‘It’s Just Everywhere Already’: How Delays in Testing Set Back the U.S. Coronavirus Response A series of missed chances by the federal government to ensure more widespread testing came during the early days of the outbreak, when containment would have been easier. A research project in Seattle tried to conduct early tests for the new coronavirus but ran into red tape before circumventing federal officials and confirming a case. A research project in Seattle tried to conduct early tests for the new coronavirus but ran into red tape before circumventing federal officials and confirming a case.Credit...Grant Hindsley for The New York Times By Sheri Fink and Mike Baker March 10, 2020 Updated 10:27 p.m. ET Dr. Helen Y. Chu, an infectious disease expert in Seattle, knew that the United States did not have much time. 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. 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. Get an informed guide to the global outbreak with our daily coronavirus newsletter. 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. 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. 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. 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. 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. 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.” 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. “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. 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. 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. 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. “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. 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. 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. 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.” Reporting was contributed by Nicholas Bogel-Burroughs, Joseph Goldstein, Sheila Kaplan, Michael D. Shear, Knvul Sheikh, Katie Thomas and Noah Weiland. The Coronavirus Outbreak How Is the U.S. Being Affected? Updated March 10, 2020 More than 973 people across the country have tested positive, according to a New York Times database, and at least 30 patients with the virus have died. We are tracking every case. Early in the outbreak of the coronavirus, the U.S. missed key opportunities to test for the disease widely. Now, "it's just everywhere already." With the coronavirus spreading, colleges and universities are cancelling classes and moving them online. Medical researchers say the half-million homeless people across the United States have a heightened vulnerability to the coronavirus. Facing the threat of the coronavirus, schools are trying distance learning on a massive scale. We followed a town in the Seattle area that was the first to move all of its classes online. Nursing homes should bar most family and friend visits, the industry says. At least 19 people have died in nursing homes in Washington State. After days awaiting clearance to come ashore, the Grand Princess arrived in the San Francisco Bay with 21 confirmed coronavirus cases on board, and possibly more. Misinformation about the coronavirus is spreading despite aggressive countermeasures from social media companies. Cut off from their relatives inside the virus-stricken nursing center in Kirkland, Wash., families are frantically searching for help and basic information. Many health care workers say they lack protective gear and protocols to keep themselves and their patients safe. Six Americans who have tested positive spoke to The Times about their experiences. An outbreak would test the American education system. Few schools have detailed plans to teach online if schools were closed for long periods. Most experts agree: To protect yourself wash your hands and avoid touching your face. For an informed guide to the outbreak, sign up for our coronavirus newsletter.
这得怪卫生部门和CDC隔离工作没做好。隔离的70个里还有20个根本没测。 怎么能怪病人 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.
看了全文 满满的frustration啊 科学家太不容易了 明明知道可以阻止一场灾难 却被捆住手脚 左B害死美国 都pandemic了 还privacy这个那个 虽然这是对的 但是在整个国家的安危都受到威胁的时候 privacy的尺度可以调整 毕竟没有真的泄露别人姓啥名啥 制度真的是太缺乏弹性了 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.
看了全文 满满的frustration啊 科学家太不容易了 明明知道可以阻止一场灾难 却被捆住手脚 左B害死美国 都pandemic了 还privacy这个那个 虽然这是对的 但是在整个国家的安危都受到威胁的时候 privacy的尺度可以调整 毕竟没有真的泄露别人姓啥名啥 制度真的是太缺乏弹性了 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. Narnia 发表于 3/11/2020 1:17:46 AM
说cdc不是故意阻挠我都不信！ 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. Dr. Chu and Dr. Lindquist tried repeatedly to wrangle approval to use the Seattle Flu Study. The answers were always no.
