I-Corps: A diagnostic platform for the analysis of biomarkers in multiplexed immunoassays

该I-Corps项目的更广泛影响/商业潜力是实现快速、高灵敏度、多重、数字免疫分析诊断平台。 在短时间内，该平台能够检测危及生命的危重患者的血液样本。如果成功商业化，该技术有望为护理人员提供即时指导，以便在病情恶化之前及时做出临床决策并积极干预。 该平台可以潜在地降低重症监护病房中感染相关急性疾病的当前死亡率。此外，该平台允许以高度可靠和准确的方式同时检测多种生物标志物。I-Corps项目将探索数字免疫分析平台的商业化潜力，探索客户为临床实验室医学、医院采购经理和病理学医生的诊断公司的使用，这个I-Corps项目是基于使用预平衡数字酶的原型数字免疫分析平台的开发，连接免疫吸附测定微阵列该微阵列已被证明可以实时分析患有癌症免疫治疗和COVID-19感染副作用的重症患者的多种生物标志物分子（蛋白质和代谢物）。该平台将抗体缀合的珠粒限制在微流体芯片上的大量飞升大小的微孔的阵列中，每个微孔形成当靶分析物结合时打开的荧光像素。抗体-抗原免疫复合物形成在如此小的体积内的高度局部化限制使得能够进行单个分析物结合事件的单分子检测。该技术从针对高度预平衡的分析物结合事件拍摄的整个微孔阵列的快照图像中计数荧光信号激活像素的数量。因此，该平台实现了高测试速度，高灵敏度，并可能降低仪器成本比当前system.This奖项反映了NSF的法定使命，并已被认为是值得的支持，通过评估使用基金会的知识价值和更广泛的影响审查标准。

The broader impact/commercial potential of this I-Corps project is to enable a rapid, high-sensitivity, multiplex, digital immunoassay diagnostic platform. With a short turnaround, the platform is able to test blood samples of critically ill patients suffering from life-threatening conditions. If successfully commercialized, the technology is expected to provide immediate guidance for caregivers to make timely clinical decisions and proactively intervene before disease conditions worsen. The platform can potentially reduce the current mortality rate of infection-related acute illnesses in intensive care units. Additionally, the platform allows for the simultaneous detection of multiple biomarkers in a highly reliable and accurate manner. The I-Corps project will explore the commercialization potential of the digital immunoassay platform, exploring the use by diagnostic companies having clients in clinical laboratory medicine, hospital procurement managers and doctors of pathology, and researchers in biopharmaceutical companies as potential customers.This I-Corps project is based on the development of a prototype digital immunoassay platform using a pre-equilibrium digital enzyme-linked immunosorbent assay microarray. The microarray has been demonstrated to allow real-time profiling of multiple biomarker molecules (proteins and metabolites) for critically ill patients suffering from the side effects of cancer immune therapy and COVID-19 infections. The platform confines antibody-conjugated beads into an array of a large number of femtoliter-sized microwells on a microfluidic chip, each forming a fluorescent pixel turned on when the target analyte is bound. The highly localized confinement of antibody-antigen immune complex formation within such a small volume enables single-molecule detection of individual analyte binding events. The technique counts the number of fluorescence signal-activated pixels from a snapshot image of the entire microwell array taken for highly pre-equilibrated analyte binding events. As a result, the platform achieves high testing speed, high sensitivity, and potentially lower instrumentation cost than current systems.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.