SBIR Phase I: Point of Care Metabolic Measurement

该SBIR第一阶段项目将克服关键技术挑战，开发新材料，以实现对现有CPT代码标记物进行全血生物标记物监测的即时检测传感器。最终，传感器将用于改善所有年龄段患者的治疗和生活质量。它将用于护理点，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（美国约60万人）的日常监测系统。最终，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）通过消除干扰物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）能够直接从全血而不是分离的血浆进行测量。目前临床上使用的测量依赖于从全血中分离的血浆，其遭受来自样品处理中的分析前可变性的不准确结果。这项工作的目标是1）化学改性材料，以创造能够消除可能混淆传感器的血液成分的新材料，2）增加传感材料表面积，以加快传感器响应，和3）与市售方法相比，分析验证全血传感器的性能。该奖项反映了NSF的法定使命，并被认为值得支持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。

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.