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
- 来源:
- 关键词:AcademiaAccident and Emergency departmentAccountingAddressAffectAntibodiesAthleticBiological AssayBiological MarkersBloodBlood TestsBlood specimenBrainBrain ConcussionBreathingCancer BurdenCaringCenters for Disease Control and Prevention (U.S.)Cessation of lifeClinicalCodeCollaborationsComplexCraniocerebral TraumaDataDecision MakingDetectionDevelopmentDevicesDiagnosisDiagnosticDiagnostic testsDropsEconomic BurdenEconomicsElementsEmergency Department PhysicianEmergency SituationEmergency department visitEnzyme-Linked Immunosorbent AssayEvaluationFingersGlial Fibrillary Acidic ProteinGoldHeadHealthHealthcareHome environmentHospitalizationHospitalsHourHumanImageIn VitroIndustryInjuryIntuitionLaboratoriesLegal patentLesionLightLocationMarketingMedicalMulti-Institutional Clinical TrialNeurobiologyNeurologyNeurosurgeonOutcomePatient TriagePatientsPhasePhysiciansPredictive ValueRadiation exposureRadiation-Induced CancerReactionRecommendationRecording of previous eventsResortRiskRouteSavingsScanningScientistSeveritiesSmall Business Innovation Research GrantSportsSteelStreamSystemTechnologyTest ResultTestingTimeTraumatic Brain InjuryTriageUncertaintyUniversitiesUnnecessary ProceduresValidationWorkX-Ray Computed Tomographyassay developmentbasebiomarker discoverybrain tissueclinical Diagnosisclinical implementationcomparativecostdesignemergency settingsfirst responderimprovedinnovationmicrofluidic technologymid-career facultymild traumatic brain injurymobile applicationmotor vehicle injurymoviemultidisciplinarypoint of carepre-clinicalprofessorprogramsprototyperadiation risksmartphone Applicationtechnology developmenttoolvalidation studies
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.
项目总结
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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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
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- 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.
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- 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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