Whole Blood Point of Care Metabolic Measurement

项目摘要 这个SBIR第二阶段项目将转化第一阶段传感器材料和原型的技术创新 将该设备转化为全功能护理点技术，用于全血生物标记物监测。它将以一场 向美国食品和药物管理局(FDA)提交的510(K)批准申请的完整草稿。目前，没有 FDA批准的商业护理点设备可用于整个生物标记物的直接测量 血。所有大型临床仪器都需要通过离心法从全血中分离血浆，然后才能 测量。此外，目前临床上使用的测量方法依赖于从整体分离的血浆 血液，由于样品处理中分析前的可变性而导致结果不准确。 一期完成国家科学基金支持的技术创新成果 传感器专用性，通过消除干扰信号，2)通过传感提高传感器灵敏度 材料的改进，以及3)直接从全血而不是血浆测量护理点 与测量设备异地分离，消除了样品处理中的分析前变异性。 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疾病，并作为新生儿进行筛查，以提高识别能力 在美国每年390万名新生儿中，约有1/3500名新生儿患有罕见的代谢紊乱。 最终，消耗品、一次性使用传感器和传感器读取器的制造将在 美国。 在这个直接二期项目中，Sequitur Health Corp.将与亚利桑那州立大学和梅奥诊所合作 创新从第一阶段开发的实验室规模传感器的批量生产工艺 计划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.