当选总统乔·拜登s承诺改革新冠肺炎(新型冠状病毒肺炎)测试给专家们带来了新的乐观情绪,他们几个月来一直警告说,美国目前的方法不起作用。
拜登的目标,比如增加测试地点,推动家庭测试套件的开发,以及寻找资金来完成他的计划,说起来容易做起来难——但是,专家说,它们不是不可能的。
这场毁灭性的大流行已经持续了将近一年,感染率正在飙升;随着美国连续经历严峻的里程碑,美国仍然缺乏对其全体人口进行例行测试的能力。
“没有行动手册”来应对因测试失败而出现的不稳定开局
随着病毒积聚力量和速度,开发一种可靠的检测方法的努力被问题困扰从一开始:缓慢的反应时间,稀缺的供应,以及瓶颈的结果。测试的便捷性面临着严重的问题不公平的分配和不一致的价格点。
“没有诊断的剧本。没有游戏计划。什么都没有,”助理卫生与公众服务部部长布雷特·吉洛尔上将说说回顾今年7月。“我们真的需要从头开始。”
专家表示,对特朗普政府来说,清晰的公共信息似乎是一场斗争:特朗普称测试是一把“双刃剑”,并一再指责正在进行的测试数量因为全国的高病例数。
拜登将继承一个以延误和混乱信息为标志的长期全球健康危机。医学官员说,我们需要每天在全国范围内进行数百万次检测,才能对这种流行病做出有意义的缓解。
“我们还没有接近发现任何一天发生的大多数病例,”哈佛陈氏公共卫生学院流行病学助理教授迈克尔·米娜博士告诉美国广播公司新闻。“现在,洪水正在涌入水桶,我们用茶匙试图将水铲出。就是不行。”
一些州一直在试验同时对人群进行测试,这被称为“集体测试”。另一项战略包括废水监控在某些人群中。联邦政府已经推出了1.5亿雅培BinaxNOW快速抗原测试,用于跟踪病毒。与此同时,纽约州一直率先将大规模测试作为一种监控工具,在“微集群”热点聚集蒸汽之前将其锁定。
专家强调,测试的重要性不在于诊断和统计病例。它可以作为阻止新冠肺炎病毒在传染性人群中传播的重要工具,尽管可能没有症状。
美国临床实验室协会主席朱莉·卡尼(Julie Khani)在3月份首次会见了特朗普政府的白宫冠状病毒特别工作组,讨论实验室在扩大足够的测试能力方面的作用。卡尼告诉美国广播公司新闻,几个月后,她在第一次会议上提出的三个核心需求保持不变。
卡尼说:“为了满足日益增长的检测需求,临床实验室需要一致的供应渠道、充足和可预测的报销以及对临床医生应该检测谁的明确指导。”“当每周都有成千上万的美国人死于新冠肺炎时,我们相信有一个全面的联邦战略来支持广泛的新冠肺炎测试是至关重要的,包括覆盖所有美国人的这些测试,无论他们的保险状况如何。”
我们有很多不同的杠杆可以利用。
当拜登在1月份执掌国家大权时,这位前副总统上任的第一天将标志着新型冠状病毒诞生整整一年最早发现于美国。
周一,拜登宣布了他的冠状病毒特遣队成员并呼吁建立一个新的流行病测试委员会;他承诺将得来速测试站点的数量增加一倍,并投资于“下一代”测试,包括在家快速测试。
“需要采取大胆的行动来抗击这一流行病。我们仍然面临一个非常黑暗的冬天,”拜登说。“底线是,一旦我们在1月20日宣誓就职,我将不遗余力地扭转这一流行病。”
他的团队还没有为他们的优先在测试和联系追踪基础设施中,作为总统交接工作的一部分,这项工作的计划刚刚开始。
“这是一个关键时刻,我认为有一个不可思议的机会来发出一个严肃的需求信号,并找到创造性的解决方案,”流行病学家、经济学家、白宫冠状病毒特别工作组前成员布莱斯·阿达姆松博士告诉美国广播公司新闻。“即使疫苗对公众开放,也需要相当长的时间来推广。而且我们还需要长时间的测试。”
领导本届政府新冠肺炎测试工作的吉洛尔周一告诉记者,他在拜登-哈里斯合作研究小组的信息中没有看到任何不同于机构已经在测试中所做的事情。
“我只知道我在文献中读到的,我没有在测试策略中看到任何东西,老实说,我们还没有这样做,”他说。“我们正在投资护理点技术。我们有高度的监管授权。我们在生态系统的各个层面上工作。...所以,还是那句话,我没有在文献上看到任何东西,或者任何新的想法。”
专家们强调了“良好的资源管理”向前推进的重要性:在正确的时间将正确的测试部署到正确的人和地点,并强化重要的供应链要素。
“我们有很多不同的杠杆可以利用,”阿达姆松说。"我希望他们先选出效果最好的."