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。
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。
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。
https://www.nytimes.com/2020/03/10/us/coronavirus-testing-delays.html
没看全文。
不管是不是他带来的。
即使是他带来的，本来可以只影响他一个人或者有限的几个人。
但扩大，是CDC的责任。
so？？人家是拒绝就诊了还是撒谎了？cdc知道有了病例还不赶紧警惕起来就是吃屎的。武汉人民的牺牲算是白费了。
有没有证据支持这20个不同意检测的人1）自己被确诊 2）他们都没有被确诊，但是最近确诊并感染源unknown的人跟他/她们有直接接触
谢谢
因为Ebola的时候，感染的人还告医院，左臂法官瞎判导致的结果。
Chu，華人吧。還是華人敢幹。
我期待着一场对渎职害命的CDC 的审判
这次风波之后，美国医学院的AA风会不会停了。希望左派认识到那真会出人命的
歪哥那个文章，真心是洗地的
“它已经无处不在”：美国如何错失了遏制新冠病毒的良机？ SHERI FINK, MIKE BAKER
2020年3月11日
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。
1月下旬，美国首例确诊冠状病毒病例落在了她所在的地区。一些关键问题有待解答：这个人感染了其他人吗？致命病毒是否已经潜伏在其他社区并在传播？
凑巧的是，海伦·朱有办法监测该地区。几个月来，作为针对流感的研究项目的一部分，她和一组研究人员一直在整个普吉特海湾地区出现症状的居民中收集鼻拭子。
为了将测试重新用于监测冠状病毒，他们需要州和联邦官员的支持。但是，采访和电子邮件表明，尽管经过了数周时间，并且感染开始在中国（感染最初开始的地方）以外的国家出现，在海伦·朱求助过的几乎所有机构里，官员们都反复拒绝了这个想法。
到2月25日，海伦·朱和她的同事再也等不下去了。他们未经政府批准就开始进行冠状病毒测试。结果证实了他们最大的恐惧。他们很快从一个没有近期旅行史的当地青少年的测试中得到了阳性结果。冠状病毒已经神不知鬼不觉地在美国领土立足。
“肯定一直都在这里，”海伦·朱惶惶不安地回忆道。“它已经无处不在。”
实际上，官员后来通过测试发现，该病毒已经造成了两人死亡，并且在接下来的几天里又导致了20人死亡。
联邦和州官员说，由于没有得到研究对象的明确许可，实验室也未获得临床工作认证，该流感研究不能被再利用。海伦·朱等人承认存在伦理问题，但同时也认为，在关乎众多生命的紧急情况下，应该有更大的灵活性。周一晚上，州监管机构要求他们完全停止测试。
在暴发初期、疫情相对容易控制的阶段，联邦政府屡屡错失进行更大范围测试的机会，本报道首次披露的未能利用流感研究一事，就是其中一例。危机在不知不觉中急剧恶化，全国各地的地方官员却只能盲目应对。
即使到了现在，由于检测试剂盒的缺陷以及繁冗的规则，人们对联邦政府的不满也与日俱增，像纽约州和加利福尼亚州这样病例数不断增加的州仍在奋力进行对冠状病毒的广泛测试。持续的延误使官员们无法对不断扩大的疫情规模有真实的了解，疫情现已蔓延至至少36个州以及华盛顿特区。
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。”
他坚称尽管起步艰难，美国仍有时间击败冠状病毒。“这将需要严格、积极主动的公众卫生——我想说的是，阻断并处理，阻断并处理，阻断并处理，阻断并处理，”他说。“这意味着如果你发现了一个新病例，要进行隔离。”
但是从西雅图的流感研究可见，现行的监管和繁琐程序——有时旨在保护隐私和健康——如何导致无法快速进行全国范围的测试，而其他国家却可以更早、更迅速地进行。面对可能是百年一遇的公共卫生突发事件，美国未能做出灵活反应。
疾控中心自己的努力，即利用现成的政府流感监控网络建立全国范围内的病毒监控系统，目前尚未运转起来。直到上周，在扩大了对商业和学术机构进行测试的授权之后，对于何时可以大量增加测试，本届政府官员给出的说法不一。在如缅因州、密苏里州和密歇根州等很少或没有已知感染的州，州公共卫生官员说他们有过剩的检测试剂盒。
