Sam Brusco, Associate Editor08.11.22
A new The Lancet Neurology study showed ability of two blood-based biomarkers to predict recovery from traumatic brain injury (TBI).
The research demonstrated when a blood test for two brain proteins is conducted soon after a possible injury, clinicians can quickly get a more accurate picture of injury severity, expected recovery course, and longer-term implications.
The markers were measured using Abbott Labs’ i-STAT TBI Plasma test and the company’s ARCHITECT core lab instrument using research prototype assays.
Researchers measured levels of Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin carboxy-terminal Hydrolase L1 (UCH-L1) present in blood plasma within 24 hours of injury. They evaluated patients six months later, tracking how individuals fared and how biomarker levels corresponded to their recovery.
"Brain injury biomarkers will one day be the standard of care to evaluate and treat patients," Dr. Fred Korley, an associate professor of emergency medicine at the University of Michigan and the first author of the study told the press. "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."
In the study, researchers examined the day-of-injury blood tests of 1,696 patients with TBI and compared those to patients' six-month assessment, using the Glasgow Outcome Scale Extended, which grades outcomes and quantifies levels of disability following TBI. The researchers found that high values of the biomarkers, GFAP and UCH-L1, correlate with death and severe injury. The day-of-injury blood tests had a high probability of predicting death at six months, 87% for GFAP and 89% for UCH-L1; and a high probability of predicting severe disability at the same timepoint, 86% for both GFAP and UCH-L1.
GFAP and UCH-L1 are proteins found in glial cells and neurons and are released into the blood stream after the brain is injured. They can be measured with diagnostic testing. Abbott's i-STAT TBI Plasma test is the first rapid test on a portable analyzer to receive FDA 510(k) clearance and can help determine the need for a computed tomography (CT) scan. Test results are available approximately 15 minutes after a plasma sample is inserted in 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 broaden access and ensure that tests are available both in the lab and in other settings where people need immediate answers and care. Abbott's TBI test on Alinity i is CE Marked and available outside the U.S.
The subjects for the study came from the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study. TRACK-TBI collected and analyzed detailed clinical data from enrolled people across the injury spectrum at 18 U.S. level I trauma centers from February 2014 through August 2018. The TRACK-TBI research team were among the first to demonstrate how this rapid TBI blood test can be used for the benefit of TBI patients in clinical care.
The research demonstrated when a blood test for two brain proteins is conducted soon after a possible injury, clinicians can quickly get a more accurate picture of injury severity, expected recovery course, and longer-term implications.
The markers were measured using Abbott Labs’ i-STAT TBI Plasma test and the company’s ARCHITECT core lab instrument using research prototype assays.
Researchers measured levels of Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin carboxy-terminal Hydrolase L1 (UCH-L1) present in blood plasma within 24 hours of injury. They evaluated patients six months later, tracking how individuals fared and how biomarker levels corresponded to their recovery.
"Brain injury biomarkers will one day be the standard of care to evaluate and treat patients," Dr. Fred Korley, an associate professor of emergency medicine at the University of Michigan and the first author of the study told the press. "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."
In the study, researchers examined the day-of-injury blood tests of 1,696 patients with TBI and compared those to patients' six-month assessment, using the Glasgow Outcome Scale Extended, which grades outcomes and quantifies levels of disability following TBI. The researchers found that high values of the biomarkers, GFAP and UCH-L1, correlate with death and severe injury. The day-of-injury blood tests had a high probability of predicting death at six months, 87% for GFAP and 89% for UCH-L1; and a high probability of predicting severe disability at the same timepoint, 86% for both GFAP and UCH-L1.
GFAP and UCH-L1 are proteins found in glial cells and neurons and are released into the blood stream after the brain is injured. They can be measured with diagnostic testing. Abbott's i-STAT TBI Plasma test is the first rapid test on a portable analyzer to receive FDA 510(k) clearance and can help determine the need for a computed tomography (CT) scan. Test results are available approximately 15 minutes after a plasma sample is inserted in 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 broaden access and ensure that tests are available both in the lab and in other settings where people need immediate answers and care. Abbott's TBI test on Alinity i is CE Marked and available outside the U.S.
The subjects for the study came from the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study. TRACK-TBI collected and analyzed detailed clinical data from enrolled people across the injury spectrum at 18 U.S. level I trauma centers from February 2014 through August 2018. The TRACK-TBI research team were among the first to demonstrate how this rapid TBI blood test can be used for the benefit of TBI patients in clinical care.