‘It’s Just Everywhere Already’: How Delays in Testing Set Back the U.S. Coronavirus Response



Grant Hindsley for The New York Times

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Dr. Helen Y. Chu, an infectious disease expert in Seattle, knew that the United States did not have much time.

西雅图的传染病专家海伦·Y·朱(Helen Y. Chu,音)博士知道美国没多少时间了。

In late January, the first confirmed American case of the coronavirus had landed in her area. Critical questions needed answers: Had the man infected anyone else? Was the deadly virus already lurking in other communities and spreading?


As luck would have it, Dr. Chu had a way to monitor the region. For months, as part of a research project into the flu, she and a team of researchers had been collecting nasal swabs from residents experiencing symptoms throughout the Puget Sound region.


To repurpose the tests for monitoring the coronavirus, they would need the support of state and federal officials. But nearly everywhere Dr. Chu turned, officials repeatedly rejected the idea, interviews and emails show, even as weeks crawled by and outbreaks emerged in countries outside of China, where the infection began.


By Feb. 25, Dr. Chu and her colleagues could not bear to wait any longer. They began performing coronavirus tests, without government approval.


What came back confirmed their worst fear. They quickly had a positive test from a local teenager with no recent travel history. The coronavirus had already established itself on American soil without anybody realizing it.


“It must have been here this entire time,” Dr. Chu recalled thinking with dread. “It’s just everywhere already.”


In fact, officials would later discover through testing, the virus had already contributed to the deaths of two people, and it would go on to kill 20 more in the Seattle region over the following days.


Federal and state officials said the flu study could not be repurposed because it did not have explicit permission from research subjects; the labs were also not certified for clinical work. While acknowledging the ethical questions, Dr. Chu and others argued there should be more flexibility in an emergency during which so many lives could be lost. On Monday night, state regulators told them to stop testing altogether.


The failure to tap into the flu study, detailed here for the first time, was just one in a series of missed chances by the federal government to ensure more widespread testing during the early days of the outbreak, when containment would have been easier. Instead, local officials across the country were left to work blindly as the crisis grew undetected and exponentially.


Even now, after weeks of mounting frustration toward federal agencies over flawed test kits and burdensome rules, states with growing cases such as New York and California are struggling to test widely for the coronavirus. The continued delays have made it impossible for officials to get a true picture of the scale of the growing outbreak, which has now spread to at least 36 states and Washington, D.C.


Dr. Robert R. Redfield, director of the Centers for Disease Control and Prevention, said in an interview on Friday that acting quickly was critical for combating an outbreak. “Time matters,” he said.

疾病控制与预防中心(Centers for Disease Control and Prevention)主任罗伯特·R·雷德菲尔德(Robert R. Redfield)博士在周五的一次采访中表示,迅速采取行动对抗击疫情至关重要。他说:“时间很重要。”

He insisted that despite the rocky start, there was still time to beat back the coronavirus in the United States. “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.”


But the Seattle Flu Study illustrates how existing regulations and red tape — sometimes designed to protect privacy and health — have impeded the rapid rollout of testing nationally, while other countries ramped up much earlier and faster. Faced with a public health emergency on a scale potentially not seen in a century, the United States has not responded nimbly.


The C.D.C.’s own effort to create a system for monitoring the virus around the country, using established government surveillance networks for the flu, has not yet built steam. And as late as last week, after expanding authorizations for commercial and academic institutions to make tests, administration officials provided conflicting accounts of when a significant increase in tests would be available.


In states like Maine, Missouri and Michigan, where there are few or no known infections, state public health officials say they have more than enough tests to meet demand.


But it remains unclear how many Americans have been tested for the coronavirus. The C.D.C. says approximately 8,500 specimens or nose swabs have been taken since the beginning of the outbreak — a figure that is almost certainly larger than the number of people tested since one person can have multiple swabs. By comparison, South Korea, which discovered its first case around the same time as the United States, has reported having the capacity to test roughly 10,000 people a day since late February.



