Accuracy of the novel automated VIDAS TBI (GFAP, UCH-L1) assay for ruling out acute intracranial traumatic lesions in patients under 65 years of age with mild traumatic brain injury in an Emergency Department: an exploratory study

Background: Combination of glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1 (UCH-L1) is useful to exclude intracranial injury after mild traumatic brain injury (mTBI). We evaluated the diagnostic performance of the novel regulatory-approved VIDAS® TBI assay for this purpose. Method: Patients under 65 years of age presenting to the Emergency Department with TBI, Glasgow Coma score 13-15, completed head computed tomography (CT) scan and blood collected within 12 hours of injury were included. UCH-L1/GFAP levels were analyzed using prespecified cutoffs and combined into a single result and evaluated against CT findings. Results: 78 enrolled participants were analyzed. Intracranial injury was detected in 4 patients. VIDAS® TBI test achieved a sensitivity and negative predictive value of 100%. Conclusion: The VIDAS TBI assay showed potential as a rule-out test in this exploratory cohort; however, estimates were based on only four CT-positive cases and require confirmation in larger prospective studies.