Refinement and Validation of a Portable, Salivary Biosensor of Psychosocial Stres

描述（由申请人提供）：我们的跨学科申请直接响应RFA-DA-07-005 （U01）的目标，提出了一种原型生物传感器的改进、现场验证和技术扩展，以促进对暴露于系统和社会心理压力源的唾液生物标志物的快速和精确测量。我们现有的手持式生物传感器利用小型化的光学平台和廉价的比色测试条来快速检测和量化唾液α -淀粉酶（SAA）， SAA是人体肾上腺素能应激反应的主要生物指标。不像复杂的、基于实验室的分析，经常涉及侵入性采样和提供静态测量，瞬时唾液生物传感器允许时间和空间分辨率，有利于压力-健康结果相互作用的大规模人群研究。我们将首先在50名健康对照者的队列中优化生物传感器的技术性能特征：a)建立便携式SAA生物传感器的校准曲线，并将其与实验室测定的SAA进行比较；b)检查生物传感器在昼夜周期中的可靠性（精度和准确性）；c)证明其作为低应激和高应激条件下暴露评估工具的有效性。随后，我们将在185名患有高度全身（面部损伤）和社会心理压力的易感患者中进行小规模的现场测试和功能验证。我们将a)测试SAA生物传感器在系统和社会心理压力（住院，手术后10天，手术后30天）变化中的收集程序和有效性，b)检查易感性脆弱性（如社会人口统计学，压力负担，社会支持）和系统环境（如物质使用，健康/生活方式行为）对生物标志物水平的潜在混淆影响。c)评估生物传感器SAA对受伤后适应不良心理（如痛苦、焦虑、抑郁）和行为症状（如物质使用增加）的预测有效性。同时，我们将完善生物传感器平台的技术能力，并扩展其能力，允许对其他唾液分析物进行多重分析，以反映应激反应（例如，皮质醇，DHEA，睾酮）以及合法和非法物质的使用。我们的最终目标是开发一个通用的便携式平台，通过检测和可靠地量化相关的唾液反应指标来操作压力和物质使用的心理生物学。互补性研究专长和致力于心理社会压力及其生物标志物的前驱研究的协同结合，最大限度地提高了我们的研究项目在资助期结束时产生可实地部署的压力反应生物传感器的可能性。

DESCRIPTION (provided by applicant): Our transdisciplinary application responds directly to the objectives of RFA-DA-07-005 (U01) by proposing the refinement, field validation and technical expansion of a prototype biosensor to facilitate rapid and precise measurement of salivary biomarkers of exposure to systemic and psychosocial stressors. Our extant hand-held biosensor utilizes a miniaturized optical platform and inexpensive, colorimetric test strips to rapidly detect and quantify salivary alpha-amylase (SAA), a primary bioindicator of the body's adrenergic stress response. Unlike elaborate, laboratory-based assays that frequently involve invasive sampling and provide static measurements, the instantaneous salivary biosensor allows a temporal and spatial resolution conducive to large-scale population studies of stress-health outcome interactions. We will first optimize the technical performance characteristics of the biosensor in a cohort of 50 healthy controls by a) establishing calibration curves for the portable SAA biosensor and comparing it to laboratory assayed SAA, b) examining biosensor reliability (precision and accuracy) over the diurnal cycle, and c) demonstrating its validity as a exposure assessment tool under conditions of low and high stress. Subsequently we will conduct small-scale field testing and functional validation of the biosensor in a cohort of 185 vulnerable patients with high systemic (facial injury) and psychosocial stress. We will a) test collection procedures and validity of the SAA biosensor across variations in systemic and psychosocial stress (hospital intake, 10 days post-surgery, 30-day post surgery), b) examine potential confounding effects of predisposing vulnerabilities (e.g., sociodemographics, stress burden, social support) and systemic milieu (e.g., substance use, health/lifestyle behaviors) on biomarker levels, and c) assess the predictive validity of biosensor SAA for maladaptive psychological (e.g., distress, anxiety, depression) and behavioral symptoms (e.g., increased substance use) following injury. Concurrently, we will refine the technical capabilities of the biosensor platform and expand its capabilities to permit multiplexed assays of other salivary analytes reflective of the stress response (e.g., cortisol, DHEA, testosterone) as well as licit and illicit substance use. Our ultimate goal is to develop a universal, portable platform to operationalize the psychobiology of stress and substance use by detecting and reliably quantifying relevant salivary response indicators. The synergistic combination of complementary research expertise and the body of precursor research devoted to psychosocial stress and its biomarkers maximize the likelihood that our research program will produce a field-deployable biosensor of the stress response by the end of the funding period.