Time-relevant Blood Sample Collection Using HemaSpot

使用 HemaSpot 采集与时间相关的血液样本

• 批准号: 8781935
• 负责人: Jeanette R. Hill
• 金额: $ 15万
• 依托单位: SPOT ON SCIENCES, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-15 至 2015-01-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8781935
• 关键词: Binding; Biohazardous Substance; Biological Markers; Blood; Blood Pressure; Blood specimen; Cardiovascular Diseases; Chronic Disease; Chronobiology; Circadian Rhythms; Cold Chains; Collection; Consent Forms; Contracts; Data; Development; Devices; Diabetes Mellitus; Diagnosis; Diagnostic Procedure; Diagnostic tests; Disease; Disease Marker; Drops; Elderly; Evaluation; Fingers; Goals; Home environment; Institutional Review Boards; Kidney Diseases; Laboratories; Life; Location; Mails; Measures; Medical Research; Methods; Monitor; Paper; Patients; Pharmaceutical Preparations; Phase; Pilot Projects; Population Study; Preparation; Procedures; Recruitment Activity; Refrigeration; Reporting; Research; Risk; Sampling; Science; Shipping; Ships; Small Business Innovation Research Grant; Spain; Spottings; Staging; Temperature; Time; TimeLine; Training; Transportation; Travel; Validation; Venipunctures; Work; analytical method; behavior change; disease diagnosis; innovation; method development; prevent; public health relevance; rural area; sample collection; usability; volunteer

DESCRIPTION (provided by applicant): Time-relevant Blood Sample Collection Using HemaSpot" Collection of blood samples at relevant time points is critical for chronobiology (circadian rhythm) research and for predicting, diagnosing and treating chronic diseases such as diabetes, kidney and cardiovascular disease. Recent studies demonstrate that survival of at-risk patients is increased up to 5-fold by the simple behavior change of taking blood pressure medications at night time instead of morning. Research to determine mechanisms of this remarkable data is hampered by limited access to time-relevant blood samples due to the requirement of an accessible phlebotomist and travel to a laboratory for venipuncture blood collection. Collection is especially difficult for critical time points such as early morning or bedtime and for patients who are ill, home-bound, elderly, live in remote or rural areas, lack transportation or who cannot take time from work. Spot On Sciences proposes an innovative and revolutionary method using HemaSpot, an easy to use device that enables a blood sample to be self-collected from any location and at any time. Using a finger stick by lancet, two drops of blood are applied to the HemaSpot device and the blood wicks into a pre-cut absorbent paper. The cartridge is then snapped closed and the sample is immediately ready to ship by mail to a central lab. Once the blood is dried by desiccant within the cartridge, the sample is stable at ambient temperature and no refrigeration or cold chain is required. The enclosed cartridge prevents sample contamination and reduces biohazard risk from downstream handling. Spot On Sciences is currently in final development stages of the HemaSpot device with the support of a DARPA SBIR Phase II contract. For this study, we propose to establish procedures to demonstrate effective use of HemaSpot for collection of timed samples throughout a 24 h period for chronobiology research. To detect disease related biomarkers, we will develop and/or transfer existing wet blood diagnostic methods for dried blood spot (DBS) analysis and will demonstrate the training requirements, ease of use and sample analysis for timed blood collections with HemaSpot. This pilot study will establish best-practice procedures for subsequent use in ongoing population studies such as the Hygia study in Spain in which time-relevant biomarkers for cardiovascular disease will be determined. Use of HemaSpot for sample collection can greatly increase access to time-relevant blood samples for medical research and for diagnostic testing to prevent, detect and monitor chronic diseases such as diabetes and cardiovascular disease.

描述（由申请人提供）：使用HemaSpot进行的时间相关血液样本采集”在相关时间点采集血液样本对于时间生物学（昼夜节律）研究以及预测、诊断和治疗慢性疾病（如糖尿病、肾脏和心血管疾病）至关重要。最近的研究表明，通过在晚上而不是早上服用血压药物的简单行为改变，高危患者的生存率提高了5倍。确定这一显著数据的机制的研究受到时间相关血液样本有限的阻碍，这是由于需要一个可访问的抽血师和前往实验室进行静脉穿刺采血。在清晨或就寝时间等关键时间点，以及生病、居家、老年、居住在偏远或农村地区、缺乏交通工具或无法从工作中抽出时间的患者，收集数据尤其困难。Spot On Sciences提出了一种使用HemaSpot的创新和革命性方法，HemaSpot是一种易于使用的设备，可以在任何时间从任何地点自行采集血液样本。使用刺血针进行手指针刺，将两滴血液施加到HemaSpot装置上，并且血液芯吸到预先切割的吸收纸中。然后将检测盒快速关闭，样品立即准备好通过邮寄运送到中心实验室。一旦血液被测试卡片内的干燥剂干燥，样本在环境温度下是稳定的，并且不需要冷藏或冷链。封闭式检测盒可防止样品污染，并降低下游处理的生物危害风险。Spot On Sciences目前正处于HemaSpot设备的最后开发阶段，并得到了DARPA SBIR第二阶段合同的支持。对于这项研究，我们建议建立程序，以证明有效使用HemaSpot收集定时样本在整个24小时内的时间生物学研究。为了检测疾病相关的生物标志物，我们将开发和/或转移现有的干血斑（DBS）分析的湿血诊断方法，并将展示培训要求，易用性和HemaSpot定时采血的样本分析。这项试点研究将建立最佳实践程序，供随后用于正在进行的人群研究，如西班牙的Hygia研究，其中将确定心血管疾病的时间相关生物标志物。使用HemaSpot进行样本采集可以大大增加获得与时间相关的血液样本的机会，用于医学研究和诊断检测，以预防、检测和监测糖尿病和心血管疾病等慢性疾病。