Digital Itap Supplement

摘要 这一倡议的目标是快速跟踪精心挑选的临床研究，这些研究可以帮助解决 新冠肺炎疫情带来的紧迫医疗问题。的广度和紧迫性 这种情况需要采取积极的方法来加快解决方案的交付速度 当前的需求。建议的方法增强了强大的技术、临床和 CAPCaT的商业化专业知识在几周内将所需的解决方案付诸实践 月份。本附录将使用数字、无站点研究方法来测试临床 SARS-CoV-2新的体外诊断方法的性能。先进点的中心 心、肺、血液和睡眠疾病的护理技术(CAPCaT)是 非常成功的医疗产品孵化器，马萨诸塞州医疗器械开发公司 马萨诸塞大学洛厄尔分校和医学院校园的M2D2中心。这个 M2D2的创立目标是加速医疗器械的发展，结合 UMassLowell(统一建模语言)的工程和业务专业知识与UMasss的临床专业知识 伍斯特医学院(UMMS)。CAPCaT与M2D2一起拥有一个行业网络 合作伙伴和资助者支持有希望的产品的开发和商业化 技术。我们的行业合作伙伴包括强生、波士顿科学、安进、 还有霍洛奇。CAPCaT是四个关怀点技术研究网络(POCTRN)之一 中心(埃默里/GA理工学院、西北大学和约翰霍普金斯大学是其他中心的所在地)。 CAPCaT与其他POCTRN中心及其协调中心(CIMIT-MASS)合作 综合医院)和我们在NHLBI和NIBIB的科学和项目官员一起审查 并了解未得到满足的需求和网络可访问的资源 有所作为。

Abstract The goal of this initiative is to fast-track carefully selected clinical studies that can help address the urgent healthcare issues created by the COVID-19 pandemic. The extent and urgency of the situation requires an aggressive approach to accelerate the delivery of solutions to address current needs. The proposed approach augments the strong technical, clinical and commercialization expertise of CAPCaT to get needed solutions into practice within weeks to months. This supplement will use a digital, site-less study approach to test the clinical performance of new in vitro diagnostics for SARS-CoV-2. The Center for Advancing Point of Care Technologies (CAPCaT) in Heart, Lung, Blood, and Sleep Diseases is an offshoot of a highly successful medical product incubator, the Massachusetts Medical Device Development Center (M2D2) at the University of Massachusetts Lowell and Medical School campuses. The founding goal of M2D2 was to accelerate the development of medical devices, combining the engineering and business expertise of UMass Lowell (UML) with the clinical expertise of UMass Medical School (UMMS) in Worcester. CAPCaT, along with M2D2, has a network of industry partners and funders to support the development and commercialization of promising technologies. Among our industry partners are Johnson & Johnson, Boston Scientific, Amgen, and Hologic. CAPCaT is one of four Point of Care Technology Research Network (POCTRN) Centers (Emory/GA Tech, Northwestern, and Johns Hopkins University house the others). CAPCaT has worked with the other POCTRN Centers and its Coordinating Center (CIMIT-Mass General Hospital) and our scientific and program officers at NHLBI and NIBIB to review the situation and to understand unmet needs and resources accessible by the network that can make a difference.