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诊断试剂研发商CorDx获得10分钟流感A/B和COVID-19测试的紧急使用授权(EUA)

CorDx Receives Emergency Use Authorization (EUA) for 10-Min Flu A/B & COVID-19 Test

BioSpace 等信源发布 2024-03-27 23:50

可切换为仅中文


SAN DIEGO, CA / ACCESSWIRE / March 27, 2024 / CorDx, a global leader in the development, manufacturing, and distribution of diagnostics and other medical devices, recently received Emergency Use Authorization (EUA) for its CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test.

加利福尼亚州圣地亚哥/ACCESSWIRE/2024年3月27日/诊断和其他医疗设备开发,制造和分销的全球领导者CorDx最近获得了CorDx Tyfast Flu a/B和COVID-19多重快速检测的紧急使用授权(EUA)。

CorDx Tyfast Flu A/B & COVID-19 Multiplex Test

CorDx Tyfast流感A/B和COVID-19多重检测

The 3-in-1 multiplex test is a lateral flow immunoassay device intended for the qualitative detection and differentiation of nucleocapsid protein antigen from SARS-CoV-2, influenza type A, and influenza type B. Samples are collected directly from nasal swabs sourced from those suspected of respiratory viral infection.

三合一多重检测是一种侧向流动免疫测定装置,用于定性检测和区分SARS-CoV-2,甲型流感和乙型流感的核衣壳蛋白抗原。样品直接从鼻拭子中收集疑似呼吸道病毒感染者。

The novel 10-minute diagnostic solution sets the standard in both detecting and distinguishing between Flu A, Flu B, and COVID-19.

这种新颖的10分钟诊断解决方案为检测和区分甲型流感、乙型流感和新型冠状病毒奠定了标准。

CorDx's Tyfast Flu A/B & COVID-19 Multiplex Rapid Test is designed for professional use at the point-of-care (POC)-administered by healthcare professionals or other individuals trained in patient-care settings. The test has only been authorized for in-vitro diagnostic use under an EUA and has not been FDA cleared or approved.

CorDx的Tyfast Flu A/B&COVID-19多重快速测试是为护理点(POC)的专业使用而设计的-由医疗保健专业人员或在患者护理环境中接受过培训的其他个人管理。该测试仅被授权用于EUA的体外诊断用途,尚未获得FDA的批准或批准。

Multiplex testing provides rapid diagnostic results at the point-of-care, especially as respiratory viruses surge. With influenza and COVID-19 cases climbing, the test gives labs and healthcare providers an efficient and accurate diagnostic solution. CorDx's high-performance multiplex test delivers results in just 10 minutes-offering a fast and accessible alternative to conventional testing methods.

多重检测可以在护理点提供快速的诊断结果,尤其是在呼吸道病毒激增的情况下。随着流感和新型冠状病毒肺炎病例的增加,该检测为实验室和医疗保健提供者提供了高效准确的诊断解决方案。CorDx的高性能多路复用测试仅需10分钟即可提供结果,为传统测试方法提供了一种快速且可访问的替代方法。

'We are pleased to receive Emergency Use Authorization for our Tyfast Flu A/B & COVID-19 Multiplex Rapid Test,' said Aiiso Li, CorDx's Founder and CSO. 'While the test is currently authorized for POC use, we hope it will be granted OTC authorization in the near future, giving families and communities yet another way to prioritize their health.'

CorDx创始人兼CSO Aiso Li说,我们很高兴获得Tyfast流感A/B和新型冠状病毒19多重快速检测的紧急使用授权虽然该测试目前已被授权用于POC,但我们希望它将在不久的将来获得OTC授权,为家庭和社区提供另一种优先考虑其健康的方式。”

For more information about CorDx's Tyfast Flu A/B & COVID-19 Multiplex Rapid Test, or to inquire about distribution opportunities, visit CorDx.com.

有关CorDx的Tyfast Flu A/B和COVID-19多重快速检测的更多信息,或询问分销机会,请访问CorDx.com。

About CorDx:

关于CorDx:

CorDx, a global biotechnology organization, is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world. CorDx develops, manufactures, and distributes diagnostics and related tools that empower users to monitor and improve their health.

全球生物技术组织CorDx正在通过创新的研发解决方案、垂直整合的供应链以及在美国和世界各地的制造足迹,改变全球诊断行业。CorDx开发、制造和分发诊断和相关工具,使用户能够监测和改善他们的健康状况。

Its proprietary diagnostic solutions are recognized by families and medical professionals for being affordable, use-friendly, and precise. To learn more, visit CorDx.com.

它的专有诊断解决方案因价格合理、使用方便和精确而受到家庭和医疗专业人员的认可。要了解更多信息,请访问CorDx.com。