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America Needed Coronavirus Tests. The Government Failed.

The Wall Street Journal. logo The Wall Street Journal. 3/19/2020 Christopher Weaver, Betsy McKay and Brianna Abbott
© Stephen M. Katz  

When cases of the new coronavirus began emerging several weeks ago in California, Washington state and other pockets of the country, U.S. public-health officials worried this might be The Big One, emails and interviews show.

The testing program they rolled out to combat it, though, was a small one.

Limited testing has blinded Americans to the scale of the outbreak so far, impeding the nation’s ability to fight the virus through isolating the sick and their contacts, public-health officials say. As of early Wednesday, about 6,500 people in the U.S. had tested positive, data compiled by Johns Hopkins University show, but the Centers for Disease Control and Prevention had reported only about 32,000 tests conducted at its facilities and other public-health labs.

Limited testing is also keeping patients like Justin LaBor in the dark, despite recent improvements. Mr. LaBor, 36 years old, said he went to the emergency room at AtlantiCare Regional Medical Center in Pomona, N.J., Monday with a fever and dry cough, symptoms typical in a coronavirus infection. Doctors admitted him, but he hasn’t been tested for the virus, he said Tuesday, gasping for breath over the phone.

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“Everyone just told me there were no tests and I didn’t check all the boxes for the state,” said Mr. LaBor, a social-media marketer from Elwood, N.J., referring to the criteria that state labs require patients to meet before running tests. A New Jersey health-department spokeswoman said the state “has sufficient lab capacity to test those who meet the testing criteria.” An AtlantiCare spokeswoman said the hospital system “is not testing patients in a widespread manner for coronavirus.”

While the virus was quietly spreading within the U.S., the CDC had told state and local officials its “testing capacity is more than adequate to meet current testing demands,” according to a Feb. 26 agency email viewed by The Wall Street Journal, part of a cache of agency communications reviewed by the Journal that sheds light on the early response. The agency’s data show it tested fewer than 100 patients that day.

When the CDC first dispersed test kits in early February, it shipped them to a network of state and local government labs and restricted testing to people with virus symptoms who had recently traveled to China, where the virus first emerged, or had been exposed to a known case. Federal officials hoped the virus could be contained—even as they disputed alarms from those on the front lines that the CDC’s guidelines weren’t keeping up with the outbreak’s spread, emails between the U.S. agency and local officials show. The government left other laboratories on the sidelines for crucial weeks.

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The narrow effort is “a failing,” said Anthony Fauci , a government doctor who has become the de facto face of the Trump administration’s coronavirus response, in congressional testimony last week that for many in Washington was a wake-up call.

While problems still clearly persist, more labs are beginning to do tests and manufacturers are ramping up production. “We can expect to see a marked acceleration of the availability and implementation of testing,” Dr. Fauci said in an interview Friday.

CDC officials botched an initial test kit developed in an agency lab, retracting many tests. They resisted calls from state officials and medical providers to broaden testing, and health officials failed to coordinate with outside companies to ensure needed test-kit supplies, such as nasal swabs and chemical reagents, would be available, according to suppliers and health officials.

When the U.S. Food and Drug Administration, also involved in the response, finally opened testing to more outside labs, a run on limited stocks of some supplies needed for the CDC-developed test quickly depleted stores, lab operators and suppliers said. Hospital and commercial lab operators said the government didn’t reach out to enlist their help until it was too late.

“This was kind of a perfect storm of three separate failures,” said Tom Frieden, who directed the CDC from 2009 to 2017, citing the botched test, overstrict FDA rules and sidelined private labs. He cautioned he didn’t have direct knowledge of details.

Now, the U.S. is testing far fewer patients than public-health and infectious-disease experts say is necessary and just a fraction as many as other countries that rolled out wide-reaching diagnostic programs. South Korea as of Tuesday was testing up to 20,000 patients a day, more than half the total of U.S. patients who have been tested since the outbreak began.

The test shortage hurt U.S. efforts to contain the virus, said Neil Fishman, chief medical officer at the Hospital of the University of Pennsylvania and an infectious-disease specialist.

“If we would have had a true understanding of the extent of disease several weeks ago, implementation of social-distancing measures could have prevented the escalation of the disease,” Dr. Fishman said, and demand for the test is now huge.

Health-care officials say the current state of testing reflects both technical and planning failures, as well as a broader failure of imagination. Leaders including President Trump and Health and Human Services Secretary Alex Azar early in the outbreak appeared unable or unwilling to envision a crisis of the scale that has now emerged, and no one stepped up to effectively coordinate among federal agencies or the private-sector labs, medical providers and manufacturers needed for a large-scale testing push, they say.

An HHS spokeswoman said Brett Giroir, a deputy Mr. Azar put in charge of testing last week, would assume that role. She said the FDA began working with private test developers in January by sharing information about the process for approving tests.

