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美国食品和药物管理局授权首次在家快速测试

2020-11-18 14:40   美国新闻网   - 

A新型肺炎大流行现在已经导致全球130多万人死亡。

超过5550万人遍布全球被诊断出患有新冠肺炎病,该病由新型呼吸道病毒,根据约翰·霍普金斯大学系统科学与工程中心汇编的数据。由于检测短缺、许多未报告的病例以及怀疑一些国家政府隐瞒或淡化疫情范围,实际数字被认为要高得多。通过临床手段或实验室测试进行诊断的标准也因国家而异。

自从1997年发现第一例病例以来中国12月,病毒已经迅速传播到除南极洲以外的所有大陆。美国是受影响最严重的国家,有超过1130万确诊病例至少248,555人死亡。

世界卫生组织正在追踪新冠肺炎近200种候选疫苗,其中至少有10种处于关键的第三阶段研究。在这10种处于后期试验阶段的潜在疫苗中,目前有五种如果获得批准,将在美国上市。

俄勒冈州下令全州冻结

俄勒冈州州长凯特·布朗发布了一项行政命令,授权全州范围内冻结,以打击不断上升的新冠肺炎病例。

该命令将关闭健身房、博物馆、动物园和室内娱乐设施等企业,将用餐限制在外卖范围内,并将社交聚会限制在六人以内。

根据行政命令,宗教集会将限制在室内最多25人,室外最多50人。

根据俄勒冈卫生部的数据,该州共有58570例冠状病毒病例和778例死亡。根据健康数据,新冠肺炎的住院人数从11月2日的180人跃升至11月17日的378人。

“我们正处于一个转折点,”布朗在一份声明中说。“如果我们不采取进一步行动,我们将面临感染和住院人数持续飙升的风险,我们还将危及邻居和亲人的生命。”

该行政命令将于周三生效,并将持续至少两周。

与此同时,布朗表示,5500万美元的联邦财政援助将用于受新冠肺炎影响的企业。

每个俄勒冈县将获得50万美元的基线,外加剩余资金的人均分配。

“我知道这还不够。布朗在一份声明中说:“我仍然致力于在联邦一级争取更多的资源,包括重新授权《关心法案》的重要功能,如工资保护计划和延长失业保险福利。”

美国食品和药物管理局授权第一次家庭快速测试

美国食品和药物管理局已经发布了SARS-CoV2病毒首次家庭快速检测的紧急使用授权。露西拉·新冠肺炎多功能一体测试套件经授权可在家中或医生办公室的护理点使用,但必须有处方。

“虽然新冠肺炎诊断测试已被授权在家中进行收集,但这是第一个可以完全自我管理并在家中提供结果的测试。美国食品和药物管理局(FDA)专员斯蒂芬·m·哈恩(Stephen M. Hahn)在一份声明中表示:“这一新的测试选项是一项重要的诊断进步,有助于应对这一流行病,减轻疾病传播的公共负担。”

美国食品和药物管理局表示,分子测试“通过在小瓶中旋转自收集的样本拭子,然后将其放入测试单元来进行”。在30分钟或更短的时间内,测试结果可以直接从测试单元的发光显示器上读取,该显示器显示一个人对SARS-CoV-2病毒是阳性还是阴性。”

PHOTO: In this Aug. 2, 2018, file photo, the U.S. Food and Drug Administration building is seen behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md.

杰奎琳·马丁/美联社,档案

在这张2018年8月2日的档案照片中,美国食品和药物管理局大楼位于食品和药物管理局后面

一些专家推动了更多的家庭快速测试的发展,他们说,如果他们负担得起和容易获得-像怀孕测试-人们可以每天在上班、上学或旅行前测试自己。由于这项测试只限于处方,它可能还不会被广泛使用,但其他公司已经提交了类似技术的申请,美国食品和药物管理局表示这将是一个优先事项。

“完全可以在实验室或医疗机构之外进行的测试一直是美国食品和药物管理局应对这一流行病的主要优先事项。美国食品和药物管理局设备和放射健康中心主任杰夫·庶人博士在一份声明中说:“现在,更多可能患有新冠肺炎的美国人将能够根据他们的结果立即采取行动,保护自己和周围的人。”。“我们期待与测试开发人员积极合作,支持更多在家测试选项的可用性。”

随着案件增多,洛杉矶发布新的商业限制

卫生官员称,由于新冠肺炎病例自本月初以来增加了一倍,平均每天有1000人住院,洛杉机县将对商业和集会发布新的限制。

如果这种趋势继续下去,官员们警告说,他们将不得不发布另一项居家命令和宵禁。

PHOTO: People eat behind protective glass at an MTO School of Sufism in LA lunch for essential workers, as the global outbreak of the coronavirus disease continues, in Los Angeles, Nov. 17, 2020.

露西·尼克尔森/路透社

在洛杉矶的一所苏菲派学校里,人们在防护镜后吃饭,午餐是为必要的工作人员准备的

从周五开始,包括商店和办公室在内的非必要业务将减少到最高25%的入住率。

根据卫生部的消息,餐馆、酿酒厂、葡萄酒厂、酒吧和所有其他非必要的零售机构将从晚上10点至早上6点关闭。

据官员称,目前洛杉矶县五天平均报告2884例病例和1126名住院患者。

根据卫生官员的说法,如果五天平均病例上升到4000例或住院人数超过每天1750人,该市将禁止面对面用餐。

卫生官员说,如果五天平均住院人数上升到4500人或每天住院人数超过2000人,该县将发布居家命令,并从晚上10点至早上6点实行宵禁。

四分之一的美国医院接近重症监护室床位容量:HHS

美国广播公司新闻(ABC News)获得的美国卫生与公众服务部(U . S . Department of Health and Human Services)的一份内部备忘录显示,美国25%的医院80%以上的重症监护室床位都已填满。

根据该机构的数据,住院人数的激增是在上周该国冠状病毒指标出现新的增长之后发生的。

PHOTO: Medical staff examine a patient suffering from coronavirus in the COVID-19 intensive care unit at United Memorial Medical Center on Nov. 16, 2020, in Houston.

