text: Traumatic brain injury is a major neurological disorder when the brain is injured by traumatic force such as a bluent trauma or blast over-pressure wave. 
  For the disorders of central nervous system, the neuronal cell body-located Ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) and Glial fibrillary acidic protein (GFAP)  are the first-in-class FDA cleared blood-based biomarker test for mild traumatic brain injury (TBI) with potential brain lesions.  These tandem biomarkers were first discovered by Dr. Kevin K. Wang and Dr. Ronald. L. Hayes’ neuroscience laboratories at the McKnight Brain Institute of University of Florida from 2003-2007). Here, traumatic brain injury (TBI) blood-based biomarker test consisted of measuring the levels of neuronal (UCH-L1) and  astroglial GFAP to aid in the diagnosis of the presence of cranial lesion(s) among moderate to mild TBI patients that is(are) otherwise only diagnosable with the use of a CT scan of the head.
  Banyan Biomarkers, Inc., a company co-founded by Drs. Wang, Hayes and Nancy Denslow developed an optimized sandwich chemiluminescent ELISA for UCH-L1/GFAP, termed Brain Trauma Indicator™ (BTI); it contains two kits - one for each of the two biomarkers as chemiluminescence assays on the Synergy 2 Multi-mode Reader  (BioTek). These assays were the basis of a pivotal TBI clinical trial called ALERT-TBI (ClinicalTrials.gov  #NCT01426919). Over 1,900 adult TBI subjects with a Glasgow Coma Scale of (GCS) 9-15 (mind TBI) were recruited with blood samples drawn within 12 hours of injury to determine  if the UCH-L1/GFAP tandem test can aid in the diagnosis of ta presence a cranial lesion that is otherwise only diagnosable with the use of a CT scan of the head. The results of the study show BTI has high sensitivity (97.6%) and negative predictive value (NPV) (99.6%). In February, 2018, FDA cleared the use the BTI for this mild TBI indication.