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Blood-based traumat...
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Wang, Kevin K.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
(author)
Blood-based traumatic brain injury biomarkers : Clinical utilities and regulatory pathways in the United States, Europe and Canad
- Article/chapterEnglish2021
Publisher, publication year, extent ...
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2021-11-29
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Expert Reviews Ltd.2021
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LIBRIS-ID:oai:DiVA.org:oru-113737
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https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-113737URI
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https://doi.org/10.1080/14737159.2021.2005583DOI
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Language:English
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Summary in:English
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Subject category:ref swepub-contenttype
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Subject category:for swepub-publicationtype
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Funding Agencies:United States Department of Health & Human ServicesNational Institutes of Health (NIH)United States Department of DefenseW81XWH-14-2-0176European UnionU.S. Army Medical Research and Material Command, from the U.S. Department of Veterans Affairs Long-term Impact of Military-related Brain InjuryConsortium/Chronic Effects of Neurotrauma ConsortiumUnited States Department of Defense
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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.
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Munoz Pareja, Jennifer C.Department of Pediatric Critical Care, University of Miami Miller School of Medicine, Miami, Florida, USA
(author)
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Mondello, StefaniaDepartment of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy
(author)
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Diaz-Arrastia, RamonDepartment of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA
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Wellington, CherylDjavad Mowafaghian Centre for Brain Health, University of British Columbia, Canada
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Kenney, KimbraDepartment of Neurology, Uniformed Service University, Bethesda, Maryland, USA
(author)
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Puccio, Ava M.Department of Neurological Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
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Hutchison, JamieThe Hospital for Sick Children, Department of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada
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McKinnon, NicoleThe Hospital for Sick Children, Department of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada
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Okonkwo, David O.Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA
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Yang, ZhihuiProgram 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
(author)
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Kobeissy, FirasProgram 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
(author)
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Tyndall, J. AdrianProgram for Neurotrauma, Neuroprotoemics & Biomarker Research, Department of Emergency Medicine, University of Florida College of Medicine, Gainesville, Florida, USA
(author)
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Büki, Andras,1966-
(author)
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Czeiter, EndreDepartment of Neurosurgery, Pecs University, Pecs, Hungary
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Pareja Zabala, Maria C.Fundación Universitaria Sanitas, Bogota, Colombia
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Gandham, NithyaProgram for Neurotrauma, Neuroprotoemics & Biomarker Research, Department of Emergency Medicine, University of Florida College of Medicine, Gainesville, Florida, USA
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Berman, RebeccaNational Institute of Neurological Disorders and Stroke, National Institute of Health, Bethesda, MD, USA
(author)
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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, USADepartment of Pediatric Critical Care, University of Miami Miller School of Medicine, Miami, Florida, USA
(creator_code:org_t)
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In:Expert Review of Molecular Diagnostics: Expert Reviews Ltd.21:12, s. 1303-13211473-71591744-8352
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Wang, Kevin K.
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Puccio, Ava M.
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Yang, Zhihui
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Kobeissy, Firas
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Tyndall, J. Adri ...
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Czeiter, Endre
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Pareja Zabala, M ...
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