但目前尚不清楚有多少美国人接受过冠状病毒检测。疾控中心表示，自疫情暴发以来已采集了约8500个标本或鼻拭子——由于一个人可以有多个拭子，这一数字几乎肯定要高于被检测的人数。相比之下，据报道，与美国在同一时间发现了第一例病例的韩国，自2月底以来每天有能力测试约一万人。
首要任务
冠状病毒的基因序列在1月发布后，疾控中心的第一项工作就是开发诊断测试。“我们的首要任务，”雷德菲尔德说，“就是能看到这东西。”
该机构还发布了决定对哪些人进行病毒检测的标准——起初仅包括那些出现发烧和呼吸道疾病且曾前往疫情起源地中国武汉的人。
该标准实在太严格，以至于西雅图地区那名有过武汉旅行史的病患都达不到要求。不放心的州卫生官员仍要求对他进行检测，然后疾控中心同意了。当地官员向亚特兰大发送了一个样本，结果呈阳性。
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。
大约在这个时候，华盛顿州卫生部开始与该州已经进行的西雅图流感研究进行讨论。
但是有一个麻烦：流感项目主要使用研究实验室，而不是临床实验室，并且其冠状病毒测试未获得美国食品药品监督管理局(FDA)的批准。因此，该小组无权向除了自己的调查人员以外的任何人提供测试结果。根据电子邮件和采访显示，他们开始与国家疾控中心和FDA官员们讨论，设法解决这个问题。
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。”
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。
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。
海伦·朱和林德奎斯特曾多次试图争取批准使用西雅图流感研究。得到的回答始终是否定的。
“我们感觉在坐以待毙，等待大流行的到来，”海伦·朱说。“我们能帮忙。但我们什么都做不了。”
令人恼怒
在华盛顿州与联邦官员就如何行动争论不休的同时，疾控中心要面对的是一项艰难的任务——进行更广泛的冠状病毒测试。
按照疫情暴发期间的一贯做法，疾控中心设计了自己的测试。其他几个国家也开发了自己的测试。
但是当疾控中心将检测试剂盒运送到全国各地的公共实验室时，一些当地官员开始报告说该测试产生了无效的结果。
CDC承诺在几天内分发新试剂盒，但问题持续了两周多。在此期间，只有5个州实验室能够进行检测。华盛顿和纽约不在其中。
到2月24日，随着新的病例开始在美国出现，州实验室一片混乱。
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。
“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。
两天后，哈恩做出了回应，在信中表示，“错误的诊断检测结果可能会导致严重的不良公共卫生后果”，并表示欢迎各实验室提交自己的检测，以获得紧急授权。
但事实证明，实验室进行检测的审批过程十分繁琐。私人和大学的临床实验室通常有自行开发检测手段的自由，然而在获得FDA紧急批准的冠状病毒检测准备申请时，它们对FDA的速度感到失望。
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。
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。
她说，她不得不从欧洲的一个实验室里匆忙获取病毒RNA。“所有人都在试图弄清楚我们能得到什么来帮助我们收集需要的数据，”她说。
FDA不同意其行动太慢的说法，并表示它在提交完整报告后的24小时内为两项实验室开发的检测提供了紧急授权——其中一个是CDC的检测，另一个是纽约沃兹沃斯实验室(Wadsworth)在核实CDC的检测遇到困难后研发的一种检测。
“我们该怎么办？”
在美国另一边的西雅图，海伦·朱博士和她研究流感的同事不愿再等下去，决定开始检测样本。
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。
