InstaCortisol:A realtime and continuous assessment of Cortisol in ISF

描述（由申请人提供）：“StressSmart”反复暴露于心理社会压力与几种人类疾病有关（例如，癌症、毒瘾、心脏病、抑郁症）的巨大公共卫生负担。然而，我们的进展受到缺乏便携式设备的限制，该设备可以实时快速，可靠，非侵入性和连续测量个人在自然环境中所经历的心理社会压力。在这个跨学科的项目中，我们建议开发一种名为InstaCortisol（TM）的新测试，通过测量受试者在自然环境中的皮质醇水平，可以可靠，选择性和快速地量化个人暴露于压力的程度。皮质醇是肾上腺皮质产生和分泌的主要类固醇，被用作压力的可靠指标。这种快速检测基于免疫电化学方法，其中当皮质醇夹在捕获和检测抗体之间时，通过使用循环伏安法测量反应信号，所述捕获和检测抗体连接到碱性磷酸酶。该项目有四个具体目标。首先是传感器制造：我们将在前两个月制造多个皮质醇传感器。其次是传感器评估：我们将测试传感器的灵敏度、特异性、酶/抗体稳定性、检测限、线性、准确度、动态范围、重复性、精密度、准确度、干扰、交叉反应性、漂移和传感器校准。我们预计将改变和/或优化制造方法，以实现这些类别中的每一个基准。第三是传感器性能：建立传感器性能与市售皮质醇传感器的对比。我们的目标是达到或超过，考虑到随时可用的皮质醇传感器的持续性能基准的需要。第四是设计集成可行性实验：虚拟评估皮质醇传感器芯片及其集成到一个紧凑的易于使用的设计。相关性：InstaCortisol（TM）测试（在第一阶段开发）将成为第二阶段StressSmart（TM）设备的一部分，将使研究人员能够量化个人在现实生活中所经历的心理社会压力。这样的能力将促进我们的理解，如何暴露于心理社会压力与遗传因素的病因学流行的人类疾病的巨大的公共卫生负担。公共卫生相关性：我们提出了一种快速检测皮质醇的测试，称为“InstaCortisol”，它将通过检测组织间液（ISF）中的皮质醇来定量，选择性，客观，可靠和安全地实时和连续测量个人暴露于心理社会压力。ISF将使用我们专有的微创设备“LightAccess”采集。拟议的产品涉及几个尖端技术的集成。该产品实际上不需要受试者或患者采取任何行动，从而大大减少了与不当使用相关的错误。这些创新将为评估在许多生物过程和疾病状态中起重要作用的分子提供一种显着改进的方法。

DESCRIPTION (provided by applicant): "StressSmart" Repeated exposures to psychosocial stress are associated with several human diseases (e.g., cancer, drug addiction, heart disease, depression) of tremendous public health burden. However, our progress is limited by the lack of a portable device that can enable rapid, reliable, non-invasive and continuous measurement of personal exposure to psychosocial stress in real-time, as experienced by individuals in their natural environments. In this interdisciplinary project, we propose to develop a new test called InstaCortisol(tm) that can be used to reliably, selectively and rapidly quantify personal exposures to stress by measuring Cortisol levels of subjects in their natural environments. Cortisol is the primary steroid produced and secreted by the adrenal cortex and is used as a reliable indicator of stress. This rapid test is based on immunoelectrochemical method where the reaction signal is measured by using cyclic voltammetry, when Cortisol sandwiches between the capture and the detector antibody, which is attached to Alkaline Phosphatase enzyme. There are four specific aims of this project. First is Sensor Fabrication: We will fabricate multiple Cortisol sensors in first two months. Second is Sensor Evaluation: we will test the sensors for sensitivity, specificity, enzyme/antibody stability, detection limit, linearity, accuracy, dynamic range, repeatability, precision, accuracy, interference, cross-reactivity, drift, and sensor calibration. We anticipate changing and/or optimizing fabrication methods to achieve benchmarks in each of these categories. Third is sensor performance: Establish sensor performance against commercially available Cortisol sensors. We aim to meet or exceed, given the need for continuous performance benchmarks of readily available Cortisol sensors. Fourth would be to Design integration feasibility experiments: A virtual evaluation of Cortisol sensor chip and its integration into a compact easy to use design. Relevance: The InstaCortisol(tm) test (being developed during Phase I), which will be part of StressSmart(tm) device during Phase II, will enable researchers to quantify personal exposure to psychosocial stress, as experienced by individuals in real-life situations. Such a capability will advance our understanding of how exposures to psychosocial stress interact with genetic factors in the etiology of prevalent human diseases of tremendous public health burden. PUBLIC HEALTH RELEVANCE: We are proposing to make a rapid test for detecting Cortisol, called "InstaCortisol", which will make real-time and continuous measurements of personal exposure to psychosocial stress quantitatively, selectively, objectively, reliably, and securely by detecting Cortisol in interstitial fluid (ISF). ISF will be harvested using our proprietary minimally invasive device called "LightAccess". The proposed product involves the integration of several cutting edge technologies. The product would require virtually no action on the part of the subject or patient thereby greatly reducing error associated with improper use. These innovations would provide a significantly improved method for assessing a molecule that plays an important role in many biological processes and disease states.