A study of Abbott’s rapid, portable blood test for evaluating concussions showed that by taking a sample on the day of a traumatic brain injury, the presence of certain biomarkers could help predict how well a patient will recover in the weeks ahead.
By testing a patient as soon as possible, clinicians may be able to spot proteins from the brain that help paint a more accurate picture of a TBI and its potential for causing long-term complications, comas or death, the company said.
“Brain injury biomarkers will one day be the standard of care to evaluate and treat patients,” Fred Korley, first author of the study published in The Lancet Neurology, said in a statement.
“Objective biomarker data can be profoundly helpful in determining prognosis for a patient, helping to gauge how severe a brain injury is, and can ultimately inform how best to counsel family members about care for their loved ones with brain injury,” added Korley, an associate professor of emergency medicine at the University of Michigan.
The researchers used Abbott’s i-STAT TBI Plasma test, a 15-minute, hand-held diagnostic device that was cleared by the FDA in January 2021, as well as a version designed for larger laboratory hardware. It measures specific proteins found in the bloodstream after an injury and can help rule out the need for a CT scan if a person receives a negative result.
They found that two proteins produced within brain cells—glial fibrillary acidic protein, or GFAP, and ubiquitin C-terminal hydrolase L1, or UCH-L1—can leak into the bloodstream in larger amounts in the 24 hours after a TBI.
After examining the day-of blood test results from nearly 1,700 patients, the researchers found that higher levels of those biomarkers were associated with deaths and the development of severe disabilities within half a year.
GFAP had an 87% probability of predicting death within six months, while UCH-L1 was 89% accurate; GFAP and UCH-L1 were both 86% accurate in predicting severe disability, according to the study. Those with biomarker levels in the highest 20% carried the greatest risk of death, with most occurring within the first month.
GFAP and UCH-L1 previously received a de novo clearance from the FDA in 2018 for a blood test developed by Banyan Biomarkers, which later licensed the use of the proteins to Abbott in a 2019 deal.
According to the National Institutes of Health (NIH), which helped fund the study, more than half of the patients within the trial suffered a TBI as the result of a road traffic accident. Patients were enrolled from 18 high-level U.S. trauma centers.
The NIH said additional studies would be needed to reproduce the results and that the biomarkers were not able to accurately predict who would experience an incomplete recovery after six months, such as those who developed a moderate disability but were still able to live independently.
The study also received funding from the Department of Defense, which has been a longtime backer of Abbott’s work in developing a portable, rapid test for brain injuries. Abbott previously received an FDA breakthrough designation for the use of its TBI test on its Alinity i and Architect core lab hardware and is currently seeking full agency clearance for the test.