Digital Itap Supplement

摘要 该计划的目标是快速跟踪精心挑选的临床研究，以帮助解决 COVID-19 大流行造成的紧急医疗保健问题。其范围和紧迫性 这种情况需要采取积极的方法来加速提供解决方案来解决 当前的需求。所提出的方法增强了强大的技术、临床和 CAPCaT 的商业化专业知识可在几周内将所需的解决方案付诸实践 几个月。该补充品将使用数字化、无地点研究方法来测试临床 SARS-CoV-2 的新型体外诊断性能。推进点中心 心脏、肺、血液和睡眠疾病护理技术 (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中心 中心 (M2D2) 位于马萨诸塞大学洛厄尔分校和医学院校园。的 M2D2 的创立目标是加速医疗设备的发展，结合 麻省大学洛厄尔分校 (UML) 的工程和业务专业知识与麻省大学的临床专业知识 伍斯特医学院（UMMS）。 CAPCaT 与 M2D2 一起拥有行业网络 合作伙伴和资助者支持有前途的开发和商业化 技术。我们的行业合作伙伴包括强生公司、波士顿科学公司、安进公司、 和豪洛吉。 CAPCaT 是四个护理点技术研究网络 (POCTRN) 之一 中心（埃默里大学/乔治亚理工学院、西北大学和约翰霍普金斯大学是其他中心）。 CAPCaT 与其他 POCTRN 中心及其协调中心 (CIMIT-Mass 总医院）以及 NHLBI 和 NIBIB 的科学和项目官员来审查 情况并了解未满足的需求和网络可访问的资源，这些资源可以 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.