T.J. Kirkpatrick for The New York Times

A prime mission


As soon as the genetic sequence of the coronavirus was published in January, the C.D.C.’s first job was to develop a diagnostic test. “That’s our prime mission,” Dr. Redfield said, “to get eyes on this thing.”


The agency also released criteria for deciding which individuals should be tested for the virus — at first only those who had a fever and respiratory issues and had traveled from the outbreak’s origin in Wuhan, China.


The criteria were so strict that the sick man in the Seattle area who had visited Wuhan did not meet it. Still, worried state health officials pushed to get him checked, and the C.D.C. agreed. Local officials sent a sample to Atlanta and the results came back positive.


Officials monitored 70 people who were in contact with the man, including 50 who consented to getting nose swabs, and none tested positive for the coronavirus. But there was still the possibility that someone had been missed, said Dr. Scott Lindquist, the state epidemiologist for communicable diseases.

官员们监测了70名与该男子有接触的人,其中有50名同意接受鼻拭子取样,无一人检测到冠状病毒呈阳性。但是,华盛顿州负责传染病的流行病学家斯科特·林德奎斯特(Scott Lindquist)博士说,仍然有可能漏掉一些人。

Around this time, the Washington State Department of Health began discussions with the Seattle Flu Study already going on in the state.


But there was a hitch: The flu project primarily used research laboratories, not clinical ones, and its coronavirus test was not approved by the Food and Drug Administration. And so the group was not certified to provide test results to anyone outside of their own investigators. They began discussions with state, C.D.C. and F.D.A. officials to figure out a solution, according to emails and interviews.


Dr. Scott F. Dowell, a former high-ranking C.D.C. official and a current deputy director at the Bill & Melinda Gates Foundation, which funds the Seattle Flu Study, asked for help from the leaders of the C.D.C.’s coronavirus response. “Hoping there is a solution,” he wrote on Feb. 10.

前疾控中心高级官员斯科特·道威尔(Scott F. Dowell)博士现在是比尔和梅琳达·盖茨基金会(Bill&Melinda Gates Foundation)的副主任,该基金会资助了西雅图流感研究,他向疾控中心负责应对冠状病毒的主管寻求帮助。他在2月10日写道:“希望能有个解决的办法。”

Later, Dr. Lindquist, the state epidemiologist in Washington, wrote an email to Dr. Alicia Fry, the chief of the C.D.C.’s epidemiology and prevention branch, requesting the study be used to test for the coronavirus.

后来,华盛顿州流行病学家林德奎斯特致信疾控中心流行病学和预防部门负责人阿丽莎·弗莱(Alicia Fry)博士,要求将该研究用于监测冠状病毒。

C.D.C. officials repeatedly said it would not be possible. “If you want to use your test as a screening tool, you would have to check with F.D.A.,” Gayle Langley, an officer at the C.D.C.’s National Center for Immunization and Respiratory Disease, wrote back in an email on Feb. 16. But the F.D.A. could not offer the approval because the lab was not certified as a clinical laboratory under regulations established by the Centers for Medicare & Medicaid Services, a process that could take months.

疾控中心官员们一再表示不可能。疾控中心国家免疫与呼吸疾病中心的官员盖尔·兰利(Gayle Langley)在2月16日的一封电子邮件中写道:“如果要将你的测试用作筛查工具,你必须去问FDA。”但是FDA无法提供批准,因为该实验室未根据联邦医疗保险与医疗补助服务中心(Centers for Medicare&Medicaid Services)建立的法规认证为临床实验室——此过程可能需要数月的时间。

Dr. Chu and Dr. Lindquist tried repeatedly to wrangle approval to use the Seattle Flu Study. The answers were always no.


“We felt like we were sitting, waiting for the pandemic to emerge,” Dr. Chu said. “We could help. We couldn’t do anything.”



CDC, via Associated Press

Sense of exasperation


As Washington State debated with the federal officials over what to do, the C.D.C. confronted the daunting task of testing more widely for the coronavirus.


