Validation of a Point of Care Diagnostic for Traumatic Brain Injury

Traumatic brain injury (TBI) is a substantial health care issue affecting both civilian and military populations. Although extremes of head injury are recognizable, mild TBI (mTBI) is more difficult to diagnose. Because of the need for more rapid, pre-hospital identification of subjects with TBI, study has turned to the quantification of circulating biomarkers of brain injury that may facilitate early identification. Current studies of biomarkers of TBI have focused on levels of multiple brain related molecules including creatine kinase, glial filament associated protein (GFAP), myelin basic protein (MBP), neuron specific enolase (NSE) and S100â protein that may be quantified in blood or cerebrospinal fluid (CSF). Unfortunately, most of the markers have been quantified using enzyme linked immunoassays (ELISAs) that are temperature sensitive and that can take as long as 12 – 16 hours to complete, well outside a potentially beneficial therapeutic window. In the search for a novel marker of TBI that could be rapidly assessed in blood, we developed a lateral flow device (LFD) that detects levels of visinin like protein 1 (VILIP-1), a neuron specific Ca2+-sensor protein released into blood following TBI. The proposed studies aim to evaluate VILIP-1 levels in archived serum samples from well characterized TBI patients across the injury spectrum and to validate use of the device in the emergency department.