Real-life Performance and Added Value of the VIDAS® TBI Blood Test in the Assessment of Mild Traumatic Brain Injury (mTBI), in Subjects with a Glasgow Coma Scale (GCS) Between 13-15
Decision Rules for an initial CT-scan in patients arriving to Emergency Department (ED) and presenting a mild traumatic brain injury could be optimized by the use of an objective parameter easily and rapidly measured. This may be the place for serum biomarkers providing a quick and accurate assessment. BioMérieux has now developed an automated assay for the measurement of serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase (UCH-L1), the VIDAS® TBI assay to fill out this unmet needs. The goal of the herein study is to generate real-world data and evidences to support the VIDAS® TBI performances.
• Adult subject ≥ 18 years old
• Subject with a Glasgow Coma Scale (GCS) score between 13-15 on admission
• Subject presenting to the Emergency Department for suspected mild Traumatic Brain Injury
• Subject with a non-contrast head Computed Tomography (CT) scan ordered per the clinical site's care usual care
• Blood sampling possible within 12 hours of injury (1 tube of 4-5 mL of blood)
• Subject expected to stay at least 2 hours in the ED or in a ward
• Subject with signed Informed Consent Form (ICF)