I-Corps: H-meter - point of care device for the analysis of hormones in blood

I-Corps项目更广泛的影响/商业潜力是改善患者的生活质量。现代医学在很大程度上依赖于使用实验室分析来评估病人的健康状况、诊断疾病和监测治疗效果。许多实验室测试可以以低成本快速进行，而其他测试则昂贵且需要更多时间，因为它们需要熟练的技术人员和昂贵的仪器。该项目涉及开发一种快速、低成本的护理点（POC）诊断系统，该系统可以仅使用一滴血就以临床实验室测试的灵敏度和特异性测量激素水平。目前，基于实验室的激素检测的高成本阻碍了它们在老年男性性腺功能减退的诊断和治疗以及性别不符合人群的临床管理中的应用。准确和负担得起的激素POC测试将使更多的患者接受最佳激素治疗，减少治疗副作用，提高患者的生活质量。提出的低成本、准确的POC诊断系统将改善农村人口、贫困社区和第三世界国家的卫生保健。拟议的系统还具有兽医应用，将改善动物健康和该部门的经济效益。这个I-Corps项目涉及一项技术，它结合了纳米技术、仪器、生物学和医学的最新进展，在一个低成本的便携式诊断测试系统中，可以使用从手指刺破处收集的血液准确地测量护理点（POC）的游离睾酮。它将包括一个新颖的条形传感器和一个可以与任何智能手机/平板电脑连接的阅读单元。该传感器可以选择性地从血液样本中捕获睾酮分子，并产生与样本中存在的浓度成比例的光信号。与目前可用的技术相反，该传感器在识别系统中不包括抗体，这导致更长的货架时间，更低的成本和更高的可靠性。阅读单元将通过蓝牙和/或WiFi接口进行通信，并与不同的移动平台进行交互；并包括隐私保护功能，以解决患者的隐私问题。该系统还将使用加密代码直接向医生提供信息，并为远程医疗环境提供支持。我们产品的评估特性将导致医生诊断的提高，从而改善患者的健康状况。概念验证于2018年进行了演示，测试原型将于2019年夏末完成。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 I-Corps project is the improvement of the quality of life of patients. Modern medicine relies heavily on the use of laboratory analysis to assess patient health, diagnose disease and monitor treatment efficacy. Many laboratory tests can be performed speedily at low cost, whereas other tests are expensive and take more time due to their need for skilled technicians and costly instruments. This project involves development of a rapid, low cost, point of care (POC) diagnostic system that can measure hormone levels with the sensitivity and specificity of clinical lab-based tests using only a single drop of blood. Currently, the high cost of laboratory-based hormonal tests is a barrier to their use in the diagnosis and treatment of hypogonadism in aging men and clinical management of gender non-conforming populations. An accurate and affordable hormone POC tests will allow more patients to receive optimal hormone therapy, reducing treatment side effects and improving patient quality of life. The proposed low cost, accurate, POC diagnostic system will improve the health care of rural populations, impoverished communities and third world countries. The proposed system also has veterinary applications that will improve animal health and the economics of the sector. This I-Corps project involves a technology that combined recent advances in nanotechnology, instrumentation, biology and medicine in a low cost, portable diagnostic test system that can accurately measure free testosterone at the point of care (POC) using blood collected from a finger prick. It will include a novel strip like sensor and a reading unit that can be interfaced with any smart phone/tablet. The sensor can selectively capture testosterone molecules from the blood sample and produce an optical signal proportional to the concentration present in the sample. As opposed to currently available technology, the sensor does not include antibodies in the recognition system, which results in longer shelf-time, lower cost and higher reliability. The reading unit will communicate via Bluetooth and/or WiFi interface, and interact with different mobile platforms; and include privacy-preserving features to address patient privacy concerns. The system will also provide information directly to the physician using encryption code and provide a support a telemedicine environment. The assessment feature of our product will lead to the improvement of doctor's diagnosis, which will result in an improvement on patient health. Proof-of-concept was demonstrated in 2018 and beta prototype will be complete by the end of summer 2019.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.