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

这个小企业创新研究（SBIR）I期项目的更广泛的影响/商业潜力解决了对快速方便的方法来监测苯丙酮尿症（简称PKU）患者血液苯丙氨酸水平的迫切需求。PKU患者不能分解代谢苯丙氨酸，因此具有升高的毒性水平。这些患者接受严格限制蛋白质饮食和其他潜在药物治疗。由于苯丙氨酸过量会导致神经系统损伤，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。这种平衡只能通过跟踪血液苯丙氨酸水平来实现，而血液苯丙氨酸水平在一天中会波动。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，患者可能会经历长时间的行为和神经认知疾病发作。PKU是一种终身遗传性疾病，需要不断调整饮食疗法。每年照顾PKU患者的社会成本可以从15，000美元到200，000美元不等;这种疾病在管理不当时会造成不可逆转的损害和高昂的护理成本。拟议的项目将为这些患者开发一种新的监测仪，以防止长期影响。这个小企业创新研究（SBIR）第一阶段项目将开发一种新的快速，苯丙氨酸监测苯丙酮尿症患者。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护理标准，因为它是今天。该设备由测试条和测试设备组成。测试条接受手指刺破的血滴。测试条包含在通过测试装置进行光学分析之前调节血液样品的各种化学物质。测试设备执行光谱学以在测试条确定苯丙氨酸量时询问测试条。本项目的重点是优化产品设计和系统算法。该项目的最终目标是开发一个简单的原型。该奖项反映了NSF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.