Study: Abbott’s 2 Blood-Based Biomarkers Can Predict Severity of Traumatic Brain Injury

Investigators used the FDA-approved concussions test i-STAT TBI Plasma and the company’s core laboratory Architect instrument.

The ability of 2 blood-based biomarkers can predict how individuals will recover from traumatic brain injuries (TBI), according to the results of a study published in The Lancet Neurology.

Testing for the 2 biomarkers in the immediate aftermath of an injury was proven to help health care providers determine the best way to treat and care for patients.

“Brain injury biomarkers will 1 day be the standard of care to evaluate and treat patients,” Fred Korley, MD, PhD, an associate professor of emergency medicine at the University of Michigan, 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.”

The findings showed that when a physician conducts a blood test for these brain proteins soon after an injury, it provides a more accurate picture of how severe the injury is, the expected course of recovery, and the long-term implications.

Investigators used the i-STAT TBI Plasma test (Abbott) and the company’s Architect core laboratory instrument using research prototype assays, both of which helped predict recovery, to help measure the markers.

Within 24 hours of an injury, investigators measured levels of glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal Hydrolase L1 (UCH-L1) present in the blood. After testing the biomarker levels on the day of the injury, investigators evaluated the patient 6 months later to track how the individual was doing and how the biomarker levels corresponded to the recovery.

The GFAP and UCH-L1 biomarkers correlate with death and severe injury.

In the study, investigators included 1696 individuals with TBI and compared those with patients’ 6-month assessment, using the Glasgow Outcome Scale Extended, a tool that grades outcomes and quantifies levels of disability following TBI.

The investigators found that there were high values of the GFAP and UCH-L1 biomarkers.

The day-of-injury blood test showed to have a high probability of predicting death at 6 months, with 87% for GFAP and 89% for UCH-L1. Additionally, it showed a high probability of predicting severe disability at the same time point, at 86% for both biomarkers.

GFAP and UCH-L1 are proteins that are found in glial cells and neurons and get released into the blood stream after a brain injury. The levels can be measured with diagnostic testing, and the i-STAT TBI Plasma test is the first rapid test on a portable analyzer to have received FDA 510(k) clearance. It can help determine the need for a computed tomography scan, and tests results are available approximately 15 minutes after a plasma sample is inserted into the test i-STAT cartridge.

Abbott is pursuing FDA clearance under breakthrough designation for the TBI test on its Alinity I and Architect core laboratory instruments, which will help broaden access to the tests and make sure they are available in both the laboratory and other settings where health care providers need immediate answers for care.

Reference

New study shows Abbott’s blood test for concussion could predict outcomes from brain injury and inform treatment interventions. News release. Abbott. August 11, 2022. Accessed August 17, 2022. https://abbott.mediaroom.com/2022-08-11-New-Study-Shows-Abbotts-Blood-Test-for-Concussion-Could-Predict-Outcomes-from-Brain-Injury-and-Inform-Treatment-Interventions