- The study concluded that elevated levels of two proteins help
predict how a person will recover from a traumatic brain injury
(TBI), providing important information to determine appropriate
care
- Researchers used Abbott's i-STAT™ TBI Plasma test – the only
FDA-cleared rapid test on a portable analyzer for concussion – and
Abbott's core laboratory ARCHITECT instrument to measure two
biomarkers in blood plasma associated with brain injury
ABBOTT PARK, Ill., Aug. 11, 2022
/PRNewswire/ -- A new study published in The Lancet
Neurology demonstrates the ability of two blood-based
biomarkers to predict how someone will recover from traumatic brain
injury (TBI). Testing for these two biomarkers in the immediate
aftermath of an injury can help health care providers determine the
best way to treat and care for patients.
This research shows that when a clinician conducts a blood test
for these brain proteins soon after a possible injury, they quickly
get a more accurate picture of how severe the injury is, the
expected course of recovery and the longer-term implications of the
TBI. The markers were measured using Abbott's i-STAT™ TBI Plasma
test, as well as on the company's ARCHITECT core laboratory
instrument using research prototype assays, both of which helped
predict recovery.
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. After testing biomarker
levels on the day of injury, researchers 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," said Dr. Fred
Korley, an associate professor of emergency medicine at the
University of Michigan and the first
author of the study. "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.
Abbott's TBI blood test was developed in collaboration with the
U.S. Department of Defense (DoD) – which has been dedicated to
developing a solution for the objective detection and evaluation of
TBI for more than a decade. The DoD, through U.S. Army Medical
Research and Development Command's (USAMRDC) U.S. Army Medical
Materiel Development Activity (USAMMDA), played a critical role in
developing the test run on Abbott's i-STAT TBI platform.
About i-STAT™ TBI Plasma
The i-STAT™ TBI Plasma test measures the level of
biomarkers associated with brain injury in the blood stream to
assist in determining the need for a CT scan of the head. The
i-STAT TBI Plasma test is used to help evaluate mild TBI and is
only available for use on the i-STAT™ Alinity™
instrument. The test is to be used with plasma prepared from EDTA
anticoagulated specimens in clinical laboratory settings by a
healthcare professional.
The i-STAT™ TBI Plasma test is
not intended to be used in point-of-care settings. More information
is available at
www.globalpointofcare.abbott/en/product-details/apoc/istat-tbi-plasma.html
About i-STAT™ Alinity™
The i-STAT™ Alinity is an easy-to-use, portable blood analyzer
that delivers real-time, lab-quality diagnostic test results.
Health care professionals simply apply a few drops of blood into a
cartridge, insert the cartridge into the analyzer and can view
results within minutes. Results can then be transmitted wirelessly.
More information is available
at www.globalpointofcare.abbott/en/product-details/apoc/istat-alinity.html
About Abbott
Abbott (NYSE: ABT) is a global healthcare leader that helps
people live more fully at all stages of life. Our portfolio of
life-changing technologies spans the spectrum of healthcare, with
leading businesses and products in diagnostics, medical devices,
nutritionals and branded generic medicines. Our 113,000 colleagues
serve people in more than 160 countries.
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