一个紧张的系统向前看
诊断实验室和测试行业消息人士告诉美国广播公司新闻,由于今年夏天病毒激增,测试结果延迟,这种刺痛仍然存在。
这种痛苦可能还没有结束。周四,卡尼警告称,随着新的感染浪潮,检测需求正在上升——再次威胁到供应链的压力。
“随着全国各地对检测的需求激增,ACLA成员实验室正在经历新冠肺炎检测订单量的大幅增加。卡尼在一份声明中说:“临床实验室也面临着关键供应品(如移液器吸头)订单的延迟或取消。”“测试需求的激增将意味着一些成员可能达到或超过他们目前的测试能力。”
对于一个紧张的系统来说,拜登进一步投资的迹象是受欢迎的。
美国临床化学协会主席大卫·格雷纳奇博士说:“我们掌握加强测试的方法是绝对必要的。”。“我不敢相信我们已经进行了10个月、11个月,现在又回到了今年春天和初夏,病例增长非常快。实验室仍然存在容量问题。”
“几个月来,每个实验室、每个州都在为自己争取获得测试、用品和我们进行这一关键测试所需的一切,我们还没有一个国家战略,”格莱纳奇继续说。“这不是一项容易的任务。这需要大量的合作。”
许多人预见拜登政府面临的挑战将是带领疲惫的人民度过漫长的健康危机--在一个极度分裂的国家。
阿达姆松说:“我们对病毒和疾病进展有了更多的了解,这将使科学小组能够给出更实际的指导……即使是以前的工作组也没有这些信息。”。“有太多的不确定性。现在我们有机会指导哪些测试应该在哪里使用,因为我们已经过了仅仅诊断病例的阶段。”
除了支撑基础设施,专家们还强调了保持清晰的公共信息的重要性。
“我们需要确定我们的目标,”米娜说。“这些测试不关心某人是否有症状。他们只关心某人是否感染了病毒。”
阿达姆松说,有了明确的公共信息,可能会引入新的激励措施,这可能会激励广泛的测试,并有助于为我们的知识库提供信息。
阿达姆松说:“雇主可以通过与诊断测试供应商合作,为员工提供批量折扣测试,以确保为员工提供测试。”。“然后你用这些数据来确保你工作场所的安全协议起作用,因为你可以记录感染情况。因此它创造了溢出效益。它不仅仅是一种为个人决策提供信息的测试,它还能促进监控和健康情报决策。”
现在,拜登团队在侧翼等待和计划。
米娜说:“现在他们应该与制造商合作,即使目前没有正式的权力,也可以进行很多握手。”。“他面前有一个艰巨的挑战。但是像这样的流行病应该是这个国家的一个振奋人心的事件——每个人都可以团结在一起战胜它。我们还没有看到这种情况发生。”
Joe Biden's COVID-19 testing plans energize scientists, but lack price tag or specifics
President-electJoe Biden'spledge to revolutionizeCOVID-19testing has offered new optimism to experts who have for months warned that the current U.S. approach isn't working.
Biden's goals, such as increasing testing locations, pushing the development of at-home test kits and finding the money to accomplish his plans, are easier said than done - but, they're not impossible, experts say.
Nearly a year into this crippling pandemic, infection rates are surging; as the nation barrels past consecutive grim milestones, the U.S. still lacks the ability to routinely test its entire population.
'No playbook' for a rocky start flecked by testing failures
As the virus gathered strength and speed, efforts to develop a reliable detection method wereplagued with problemsfrom the start: slow response times, scarce supplies, and bottlenecked results. Easy access to testing has facedserious issuesof inequitable distribution and inconsistent price points.
"There was no playbook for diagnostics. There's no game plan. There was nothing,” Assistant Health and Human Services Secretary Adm. Brett Giroirsaidlooking back in retrospect this July. “We really needed to start from square one.”
Clarity of public messaging appeared to be a struggle for the Trump administration, experts say: Trump, calling testing a "double-edged sword," has repeatedly blamed thenumber of tests being donefor the nation's high case count.
Biden will inherit an extended global health crisis mile-marked by delay and muddled messaging. Medical officials say we need millions more tests a day nationwide to make a meaningful dent in the pandemic.
"We haven't come anywhere close to finding a majority of the cases occurring on any given day," Dr. Michael Mina, assistant professor of epidemiology at Harvard T.H. Chan School of Public Health, told ABC News. "Right now, we have a flood happening that's pouring into a bucket, and we're using a teaspoon to try and shovel the water out. It's just not working."
Some states have been experimenting with testing groups of people at once, known as “pool testing.” Another strategy has includedwastewater surveillanceof certain populations. The federal government has pushed out 150 million Abbott BinaxNOW rapid antigen tests to be used to track the virus. New York state, meanwhile, has been at the vanguard of making tests available on a large scale as a surveillance tool, targeting "micro-cluster" hot spots before they gather steam.
Experts emphasize that the importance of testing is not relegated to diagnosing and tallying cases. It can serve as an essential tool in stemming COVID-19's spread among contagious -- though perhaps asymptomatic -- individuals.
