SBIR Phase I: Rapid and Sensitive Quantification of Phenylalanine within Test Strip

这项小企业创新研究（SBIR）一期项目的广泛影响/商业潜力解决了对苯丙酮尿症（简称PKU）患者血液苯丙氨酸水平监测的快速便捷方法的迫切需求。PKU患者不能分解苯丙氨酸，因此毒性水平升高。这些患者接受严格限制蛋白质饮食和其他可能的药物治疗。由于过量的苯丙氨酸会导致神经损伤，而苯丙氨酸不足会导致蛋白质营养不良，因此患者的饮食必须仔细平衡。这种平衡只能通过追踪血液中的苯丙氨酸水平来实现，而苯丙氨酸水平在一天中波动。目前，实验室检查的周转时间为5至7天，有时更长，在此期间，患者可能会经历长期的行为和神经认知疾病发作。PKU是一种终生遗传性疾病，需要不断调整饮食治疗。每年照顾PKU患者的社会成本从1.5万美元到20万美元不等；如果管理不当，这种疾病会造成不可逆转的损害和高昂的护理费用。拟议中的项目将为这些患者开发一种新的监测器，以防止长期影响。这个小企业创新研究（SBIR）一期项目将为苯丙酮尿患者开发一种新的快速苯丙氨酸监测仪。快速定量血液苯丙氨酸水平以改善患者预后。该设备也将是一个具有成本效益的替代标准护理，因为它是今天。本设备由测试条和测试装置组成。试纸可以接受手指上的血滴。测试条包含各种化学物质，在测试设备进行光学分析之前对血液样本进行调理。该测试装置在确定苯丙氨酸的数量时实现了光谱学来询问测试条。本课题的重点是优化产品设计和系统算法。拟议的工作使设备的成本效益制造和部署到最终用户；这个项目的最终目标是开发一个简单的原型。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。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project addresses an urgent need for a rapid and convenient method to monitor blood phenylalanine levels for patients with phenylketonuria, or PKU for short. Patients with PKU are unable to catabolize phenylalanine and therefore have elevated, toxic levels. These patients are treated with a severely protein-restricted diet and other potential medications. Since excess phenylalanine results in neurologic injury, and inadequate phenylalanine results in protein malnutrition, the diet of patients must be carefully balanced. This balance can only be accomplished by tracking blood phenylalanine levels, which fluctuate throughout the day. Currently the turnaround time of laboratory tests is 5 to 7 days, and sometimes longer, during which patients may experience prolonged episodes of behavioral and neurocognitive morbidities. PKU is a lifelong genetic disorder and requires constant tuning of diet therapy. The annual societal cost for taking care of patients with PKU can range from $15,000 to $200,000; this disease causes irreversible damage and high costs of care when improperly managed. The proposed project will develop a new monitor for these patients to prevent long-term effects. This Small Business Innovation Research (SBIR) Phase I project will develop a new rapid, phenylalanine monitor for patients with phenylketonuria. Rapid quantification of blood phenylalanine levels to improve patient outcomes. The device will also be a cost effective alternative to the standard of care as it is today. This device consists of a test strip and a test device. The test strip accepts a blood drop from a finger prick. The test strip contains various chemistries that condition the blood sample prior to optically analysis by the test device. The test device implements spectroscopy to interrogate the test strip as it determines phenylalanine quantity. The focus of this project is to optimize the product design and system algorithm. The proposed work enables cost-effective manufacturing and deployment of the device to the end user; the end goal of this project is to develop a simple prototype.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.