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.

项目概要 据 CDC 称，在美国，超过 280 万人次的急诊就诊与 每年都有超过 288,000 例脑外伤 (TBI) 导致患者住院。脑外伤性脑损伤 程度不等，超过 75% 的损伤被归类为“轻度”TBI (mTBI)，也称为“轻度”TBI 作为脑震荡。 TBI 的临床诊断及其严重程度仍然具有挑战性。医生 经常采用计算机断层扫描 (CT) 扫描来检测脑组织损伤或颅内损伤 病变，并诊断 TBI。然而，大多数这些扫描都是阴性的，因为 mTBI 很少 导致可检测到的病变。因此，每年进行的 150 万次头部 CT 扫描中 可能的TBI患者中，多达80%是不必要的。 CT 扫描带有明显的辐射 暴露，增加辐射诱发癌症的风险和经济负担。提示和 准确分类应该或不应该接受 CT 扫描的患者仍然是一项重要的医学研究 挑战。 该 SBIR 第一阶段提案旨在开发和验证基于血液的即时诊断 用于对头部受伤患者进行分类和管理的设备。该设备，pScreen- TBI，利用 Accel Diagnostics 的创新专利检测技术，准确地 量化两个关键生物标志物（UCH-L1 和 GFAP）的水平。这些的使用 FDA 最近批准了生物标志物，以帮助评估哪些患者受到影响 头部受伤应进行 CT 扫描。 FDA 的决定得到了众多研究的支持 研究表明，这些生物标志物水平升高，在确定哪些生物标志物具有 99.7% 的敏感性 患者在 CT 扫描上有可见病变，而那些 NPV 未达到 99.6%（阴性）的患者 预测值）。 pScreen-TBI 首次结合了这些的预测能力 生物标志物采用一次性、易于使用且经济的工具，可提供快速、灵敏的检测 在紧急情况和护理点设置中读出。该设备对于运动和 战场伤害和机动车事故。急救人员可以使用该设备来 关于患者的决定需要进行 CT 扫描，将关键信息传递给临床医生，同时 通过连接的智能手机应用程序前往医院的路线。 第一阶段的工作重点是开发、优化和验证功能原型 从单个指尖血样中平行定量 UCH-L1 和 GFAP。具体来说， 我们将完成两个具体目标： 目标 1) 设计和制造双工平台，选择 最佳的捕获和检测抗体对，并优化每个抗体的反应组分 生物标志物；和目标 2）针对黄金进行比较临床前验证研究 使用人体血液样本进行标准、高灵敏度实验室测定 (ELISA)。 拟议的项目得到了广泛的初步数据和多学科团队的支持 将工业界和学术界聚集在一起，包括一名生物化学家、一名物理学家、两种分析方法 发展科学家、神经外科医生、TBI 生物标志物发现专家、神经科学家，以及 两位美国顶尖 TBI 专家 B. Omalu 博士的支持（电影的灵感来源 脑震荡）和 J. Maroon 博士（匹兹堡钢人队神经外科医生）。 总之，第一阶段解决了未满足的临床需求，具有重要的商业价值 机会。这项技术的成功开发可以最大限度地减少诊断的不确定性 消除不必要的程序，直接带来更好的整体健康结果 降低成本。