The C.D.C. had designed its own test as it typically does during an outbreak. Several other countries also developed their own tests.


But when the C.D.C. shipped test kits to public labs across the country, some local health officials began reporting that the test was producing invalid results.


The C.D.C. promised that replacement kits would be distributed within days, but the problem stretched on for over two weeks. Only five state laboratories were able to test in that period. Washington and New York were not among them.


By Feb. 24, as new cases of the virus began popping up in the United States, the state labs were growing frantic.


The Association of Public Health Laboratories made what it called an “extraordinary and rare request” of Dr. Stephen Hahn, the commissioner of the F.D.A., asking him to use his discretion to allow state and local public health laboratories to create their own tests for the virus.

美国公共卫生实验室协会(Association of Public Health Laboratories)向FDA局长斯蒂芬·哈恩(Stephen Hahn)博士提出了一个“非同寻常而罕见的要求”,要求他使用自由裁量权,允许州和地方公共卫生实验室自行进行病毒检测。

“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, the chief executive of the association, wrote in a letter to Dr. Hahn.

“我们的应对行动已经进行了好几个星期,绝大多数成员实验室在CDC之外仍然没有可用的诊断或监测检测,”该协会的首席执行官斯科特·贝克尔(Scott Becker)在给哈恩的信中写道。

Dr. Hahn responded two days later, saying in a letter that “false diagnostic test results can lead to significant adverse public health consequences” and that the laboratories were welcome to submit their own tests for emergency authorization.


But the approval process for laboratory-developed tests was proving onerous. Private and university clinical laboratories, which typically have the latitude to develop their own tests, were frustrated about the speed of the F.D.A. as they prepared applications for emergency approvals from the agency for their coronavirus tests.


Dr. Alex Greninger, an assistant professor at the University of Washington Medical Center in Seattle, said he became exasperated in mid-February as he communicated with the F.D.A. over getting his application ready to begin testing. “This virus is faster than the F.D.A.,” he said, adding that at one point the agency required him to submit materials through the mail in addition to over email.

西雅图华盛顿大学医学中心(University of Washington Medical Center)的助理教授亚历克斯·格瑞宁格(Alex Greninger)博士说,他在2月中旬与FDA就开始检测进行申请沟通时,被弄得不胜其烦。“这种病毒可比FDA快,”他还说,该机构曾一度要求他除了通过电子邮件提交材料外,还要通过信件提交材料。

New tests typically require validation — running the test on known positive samples from a patient or a copy of the virus genome. The F.D.A.’s process called for five. Obtaining such samples has been hard because most hospital labs have not seen coronavirus cases yet, said Dr. Karen Kaul, chair of the department of pathology and laboratory medicine at NorthShore University HealthSystem in Illinois.

新检测通常需要验证——对来自患者或病毒基因组副本的已知阳性样本进行检测。FDA的程序需要五个样本。伊利诺伊州北岸大学卫生系统(NorthShore University HealthSystem)病理与实验室医学部主任凯伦·考尔(Karen Kaul)博士说,获得这样的样本很困难,因为大多数医院的实验室还没有发现冠状病毒病例。

She said she had to scramble to obtain virus RNA from a laboratory in Europe. “Everyone is trying to figure out what we can get to help us gather the data that we need,” she said.


The F.D.A. has disputed that it moved too slowly, saying that it provided emergency authorization for two laboratory-developed tests within 24 hours of a completed submission — one was the C.D.C.’s test and the other a test developed by New York’s Wadsworth laboratory after it had trouble verifying the C.D.C.’s test.


‘What do we do?’


On the other side of the country in Seattle, Dr. Chu and her flu study colleagues, unwilling to wait any longer, decided to begin running samples.


A technician in the laboratory of Dr. Lea Starita who was testing samples soon got a hit.

利亚·斯塔里塔(Lea Starita)实验室检测样本的一名技术员,很快就遭到当头一棒。

“I’m like, ‘Oh my God,”’ Dr. Starita said. “I just took off running” to the office of the study’s program managers. “We got one,” she told them. “What do we do?”


