By Robert P. Baird
Trump and his team sought to reassure the governors. Admiral Brett Giroir, an assistant secretary at the Department of Health and Human Services, who was appointed two weeks ago to coördinate the federal effort to get testing back on track, said, “We’re very effectively transitioning to large-scale testing by leveraging all components of our American health-care system, including C.D.C. and the state public-health labs, health care and hospitals, and large commercial labs.” Giroir told the governors that, in the twelve days between March 2nd and March 14th, more than ten million tests had been made available in the U.S. And, citing numbers from the F.D.A., he suggested that another seventeen million would be added by March 28th. “We have plenty of tests on the back side. We have plenty of supplies on the front side,” Giroir said. Pence, too, emphasized that “now tens of thousands of more tests are being performed literally every day,” while Trump, responding to Noem’s difficulties securing reagents, told her not to be concerned. “We got you, Kristi,” he said. “There is tremendous supply.”
The next day, the Association of State and Territorial Health Officials, the Association of Public Health Laboratories, and the Council of State and Territorial Epidemiologists—which, together, represent virtually the whole of the country’s state-level public-health infrastructure—issued a joint statement warning about “widescale shortages of laboratory supplies and reagents” for covid-19 testing. Because of these shortages, the statement said, testing ought to be reserved for three groups of suspected cases: health-care workers and first responders; the elderly, especially those who live in nursing homes and other group settings; and people for whom a confirmed covid-19 diagnosis had the potential to meaningfully change their treatment plan, such as those with underlying health conditions.
An alert sent out earlier in the day by New York City’s Department of Health and Mental Hygiene was even more dire. Mildly or moderately ill people seeking covid-19 tests, the D.O.H.M.H. warned, posed a serious infection risk for hospitals and clinics, and were creating a run on the city’s extremely limited P.P.E. stocks and testing supplies. For that reason, the department was “directing healthcare facilities to IMMEDIATELY STOP TESTING NON-HOSPITALIZED PATIENTS FOR COVID-19 unless test results will impact the clinical management of the patient.” Even health-care workers and first responders who had been exposed to infected patients but did not have symptoms would no longer be tested. As the alert went on to warn, again in bold capital letters: “COVID-19 testing is only indicated for HOSPITALIZED PATIENTS.”
In late February, nearly three weeks after the first batch of C.D.C. test kits that was shipped to state and local labs proved faulty, the Trump Administration pushed through a series of regulatory moves to expand the nation’s test capacity. On February 29th, the F.D.A. allowed so-called high-complexity labs to develop and run their own tests. Starting on March 12th, the F.D.A. issued a series of Emergency Use Authorizations to commercial test companies, which allowed those companies to manufacture and distribute tests without going through the agency’s normally onerous approval process. And, last Monday, the F.D.A. announced a new policy that allows state and territorial public-health laboratories to authorize tests at other labs without the need for additional federal approval. In effect, the policy pushed regulatory authority for covid-19 testing out of the federal government and down to the states and territories.
The F.D.A.’s changes succeeded in clearing away many of the regulatory obstacles to new testing. And yet they did little to solve what now appears to be the major bottleneck in deploying widespread testing across the United States. No longer do we need to worry about a single authorized test protocol, or a limited number of laboratories that are allowed to carry out that test. The current trouble is a critical shortage of the physical components needed to carry out tests of any variety. Among these components are so-called viral transport media, which are used to stabilize a specimen as it travels from patient to lab; extraction kits, which isolate viral RNA from specimens once they reach the lab; and the reagents that do the actual work of determining whether the coronavirus that causes covid19 is present in the sample. Perhaps the most prosaic shortage, but also the most crucial, is a lack of test swabs, which look like glorified Q-tips. Specially designed to preserve viral specimens, they’re what a doctor sticks up your nose or down your throat to collect the necessary biological material.
