SBIR Phase I: Point of Care Metabolic Measurement

该SBIR一期项目将克服关键技术挑战，开发新材料，使护理点传感器能够用于全血生物标志物监测现有CPT代码的标记物。最终，传感器将用于改善所有年龄的患者的治疗和生活质量。它将被用于护理点，作为新生儿筛查的快速诊断（美国每年约有390万婴儿出生），并作为患有特定疾病的人的日常监测系统（美国约有60万人）。最终，消耗品、一次性传感器和传感器读取器的制造将在美国创造新的就业机会。技术创新在于1)通过消除来自干扰的信号来提高传感器特异性的能力，2)通过改进传感材料来提高传感器灵敏度，以及3)可以直接从全血而不是分离的血浆中进行测量。目前临床使用的测量依赖于从全血中分离的血浆，由于样品处理的分析前可变性，结果不准确。这项工作的目标是1)对材料进行化学修饰，以创建能够消除可能混淆传感器的血液成分的新材料，2)增加传感材料的表面积，以提高传感器的响应速度，以及3)与市售方法相比，用全血分析验证传感器的性能。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

This SBIR Phase I project will overcome key technical challenges to develop new materials to enable a point of care sensor for whole blood biomarker monitoring for markers with existing CPT codes. Ultimately this, sensor will be used to improve treatment and quality of life for diseased persons of all ages. It will be used at the point of care as a rapid, diagnostic for newborn screening (~3.9 million babies born annually in the U.S.) and as a daily monitoring system for people living with specific diseases (~600,000 people in the U.S.). Ultimately, manufacturing of consumable, single use sensors and sensor readers will create new jobs in the United States. The technical innovation lies in 1) the ability to increase sensor specificity, by eliminating signals from interferents, 2) increasing sensor sensitivity by improving the sensing material, and 3) enabling measurement directly from whole blood, instead of separated plasma. Current clinically used measurements, which rely on plasma separated from whole blood, suffer from inaccurate results from pre-analytical variability in sample handling. The goals of this work are 1) to chemically modify materials to create new materials capable of eliminating blood components that could confound the sensor, 2) increase the sensing material surface area for faster sensor response, and 3) to analytically validate the performance of the sensor with whole blood as compared to commercially available methods.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.