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基于Fluidigm微流控芯片技术开发的新冠病毒检测试剂盒申请美国FDA紧急使用授权(EUA)


        近日,美国Fox、NBC等多家主流媒体竞相报道,美国俄克拉何马大学健康科学中心(OU Medicine, University of Oklahoma Health Sciences Center)宣布开发出一套新的新冠病毒检测试剂盒,可用于大规模新冠肺炎患者及疑似病例的病毒检测。该试剂盒由俄克拉何马大学健康科学中心及俄克拉荷马州医学研究基金会与Fluidigm公司合作,基于Fluidigm微流控芯片技术开发而成。这项革新技术将大幅提升现有的新冠病毒检测能力,可在未来90天内完成18万例样本检测,且检测的准确度也将大大提高。目前,OU Medicine已就此试剂盒向美国FDA申请了紧急使用授权EUA。一旦获得批准,OU Medicine将是全美目前唯一可以进行此测试的实验室。        该试剂盒基于Fluidigm微流控技术开发。利用Fluidigm Biomark HD平台及微流控芯片,每日可获取数千个检测结果,单张芯片手工操作时间仅需1小时左右。同时,与传统的基于微孔板的PCR技术相比,Fluidigm微流控技术每个样本检测所有Assays仅需2ul左右的样本量,样本使用量极低;另外,纳升级PCR反应体系可大大降低试剂、耗材、人工和时间成本。更重要的是,利用Fluidigm Biomark HD平台高通量及低成本的优势,OU Medicine可将每个检测重复执行5次,相较于其他检测平台,不但检测速度得到大幅提升,更极大提高了检测的准确性。        该检测试剂盒的成功开发,大幅提升了新冠病毒的检测能力,不仅有助于加快确诊患者的治疗速度,并且还能够为医护人员提供定期检测,以确保他们及所接触人群的安全。同时,对于其他疾病患者,尽早获得未感染新冠病毒的检测结果,将能够保证他们得以及时接受包括手术、放化疗或其他诊断测试等治疗。这项颠覆性的技术革新,或将彻底改变新冠检测和治疗的进程!访问以下媒体链接可获取详细信息: NBCA game changer for testing will soon be available at OU Medicine. On Thursday, doctors announced a new test that can reach thousands of people. The Oklahoma COVID-19 PCR test was designed by researchers at OU Medicine, the OU Health Sciences Center, the Oklahoma Medical Research Foundation, and Fluidigm Corporation.https://kfor.com/news/local/new-covid-19-test-developed-in-oklahoma-can-test-180000-in-3-months/FOX23OU Medicine, OU Health Sciences Center and Oklahoma Medical Research Foundation collaborated to create the new test for COVID-19. The test came about using technology and reagants from Fluidigm Corporation -- a biotechnology tools provider.https://www.fox23.com/news/local/ou-medicine-announce-large-scale-coronavirus-testing/E7UOSV4PS5FZTFRF3YGBS6RYNM/KOSUA new COVID-19 test has been developed in Oklahoma to expand testing and increase the accuracy of the results. Dr. Michael Talbert, the Chief of Pathology Services for OU Medicine, said during an online press conference Thursday that Fluidigm's microfluidics technology was an important part in the creation and validation of this test.https://www.kosu.org/post/new-covid-19-test-aimed-expanding-testing-increasing-accuracy




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