“我说，‘哦，天哪，’”斯塔里塔博士说。“我一路跑着”去了研究项目经理的办公室。“我们有一个确诊，”她告诉他们。“我们该怎么办？”
研究小组的成员讨论了下一步行动的道德问题。
“我们被允许做的事情是不让别人知道，”海伦·朱说，“但我们觉得我们需要做的，是告诉公共卫生部门。”
他们决定，正确的做法是通知当地的卫生官员。
该病例为一名十来岁的青少年，与首例冠状病毒病例在同一个县，他在几天前刚做过流感拭子，但他没有旅行史，与任何已知病例也没有联系。
终于可以开始进行测试的州实验室在第二天早上确认了结果。这名少年刚进入学校大楼就被找到，并通知了警方。他被送回家，后来为了预防起见，学校停课。该少年目前已从疾病中恢复。
当天晚些时候，调查人员、西雅图卫生官员与CDC和FDA的代表聚集在一起，讨论发生的事情。来自联邦政府的信息直截了当。“他们在电话里说的很清楚，就是让海伦·朱住手，不要再这么干了，”林德奎斯特回忆说，“停止测试”。
无声的蔓延
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。
其含义令人不安。该病毒很有可能已经在社区内悄无声息地传播了大约六周，感染了数百人。
研究人员回忆说，在CDC和FDA要求海伦·朱停止检测的第二天，官员们打来电话，态度有所缓和，但只是部分缓和。他们将允许该研究所的实验室测试病例，并只对未来的样本报告结果。他们将需要使用一份新的同意书，明确提到冠状病毒检测的结果可能会与当地卫生部门共享。
他们不对已收集的数千个样本进行检测。
同一天，FDA表示将放宽规定，允许临床实验室开始使用自己的冠状病毒测试，只要他们向FDA提交他们工作的证据。周二，一名机构代表称，根据这项新政策，它已经收到14家实验室的提交，其中10家已经开始对患者进行检测。
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。
在新样本到来的同时，斯塔里塔的实验室也开始追溯一些较老的、在冰柜里放了几周的样本，发现了至少可以追溯到2月20日的病例——这是在公共卫生官员对这种病毒有概念的七天前。
科学家们说，他们相信会找到证据，证明这种病毒在更早的时间里就感染了人，如果允许他们进行检测，他们本可以更早地通知有关部门。
但在周一晚上，执行医疗保险规定的州监管机构介入，再次要求他们停止工作，直到完成临床实验室的认证，这一过程可能需要数周时间。
在那名少年接受检测后的几天里，西雅图地区陷入了危机，数十人检测呈阳性，至少22人死亡，其中许多人是在一家疗养院感染的，自2月19日以来，这家疗养院一直在不知不觉中有人感染。
冠状病毒检测仍然不是哪里都可以做，美国某些地区可以轻松进行检测，有些则不行。一些州的官员担心，病毒的传播速度远远超过了检测能力的增长速度。
海伦·朱说，现在回想起来，她能理解为什么过去几周有那些阻碍疫情研究的规定。“这些保护措施的存在是有原因的，”她说。“你想保护实验对象。你想以合乎道德的方式做事。”
她说，令人沮丧的是，在一场可能在华盛顿州暴发，并在许多其他地区蔓延的疫情中，人们花了许多时间才得以突破繁文缛节去挽救生命。“我想那时候人们不知道，”她说。“我们现在知道了。”
小左左不如仔细看看研究一下Ebola的时候，拒绝隔离的病人是如何告的，再好好瞧一瞧左臂法官是如何判的。美国就是被左左搞的一团乱的。
被拒绝的那个不是从非洲故意坐飞机跑来美国的那个？
没irb的情况下敢测敢报
这可以算是美国的whistleblower了
隔壁说美国医疗系统不可能封口的出来走两步？
这一次华人很长脸啊。
还要感谢为Seattle Flu Study买单的Bill Gates! 不靠政府funding,说话办事就是有底气！
是的，税钱交了真是钱扔到水里的感觉，还因为养的这堆官僚废物浪费了宝贵时间。
其实对熬身份的小左来说，美国毁了，你的努力还有什么意义呢。想明白这点，就知道屁股做哪里了
美国主党的这种幺蛾子政策才是各种乱象的根源，之前据说医学院已经要AA了...如果这你都能为主党叫好，只能是真爱了
那保险可以拒付费用吗？因为耽搁，所以病情恶化，需要更多治疗。
好像也不能，除非保险有要求。
撤侨的时候就有人拒绝检测。