美國向雅培購買1.5億張2019冠狀病毒病快速檢測卡。

10.7 (紐約時報)本文中文由Google翻譯，最後逐段對照處才經過翻譯改正。

The White House Bet on Abbott’s Rapid Tests. It Didn’t Work Out.

Federal officials relied too heavily on the tests, then took the results for granted, experts say.

Credit...Al Drago for The New York Times

Oct. 6, 2020, 11:48 a.m. ET

After months of crowded events and often maskless encounters, a growing number of top government officials, including President Trump, and their close contacts have tested positive for the coronavirus.

The fault for the outbreak lies in no small part with an ill-conceived disease-prevention strategy at the White House, health experts said: From the early days of the pandemic, federal officials have relied too heavily on one company’s rapid tests, with little or no mechanism to identify and contain cases that fell through the diagnostic cracks.

“It seems the White House put all their eggs in one basket: testing,” said Dr. Megan Ranney, an emergency medicine physician at Brown University. “But there is no single strategy, no single thing we can do to be safe. It has to be multimodal.”

Other health experts noted that the tests deployed by the White House, manufactured by Abbott Laboratories, were given emergency clearance by the Food and Drug Administration only for people “within the first seven days of the onset of symptoms.” But they were used incorrectly, to screen people who were not showing any signs of illness. Such off-label use, experts said, further compromised a strategy that presumably was designed to keep leading officials safe from a pandemic that so far has killed more than 210,000 Americans.

白宮押寶雅培快速測試。沒有成功。

專家說，聯邦官員過分依賴測試，然後認為結果是理所當然的。

特朗普總統於三月在白宮檢查了雅培實驗室的一項快速冠狀病毒測試。

特朗普總統於3月在白宮檢查了雅培實驗室的一項快速冠狀病毒檢測。Credit... Al Drago for the New York Times

凱瑟琳·吳

美國東部時間2020年10月6日，上午11:48

經過數月的擁擠事件和經常無遮遮掩掩的相遇後，包括特朗普總統在內的越來越多的高級政府官員及其親密接觸者的冠狀病毒測試呈陽性。

健康專家說，疫情的爆發絕大部分在於白宮的防病策略不周到：從大流行初期開始，聯邦官員就過於依賴一家公司的快速檢測，幾乎沒有或沒有機制來識別和遏制因診斷漏洞而導致的病例。

布朗大學的急診醫學醫師梅根·蘭尼（Megan Ranney）博士說：“白宮似乎把所有的雞蛋都放在一個籃子裡：進行檢測。” “但是沒有單一的策略，為了安全起見，我們無法做任何一件事情。它必須是多模式的。”

其他健康專家指出，由美國雅培實驗室（Abbott Laboratories）製造的白宮部署的測試僅在“出現症狀的前7天內”由美國食品藥品監督管理局（FDA）緊急批准。但是它們被錯誤地用來篩選沒有疾病跡象的人。專家說，這種不合規定的使用進一步削弱了一種策略，該策略可能旨在使主要官員免受大流行的威脅，迄今為止，大流行已經殺死了超過21萬名美國人。

“It’s not being used for the intended purpose,” said Syra Madad, an infectious disease epidemiologist based in New York. “So there will be potentially a lot of false negatives and false positives.”

Abbott’s rapid coronavirus tests, called the ID NOW and BinaxNOW, are speedy, portable and easy to operate, delivering results in minutes. But the convenience comes at a cost: The products are less accurate than laboratory tests that use a technique called polymerase chain reaction, or P.C.R., and they more frequently miss infections or mistakenly designate healthy people as infected, as happened to Gov. Mike DeWine of Ohio in August.

Nonetheless, shortly after Abbott’s ID NOW test received emergency approval from the F.D.A. in the spring, the White House adopted it as a rapid screening tool for staff members and visitors who came into close contact with the president. Sometime around the end of August or early September, the White House switched to using the BinaxNOW — a similarly quick test that hunts for bits of coronavirus protein rather than viral RNA — according to a senior administration official.

Federal officials recently purchased the BinaxNOW to distribute by the millions to governors and vulnerable communities around the country. Rapid tests have been hailed by some experts as a welcome solution to the lengthy delays that have plagued expensive laboratory tests, although the products come with problems of their own.

