The objective of AiDx study is to evaluate the performance of the TBI biomarkers test on the Alinity I system as an aid in the diagnosis of TBI. The current standard of care for diagnosis of TBI relies on clinical assessment, GCS (known to have many confounders) and CT (not as sensitive as to mild TBI as MRI), while a blood test could offer a rapid (objective) diagnostic aid, an important tool to add to the clinician’s toolbox.

This study will evaluate adult patients (approximately n = 350) presenting to a participating level I trauma center emergency department following a biomechanically plausible mechanism of TBI.  Subjects will have up to 20 mL of blood drawn ≤ 24 hours from injury by venipuncture or indwelling line placed as part of standard of care, processed for serum and plasma, and then tested on the TBI biomarkers test on the Alinity system for GFAP and UCHL1. Baseline clinical data will be collected, and subjects will be asked to complete two follow-up visits post injury to obtain additional information about their health status and a 3T MRI. Demographic, clinical data, imaging, and medical information will be collected and used for the diagnostic adjudication of TBI. A determination of TBI for each study subject will be made by an independent adjudication panel composed of practicing board certified clinicians with experience in the diagnosis of TBI. Subjects will be adjudicated as TBI positive or TBI negative and the diagnosis will be based on the American College of Rehabilitative Medicine guidelines. To assess its performance as an aid in the diagnosis and assessment of severity of individuals suspected or having TBI, the TBI biomarker test results will then be evaluated against the adjudication panel’s determination of diagnosis.

This study will serve as the training set to establish the TBI biomarkers test parameters prior to the clinical validation phase which will enroll approximately 1500 subjects across the spectrum of TBI.