- Using Abbott Laboratories technology to measure two blood-based biomarkers on the day a patient suffers a traumatic brain injury (TBI) can provide insights into their prospects, researchers say.
- Writing in The Lancet Neurology, researchers describe the use of Abbott's i-STAT TBI Plasma test and ARCHITECT core laboratory instrument to measure the biomarkers.
- Abbott is pursuing clearance from the Food and Drug Administration for the breakthrough-designated TBI test to expand access to a diagnostic that predicted death and severe disability in the study published in the Lancet.
While physicians can use glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1) to help assess whether to perform brain CT scans after TBI, they lack evidence to support the use of the biomarkers to predict the functional outcomes of patients on the day of injury. Researchers at the University of California and other institutions sought to address the evidence gap by running a study.
The study enrolled 2,552 patients from the Transforming Research and Clinical Knowledge in Traumatic Brain Injury observational cohort study, 1,696 of whom were included in the analysis because they had baseline and six-month data.
GFAP’s area under the curve for predicting death at six months in all patients was 0.87, for unfavorable outcome was 0.86 and for incomplete recovery was 0.62. The study defined unfavorable outcome as a score of four or lower on the Extended Glasgow Outcome TBI Scale, indicating severe disability or worse. The death, unfavorable outcome and incomplete recovery figures for UCH-L1 were 0.89, 0.86 and 0.61, respectively.
The researchers found the predictive figures were higher for patients with severe brain injury, as defined by the Glasgow Coma Scale, than for individuals with minor brain injury. In patients with severe injuries, adding GFAP and UCH-L1, alone or in combination, to International Mission for Prognosis and Analysis of Clinical Trials in traumatic brain injury models improved predictions of death and unfavorable outcome.
Abbott's i-STAT TBI Plasma test, a portable analyzer that provides results in 15 minutes, already has FDA 510(k) clearance and is used to determine the need for a CT scan. The company now is working to secure clearance for an expanded TBI label.