학술논문

Point-of-Care Platform Blood Biomarker Testing of Glial Fibrillary Acidic Protein versus S100 Calcium-Binding Protein B for Prediction of Traumatic Brain Injuries: A Transforming Research and Clinical Knowledge in Traumatic Brain Injury Study
Document Type
article
Source
Journal of Neurotrauma. 37(23)
Subject
Brain Disorders
Clinical Research
Physical Injury - Accidents and Adverse Effects
Traumatic Brain Injury (TBI)
Traumatic Head and Spine Injury
Neurosciences
Injuries and accidents
Good Health and Well Being
Adult
Aged
Biomarkers
Brain Injuries
Traumatic
Cohort Studies
Female
Glial Fibrillary Acidic Protein
Humans
Male
Middle Aged
Point-of-Care Systems
S100 Calcium Binding Protein beta Subunit
Sensitivity and Specificity
biomarkers
glial fibrillary acidic protein
S100 calcium-binding protein B
traumatic brain injury
Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Investigators
Clinical Sciences
Neurology & Neurosurgery
Language
Abstract
Glial fibrillary acidic protein (GFAP) is cleared by the Food and Drug Administration (FDA) to determine need for head computed tomography (CT) within 12 h after mild traumatic brain injury (TBI) (Glasgow Coma Score [GCS] 13-15); S100 calcium-binding protein B (S100B) serves this function in Europe. This phase 1 biomarker cohort analysis of the multi-center, observational Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study compares GFAP's diagnostic performance, measured on a rapid point-of-care platform, against protein S100B to predict intracranial abnormalities on CT within 24 h post-injury across the spectrum of TBI (GCS 3-15). Head CT scan performed in TBI subjects and blood was collected for all consenting subjects presenting to 18 United States level 1 trauma centers. Plasma was analyzed on a point-of-care device prototype assay for GFAP and serum was analyzed for S100B. In 1359 patients with TBI (GCS 3-15), mean (standard deviation [SD]) age = 40.1 (17.0) years; 68% were male. Plasma GFAP levels were significantly higher in CT+ TBI subjects (median = 1358 pg/mL, interquartile range [IQR]: 472-3803) than in CT- TBI subjects (median = 116 pg/mL, IQR: 26-397) or orthopedic trauma controls (n = 122; median = 13 pg/mL, IQR: 7-20), p