The swab shortage is happening for the same reason that all the other test components are limited—namely, a global pandemic has created a global demand for them—but it is subject to a further complication. Copan, one of the major manufacturers of the sort of swabs needed for covid-19 tests, has its headquarters and manufacturing facilities in Lombardy, Italy, which has been hit particularly hard by the disease. A spokesperson for the company says that the national lockdown in Italy has not affected production at its factories, but last week the U.S. Air National Guard had to use one of its C-17 cargo planes to bring an order of eight hundred thousand swabs back to the U.S. According to Defense One, the plane flew on Monday from the Aviano Air Base, in Italy, not far from the headquarters of Copan, to Memphis, where a FedEx distribution center is situated; the Times later reported that the airlift had been arranged by Peter Navarro, a Presidential trade adviser, and that the Administration hoped similar efforts would bring 1.5 million swabs into the country every week. On Saturday, a company spokesperson told me that Copan did not make “special deals” with governments but was “shipping to the U.S.A. the maximum amount that we are capable of, on a best effort basis” through its usual distributors.
The shortage of testing components is having its most drastic effects in the parts of the country that are seeing the highest prevalence of covid-19. According to Deborah Birx, the response coördinator for the White House Coronavirus Task Force, more than fifty per cent of confirmed cases of the disease have been found in just ten counties, in three states—Washington, New York, and California. In New York City, as of Monday, some fifteen thousand cases have been confirmed, about a third of the country’s total. (Given the testing deficit, the actual prevalence may be several times that.) According to Jennifer Rakeman, the director of the city’s public-health laboratory, “There’s widespread community transmission in New York City.” What that means for residents of the city, she said, is that “if you have symptoms of influenza—like a cough, shortness of breath, fever, sore throat—the pre-test probability that you have covid-19 is very, very high.”
Rakeman’s lab, on First Avenue across from Bellevue Hospital, has been running tests for covid-19 since March 2nd, a few days after it was sent a new set of reagents to replace the first faulty kit it received from the C.D.C. At ordinary peak times, she told me, the lab operates one shift a day, five days a week. Since the outbreak hit the U.S., however, the lab’s staff has been working two shifts a day, seven days a week. By Monday, according to Andrew Cuomo, labs in the state of New York had tested nearly eighty thousand people, and were now processing sixteen thousand tests a day, a quarter of all tests nationwide. But that capacity has been threatened by what Rakeman describes as “critical” shortages of test components, including an enzyme called TaqPath, about which Rakeman said, “There are labs that are running out and begging other labs for a single tube so that they can get another day’s worth of testing done.”
Rakeman told me that, after only ten days of using the C.D.C.-provided tests, her lab was down to its final two extraction kits. On March 12th, she sent members of the city’s Health Department to Albany, to pick up a batch of reagents that had been manufactured for a new test, based on the C.D.C. protocol but developed by New York State’s Wadsworth Laboratory, which would allow the city to use a wider range of extraction kits. “The car pulled into the lab at four o’clock in the afternoon,” she said. “Within minutes, those reagents were in the lab, and the lab started doing the validation and verification of that test. We ran that overnight, and finished it up on the morning of the 13th. That morning, we ran the last batch of specimens on the C.D.C. assay, finished up the last drop of our extraction kits for that test, and then immediately were able to switch over to the Wadsworth test.”
In states with far less prevalence of covid-19 than New York, the shortages are hampering the ability to keep the outbreak under manageable control. By Monday afternoon, the state of Minnesota had confirmed fewer than three hundred cases of the disease. Joanne Bartkus, the director of the state’s public laboratory, told me that she and her staff are capable of processing five hundred tests a day, but shortages of reagents and other test components have caused that number to drop as low as two hundred. “It really is a day-to-day thing as to how many we can test,” she said. When Bartkus’s lab started testing, at the beginning of March, demand was low. “We got five samples in the first day, and then maybe seven the next,” she said. But within days of the President’s announcement, on March 6th, that anyone who wanted a test could get a test, that trickle became a flood. “We started getting four hundred, six hundred, eight hundred, a thousand samples a day.” The influx of specimens created a backlog in the lab that only eased last week, after the Mayo Clinic in Rochester, Minnesota, was able to begin testing.