American Clinical Laboratory Association President Julie Khani met with the Trump administration's White House coronavirus task force for the first time in March to discuss the role of labs in scaling up adequate testing capacity. Khani told ABC News, the same three core needs she took into that first meeting remain the same, months later.
"To meet the growing need for testing, clinical labs need consistent access to supplies, adequate and predictable reimbursement and clear guidance to clinicians about who should be tested," Khani said. "At a time when thousands of Americans are dying from COVID-19 each week, we believe it's critically important there is a comprehensive federal strategy in place to support broad access to COVID-19 tests, including coverage of these tests for all Americans -- regardless of their insurance status."
'We have a lot of different levers that we can pull.'
When Biden takes the nation's reins in January, the former vice president's first full day in office will mark exactly one year since the novel coronavirus wasfirst discovered in the United States.
On Monday, Biden announced themembers of his coronavirus task forceand called for a new pandemic testing board; he pledged to double the number of drive-thru testing sites and invest in "next-generation" testing, including at-home rapid tests.
"There's a need for bold action to fight this pandemic. We're still facing a very dark winter," Biden said. "The bottom line, I will spare no effort to turn this pandemic around once we are sworn on Jan. 20."
His team has not yet specified a dollar amount for theirprioritiesin the testing and contact tracing infrastructure, as planning for that work just now gets underway as part of the presidential transition effort.
"It's a pivotal moment, and I think there's an incredible opportunity to send a serious demand signal, and find creative solutions," Dr. Blythe Adamson, an epidemiologist, economist and former member of the White House coronavirus task force, told ABC News. "Even when the vaccine becomes available to the public, it will take a meaningful amount of time for that to get rolled out. And we will still need tests for a long time."
Giroir, who has led the current administration's efforts on COVID-19 testing, told reporters Monday he didn't see anything in the information about the Biden-Harris COVID task force that's different from what the agencies are already doing on testing.
"I only know what I read in the literature and I haven't seen anything in the testing strategy, quite honestly, that we are not already doing," he said. "We're investing in point-of-care technologies. We have high regulatory authorizations on tap. We're working at all levels of the ecosystem. ... So, again, I haven't seen anything in the literature, or any new idea."
Experts emphasize the importance of "good stewardship of resources" moving forward: deploying the right tests to the right people and places at the right time, and fortifying essential supply chain elements.
"We have a lot of different levers that we can pull," Adamson said. "And my hope is that they pull the ones that work the best first."
A strained system looks ahead
Diagnostic labs and testing industry sources told ABC News that the sting is still raw from delayed test results amid the virus's surge this summer.
And that pain may not be over. On Thursday, Khani warned that the testing demand is rising with new infection waves -- again threatening to put strain on the supply chain.
"With demand for testing surging across the country, ACLA member laboratories are experiencing a significant increase in the volume of COVID-19 test orders. Clinical labs are also facing delays or cancellations on orders for critical supplies, such as pipette tips," Khani said in a statement. "The surge in demand for testing will mean that some members could reach or exceed their current testing capacities."
For a strained system, Biden's indication of further investment is welcome.
"It's absolutely essential that we get a handle on ramping up testing," Dr. David Grenache, president of the American Association for Clinical Chemistry, said. "I can't believe that we're 10, 11 months into this, and we're currently back to where we were this spring and early summer, with cases rising very quickly. And laboratories still have capacity issues."
"For months, it's been every laboratory, every state for themselves, clawing and fighting for access to tests, supplies, everything that we need to perform this critical testing, and we haven't had a national strategy," Grenache continued. "It's no easy task. And it's going to require an incredible amount of cooperation."
The challenge for Biden's administration that many foresee will be confronting the challenge of steering a weary people through the protractedhealthcrisis -- and amid a bitterly divided nation.
"There's opportunity in how much more we understand about the virus and disease progression that will enable science teams to be able to give more practical guidance… even the previous task force didn't have that information," Adamson said. "There was just so much uncertainty. Now we have the opportunity to guide which tests should be used where, now that we're past the point of just diagnosing cases."
Along with shoring up infrastructure, experts emphasize the importance of sustaining a clear public message going forward.
"We need to define our goals," Mina said. "These tests don't care if somebody has symptoms. They only care about whether somebody has the virus."
With clear public messaging, new incentives might be introduced that could motivate widespread testing and help inform our knowledge base, Adamson said.
"Employers could offer their employees testing, with a bulk discount by working with a diagnostic testing vendor to secure a supply for your employees," Adamson said. "Then you use that data to make sure the safety protocols in your workplace work, because you're able to keep a tab on the infections. And so it creates the spillover benefit. It's not just a test informing individual decision making, it fuels surveillance and health intelligence decisions."
For now, the Biden team waits, and plans, in the wings.
"Right now they should be working with manufacturers, and even if there's no formal power at the moment, there's a lot of handshakes that can be made," Mina said. "He has a formidable challenge in front of him. But something like an epidemic like this should be a galvanizing event for the country -- something everyone can rally around in defeating. And we haven't seen that happen yet."