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COVID-19测试,用于白宫工作人员,产生假阴性:研究

2020-05-14 16:46   美国新闻网   - 

根据纽约大学研究人员的一项新研究,一种用于白宫官员的快速冠状病毒测试遗漏了几乎一半的阳性感染。

在一项预先公布的研究中,NYU·朗格健康研究人员将雅培实验室生产的测试与45分钟内返回测试的机器进行了比较,雅培实验室生产的测试在5分钟内得出阳性结果,在13分钟内得出阴性结果。作者说,他们对测试的准确性进行了探索,因为它的快速周转可能对该机构的医疗中心急诊部有用。

他们发现,当用于病毒样本的鼻拭子是干的时,快速雅培试验产生了48%的假阴性试验,当拭子被置于液体溶液中时,产生了大约33%的假阴性试验。公司向顾客推荐干法。

该研究的作者写道,该研究“揭示了雅培立即诊断平台的低敏感性和高假阴性结果”,这引发了对该测试“作为有症状患者的诊断工具的适用性”的担忧。

雅培立即对这项尚未经过同行评审的研究提出质疑,并声称研究人员可能没有正确采集样本。雅培公司发言人斯科特·斯托菲尔说:“虽然没有一种测试是完美的,但雅培公司现在的标识在最需要的时间和地点提供了可靠的结果。”新闻周刊在一份声明中。"使用COVID-19立即识别的1,000多个站点的测试正在按预期进行."

“如果我们要帮助降低人们每天感染病毒的风险,世界需要在实验室和护理点进行各种各样的测试,并且尽可能多的测试,”他补充道。

斯托菲尔还断言,NYU的研究与之前显示测试更准确的研究“不一致”。“例如,在华盛顿州最近的另一项研究中,在大约1000名受试者中,有23名在实验室测试中对COVID-19呈阳性,而现在识别出21名,显示出91%的敏感性和100%的特异性,”他说。

虽然雅培的断言可能是真的,但他们的测试在过去的一个月里受到了其他研究人员的质疑。今年4月,雅培指示实验室在测试前不要将样本储存在“病毒传输介质”中,此前有指控称该测试产生了许多假阴性。

根据彭博社的数据,研究发布后,雅培在纽约的股价下跌1.8%,至92.16美元。

3月30日,美国总统唐纳德·特朗普(Donald Trump)在雅培测试机获得美国食品和药物管理局(FDA)批准后,大肆吹捧该测试机,称其“在短短五分钟内就能产生惊人的结果”白宫也经常对接近特朗普的官员进行测试。

这篇报道已经被雅培发言人斯科特·斯托菲尔的评论更新。

2020年5月13日,美国总统唐纳德·特朗普在DC首都华盛顿的白宫内阁厅会见科罗拉多州州长杰瑞德·波利斯和北达科他州州长道格·布尔根时,看着他。

ABBOTT'S RAPID CORONAVIRUS TEST, USED ON WHITE HOUSE OFFICIALS, MISSES ALMOST HALF OF POSITIVE INFECTIONS, STUDY FINDS

A rapid coronavirus test, used on White House officials, misses almost half of all positive infections, according to a new study by researchers at New York University.

In a pre-published study, NYU Langone Health researchers compared the test produced by Abbott Laboratories, which turns out positive tests within five minutes and negative cases within 13 minutes, with machines that return tests in 45 minutes. The authors said they probed the test for accuracy because its speedy turnaround could be useful for the institution's medical center's emergency department.

They found that the rapid Abbott test produced 48 percent false negative tests when the nasal swab used for the virus sample was dry and roughly 33 percent when the swab was placed in liquid solution. The company recommends the dry method to its customers.

The study "revealed low sensitivity with high false negative results by Abbott ID NOW platform" which raised concerns about the test's "suitability as a diagnostic tool for symptomatic patients," the study's authors wrote.

Abbott immediately disputed the study, which has yet to be peer reviewed, and claimed that the researchers may not have taken the samples correctly. "While no test is perfect, Abbott's ID NOW is delivering reliable results when and where they're needed most," Abbott spokesperson Scott Stoffel told Newsweek in a statement. "The test is performing as expected by the more than 1,000+ sites using ID NOW for COVID-19."

"The world needs a variety of tests in labs and at point of care, and as many as possible, if we are to help reduce the risk people have every single day of contracting the virus," he added.

Stoffel also asserted that the NYU study was "not consistent" with previous studies that show the tests as more accurate. "For example, in another recent study in Washington state, out of approximately 1,000 subjects there were 23 positive for COVID-19 on a lab test and ID NOW picked up 21, demonstrating 91% sensitivity and 100% specificity," he said.

While Abbott's assertion may be true, their tests have been called into question by other researchers over the past month. In April, Abbott instructed labs to refrain from storing samples in "viral transport media" before testing following allegations that the test produced many false negatives.

Following the study's release, shares in Abbott fell 1.8 percent to $92.16 in New York, according to Bloomberg.

President Donald Trump touted the Abbott testing machine on March 30, after it was approved by the Food and Drug Administration (FDA), saying it "delivers lightning-fast results in as little as five minutes." The White House also frequently uses the test on officials who come within close proximity to Trump.

This story has been updated with comment from Abbott spokesperson Scott Stoffel.

U.S. President Donald Trump looks on he as meets with Colorado Governor Jared Polis and North Dakota Governor Doug Burgum in the Cabinet Room of the White House on May 13, 2020 in Washington, DC.


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