Silk-based biospecimen stabilization for exposure assessment diagnostics

用于暴露评估诊断的丝基生物样本稳定

• 批准号: 9348021
• 负责人: Jonathan August Kluge
• 金额: $ 75万
• 依托单位: VAXESS TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9348021
• 关键词: Adoption; Aliquot; Ambulatory Care Facilities; Area; Back; Biological Markers; Biological Monitoring; Blood; Blood capillaries; Cardiovascular Diseases; Cohort Studies; Cold Chains; Collection; Control Groups; Cryopreservation; Data; Detection; Devices; Diagnosis; Diagnostic; Elements; Epidemiology; Fingers; Freezing; Goals; Gold; Government; Government Agencies; Healthcare Systems; Hormones; Human Resources; India; Inductively Coupled Plasma Mass Spectrometry; Institutes; International; Liquid substance; Liver diseases; Medical; Methods; Mind; Outcome; Outpatients; Paper; Patients; Persons; Phase; Plasma; Plasma Proteins; Plasticizers; Population; Process; Proteins; Public Health; Publishing; Recovery; Recruitment Activity; Research; Research Personnel; Resources; Routine Diagnostic Tests; Rural; Saliva; Sampling; Sensitivity and Specificity; Serum Proteins; Ships; Silk; Site; Solid; Specimen; Spottings; System; Techniques; Technology; Temperature; Testing; Thyroid Diseases; Time; Translating; Translations; Transportation; Travel; Tube; Universities; Validation; Venous; Vial device; Visit; Weight; Whole Blood; Work; base; cohort; cost; design; hazard; improved; insight; laboratory facility; liquid chromatography mass spectrometry; medical schools; method development; molecular subtypes; novel; point of care; programs; protein biomarkers; prototype; sample collection; screening; success

Silk-Based Biospecimen Stabilization for Exposure Assessment Project Summary/Abstract There is a critical need for a stabilization platform that can preserve biospecimen integrity, completely free of cold storage requirements. Such a technology would allow researchers, clinicians, government personnel and consumers to conduct biomonitoring in field conditions (i.e. without requiring visits to the outpatient lab). Our long-term goal is to develop a platform technology that maximizes the stability of a wide range of biospecimens in a novel silk protein matrix and that seamlessly integrates with downstream analytics. The objective of the current proposal is to build a novel collection device capable of capturing known volumes of specimen, integrating with the silk matrix stabilizer investigated in our Phase I program, and allowing for immediate storage and shipment via the use of desiccant drying. Our central hypothesis is that a new collection device can be designed in order to overcome both practical design-oriented and fundamental technological limitations of current sample collection options. Our hypothesis has been formulated based on our recent published and unpublished data using silk to stabilize a range of serum/plasma proteins and new insights into processing techniques that allow silk to be stored and shipped for extended durations at elevated temperatures. Therefore, in the first aim we will develop a novel collection device to accommodate the new silk feature. As a second aim, a 50-person cohort will be recruited for venous blood, capillary blood, and saliva samples, to be aliquoted and stored in the silk system, dried paper, or as liquid aliquots subject to various processing delays to simulate remote transportation use cases. In the third aim, two hundred subjects taken from an existing Indian cohort will be evaluated for hazard exposure (Vaxess) and plasma levels of liver, thyroid, and cardiovascular disease biomarkers (Agada medical). The expected outcomes would be a broader fundamental basis behind silk stabilization and new methods to translate these findings towards biospecimen recovery and storage as they pertain to biomonitoring. The rationale for the proposed research is that, once collection devices are validated, they can be used in a variety of external partnership settings. Success with the planned approach can positively impact many areas of need in the field of diagnostics and epidemiology. These needs include alternative approaches at solid biospecimen stabilization, and translation/validation of analytical techniques important for hazard exposures. Furthermore, by offering methods to interface with finger-prick volumes (i.e. less invasive quantities) of whole blood, a silk-based stabilization system could significantly reduce financial burdens associated with the outpatient clinic, and in turn increase accessibility.

用于暴露评估的丝基生物样本稳定性 项目概要/摘要 迫切需要一个能够保持生物样本完整性、完全不受污染的稳定平台。 冷库要求。这样的技术将使研究人员、临床医生、政府人员和 消费者在现场条件下进行生物监测（即无需前往门诊实验室）。我们的 长期目标是开发一种平台技术，最大限度地提高各种生物样本的稳定性 位于新型丝蛋白基质中，并与下游分析无缝集成。该计划的目标 目前的建议是建造一种新型收集装置，能够捕获已知体积的样本，集成 与我们第一阶段计划中研究的丝基质稳定剂一起使用，并允许立即储存和 通过使用干燥剂干燥运输。我们的中心假设是可以设计一种新的收集装置 为了克服当前样品的实际设计导向和基本技术限制 收集选项。我们的假设是根据我们最近发表和未发表的数据制定的 使用丝来稳定一系列血清/血浆蛋白以及对加工技术的新见解，使 丝绸需要在高温下长期储存和运输。因此，在第一个目标中，我们将 开发一种新颖的收集装置来适应新的丝绸特征。第二个目标是建立一个 50 人的队列 将招募静脉血、毛细血管血和唾液样本，等分并储存在丝中 系统、干纸或液体等分试样，受到各种处理延迟的影响，以模拟远程运输 用例。在第三个目标中，将对来自现有印度队列的 200 名受试者进行评估 危险暴露 (Vaxess) 以及肝脏、甲状腺和心血管疾病生物标志物的血浆水平 (Agada 医疗的）。预期结果将成为丝绸稳定和新丝绸之路背后更广泛的基础基础。 将这些发现转化为生物样本回收和储存的方法，因为它们与生物监测有关。 拟议研究的基本原理是，一旦收集设备经过验证，它们就可以用于 各种外部合作伙伴设置。计划方法的成功可以对许多领域产生积极影响 诊断和流行病学领域的需求。这些需求包括可靠的替代方法 生物样本的稳定以及对危险暴露很重要的分析技术的转化/验证。 此外，通过提供与整个手指刺破体积（即侵入性较小的量）接口的方法， 血液，基于丝绸的稳定系统可以显着减轻与血液相关的财务负担 门诊诊所，进而增加可及性。