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Blood-based traumatic brain injury biomarkers : Clinical utilities and regulatory pathways in the United States, Europe and Canad

Wang, Kevin K. (författare)
Program for Neurotrauma, Neuroprotoemics & Biomarker Research, Department of Emergency Medicine, University of Florida College of Medicine, Gainesville, Florida, USA; Brain Rehabilitation Research Center (BRRC), Malcom Randall Veterans Affairs Medical Center, Gainesville, Florida, USA
Munoz Pareja, Jennifer C. (författare)
Department of Pediatric Critical Care, University of Miami Miller School of Medicine, Miami, Florida, USA
Mondello, Stefania (författare)
Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy
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Diaz-Arrastia, Ramon (författare)
Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA
Wellington, Cheryl (författare)
Djavad Mowafaghian Centre for Brain Health, University of British Columbia, Canada
Kenney, Kimbra (författare)
Department of Neurology, Uniformed Service University, Bethesda, Maryland, USA
Puccio, Ava M. (författare)
Department of Neurological Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
Hutchison, Jamie (författare)
The Hospital for Sick Children, Department of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada
McKinnon, Nicole (författare)
The Hospital for Sick Children, Department of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada
Okonkwo, David O. (författare)
Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA
Yang, Zhihui (författare)
Program for Neurotrauma, Neuroprotoemics & Biomarker Research, Department of Emergency Medicine, University of Florida College of Medicine, Gainesville, Florida, USA; Brain Rehabilitation Research Center (BRRC), Malcom Randall Veterans Affairs Medical Center, Gainesville, Florida, USA
Kobeissy, Firas (författare)
Program for Neurotrauma, Neuroprotoemics & Biomarker Research, Department of Emergency Medicine, University of Florida College of Medicine, Gainesville, Florida, USA; Brain Rehabilitation Research Center (BRRC), Malcom Randall Veterans Affairs Medical Center, Gainesville, Florida, USA
Tyndall, J. Adrian (författare)
Program for Neurotrauma, Neuroprotoemics & Biomarker Research, Department of Emergency Medicine, University of Florida College of Medicine, Gainesville, Florida, USA
Büki, Andras, 1966- (författare)
Czeiter, Endre (författare)
Department of Neurosurgery, Pecs University, Pecs, Hungary
Pareja Zabala, Maria C. (författare)
Fundación Universitaria Sanitas, Bogota, Colombia
Gandham, Nithya (författare)
Program for Neurotrauma, Neuroprotoemics & Biomarker Research, Department of Emergency Medicine, University of Florida College of Medicine, Gainesville, Florida, USA
Berman, Rebecca (författare)
National Institute of Neurological Disorders and Stroke, National Institute of Health, Bethesda, MD, USA
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 (creator_code:org_t)
2021-11-29
2021
Engelska.
Ingår i: Expert Review of Molecular Diagnostics. - : Expert Reviews Ltd.. - 1473-7159 .- 1744-8352. ; 21:12, s. 1303-1321
Relaterad länk:
https://urn.kb.se/re...
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https://doi.org/10.1...
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  • Forskningsöversikt (refereegranskat)
Abstract Ämnesord
Stäng  
  • Introduction: Traumatic brain injury (TBI) is a major global health issue, resulting in debilitating consequences to families, communities, and health-care systems. Prior research has found that biomarkers aid in the pathophysiological characterization and diagnosis of TBI. Significantly, the FDA has recently cleared both a bench-top assay and a rapid point-of-care assays of tandem biomarker (UCH-L1/GFAP)-based blood test to aid in the diagnosis mTBI patients. With the global necessity of TBI biomarkers research, several major consortium multicenter observational studies with biosample collection and biomarker analysis have been created in the USA, Europe, and Canada. As each geographical region regulates its data and findings, the International Initiative for Traumatic Brain Injury Research (InTBIR) was formed to facilitate data integration and dissemination across these consortia.Areas covered: This paper covers heavily investigated TBI biomarkers and emerging non-protein markers. Finally, we analyze the regulatory pathways for converting promising TBI biomarkers into approved in-vitro diagnostic tests in the United States, European Union, and Canada.Expert opinion: TBI biomarker research has significantly advanced in the last decade. The recent approval of an iSTAT point of care test to detect mild TBI has paved the way for future biomarker clearance and appropriate clinical use across the globe.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Neurologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Neurology (hsv//eng)

Nyckelord

Biomarkers
consortiums
point of care
regulatory pathways
traumatic brain injury

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