Digital Itap Supplement

摘要 该倡议的目标是快速跟踪精心挑选的临床研究， COVID-19大流行造成的紧急医疗问题。问题的范围和紧迫性 这种情况需要采取积极的办法，以加快提供解决办法， 目前的需要。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，在数周内将所需的解决方案付诸实践， 个月该补充将使用数字化、无研究中心的研究方法来测试临床 新的SARS-CoV-2体外诊断方法的性能。推进点中心 心、肺、血液和睡眠疾病护理技术（CAPCaT）是一个分支， 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（M2 D2）在马萨诸塞州洛厄尔大学和医学院校园。的 M2 D2的成立目标是加速医疗设备的发展， 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M2 D2沿着，拥有一个行业网络， 合作伙伴和资助者，以支持有前途的 技术.我们的行业合作伙伴包括约翰逊和约翰逊、波士顿科学、安进、 和Hologic。CAPCaT是四个护理点技术研究网络（POCTRN）之一 中心（埃默里/佐治亚理工学院，西北大学和约翰霍普金斯大学的房子其他）。 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， 了解未满足的需求和网络可获得的资源， 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.