A rapid blood test to aid the triage of patients affected by head injuries.

快速血液检测可帮助对头部受伤的患者进行分类。

• 批准号: 10009497
• 负责人: Alberto Gandini
• 金额: $ 22.4万
• 依托单位: ACCEL DIAGNOSTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10009497
• 关键词: Academia; Accident and Emergency department; Accounting; Address; Affect; Antibodies; Athletic; Biological Assay; Biological Markers; Blood; Blood Tests; Blood specimen; Brain; Brain Concussion; Breathing; Cancer Burden; Caring; Centers for Disease Control and Prevention (U.S.); Cessation of life; Clinical; Code; Collaborations; Complex; Craniocerebral Trauma; Data; Decision Making; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic tests; Drops; Economic Burden; Economics; Elements; Emergency Department Physician; Emergency Situation; Emergency department visit; Enzyme-Linked Immunosorbent Assay; Evaluation; Fingers; Glial Fibrillary Acidic Protein; Gold; Head; Health; Healthcare; Home environment; Hospitalization; Hospitals; Hour; Human; Image; In Vitro; Industry; Injury; Intuition; Laboratories; Legal patent; Lesion; Light; Location; Marketing; Medical; Multi-Institutional Clinical Trial; Neurobiology; Neurology; Neurosurgeon; Outcome; Patient Triage; Patients; Phase; Physicians; Predictive Value; Radiation exposure; Radiation-Induced Cancer; Reaction; Recommendation; Recording of previous events; Resort; Risk; Route; Savings; Scanning; Scientist; Severities; Small Business Innovation Research Grant; Sports; Steel; Stream; System; Technology; Test Result; Testing; Time; Traumatic Brain Injury; Triage; Uncertainty; Universities; Unnecessary Procedures; Validation; Work; X-Ray Computed Tomography; assay development; base; biomarker discovery; brain tissue; clinical Diagnosis; clinical implementation; comparative; cost; design; emergency settings; first responder; improved; innovation; microfluidic technology; mid-career faculty; mild traumatic brain injury; mobile application; motor vehicle injury; movie; multidisciplinary; point of care; pre-clinical; professor; programs; prototype; radiation risk; smartphone Application; technology development; tool; validation studies

Project Summary According to the CDC, in the U.S. over 2.8M emergency department visits are associated with Traumatic Brain Injury (TBI) each year, and over 288,000 result in patients' hospitalization. TBI ranges in degree, with over 75% of these injuries classified as “mild” TBI (mTBI), also referred to as concussions. The clinical diagnosis of TBI and its severity remains challenging. Physicians often resort to Computed Tomography (CT) scans to detect brain tissue damage or intracranial lesions, and diagnose TBI. However, the majority of these scans are negative, as mTBI rarely results in detectable lesions. As such, of the 1.5 million head CT scans performed every year on possible TBI patients, as many as 80% are unnecessary. CT scans carry significant radiation exposure, increasing the risk of radiation-induced cancer and economic burden. The prompt and accurate triage of patients that should or should not receive a CT scan remains a major medical challenge. This SBIR Phase I proposal aims to develop and validate a point-of-care blood based diagnostic device for triaging and managing patients presenting with head injury. The device, the pScreen- TBI, leverages Accel Diagnostics' innovative and patented detection technology to accurately quantify the level of two key biomarkers, known as UCH-L1 and GFAP. The use of these biomarkers were recently cleared by the FDA to aid the evaluation of which patients affected by head injuries should be CT scanned. The FDA decision is supported by numerous studies that showed that elevated levels of these biomarkers have 99.7% sensitivity in determining which patients have lesions visible on a CT scans and those which not with a 99.6% NPV (negative predictive value). The pScreen-TBI incorporates, for the first time, the predictive power of these biomarkers in a disposable, easy to use, and economic tool that delivers a rapid and sensitive readout in an emergency and Point-of-Care setting. The device has clear utility for athletic and battlefield injuries and motor vehicle accidents. First responders can use the device to make decisions on patient need to be CT scanned, routing critical information to clinicians while en route to the hospital via the connected smart-phone application. Phase I efforts will focus on developing, optimizing, and validating a functional prototype for the parallel quantification of UCH-L1 and GFAP from a single finger-stick blood sample. Specifically, we will completed two Specific Aims: Aim 1) design and fabricate the dual-plex platform, select the optimal pair of capture and detection antibodies, and optimize reaction components for each biomarker; and Aim 2) conduct a comparative pre-clinical validation study against a gold- standard, high-sensitivity lab-assay (ELISA) using human blood samples. The proposed project is supported by extensive preliminary data, and a multi-disciplinary team bringing industry and academia together, and including a biochemist, a physicist, two assay development scientist, a neurosurgeon, a TBI biomarker discovery expert, a neuroscientist, and the support of two of the Nation's leading TBI experts, Dr. B. Omalu (inspiration for the movie Concussion), and Dr. J. Maroon (team neurosurgeon of the Pittsburgh Steelers). In summary this Phase I addresses an unmet clinical need with significant commercial opportunity. The successful development of this technology could minimize diagnostic uncertainty and eliminating unnecessary procedures, leading directly to better overall health outcomes and reduce costs.

