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快讯:FDA批准了Danaher Cepheid进行的首个床头Covid-19测试

快讯:FDA批准了Danaher Cepheid进行的首个床头Covid-19测试


今天,FDA紧急授权,Covid-19测试可以在不到一个小时的时间内提供结果,这标志着临床医生可以在床边使用的第一项测试。

测试短缺是美国遏制大流行的一项持续挑战。白宫已经承诺,随着越来越多的私营公司加入,测试工作将加速进行。

星期六美国卫生与公众服务部卫生助理部长布雷特·吉罗尔(Brett Giroir)在白宫简报会上说,迄今为止,公共卫生和临床实验室已经进行了超过195,000项测试,但这还不包括运行自己的测试的医院实验室。

作为丹纳赫公司旗下子公司的硅谷分子诊断公司Cepheid周六宣布,已获得美国食品和药物管理局的紧急授权,可使用该检测方法,这使其成为该机构只要存在公共卫生紧急情况就允许在市场上进行的第13Covid-19检测。

但这是可在护理现场第一次使用,这意味着医疗服务提供者不必将患者样本发送到单独的实验室进行处理,然后再回到医院或医疗服务提供者的办公室。Cepheid表示,预计下周将开始出货测试。

现场近距离对患者检测的准确测试是变革性的,并有助于减轻Covid-19爆发的压力,因Covid-19的爆发给准确分配呼吸隔离资源的医疗机构带来了压力, Cepheid首席医学博士兼技术官员David Persing表示。

原文:A Covid-19 test can deliver results in less than an hour has been approved under an FDA emergency authorization, marking the first test that clinicians can use at the bedside.

Testing shortages have been an ongoing challenge in the U.S. response to curb the pandemic. The White House has promised testing will ramp up as more private companies come on board.

Public health and clinical labs have run more than 195,000 tests to date, but that doesn’t include hospital laboratories running their own test, Brett Giroir, assistant secretary for health at the U.S. Department of Health and Human Services, said during a White House briefing Saturday.

Cepheid, a Silicon Valley molecular diagnostics company that’s a unit ofDanaher Corp.announced Saturday it received an emergency authorizationfrom the U.S. Food and Drug Administration to use the test, making it the 13th Covid-19 test the agency has allowed on the market as long as the public health emergency exists.

But it’s the first one that can be used at the point of care, meaning providers don’t have to send patient samples to a separate lab to be processed and then come back to the hospital or provider’s office. Cepheid said it expects to start shipping tests next week.

“An accurate test delivered close to the patient can be transformative—and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources,” David Persing, Cepheid chief medical and technology officer.

(原创)美国希望之光医疗翻译,请注明出处。

全球顶级医生协会(Global Top Doctors Association是美国加州政府正式注册的联邦政府批准的一个非营利性,非宗教,非政治性国际社会组织,总部位于洛杉矶。全球顶级医生协会为中西方医学和精神专业人士的科学研究创造更有利的环境,为他们提供机会在社区,全国以及全球服务人群,满足民众的身体与精神健康需求。

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