Point-of-care biomarker assay for traumatic brain injury

Intracranial abnormalities on CT scan in patients with traumatic brain injury (TBI) can be predicted by glial fibrillary acidic protein (GFAP) levels in the blood. These interim findings from the TRACK-TBI study are published in the peer-reviewed Journal of Neurotrauma.

GFAP's diagnostic performance was significantly better than that of the S100B biomarker, to which it was compared. S100B is approved for use in Europe, but not in the U.S.

"GFAP substantially outperformed S100B as a TBI diagnostic biomarker of positive head CT scans," state David Okonkwo, MD, Ph.D., University of Pittsburgh Medical Center, Amy Markowitz, JD, University of California, San Francisco, and coauthors.

"Our results validate a point-of-care platform prototype GFAP assay that delivers results in minutes (<15 min) versus hours for the current FDA-cleared assay," state the authors.

"This is a particularly important study with major implications for the diagnosis and prognoses of traumatic brain injury. The large sample size and the rigorous inclusion criteria increase the impact of the reported study, which strongly reaffirms the utility of GFAP as a diagnostic marker for CT-detected lesions. It also demonstrates the utility of a point-of-care approach. As noted by the authors, the reported studies demonstrate GFAP's utility across the spectrum of TBI, evaluated over a relatively prolonged posttraumatic time course," says John Povlishock, Ph.D., Editor-in-Chief of Journal of Neurotrauma.