Bartkus has been in contact with other lab directors who are experiencing similar shortages. As of late last week, she said, a number of states were running out of TaqPath and extraction kits. Bill Whitmar, the director of Missouri’s state lab, says that he has so far received only three test kits from the C.D.C., and that he knows of commercial labs that have taken to freezing their specimens because they lack adequate test components and testing capacity. In recent weeks, Whitmar said, political pressure has made the problems even worse. Missouri is still, he guesses, at least several weeks behind New York and California on the epidemiological curve, which means that containing the outbreak through targeted testing of suspect cases remains a possibility. But recently, Whitmar told me, “National and state policymakers decided that we needed to offer testing to more individuals. Then the floodgates opened. When that happens, then the supply chain on the front end—which is the swabs, the viral transport media, the collection tubes—started to evaporate from the suppliers.” He went on: “If you think you’re going to test everybody, you have to look at your supply chain and analyze it closely. Not just make a promise, but look at your ability to provide a test for everybody. If you think you can, you may be surprised.”
The testing situation in the United States is not wholly grim. According to the covid Tracking Project, the number of daily tests has grown from just under a thousand, on March 4th, to more than sixty-five thousand, on Monday. And the federal government has taken steps, such as the Aviano airlift, to address the test-component shortages. Scott Becker, the C.E.O. of the A.P.H.L., told me on Saturday that the Department of Health and Human Services had purchased two hundred thousand swabs, primarily from a company called Princeton Biomeditech, which it was shipping to state labs this past weekend. What’s more, the C.D.C. addressed the shortage in viral transport media by posting a protocol—essentially a recipe—for labs to make their own. (The protocol uses a mixture of saline solution and, among other things, blood serum drawn from fetal cattle.) The federal government, Becker said, was “slowly waking up to the fact that this is an incredibly complex process. There’s no one-size-fits-all solution. Throwing money at the problem isn’t necessarily going to help it.”
Still, the shortages are severe enough that they’re affecting even the large commercial labs, which as of Sunday were running more than fifty thousand tests per day. According to Julie Khani, the president of the American Clinical Laboratory Association, a trade group representing those labs, “What I’m hearing about as the most critical needs are swabs, and also access to personal protective equipment, to make sure that laboratory employees and other health-care workers are protected.” Khani told me that her member companies had also noted critical shortages of extraction kits, reagents, and test kits. The companies plan to continue gradually expanding their testing capacity as much as they’re able, but to ease the supply-chain shortages, she said, they will “need the support of the U.S. government: we need the resources, we need the funding, and we need supplies.”
If the most immediate problem in the United States is that there are too few available covid-19 tests, another concern is that there may soon be too many. On March 12th, the F.D.A. allowed the Wadsworth Laboratory, in Albany, to authorize other labs in the state to develop and run covid-19 tests. The next day, President Trump signed a memorandum instructing the F.D.A. to allow every other state public-health lab the same regulatory authority, which the agency put into effect on March 16th. Bill Whitmar, of Missouri, told me that he had received dozens of e-mails from companies seeking approval for their tests. “If I had a nickel for every company that said, ‘I’ve got a covid-19 test. I want you to take a look at her. Give me a call,’ I’d have enough for a tank of gas, for sure, and I’ve got a big truck.” As another clinical-lab director put it, “Every company is coming out of the woodwork saying, ‘I have the best test in the world,’ and ninety-five per cent of them will probably be crap.”
