InstaCortisol:A realtime and continuous assessment of Cortisol in ISF

描述（由申请人提供）：“压力智能”反复暴露于心理社会压力与几种人类疾病（如癌症、吸毒成瘾、心脏病、抑郁症）有关，对公共卫生造成巨大负担。然而，我们的进展受到限制，因为缺乏一种便携式设备，可以快速、可靠、无创和连续地实时测量个人在自然环境中所经历的心理社会压力。在这个跨学科项目中，我们建议开发一种名为InstaCortisol（tm）的新测试，它可以通过测量受试者在自然环境中的皮质醇水平来可靠、有选择地快速量化个人暴露于压力下的程度。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。这种快速测试基于免疫电化学方法，当皮质醇夹在捕获物和附着在碱性磷酸酶上的检测器抗体之间时，通过循环伏安法测量反应信号。这个项目有四个具体目标。首先是传感器制造：我们将在头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、线性度、准确性、动态范围、可重复性、精度、准确性、干扰、交叉反应性、漂移和传感器校准。我们期望改变和/或优化制造方法，以达到这些类别的基准。第三是传感器性能：根据市售的皮质醇传感器建立传感器性能。我们的目标是满足或超过，鉴于需要持续的性能基准随时可用的皮质醇传感器。第四是设计集成可行性实验：对皮质醇传感器芯片进行虚拟评估，并将其集成到一个紧凑易用的设计中。相关性：InstaCortisol（tm）测试（在第一阶段开发中）将成为stress smart （tm）设备在第二阶段的一部分，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。这种能力将促进我们对暴露于社会心理压力如何与造成巨大公共卫生负担的流行人类疾病病因学中的遗传因素相互作用的理解。公共卫生相关性：我们建议建立一种快速检测皮质醇的方法，称为“InstaCortisol”，它将通过检测间质液（ISF）中的皮质醇，定量地、选择性地、客观地、可靠地、安全地实时和连续地测量个人暴露于心理社会压力下的情况。ISF将使用我们专有的微创设备“LightAccess”进行采集。提议的产品涉及几种尖端技术的集成。该产品几乎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著改进的方法。

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.