 10 days, only to be given the same promise a week later.

Asked about criticism of his agency’s response to the pandemic, Dr. Redfield said: “I’m personally not focused on whether they’re pointing fingers here or there. We’re focused on doing all we can to get through this outbreak as quickly as possible and keep America safe.”

For all Mr. Azar’s complaints, however, he continued to defer to the scientists at the two agencies, according to several administration officials. Mr. Azar’s allies said he was told by Dr. Redfield and Dr. Fauci that the C.D.C. had the resources it needed, that there was no reason to believe the virus was spreading through the country from person to person and that it was important to test only people who met certain criteria.

But even in the face of a crescendo of complaints from doctors and health care researchers around the country, Mr. Azar failed to push those under him to do the one thing that could have helped: broader testing.

In a statement, Caitlin Oakley, Mr. Azar’s spokeswoman, said that the secretary had “empowered and followed the guidance of world-renowned U.S. scientists” on the testing issue. “Any insinuation that Secretary Azar did not respond with needed urgency to the response or testing efforts,” she said, “are just plain wrong and disproven by the facts.”

By Feb. 26, Dr. Fauci was concerned that the stalled testing had become an urgent issue that needed to be addressed. He called Brian Harrison, Mr. Azar’s chief of staff, and asked him to gather the group of officials overseeing screening efforts.

Around noon on Feb. 27, Dr. Hahn, Dr. Redfield and top aides from the F.D.A. and H.H.S. dialed in to a conference call. Mr. Harrison began with an ultimatum: No one leaves until we resolve the lag in testing. We don’t have answers and we need them, one senior administration official recalled him saying. Get it done.

By the end of the day, the group agreed that the F.D.A. should loosen regulations so that hospitals and independent labs could move forward quickly with their own tests.

But the evening before, Mr. Azar had been effectively removed as the leader of the task force when Mr. Trump abruptly put Mr. Pence in charge, a decision so last-minute that even the top health officials in the White House learned of it while watching the announcement.

Previous presidents have moved quickly to confront disease threats from inside the White House by installing a “czar” to manage the effort.

During an outbreak of the Ebola virus in 2014, President Barack Obama tapped Ron Klain, his vice president’s former chief of staff, to direct the response from the West Wing. Mr. Obama later created an office of global health security inside the National Security Council to coordinate future crises.

“If you look historically in the United States when it is challenged with something like this — whether it’s H.I.V. crises, whether it’s pandemic, whether it’s whatever — man, they pull out all the stops across the system and they make it work,” said Dr. Aylward, the W.H.O. epidemiologist.

But faced with the coronavirus, Mr. Trump chose not to have the White House lead the planning until nearly two months after it began. Mr. Obama’s global health office had been disbanded a year earlier. And until Mr. Pence took charge, the task force lacked a single White House official with the power to compel action.

Since then, testing has ramped up quickly, with nearly 100 labs at hospitals and elsewhere performing it. On Friday, the health care giant Abbott said it had received emergency approval for a portable test that could detect the virus in five minutes.

The president boasted on Tuesday that the United States had “created a new system that now we are doing unbelievably big numbers” of tests for the virus. The U.S., he said, had done more testing for the coronavirus in the last eight days than South Korea had done in eight weeks.

Yet hospitals and clinics across the country still must deny tests to those with milder symptoms, trying to save them for the most serious cases, and they often wait a week for results. In tacit acknowledgment of the shortage, Mr. Trump asked South Korea’s president on Monday to send as many test kits as possible from the 100,000 produced there daily, more than the country needs.

Public health experts reacted positively to the increased capacity. But having the ability to diagnose the disease three months after it was first disclosed by China does little to address why the United States was unable to do so sooner, when it might have helped reduce the toll of the pandemic.

“Testing is the crack that split apart the rest of the response, when it should have tied everything together,” said Dr. Nahid Bhadelia, ​the medical director of the Special Pathogens Unit at Boston University School of Medicine.

“It seeps into every other aspect of our response, touches all of us,” she said. “The delay of the testing has impacted the response across the board.”