The clinical lab director expressed concern that granting regulatory authority to the states means that “we are now in the Wild West of laboratory regulation. It’s really a let-the-buyer-beware world. Essentially, apart from the F.D.A.’s E.U.A. process, there is very limited regulation of the quality, accuracy, and specificity of diagnostic tests for covid-19, and I think that’s a dangerous situation.” Bartkus, in Minnesota, said, “I will tell you, there is pressure to get these tests out: from the public, from the laboratories, from the politicians. It is a challenge to do that in a scientific and equitable way when you have no expertise in authorizing other labs to do testing.” She forwarded me an infographic published by the F.D.A. that explains the new policy. Its headline says, “States Are Now in Charge of Testing.” “Other laboratory directors looked at it and thought it was a hoax,” she said. “It’s almost like the F.D.A. has thrown in the towel and said, ‘Hey, you know, do whatever.’ ” According to Becker, who called Trump’s memorandum an “overcorrection,” the Wadsworth Laboratory, in New York, has both the infrastructure and the experience to conduct oversight on other labs, but the same was not true in most other states. “It’s an added burden to labs that are already under excruciating pressure,” he said. “In the midst of an emergency, it sounds like a good idea, but I don’t think it’s very practical.” (In response to these criticisms, on Monday, an F.D.A. spokesperson said, in a statement, “This action demonstrates the F.D.A.’s ability to pivot and adapt as the situation warrants in light of a public-health emergency,” adding that “our guidance provides recommendations for states that choose to utilize this voluntary and flexible approach.”)
Last week, I received my own pitch from a company hoping to bring a new covid-19 test to market. The company, PathogenDx, was founded in 2014, and sells DNA-based microarray tests to help farmers and agricultural distributors detect biological contaminants on their crops. According to Milan Patel, the company’s C.E.O. and co-founder, PathogenDx has found a particular market niche among cannabis growers. When we spoke on Friday, Patel told me that he had previously hoped to bring the microarray technology to the medical market, but that the F.D.A. approval process had made that impractical. “It would have taken ten years and fifty times more money for us to have to educate the F.D.A. to accept such a technology, because it was completely new and groundbreaking and disruptive. And we just didn’t have the money.” At best, he thought, the company might have been able to enter the human-diagnostics market in the next few years. “But this window of opportunity happened now,” he said, referring to the present pandemic, “and so we have to act.”
When I asked what he would tell someone who might be concerned that a cannabis company was pivoting to covid-19 testing in the middle of an emergency, he admitted that he would be nervous, too. “But at the end of the day what we would say is, look, we’ve gotten a hundred labs doing just the same level of testing, but it’s for E. coli, salmonella, and a bunch of pathogens. And we have enough validation data to show you. We’re going to go to the same level of validation with the F.D.A. as well.”
Patel told me that PathogenDx applied for an emergency-use authorization from the F.D.A. this past Saturday, even though the company does not yet have a test that it is ready to submit for external validation. Why not, I asked, wait to file for the E.U.A. until the test was externally validated? “The thinking is, there’s a hundred companies ahead of us,” Patel told me. “The F.D.A. will close the door. They’ll say, ‘We’ve got more than enough companies.’ So we’re submitting it so that we can get our foot through the door.”
Also last week, at least two companies with previous medical-diagnostic experience, Nurx and Everlywell, announced that they would soon begin selling home-testing kits for covid-19. Both companies said that they would use telemedicine health-care providers to screen orders, and both planned to send qualified patients swabs and collection kits that will be mailed to clinical laboratories for analysis. Frank Ong, the chief medical and scientific officer of Everlywell, told me on Friday that his company had thirty thousand kits, including swabs, on hand, and hoped to be able to supply more than two hundred thousand kits in the coming weeks. Some of those kits may go to corporate partners, while others would be sold to consumers through Everlywell’s Web site.
According to Ong, his company believed that it could legally distribute its kits because the labs it was using to analyze test specimens were operating under the F.D.A.’s revised emergency-use policy. But that policy explicitly stated that it “does not apply to at home testing.” On Friday, after I spoke to Ong, the agency repeated that warning in a strongly worded public notice. After acknowledging that it saw the “public health value in expanding the availability of covid-19 testing through safe and accurate tests that may include home collection,” and noting that it was working with at-home test-kit developers, the agency said that it had “not authorized any test that is available to purchase for testing yourself at home for covid-19.” (Nurx paused its plans to provide at-home testing for covid-19 following the F.D.A.’s announcement.)
