Time-relevant Blood Sample Collection Using HemaSpot

“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，通过在夜间而不是早晨服用降压药这一简单的行为改变，高危患者的生存率可提高5倍。确定这一重要数据的机制的研究受到限制，因为与时间相关的血液样本的获取有限，这是由于需要方便的采血师和前往实验室进行静脉穿刺采血。在关键时间点，如清晨或就寝时间，以及生病、居家、老年人、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，收集工作尤其困难。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，可以在任何地点和任何时间自行收集血液样本。用一根刺胳针，将两滴血滴在HemaSpot装置上，然后将血液吸到预先切开的吸收纸上。然后将墨盒合上，样品立即准备通过邮件发送到中心实验室。一旦血液被盒内的干燥剂干燥，样品在环境温度下是稳定的，不需要冷藏或冷链。封闭的药筒防止样品污染，减少下游处理的生物危害风险。Spot On Sciences公司目前在DARPA SBIR第二阶段合同的支持下，处于HemaSpot设备的最后开发阶段。在这项研究中，我们建议建立程序，以证明HemaSpot在时间生物学研究的24小时内收集定时样本的有效使用。为了检测疾病相关的生物标志物，我们将开发和/或转移现有的湿血诊断方法，用于干血斑（DBS）分析，并将展示HemaSpot的培训要求、易用性和样本分析，用于定时采血。这项试点研究将建立最佳实践程序，供随后在正在进行的人群研究中使用，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采集样本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测试，以预防、检测和监测糖尿病和心血管疾病等慢性疾病。

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.