中村豪/盖蒂影像公司

医务人员在新冠肺炎重症监护室检查一名冠状病毒患者

根据这份备忘录,11月10日至11月16日期间,该国确诊了近110万例新病例,比前一个7天期间增加了35.2%。

HHS说,上周全国的阳性率超过了10%。

备忘录称,从11月10日至11月16日,美国新增8501例新冠肺炎死亡病例,较上周增长11.8%。

Coronavirus live updates: FDA authorizes 1st at-home rapid test

Anovel coronaviruspandemic has now killed more than 1.3 million people worldwide.

Over 55.5 million peopleacross the globehave been diagnosed with COVID-19, the disease caused bythe new respiratory virus, according todata compiled by the Center for Systems Science and Engineering at Johns Hopkins University. The actual numbers are believed to be much higher due to testing shortages, many unreported cases and suspicions that some national governments are hiding or downplaying the scope of their outbreaks. The criteria for diagnosis -- through clinical means or a lab test -- has also varied from country to country.

Since the first cases were detected inChinain December, the virus has rapidly spread to every continent except Antarctica. The United States is the worst-affected nation, with more than 11.3 million diagnosed cases andat least 248,555 deaths.

Nearly 200 vaccine candidates for COVID-19 are being tracked by the World Health Organization, at least 10 of which are in crucial phase three studies. Of those 10 potential vaccines in late-stage trials, there are currently five that will be available in the United States if approved.

Oregon orders statewide freeze

Oregon Gov. Kate Brown issued an executive order that authorized a statewide freeze to combat rising COVID-19 cases.

The order will close businesses such as gyms, museums, zoos and indoor recreational facilities, restrict dining to takeout only and limit social gatherings to six people.

Religious gatherings will be limited to a maximum of 25 people indoors and 50 people outdoors, according to the executive order.

The state has 58,570 total coronavirus cases and 778 deaths, according to the Oregon Health Department. The number of COVID-19 hospitalizations jumped from 180 on Nov. 2 to 378 on Nov. 17, according to the health data.

"We are at a breaking point," Brown said in a statement. "If we don't take further action, we risk continued alarming spikes in infections and hospitalizations, and we risk the lives of our neighbors and loved ones."

The executive order goes into effect on Wednesday and will last for at least two weeks.

In the meantime, Brown said $55 million in federal financial assistance will be committed to businesses that are impacted by COVID-19.

Each Oregon county will get a baseline of $500,000 plus a per capita allocation of the remainder of the funds.

"I know that this is not enough. I remain committed to fighting for additional resources at the federal level, including a reauthorization of the important features of the CARES Act, like the Payroll Protection Program and an extension of unemployment insurance benefits," Brown said in a statement.

FDA authorizes 1st at-home rapid test

The Food and Drug Administration has issued an emergency use authorization for the first at-home rapid test for the SARS-CoV2 virus. TheLucira COVID-19 All-In-One Test Kit is authorized for use at home or point of care in a doctor's office, but only with a prescription.

"While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” FDA Commissioner Stephen M. Hahn said in a statement.

FDA says the molecular test "works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus."

Some experts have pushed for more development of at-home rapid tests, saying that if they were affordable and accessible -- like a pregnancy test -- people could test themselves daily before going to work, school or traveling. Since this test is prescription-only, it likely won't be that widely available yet, but other companies have submitted applications for similar technology and the FDA says that will be a priority.

"A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic. Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them," said Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, in a statement. "We look forward to proactively working with test developers to support the availability of more at-home test options."

LA issues new business restrictions as cases rise

Los Angeles County will issue new limits on business and gatherings as the number of COVID-19 cases have doubled since the beginning of the month and hospitalizations are averaging 1,000 a day, according to health officials.

And if the trend continues, officials warn they will have to issue another stay-at-home order and curfew.

Starting Friday, nonessential businesses, including stores and offices, will be reduced to a maximum 25% occupancy.

Restaurants, breweries, wineries, bars and all other nonessential retail establishments will have to close from 10 p.m. to 6 a.m, according to the health department.

Currently, LA County is reporting a five-day average of 2,884 cases and 1,126 hospitalized patients, according to officials.

If the five-day average rises to 4,000 cases or hospitalizations are more than 1,750 per day, the city will prohibit in-person dining, according to health officials.

If the five-day average rises to 4,500 or hospitalizations are more than 2,000 per day, the county will issue a stay-at-home order and general curfew from 10 p.m. to 6 a.m, health officials said.

1 in 4 US hospitals nearing capacity ICU beds: HHS

Twenty-five percent of the nation's hospitals have more than 80% of their intensive care unit beds filled, according to an internal memo by the U.S. Department of Health and Human Services that was obtained by ABC News.

The jump in hospitalizations came after the country saw new increases in coronavirus metrics over the last week, according to the agency.

Between Nov. 10 and Nov. 16, nearly 1.1 million new cases were confirmed in the country, a 35.2% increase from the previous seven-day period, according to the memo.

The positivity rate in the country surpassed 10% over the last week, HHS said.

The U.S. saw 8,501 new COVID-19 deaths from Nov. 10 to Nov. 16, which marked a 11.8% increase from the previous week, the memo said.

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