People without Covid-19 symptoms have been among those taking the test on White House grounds, where individuals who received negative results were granted swift access to the president and his advisers.

紐約的傳染病流行病學家西拉·馬達德（Syra Madad）說：“它沒有被用於預定目的。” “因此，可能會有很多假陰性和假陽性。”

雅培的快速冠狀病毒測試（稱為ID NOW和BinaxNOW）快速，便攜式且易於操作，可在數分鐘內得出結果。但是，便利是有代價的：與使用稱為聚合酶鏈反應或PCR技術的實驗室測試相比，產品的準確性較差，而且它們更容易錯過感染或錯誤地將健康的人指定為受感染的人，就像Gov.俄亥俄州，八月。

儘管如此，雅培的ID NOW測試不久後就獲得了F.D.A.的緊急批准。春天，白宮將其用作與總統密切聯繫的工作人員和訪客的快速篩選工具。據一位高級行政官員說，在八月底或九月初的某個時候，白宮轉而使用BinaxNOW-一種類似的快速測試，可以尋找冠狀病毒蛋白而不是病毒RNA。

聯邦官員最近購買了BinaxNOW，將其分發給全國各地的州長和弱勢社區。快速測試被一些專家讚揚為解決困擾昂貴的實驗室測試的長期延遲的一個受歡迎的解決方案，儘管產品本身也存在問題。

那些沒有Covid-19症狀的人都屬於在白宮進行測試的人，接受消極結果的人可以迅速與總統及其顧問取得聯繫。

Dr. Scott Gottlieb, the former commissioner of the F.D.A., described these procedures as a misguided attempt at a “zero-fail testing protocol” in an interview on CBS’ “Face the Nation” on Sunday, saying that officials “weren’t taking any precautions beyond testing people who are going to be in contact with the president.”

However, according to the products’ packaging, both Abbott rapid tests are intended for people with Covid-19 symptoms, early on in their illness. When Abbott submitted the tests for emergency authorization from the F.D.A., the company provided data only for people with symptoms. When used appropriately, the company has said, both tests perform about 95 percent as well as P.C.R. But how well the products do in asymptomatic individuals remains murky.

In a statement, Darcy Ross, Abbott’s senior director of external communications, said the instructions that came with both products gave physicians the power to administer tests at their discretion, regardless of whether the recipients had symptoms. “As with all tests that have received an E.U.A., a health care provider will determine if a person needs a Covid-19 test,” she said.

Dr. Krutika Kuppalli, an infectious disease physician based in South Carolina, said she would not feel comfortable administering such tests to healthy patients: “We don’t have data to show how this test is going to perform in that population.”

Abbott was not required to submit data evaluating either test’s performance in asymptomatic populations when applying for emergency approval from the F.D.A. But Ms. Ross confirmed that such studies are underway, and the company has told experts that it thinks asymptomatic testing is likely to pan out.

On Saturday evening, Andrea Wainer, Abbott’s executive vice president of rapid and molecular diagnostics, emailed a document entitled “Perspectives on Testing” to several public health experts, including Dr. Ashish Jha, dean of the Brown University School of Public Health, containing preliminary results outlining the ID NOW’s performance in people without symptoms. Among an unspecified number of individuals, the test picked up about 88 percent of the infections found by laboratory P.C.R. tests, the company statement said. Numbers were not reported for the BinaxNOW.

“By studying the test in the asymptomatic people, Abbott knows it works in that population,” the document said. “It can’t say that for itself, because the test isn’t approved for that, but that data has been shared with others and the F.D.A. too.”

FDA前專員斯科特·戈特利布（Scott Gottlieb）博士在周日接受哥倫比亞廣播公司（CBS）的《面對國家》採訪時，將這些程序描述為“零失敗測試協議”的誤導嘗試，稱官員“不會採取任何行動”。除了測試將要與總統接觸的人以外，還需要採取任何預防措施。”

但是，根據產品的包裝，兩種雅培快速測試均適用於患有Covid-19症狀的人，他們的病情較早。雅培（Abbott）將測試提交給F.D.A.進行緊急授權時，該公司僅提供有症狀者的數據。該公司表示，如果使用得當，這兩項測試的性能和P.C.R值均約為95％。但是，該產品在無症狀人群中的表現還很模糊。

