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。

基本信息

  • 批准号:
    10009497
  • 负责人:
  • 金额:
    $ 22.4万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 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

项目摘要

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 根据疾病预防控制中心的数据,在美国,超过280万次急诊就诊与以下疾病有关: 创伤性脑损伤(TBI)每年有超过288,000例导致患者住院治疗。TBI 这些损伤中有超过75%被归类为“轻度”TBI(mTBI),也被称为 脑震荡TBI的临床诊断及其严重程度仍然具有挑战性。医生 通常借助于计算机断层扫描(CT)来检测脑组织损伤或颅内损伤。 损伤,并诊断TBI。然而,这些扫描大多数是阴性的,因为mTBI很少 导致可检测的损伤。因此,在每年进行的150万次头部CT扫描中, 可能的TBI患者,多达80%是不必要的。CT扫描携带大量辐射 这将增加辐射暴露的风险,增加辐射诱发癌症的风险和经济负担。得到迅速 准确分类应该或不应该接受CT扫描的患者仍然是一个主要的医疗问题 挑战. SBIR第一阶段提案旨在开发和验证基于血液的即时诊断 用于对出现头部损伤的患者进行分类和管理的装置。这个装置,pScreen- TBI利用Accel Diagnostics的创新和专利检测技术, 量化两个关键生物标志物的水平,称为UCH-L1和GFAP。使用这些 FDA最近批准了生物标志物,以帮助评估哪些患者受 头部受伤应该做CT扫描。FDA的决定得到了许多研究的支持, 表明这些生物标志物的水平升高在确定哪些生物标志物中具有99.7%的灵敏度。 患者在CT扫描上有可见的病变,而那些没有99.6%NPV的患者(阴性 预测值)。pScreen-TBI首次整合了这些预测能力, 生物标志物在一次性的,易于使用的,经济的工具,提供快速和敏感的 在紧急情况和护理点设置中读取。该装置具有明显的实用性, 战场伤害和机动车事故。急救人员可以用这个装置 关于患者需要进行CT扫描的决定,将关键信息发送给临床医生, 通过所连接的智能手机应用程序路由到医院。 第一阶段的工作重点是开发、优化和验证 来自单个手指针刺血液样品的UCH-L1和GFAP的平行定量。具体地说, 我们将完成两个具体的目标:目标1)设计和制作双路平台,选择 捕获和检测抗体最佳配对,以及各自的最佳反应组分 目标2)针对金-生物标志物进行比较性临床前验证研究, 使用人血液样品的标准、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,包括一位生物化学家,一位物理学家, 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, 两个国家领先的TBI专家的支持,博士B。Omalu(电影灵感) 脑震荡),和J马龙博士(匹兹堡钢人队的团队神经外科医生)。 总之,该I期研究解决了未满足的临床需求, 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,直接导致更好的整体健康结果, 降低成本

项目成果

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Alberto Gandini其他文献

Alberto Gandini的其他文献

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{{ truncateString('Alberto Gandini', 18)}}的其他基金

A COVID-19 Point of Care Serological Assay for Rapid Quantification of Antibody Titer.
用于快速定量抗体滴度的 COVID-19 护理点血清学测定。
  • 批准号:
    10542478
  • 财政年份:
    2021
  • 资助金额:
    $ 22.4万
  • 项目类别:
A COVID-19 Point of Care Serological Assay for Rapid Quantification of Antibody Titer.
用于快速定量抗体滴度的 COVID-19 护理点血清学测定。
  • 批准号:
    10157509
  • 财政年份:
    2021
  • 资助金额:
    $ 22.4万
  • 项目类别:
A COVID-19 Point of Care Serological Assay for Rapid Quantification of Antibody Titer.
用于快速定量抗体滴度的 COVID-19 护理点血清学测定。
  • 批准号:
    10574627
  • 财政年份:
    2021
  • 资助金额:
    $ 22.4万
  • 项目类别:
I-Corps Program for A rapid instrument-free diagnostic assay for the early detection and quantification of sepsis biomarkers in blood.
I-Corps 计划用于快速无仪器诊断测定,用于血液中脓毒症生物标志物的早期检测和定量。
  • 批准号:
    9411541
  • 财政年份:
    2017
  • 资助金额:
    $ 22.4万
  • 项目类别:
A disposable assay for the monitoring of heart failure in the home setting
一种用于家庭环境中监测心力衰竭的一次性检测方法
  • 批准号:
    8905933
  • 财政年份:
    2015
  • 资助金额:
    $ 22.4万
  • 项目类别:
A disposable assay for the monitoring of heart failure in the home setting.
用于在家庭环境中监测心力衰竭的一次性测定。
  • 批准号:
    9408688
  • 财政年份:
    2015
  • 资助金额:
    $ 22.4万
  • 项目类别:
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