After examining blood test results on the day of collection from nearly 1,700 patients, the researchers found that higher levels of certain biomarkers were associated with death or severe disability within six months. (Jolygon/Getty Images)
A study of Abbott’s rapid portable blood test to assess 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 following weeks.
By testing the patient as early as possible, doctors can detect proteins from the brain that will help build a more accurate picture of TBI and its potential to cause long-term complications, coma or death, the company said.
“Biomarkers of brain injury will one day become the standard of care in the evaluation and treatment of patients,” Fred Korley, first author of the study published in The Lancet Neurology, said in a statement
about caring for their loved one with a brain injury,” added Korley, associate professor of emergency medicine at the University of Michigan.
The researchers used Abbott’s i-STAT TBI Plasma test, a 15-minute handheld diagnostic device that was approved by the FDA in January 2021, as well as a version designed for larger lab 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 gets a negative result.
They found that two proteins produced in brain cells—glial fibrillary acidic protein, or GFAP, and ubiquitin C-terminal hydrolase L1, or UCH-L1—can leak into the bloodstream in greater amounts within 24 hours of TBI.
After examining blood test results on the day of collection from nearly 1,700 patients, the researchers found that higher levels of these biomarkers were associated with death and the development of severe disability within half a year.
GFAP had an 87% chance of predicting death within six months, while UCH-L1 was 89% accurate; GFAP and UCH-L1 were 86% accurate in predicting severe disability, according to the study. Those with biomarker levels in the top 20% carried the greatest risk of death, with most cases occurring within the first month.
GFAP and UCH-L1 previously received de novo clearance from the FDA in 2018 for a blood test developed by Banyan Biomarkers, which later licensed the proteins to Abbott in a 2019 agreement.
According to the National Institutes of Health (NIH), which helped fund the study, more than half of the patients in the study suffered a TBI as a result of a traffic accident. Patients were recruited from 18 top US trauma centers.
The NIH said more studies would be needed to reproduce the results and that the biomarkers were not able to accurately predict who would experience incomplete recovery at six months, such as those who developed moderate disability but were still able to live independently.
The study also received funding from the Department of Defense, which has long supported Abbott’s work to develop a portable rapid brain injury test. Abbott previously received FDA breakthrough designation for its TBI test using the Alinity i and Architect core laboratory hardware and is currently seeking full agency approval for the test.