雅培公司對外溝通高級總監達西·羅斯在一份聲明中說，兩種產品隨附的說明使醫生有權自行決定是否進行檢查，而不論接受者是否有症狀。她說：“如同已收到歐盟所有測試一樣，醫療保健提供者將確定一個人是否需要Covid-19測試。”

居住在南卡羅來納州的傳染病醫生Krutika Kuppalli博士說，對健康的患者進行此類檢查很不舒服：“我們沒有數據顯示該檢查在該人群中的表現。”

在申請F.D.A緊急批准時，雅培無需提交評估無症狀人群中任一測試性能的數據。但羅斯女士證實，此類研究正在進行中，該公司告訴專家，它認為無症狀檢測很可能會成功。

星期六晚上，雅培快速與分子診斷學執行副總裁安德里亞·懷納（Andrea Wainer）通過電子郵件將題為“測試觀點”的文件通過電子郵件發送給了幾位公共衛生專家，包括布朗大學公共衛生學院院長Ashish Jha博士，其中包括結果概述了ID NOW在無症狀人群中的表現。在人數不明的個體中，該測試檢出了實驗室P.C.R.發現的約88％的感染。測試中，公司聲明說。沒有報告BinaxNOW的數字。

該文件說：“通過在無症狀人群中研究該測試，雅培知道該測試在該人群中有效。” “它不能一味地說出來，因為該測試尚未獲得批准，但該數據已與其他人和F.D.A.共享。太。”

In response to queries about the document, Ms. Ross said the data had been collected from “a few dozen individuals.”

在回答有關該文件的疑問時，羅斯女士說數據是從“幾十個人”那裡收集的。

特朗普測試呈陽性

最新更新

更新

2020年10月6日，下午1:23 ET33分鐘前

33分鐘前

特朗普的醫生說，總統在第一天晚上回到白宮後“沒有任何症狀”。

白宮爆發後，隨著國會醫生試圖追踪這種病毒的傳播，有40名參議員尋求冠狀病毒檢測。

包括參謀長聯席會議主席在內的美國最高軍事領導人正在暴露於該病毒後進行隔離。

Zài huídá yǒuguān gāi wénjiàn

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Susan Butler-Wu, a clinical microbiologist at the University of Southern California, expressed concern about the private release of the data. Without more transparency about how and when the results were achieved, and in whom, she said, “I have to take their numbers with a grain of salt.” Dr. Butler-Wu also noted that tests like the ID NOW have produced lackluster results in the hands of other researchers, missing 25 percent or more infections in people with symptoms.

Even less data are available on the BinaxNOW, reportedly the principal test now used in the White House and a product that Adm. Brett Giroir, the senior official leading the administration’s testing effort, recently touted for off-label use on Twitter. The post provoked confusion and ire from health experts and members of the public.

“No, no, no,” said Dr. Butler-Wu, who recalled her dismay on seeing the tweet. “You can’t just take a product and off-label it and assume it’s happy days.”

Still, experts said, fault for the outbreak at the White House lay with officials who blindly trusted that testing alone could act as an impervious filter to the coronavirus. Even if Abbott’s tests had performed as well as advertised on everyone, regardless of symptoms, “it’s statistically impossible it wouldn’t have missed some infections,” Dr. Butler-Wu said. “And clearly, it did.”

White House officials have repeatedly declined to provide specific details about the testing procedures for staff members and visitors, sparking frustration among experts trying to assess the situation.

“There should be a very clear protocol that everyone could recite,” said Jennifer Nuzzo, an epidemiologist at Johns Hopkins University. Especially ambiguous, Dr. Nuzzo added, was how often people in the White House were taking tests, and under what circumstances, especially those who might not qualify as “close contacts” of the president. Any slip-ups could create ample opportunity for the coronavirus to hop into a new host.

