Whole Blood Point of Care Metabolic Measurement

项目摘要 该SBIR第二阶段项目将转化为传感器材料和原型的第一阶段技术创新 设备转化为全功能的护理点技术，用于全血生物标志物监测。它将在一个 向美国食品药品监督管理局（FDA）提交510（k）许可申请的完整草案。当前没有任何 市售FDA批准的床旁设备可用于直接测量该生物标志物的整体 血所有大型临床仪器都需要在离心前通过离心从全血中分离血浆， 测量.此外，目前临床上使用的测量依赖于从全血中分离的血浆， 血液，遭受来自样品处理中的分析前可变性的不准确结果。 第一阶段完成的由国家科学基金会支持的技术创新产生了1）增加 传感器特异性，通过消除来自干扰物的信号，2）通过感测增加传感器灵敏度 材料改进，以及3）从全血而不是血浆直接进行护理点测量 与测量装置非原位分离，从而消除了样品处理中的分析前可变性。 这种新型的护理点全血测量设备将用于改善家庭管理， 约10，000人患有这些罕见的代谢紊乱，并作为新生儿筛查，以提高识别率 在美国每年390万新生儿中，约有1/3500的新生儿患有罕见的代谢紊乱。 最终，制造消耗品，一次性传感器和传感器读取器将在美国创造新的就业机会。 美国的 在这个直接二期项目中，Sequitur Health Corp.将与亚利桑那州立大学和马约诊所合作 创新的过程，大规模生产的实验室规模的传感器开发的第一阶段， 项目，并随后分析和临床验证批量生产的传感器和读取器 FDA 510（k）许可的技术。

Project Summary This SBIR Phase II project will translate Phase I technical innovations in sensor materials and a prototype device into a fully functional point of care technology for whole blood biomarker monitoring. It will culminate in a complete draft of a 510(k) clearance application to the U.S. Food & Drug Administration (FDA). Currently, no commercial FDA cleared point of care device is available for direct measurement of this biomarker in whole blood. All large clinical instruments require separation of plasma from whole blood via centrifugation prior to measurement. Further, current clinically used measurements, which rely on plasma separated from whole blood, suffer from inaccurate results from pre-analytical variability in sample handling. Phase I completed technical innovations supported by the National Science Foundation yielded 1) increased sensor specificity, by eliminating signals from interferents, 2) increased sensor sensitivity through sensing material improvements, and 3) direct point of care measurement from whole blood, instead of plasma separated ex-situ from the measurement device which eliminated pre-analytical variability in sample handling. This novel point of care whole blood measurement device will be used to improve at-home management of the ~10,000 people living with these rare metabolic disorders and as a newborn screening to improve identification of the ~1/3500 newborns with rare metabolic disorders out of the 3.9 million annual births in the United States. Ultimately, manufacturing of consumable, single use sensors and sensor readers will create new jobs in the United States. In this Direct Phase II project, Sequitur Health Corp. will partner with Arizona State University and Mayo Clinic to innovate a process for mass production of the laboratory-scale sensors developed from the Phase I project and subsequently analytically and clinically validate the mass-produced sensors and reader technology for FDA 510(k) clearance.