The CDC said in an email to the Journal on Monday that its work with public-health labs is meant to fill “the short-term gap until experienced commercial diagnostic manufacturers come to market.”

Mr. Trump repeatedly dismissed the threat of a broad U.S. outbreak, saying in late February, “One day it’s like a miracle, it will disappear.” The next day, the first reported American death tied to Covid-19, the disease caused by the coronavirus, occurred in Washington state.

Some White House aides learned of complaints about the availability of testing from the media, not the public-health officials in their own government, an administration official familiar with the matter said. Only in the first week of March did discussions in a White House coronavirus task force about the testing shortfall take on a sense of urgency, the person said.

Even then, Mr. Azar, defended the testing program in television interviews including twice on ABC News that week, citing the low number of confirmed cases—at a time when almost no tests were available to detect them.

The White House didn’t respond to requests for comment. The HHS spokeswoman said health officials are focused on efforts to increase test accessibility and pointed to a series of recent statements on the topic.

At the CDC, the tone was more dire. “While leaning forward aggressively with the hope that we will be able to prevent community spread, we also are preparing for the worst,” the agency told state public-health officials in a Feb. 20 email.

The Government Accountability Office had warned federal officials in early January that its readiness for something like a pandemic fell short, a GAO official said. GAO investigators found crisis plans didn’t fully account for the huge role the private sector would have to play, documents show.

The HHS spokeswoman said the agency’s coronavirus response was guided by other “well-practiced” operational plans, and not the strategic one the GAO reviewed. An HHS official told the GAO, in a letter dated Jan. 31, that the agency had addressed their concerns and put in place policies that would “prevent early implementation challenges from becoming institutionalized.”

In the weeks ahead, however, those very challenges did become institutionalized. The FDA first announced labs seeking to perform testing would have to submit a special application to get permission to start on Feb. 4. That initially deterred some hospitals and other lab operators—which normally aren’t required to submit any application—from developing tests, experts say.

“We had considered developing a test but had been in communication with the CDC and FDA and had been told that the federal and state authorities would be able to handle everything,” Alan Wells, the medical director for the University of Pittsburgh Medical Center’s clinical laboratories, told reporters over the weekend. He said in an interview on Monday that it later became clear the CDC and states were overwhelmed.

Once the CDC launched its initial test in the first week of February, the response was quickly stymied by setbacks, including flaws that forced the CDC to claw back many of the kits it had already sent out to state public-health laboratories, according to the agency and public-health officials.

An email to state public-health-lab officials later in February gives the fullest account from the CDC to emerge yet of what happened: The agency said some labs had encountered “sporadic reactivity in the negative control of one of the three assay components.” That means the test in some cases wrongly indicated it had detected coronavirus in samples of laboratory-grade water.

“It is unclear why quality control did not detect this issue before the kits were sent out to states,” said the email.

The CDC on Monday said it “has not yet determined if the problem involves the assay design or contamination. It could have been either.”

At one critical juncture, just before the CDC opened up testing to more state laboratories in February, its officials clashed with state epidemiologists on the front lines of the response to the epidemic over the scale of testing.

Despite news and official reports heralding the rapid spread of the virus in Japan and Hong Kong, on Feb. 22 CDC officials told state officials to refer for testing only patients showing symptoms who had travel histories in mainland China.

When a top Minnesota epidemiologist pointed out in an email to CDC officials that agency director Robert Redfield had recently tweeted that doctors treating patients who had visited Hong Kong and Japan should consider “#COVID19,” the CDC’s deputy incident commander responded: “This tweet is being taken down.” And, in fact, it was.

The CDC hasn’t responded to requests for comment on why the tweet was deleted.

Hawaii’s top epidemiologist, Sarah Park, chimed in on the thread, saying the bar for testing should be lowered. Dr. Park pointed out that the CDC’s own travel website said travelers from Japan with symptoms should be considered for coronavirus even though the guidelines precluded testing.

Rather than expand testing, the CDC replied that it was considering changes to its travel notices.

The epidemiologists, too, recognized the current testing program wouldn’t meet the widening need. As they debated expanding testing to more people, Marcelle Layton, a top official with the New York City Department of Health and Mental Hygiene, expressed the worry that too many returning travelers would expect to be screened as the list of affected countries expanded.

“We all know this is not sustainable,” Dr. Layton said in a Feb. 25 email to other public-health officials. She and Dr. Park didn’t respond to requests for comment.

As the CDC sought to get the network of state labs up and running, it finally turned to an outside manufacturer, Integrated DNA Technologies Inc., to order a run of custom reagents—substances used in a chemical reaction—needed to identify the genetic imprint of coronavirus in late February, according to the company and a timeline provided by the CDC. IDT said in a statement that it shipped the CDC’s first order on Feb. 26.

