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西门子Healthineers推出新型冠状病毒快速抗原检测试剂盒

2020-10-15 13:21

 

柏林,10月14日(新华社)——德国医疗技术公司西门子Healthineers周三宣布,该公司在欧洲推出了一种“快速易用”的抗原检测试剂盒,用于检测导致COVID-19的新型冠状病毒SARS-CoV-2。


根据西门子Healthineers的说法,即时护理盒式测试套件不需要实验室仪器或专门的实验室人员来管理并在15分钟内交付结果。


西门子Healthineers的护理诊断部门负责人Christoph Pedain在一份声明中说:“公众非常需要可靠的检测,以快速识别感染人群,帮助将COVID-19的传播降至最低,尤其是在人流密集的地区和人们通常聚集的地方。”


Siemens Healthineers称,在一项针对317名受试者的临床研究中,带有欧洲CE标记的快速抗原检测试剂盒显示出96.72%的敏感性和99.22%的特异性。


该研究使用了6个不同地点,包括医院、社区诊所、大学校园和肿瘤单位的不同证书的操作员。西门子Healthineers还计划向美国食品和药物管理局(FDA)提交快速检测,以获得美国紧急使用的授权。


快速抗原检测套件可以在更广泛的环境下进行检测,Pedain补充说,“特别是在需要快速检测的地方,比如机场,或者学校等实验室资源有限的地方。”

 

BERLIN, Oct. 14 (Xinhua) -- Siemens Healthineers launched a "rapid and easy-to-use" antigen test kit in Europe for the detection of SARS-CoV-2, the novel coronavirus that causes COVID-19, the German medical technology company announced on Wednesday.

According to Siemens Healthineers, the point-of-care cassette test kit did not require laboratory instruments or specialized lab personnel to administer and delivered results in 15 minutes.

"There is a great public need for reliable tests that can quickly identify contagious individuals and help to minimize the spread of COVID-19, especially in high-traffic areas and where people commonly congregate," said Christoph Pedain, head of Point of Care Diagnostics at Siemens Healthineers in a statement.

The rapid antigen test kit with a European CE marking demonstrated 96.72 percent sensitivity and 99.22 percent specificity in a clinical study of 317 subjects, according to Siemens Healthineers.

The study was performed using operators with varied credentials at six diverse sites including a hospital, a community clinic, a college campus, and an oncology unit. Siemens Healthineers also planned to submit the rapid test to the Food and Drug Administration (FDA) for emergency use authorization in the United States.

The rapid antigen test kit would enable testing across a wider variety of settings, added Pedain, "particularly in locations that need to test people quickly such as airports or that have limited access to laboratory resources such as schools."

 

来自: xinhua