Members of the research group discussed the ethics of what to do next.


“What we were allowed to do was to keep it to ourselves,” Dr. Chu said. “But what we felt like we needed to do was to tell public health.”


They decided the right thing to do was to inform local health officials.


The case was a teenager, in the same county where the first coronavirus case had surfaced, who had a flu swab just a few days before but had no travel history and no link to any known case.


The state laboratory, finally able to begin testing, confirmed the result the next morning. The teenager, who had recovered from his illness, was located and informed just after he entered his school building. He was sent home and the school was later closed as a precaution.


Later that day, the investigators and Seattle health officials gathered with representatives of the C.D.C. and the F.D.A. to discuss what happened. The message from the federal government was blunt. “What they said on that phone call very clearly was cease and desist to Helen Chu,” Dr. Lindquist remembered. “Stop testing.”


A silent spread


Still, the troubling finding reshaped how officials understood the outbreak. Seattle Flu Study scientists quickly sequenced the genome of the virus, finding a genetic variation also present in the country’s first coronavirus case.

尽管如此,这一令人不安的发现改变了官员们对疫情的理解。西雅图流感研究所(Seattle Flu Study)的科学家迅速对病毒的基因组进行了测序,发现在美国首例冠状病毒病例中也存在遗传变异。

The implications were unnerving. There was a good chance that the virus had been circulating silently in the community for around six weeks, infecting potentially hundreds of people.


On a phone call the day after the C.D.C. and F.D.A. had told Dr. Chu to stop, officials relented, but only partially, the researchers recalled. They would allow the study’s laboratories to test cases and report the results only in future samples. They would need to use a new consent form that explicitly mentioned that results of the coronavirus tests might be shared with the local health department.


They were not to test the thousands of samples that had already been collected.


The same day, the F.D.A. said it would relax its rules and allow clinical labs to begin using their own coronavirus tests as long as they submitted evidence that they worked to the agency. Under that new policy, according to an agency representative on Tuesday, it had heard from 14 labs, with 10 already beginning patient testing.


On March 2, the Seattle Flu Study’s institutional review board at the University of Washington determined that it would be unethical for the researchers not to test and report the results in a public health emergency, Dr. Starita said. Since then, her laboratory has found and reported numerous additional cases, all of which have been confirmed.

斯塔里塔说,3月2日,华盛顿大学(University of Washington)西雅图流感研究所审查委员会认定,在公共卫生紧急情况下,研究人员如果不进行检测并报告结果,是不道德的。从那时起,她的实验室发现并报告了许多其他病例,所有病例均已得到确认。

As new samples came in, Dr. Starita’s laboratory also worked their way backward through some older samples that had been sitting in the freezers for weeks, finding cases that date back to at least Feb. 20 — seven days before public health officials had any idea the virus was in the community.


The scientists said they believe that they will find evidence that the virus was infecting people even earlier, and that they could have alerted authorities sooner if they had been allowed to test.


But on Monday night, state regulators, enforcing Medicare rules, stepped in and again told them to stop until they could finish getting certified as a clinical laboratory, a process that could take many weeks.


In the days since the teenager’s test, the Seattle region has spun into crisis, with dozens of people testing positive and at least 22 dying — many of them infected in a nursing home that had unknowingly been suffering casualties since Feb. 19.



Hiroko Masuike/The New York Times

The availability of testing for coronavirus remains uneven, with some people able to easily obtain tests in certain parts of the country while others have been turned away. Some state officials fear that the virus is spreading far faster than the capacity for testing is increasing.


Looking back, Dr. Chu said she understood why the regulations that stymied the flu study’s efforts for weeks existed. “Those protections are in place for a reason,” she said. “You want to protect human subjects. You want to do things in an ethical way.”


The frustration, she said, was how long it took to cut through red tape to try to save lives in an outbreak that had the potential to explode in Washington State and spread in many other regions. “I don’t think people knew that back then,” she said. “We know it now.”