The CDC said it signed a contract with IDT to supply reagents on Feb. 20. Contracting records show one IDT order from that day, for only about $90,000 of testing supplies. The CDC said that contract was for coronavirus-test material. IDT denied that contract was related to the coronavirus tests.

With IDT creating special coronavirus test kits, the federal government abruptly began to make moves that would open the door to more and broader testing, including expanding its criteria for whom to test. On Feb. 26, Nancy Messonnier, a top CDC official, promised in a call with reporters that commercial labs would “be coming online soon,” and a couple of days later, the FDA allowed some labs seeking to use the CDC’s testing method or developing their own to jump through fewer hoops.

IDT would produce millions of tests worth of its coronavirus-detecting reagent over the next couple of weeks, according to the company’s statement.

Even still, the wave of private labs joining the fight against the virus didn’t arrive on schedule. One reason was that many of the off-the-shelf supplies used in the CDC’s testing method weren’t readily available on the scale needed, the Journal found. That included both the simple products like synthetic swabs—cotton interferes with readings—used to collect mucus samples, and complex ones. Because labs copying the CDC’s test method have to use its exact chemical recipe, there has been a run on manufacturer Qiagen NV’s reagent for separating viral RNA from human mucus, one of the products used by the agency.

“We have heard concerns from labs who have questions about the availability of certain supplies,” said the HHS spokeswoman. The agency was providing labs with “information on alternative sources of reagents, extraction kits, swabs and more,” she said.

“Everyone in the world is going to want to get swabbed at one point or another,” said Iyda Antony a lab director at UC Davis Health, a large California health system that is ramping up its own testing program and worries its stores of swabs might not be sufficient.

A small lab owned by lab-manager Clinical Lab Consulting, in Dayton, Ohio, paid $2 per unit—six times its usual rate—for swabs from a Pittsburgh-based vendor on Sunday, email records show. On Tuesday, the vendor told the lab’s owners it was actually out of stock.

The U.S. government “could have just got out in front of it,” said Greg Ingle, one of the Dayton lab’s owners and an industry consultant. Rather, “we watched it play out in the rest of the world before getting into the market.”

Through mid-March, Qiagen spokesman Thomas Theuringer said the Dutch biotech has shipped more than twice as many units of the product in question as in the whole of 2019 to U.S. clients.

“It’s like queuing up in line to buy toilet paper at the grocery store,” said Richard Scanlan, the medical director of the Oregon Health and Sciences University Hospital laboratory, comparing the lab’s predicament to the empty shelves consumers are facing around the country. “Everyone is trying to buy it at the same time,” he said.

Qiagen said it was rationing test kits to its “most critical customers” and acknowledged the company was struggling to meet demand. Dr. Theuringer said the factories producing the kits had ramped up to “three shifts working seven days a week.”

Virus researcher Scott Weaver, at the University of Texas Medical Branch at Galveston, said a group he directs has sent out coronavirus RNA samples needed to do the validation studies to around 50 labs. Nonetheless, he said, some of those labs, including one at his own institution, were delayed as they waited for Qiagen to fill orders in order to begin testing. The Galveston lab is now able to perform tests, he said, but supplies remain limited.

On Wednesday, Mr. Trump said in a briefing that, “in case we need it,” he would invoke a Korean War-era law called the Defense Production Act that allows the federal government to force U.S. companies to produce needed supplies.

In recent days, the FDA has tried to confront the testing shortage by approving new test designs by manufacturers such as Thermo Fisher Scientific Inc. and testing firms like Laboratory Corporation of America Holdings Inc., and relaxing requirements for labs to prove their tests actually work and stick strictly to the CDC recipe. Thermo said Tuesday it has 1.5 million tests ready to ship.

FDA Commissioner Stephen Hahn maintained the agency’s insistence on test accuracy has been vital. “If you don’t have that check on the test findings,” he said, “you run the risk of inaccurate test results which means you aren’t truly assessing the full scope of the outbreak.”

Now, in a concession to demand, the agency is letting labs run tests first and prove they are accurate later—within about two weeks.

After hearing news reports saying more tests had become available, Nathan Conder, a 30-year-old in Salt Lake City, called Utah’s coronavirus hotline Monday to ask about getting tested. He’d been sick with a fever, dry cough and fatigue for a week—all coronavirus symptoms, although also of other maladies.

“They told me all my symptoms match, but they don’t have enough tests so they’re only testing people who were in contact with someone who already tested positive,” said Mr. Conder, a regulatory specialist at a microbiology lab. Public-health officials said “that I should act like I had it, but they can’t test,” he recalled.

On Tuesday, a doctor prescribed a coronavirus test for Mr. Conder after extensive screening and sent him to a nearby hospital lab. From there, he said, he was diverted to a new drive-in testing facility, where workers requested an additional form that took hours to obtain. After an ordeal of nearly six hours in total, he said, he got the test and was told he would get results within three days.

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