项目摘要 据疾病预防控制中心（CDC）称，在美国，超过280万急诊室就诊 每年创伤性脑损伤（TBI），超过288,000人导致患者住院。 TBI 程度范围，其中75％的伤害被归类为“轻度” TBI（MTBI），也称为 作为咨询。 TBI及其严重程度的临床诊断仍然受到挑战。医师 通常诉诸计算机断层扫描（CT）扫描以检测脑组织损伤或颅内 病变和诊断TBI。但是，这些扫描中的大多数是负面的，因为mtbi很少 导致可检测的病变。因此，每年进行的150万头CT扫描中 可能的TBI患者，多达80％是不必要的。 CT扫描带有明显的辐射 暴露，增加辐射引起的癌症和经济负担的风险。提示和 精确的患者应或不应接受CT扫描的患者仍然是主要的医学 挑战。 SBIR I期建议旨在开发和验证基于护理的血液诊断 用于分类和管理患有头部受伤的患者的设备。设备，pscreen- TBI，利用Accel Diagnostics的创新和专利的检测技术准确 量化两个关键生物标志物的水平，称为UCH-L1和GFAP。这些使用 FDA最近清除了生物标志物，以帮助评估哪些患者受影响 头部受伤应扫描。 FDA决定得到了许多研究的支持 表明，这些生物标志物的升高水平在确定哪个的敏感性99.7％ 患者在CT扫描中可见病变，而NPV的病变则不可见（阴性） 预测价值）。 Pscreen-TBI首次合并这些预测能力 一次性，易于使用和经济工具中的生物标志物可提供快速而敏感的 在紧急情况和护理点环境中进行读数。该设备具有明确的运动用途，并且 战场受伤和汽车事故。第一响应者可以使用该设备制作 需要扫描有关患者的决定，向临床医生提供关键信息，同时 通过连接的智能手机应用程序途径到医院。 第一阶段的努力将着重于开发，优化和验证功能原型 从单个手指粘的血液样本中对UCH-L1和GFAP的平行定量。具体来说， 我们将完成两个具体目标：目标1）设计和制造双重平台，选择 最佳的捕获和检测抗体对，并优化每种抗体 生物标志物；目标2）对金 - 进行比较的临床前验证研究 使用人类血液样本的标准，高敏性实验室测定（ELISA）。 拟议的项目得到了广泛的初步数据的支持，并且是一个多学科团队 将行业和学术界汇集在一起​​，包括生物化学家，一名物理学家，两个测定法 开发科学家，神经外科医生，TBI生物标志物发现专家，神经科学家和 美国两位领先的TBI专家B. Omalu博士的支持（电影的灵感 脑震荡）和J. Maroon博士（匹兹堡钢人队的神经外科医生）。 总而言之，本阶段I解决了未满足的临床需求 机会。该技术的成功开发可以最大程度地减少诊断不确定性 并消除不必要的程序，直接导致更好的整体健康成果和 降低成本。