On Sunday, I spoke to Julia Cheek, Everlywell’s C.E.O. and founder, about the F.D.A.’s announcement. Cheek told me that, unlike a pregnancy test, which was a true at-home test, her company was technically selling an at-home collection kit. Therefore, as she understood it, the test was not in conflict with the F.D.A’s revised emergency-use policy. Everlywell had planned to start selling kits on Monday, for a hundred and thirty-five dollars each. But given the agency’s notice on Friday, she said, the company had decided that it would wait for further guidance before selling to consumers. (On Monday evening, Deborah Birx, of the Coronavirus Task Force, said at a press briefing that “for all of us waiting for self-swabbing options, those are going to be available at some time this week.” But an F.D.A. spokesperson on Tuesday pointed me to a statement, published a day earlier, that said “self-collection at home or at sites other than designated collection sites staffed by [health-care providers] is currently not recommended.”) In the meantime, Everlywell planned to make some of its kits available for those in health-care settings, such as doctors and nurses in front-line-care settings and older patients in long-term-care facilities.
The ability to test at scale appears to have been a crucial—though far from the only—means by which China, South Korea, Singapore, and other countries have been able to control their epidemics. In the U.S., the imposition of lockdowns in Washington, New York, and California have only amplified the demand for a comprehensive testing program that would, ideally, allow for a more targeted strategy of contact tracing, isolation, and quarantine. During an interview on CNN on Monday night, Governor Andrew Cuomo said, “That’s how we’ll restart the economy.” But multiple public-health officials told me that the supply-chain constraints mean that such a program will be, for the near future, impossible to implement. And if there’s anything worse than not having tests for covid-19 broadly available, they say, it’s treating what testing capacity we do have like an unlimited resource.
“Had we had access to high-volume, quality testing prior to there being community transmission,” Rakeman, the director of the New York City lab, told me, “a lot of testing would have been helpful, and maybe would have helped containment.” But, given the prevalence of covid-19 in the city, she said, test results for people who are mildly or moderately ill have little therapeutic or epidemiological value. “When we talk about testing capacity, it sort of gives this tacit message that people should be tested, and feeds into that anxiety: ‘I need to get tested. I need to know my status,’ ” Rakeman said. “You don’t need to know your covid status.” Anyone who suspects they have covid-19 should call a doctor, but in New York, unless you belong to a high-priority category, the recommendation will likely be the same regardless of whether you have the test: stay home for two weeks, or until you’re fever-free for seventy-two hours. In any case, Rakeman said, “If you have a cough and a fever and a sore throat, or any of those, you probably have it.”
A larger problem, Rakeman told me, is that widespread demand for testing is exacerbating the critical shortage of masks and other P.P.E. The supply of available P.P.E. in New York is currently so low that, on Friday, Cuomo put out a public call to manufacturers to address it: “We will pay a premium for these products,” he said. As Rakeman told me, “Hospitals are going to run out of P.P.E. in the next couple of weeks, if not sooner. And any mask that is used now at a doctor’s office or a pop-up tent that’s providing ‘drive-through testing’ is a mask that’s not going to be available for a health-care worker in a couple of weeks.”
Patients seeking testing can also be potent vectors for the disease. “Take a scenario where, say, I have a cough, or a sore throat and a fever, but I’m not sick enough that I need to go to the hospital,” Rakeman said. “If I travel from my home to an urgent-care facility, I’m going to spread the virus to whomever I come into contact with. When I get there, the person who collects my specimen has to wear P.P.E. I’ve also exposed that health-care worker and everybody who works in that office, and all of the other patients, who may not be there for flulike illness.” She added, “By going out and getting a test, you’re potentially killing somebody’s loved one.”
Even outside of New York City, Khani told me, “You have to prioritize who gets tested. We don’t have the testing capacity that we need, and that’s why we want to make sure that those who need testing most have access to testing.” In Missouri, where the odds that someone has covid-19 are still likely lower than they are in other states, Bill Whitmar said that he understands why the first instinct for someone suffering covid-like symptoms would be to seek out confirmation. The tests “give people a feeling that they’re being taken care of. It’s a step that will make you feel a little bit better in this time of unease.” Nevertheless, he said, it was crucial to suppress this urge, at least for the time being. “I understand that the policymakers are trying to help their constituents. However, by doing that, you’re actually reducing the ability for people who really need the test to be able to get the test.”
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