翻譯待審

南加州大學的臨床微生物學家Susan Butler-Wu對數據的私人發布表示關注。她說，在如何以及何時實現結果以及在誰方面取得更大的透明度，她說：“我必須以一粒鹽來記錄他們的數字。” Butler-Wu博士還指出，像ID NOW這樣的測試在其他研究人員的手中卻產生了乏善可陳的結果，使有症狀的人的感染率降低了25％或更多。

BinaxNOW的數據更少，據報導，BinaxNOW是白宮目前使用的主要測試方法，也是領導政府測試工作的高級官員布雷特·吉羅爾將軍（Adm。Brett Giroir）最近在推特上大肆宣傳在標籤外使用的產品。該職位引起了衛生專家和公眾的困惑和憤怒。

“不，不，不，” Butler-Wu博士說。她回憶起她對看到這條推文感到沮喪。 “您不能只拿產品貼上標籤，並假設它是快樂的日子。”

專家們說，白宮疫情的過失仍然在於官員們，他們盲目地相信，單獨進行檢測可以作為對冠狀病毒的不滲透過濾器。 Butler-Wu博士說，即使雅培的測試在每個人身上都表現出色，並且不論其症狀如何，都在宣傳，但“從統計學上講，它不會漏掉某些感染，這是不可能的。” “顯然，確實如此。”

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On Monday, Kayleigh McEnany, the White House press secretary, announced that she had tested positive and would isolate herself. Ms. McEnany, who had been in close contact with several White House staff members who have since tested positive, had tested negative “every day since Thursday,” she said. But she was likely infectious for several days before her positive result, including on Sunday, experts said, when she spoke briefly without a mask to reporters outside the White House.星期一，白宮新聞秘書凱里·麥肯尼（Kayleigh McEnany）宣布她的測試結果呈陽性，並將隔離自己。她說，麥肯尼女士一直與幾名白宮工作人員保持密切聯繫，自那以後，他們一直被測為陽性。但是，專家們說，在她呈陽性ˋ之前，包括星期天，她可能已經感染了幾天，當時她在白宮外不帶口罩，向記者簡短講話。

These and other encounters illustrated to Dr. Madad that officials were treating negative results as a free pass to eschew masks and to mingle, regardless of exposure history. “That’s absolutely incorrect,” Dr. Madad said. Madad博士說，這些和其他遭遇說明，官員們將呈陰性視為免費通行證，可以免戴口罩又可和他人打成一片，而不管暴露史如何。馬達德博士說：“那絕對是不正確的。”

Exposure to an infected person should be reason enough to quarantine for 14 days, according to the guidelines of the Centers for Disease Control and Prevention. A negative test result might simply be failing to pick up on low amounts of the coronavirus as the pathogen slowly accumulates in the body. Symptoms can take up to two weeks after an exposure to appear, if symptoms appear at all. And levels of the virus, which might correlate with contagiousness, can often be at their highest right before an infected person starts feeling ill.

根據疾病控制與預防中心的指導原則，接觸受感染者應足足隔離14天。陰性結果可能只是病原體在體內緩慢積累，還未能呈現冠狀病毒。可能根本未出現症狀，如果出現症狀，則暴露之後最多可能需要兩個星期才出現。病毒之水平，可能與傳染性正相關，通常在感染者開始生病之前，病毒就處於最高水平。

Even people who remain asymptomatic throughout the duration of their infection are known to harbor the virus in abundance, and appear to be responsible for a large proportion of transmission events.即使是在感染期間仍無症狀的人，也可能攜帶大量病毒，這似乎是造成大部分傳播事件的原因。

“The guidelines have been very clear,” Dr. Madad said. “Even if you have a negative test, you quarantine if you’ve been exposed.” White House officials, however, seem to have been emboldened by the false sense of security imbued by negative results, even though they represent only a snapshot in time.馬達德博士說：“指導方針非常明確。” “一但您被暴露，即使您的測試陰性，也要隔離。”然而，白宮官員似乎對陰性結果有錯誤安全感，認為可放心，儘管它們只是一時的病毒快照而已。

To Dr. Jha, the White House’s unfolding outbreak was no surprise. “It’s remarkable that it hasn’t happened until now,” he said.對賈博士來說，白宮的疫情爆發並不奇怪。他說：“直到目前才爆發，這太幸運了。”

Pinning the protection strategy entirely on testing, while disregarding masks and physical distancing, he added, “shows they fundamentally don’t understand a negative test, and how infectious disease works.”他補充說，將保護策略完全依賴於快速測試，而忽略了口罩和保持社交距離，“這表明他們從根本上不了解測試呈陰性的意義，又不懂傳染病的工作原理。”

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