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 根据疾控中心的数据，在美国，超过280万急诊科就诊与 每年有超过28.8万人因颅脑损伤住院。TBI 程度不同，其中超过75%的损伤被归类为“轻度”脑外伤(MTBI)，也称为 就像脑震荡一样。颅脑损伤的临床诊断及其严重程度仍然具有挑战性。内科医生 经常求助于计算机断层扫描(CT)来检测脑组织损伤或颅内 损害，并诊断脑外伤。然而，这些扫描的大多数都是阴性的，因为mTBI很少 导致可检测到的损伤。因此，在每年进行的150万次头部CT扫描中， 可能的颅脑损伤患者，多达80%是不必要的。CT扫描会带来显著的辐射 暴露，增加了辐射诱发癌症的风险和经济负担。提示符和 对应该或不应该接受CT扫描的患者进行准确的分诊仍然是一项重要的医学任务 挑战。 此SBIR第一阶段提案旨在开发和验证基于血液的护理点诊断 用于对出现头部损伤的患者进行分类和管理的设备。这个设备，pScreen- TBI，利用Accel诊断公司的创新和专利检测技术准确地 量化两个关键生物标志物的水平，即UCH-L1和GFAP。这些产品的使用 生物标志物最近被FDA清除，以帮助评估哪些患者受到 头部损伤应做CT扫描。FDA的决定得到了大量研究的支持，这些研究 结果表明，这些生物标志物水平的升高在确定 患者在CT扫描上可见病变，而在99.6%的NPV(阴性)中未见病变 预测值)。PScreen-TBI首次整合了以下各项的预测能力 一次性、易于使用、经济实惠的工具中的生物标志物，提供快速而灵敏的 在紧急情况下和护理点设置下的读数。该装置对运动和体育运动具有明显的实用价值 战场伤病和机动车事故。急救人员可以使用该设备进行 需要对患者的决策进行CT扫描，将关键信息发送给临床医生 通过连接的智能手机应用程序前往医院的路线。 第一阶段的工作将集中于开发、优化和验证 从单个手指棒状血样中平行定量UCH-L1和GFAP。具体来说， 我们将完成两个具体目标：目标1)设计和制造双复用平台，选择 捕获和检测抗体的最佳组合，并优化每个抗体的反应成分 BioMarker；和Aim 2)进行一项对照黄金的临床前验证研究 使用人类血液样本的标准、高灵敏度实验室检测(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 将产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，两个化验师 发展科学家，神经外科医生，脑损伤生物标记物发现专家，神经科学家，以及 国家两位顶尖的脑损伤专家B.OMalu博士的支持(电影的灵感来自 脑震荡)和J.Maroon博士(匹兹堡钢人队神经外科医生)。 总而言之，这一阶段解决了未得到满足的临床需求，具有重要的商业价值 机会。这项技术的成功开发可以将诊断的不确定性降到最低 以及消除不必要的程序，直接导致更好的整体健康结果和 降低成本。