Whole Blood Point of Care Metabolic Measurement

全血护理点代谢测量

基本信息

批准号：
10385505
负责人：
Marylaura Lind Thomas
金额：
$ 63.78万
依托单位：
SEQUITUR HEALTH CORP.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-17 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10385505
关键词：
Affect Ammonia Arizona Award Biological Markers Birth Blood Blood specimen Calibration Centrifugation Chronic Clinic Clinical Code Dangerousness Devices Diagnosis Disease Dose Drops Effectiveness Electromagnetics Engineering Event Food Technology Foundations Health Health Insurance Portability and Accountability Act Hereditary Disease Home Hospitalization Hyperammonemia Impaired cognition Individual Institution Laboratories Legal patent Length of Stay Letters Licensing Measurement Medical Device Metabolic Metabolic Diseases Metabolism Methods Monitor Neonatal Mortality Neonatal Screening Nervous System Trauma Neurologic Symptoms Newborn Infant Occupations Output Patient Care Patients Pediatric Hospitals Performance Pharmaceutical Preparations Phase Plague Plasma Point of Care Technology Process Production Public Health Quality Control Quality of life Reader Reporting Sampling Science Secure Signal Transduction Small Business Innovation Research Grant Specificity Spottings System Technology Testing Time Translating United States United States Food and Drug Administration United States National Institutes of Health Universities Update Whole Blood Work base central database clinically relevant computerized data processing cost data exchange dietary dietary control effective therapy handheld mobile device improved innovation instrument manufacturing process manufacturing scale-up member novel point of care point of care testing prevent prototype response screening sensor signal processing time use user-friendly

项目摘要

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.

项目摘要这个SBIR II期项目将转换I期传感器材料和原型的技术创新设备进入功能齐全的护理技术，以进行全血生物标志物监测。它将在美国食品药品监督管理局（FDA）的510（k）清算申请的完整草案。目前，没有商业FDA清除护理设备可用于直接测量该生物标志物血。所有大型临床仪器都需要通过离心在测量。此外，当前临床使用的测量值依赖于与整体分离的血浆血液，因样品处理前的分析前变异性而遭受不准确的结果。第一阶段完成了国家科学基金会支持的技术创新1）传感器特异性，通过消除干扰物的信号，2）通过传感提高传感器灵敏度材料改进，以及3）全血的直接护理点测量，而不是血浆与测量设备分开的距离设备，该设备消除了样品处理中的分析前变异性。这个新颖的护理点全血液测量装置将用于改善家庭管理约有10,000人患有这些罕见的代谢障碍，并作为新生儿筛查以改善身份证明在美国390万年龄中，有罕见的代谢疾病的〜1/3500名新生儿中，有390万人。最终，消耗的，一次使用传感器和传感器读取器的制造将在美国。在这个直接II期项目中，Seeitur 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尺度传感器的大规模生产过程项目并随后在分析和临床上验证质量生产的传感器和读取器 FDA 510（k）清除的技术。