ABBOTT PARK, Ill., Aug. 26, 2019
/PRNewswire/ -- Abbott (NYSE: ABT) announced that a new
study, published in Lancet Neurology, found that elevated levels of
a protein measured with the company's blood test under development
could help detect mild traumatic brain injuries (TBIs), even when a
CT scan did not detect it.1 Findings from the
Transforming Research and Clinical Knowledge in Traumatic Brain
Injury (TRACK-TBI) study – one of the largest TBI efforts of
its kind – show this new technology could help fill a gap in
emergency rooms today by identifying patients who might otherwise
have gone undiagnosed.
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"Blood-based biomarkers are emerging as an important tool to
detect TBI, and this research opens up the next chapter for how the
condition is evaluated," said Geoffrey T.
Manley, M.D., Ph.D., principal investigator of TRACK-TBI,
neurosurgeon and professor of neurosurgery, University of California, San Francisco (UCSF).
"Having these sensitive tools could provide physicians more
real-time, objective information and improve the accuracy of
detecting TBI. This research shows that blood tests have the
potential to help physicians triage patients suspected of brain
injury quickly and accurately."
The need for fast, accurate, objective testing of TBI
More than 4.8 million people in the U.S. visit the emergency
room each year to be evaluated for brain injury.2 An
accurate diagnosis is critical to making sure the patient's care is
managed appropriately. To currently detect a brain injury, doctors
use a physical examination, a series of screening questions for
cognitive and neurological symptoms and often order a CT scan to
confirm the diagnosis of TBI. CT scans have become the standard of
care to acutely look for bleeding or swelling in the brain. Yet, in
this study, nearly 30% of patients with a normal CT scan showed
signs of TBI when doctors used an imaging technology that is more
sensitive: an MRI scan. However, MRIs are not available at all
hospitals, are considerably slower to produce results, and are
generally more expensive than CT scans and blood tests.
Researchers from TRACK-TBI evaluated 450 patients admitted to
the emergency department of 18 U.S. Level 1 trauma centers with a
suspected TBI, who also received a negative CT scan, to determine
if the brain-specific glial fibrillary acidic protein (GFAP) could
be a biomarker, or indication, that helps physicians detect TBIs.
The study used Abbott's i-STAT™ Alinity™ device – a handheld,
portable blood analyzer that produces test results in minutes right
by a person's side – and its blood test under development to
measure a patient's GFAP protein level.3-4 The i-STAT
Alinity device is available outside of the U.S. and is not yet
commercially available in the U.S.
Among these 450 participants with a negative CT scan,
researchers evaluated GFAP levels in their blood and then reviewed
their MRI scans taken up to two weeks later to confirm the TBI.
When looking at the people who had detectable levels of this
protein, the study found that among the 90 people with the highest
levels of GFAP detected, 64% were confirmed to have a TBI by the
MRI scan. By contrast, for the 90 people with the lowest levels of
GFAP, 8% were confirmed to have a TBI. The research showed
that GFAP could be used to determine which group of people should
be screened further or referred for an MRI to confirm their
Researchers found that GFAP levels:
- Were significantly higher in patients who had a positive MRI
but a negative CT scan, compared to people with both negative CT
and MRI scans.
- Could potentially be used to predict the type of damage, as
well as the extent of injury.
- Were not significantly elevated in the control groups of
healthy individuals as well as those who had only orthopedic
The study also looked at three additional brain biomarkers to
assess any association between elevated levels of those proteins
and brain injury: S100 calcium-binding protein B (S100B); ubiquitin
C-terminal hydrolase L1 (UCH-L1); and neuron-specific enolase (NSE)
protein. Researchers found that elevated GFAP levels were more
sensitive for detecting brain injury in patients with a negative CT
scan than were elevated levels of UCH-L1, S100B or NSE.
Developing a blood test to evaluate brain injuries
When a brain injury occurs, damaged cells release proteins that
leak out of the brain and into the bloodstream. If a person has a
suspected brain injury, elevated levels of these protein biomarkers
in the person's blood sample could help doctors evaluate their
condition and determine optimal treatment.
As the global leader in diagnostic point-of-care testing, Abbott
has more than 120 scientists and engineers who are researching and
developing Abbott's concussion assessment test. The test in
development by Abbott measures specific proteins, such as GFAP,
that are released from the brain when it's been injured – serving
as a warning bell that further evaluation is needed.
"Healthcare providers rely on blood tests for a variety of
conditions because of their accuracy and speed, yet we haven't had
a blood test for the brain as part of the standard of care," said
Beth McQuiston, M.D., R.D.,
neurologist and medical director, Diagnostics, Abbott. "Abbott's
i-STAT device has become a trusted brand in hospitals globally
today. In the future, our TBI test and next generation device could
also be added to the standard of care, working together with CT
scans and other diagnostic tools to provide doctors with a more
complete understanding of a patient's condition."
About the study
The research, published online August 23,
2019 in Lancet Neurology, is part of TRACK-TBI, a
prospective, multi-center observational study. The study enrolled
TBI patients receiving a head CT within 24 hours of injury at 18
U.S. Level 1 trauma centers. As part of this sub-analysis,
researchers evaluated 450 participants who each received a CT scan
that was read by a radiologist as negative for TBI, a blood draw
within 24 hours, and an MRI within seven to 18 days post injury. Of
these 450 participants with a negative CT scan, nearly all cases
(99.1%) were classified as mild TBIs, and mainly resulted from
traffic accident (67%) or incidental fall (20%).
The Transforming Research and Clinical
Knowledge in Traumatic Brain Injury
Network (TRACK-TBI NET) is a collaborative research
effort of observational and interventional studies funded by the
National Institute of Neurological Disorders and Stroke (NINDS),
the U.S. Department of Defense (DoD) through U.S. Army Medical
Research and Development Command (USAMRDC) and U.S. Army Medical
Materiel Development Activity (USAMMDA), with support from private
and philanthropic partners. TRACK-TBI NET evolved from the
TRACK-TBI study, the largest and most comprehensive precision
natural history study of TBI ever conducted in the U.S. The
foundational observational study enrolled more than 3,000
participants across age (0-100 years old) and injury spectra from
concussion to coma, including those with TBI, and orthopedic and
healthy control comparison groups, at 18 U.S. Level 1 trauma center
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- Yue JK, Yuh EL, Korley FK, et al. Lancet Neurol 2019;
published online Aug 23.
- Korley, FK et al. J Head Trauma Rehabil. 2016; 31(6):
- Abbott's concussion assessment test is currently in development
and is for research purposes only. It is not yet commercially
- Abbott's i-STAT Alinity is available outside of the U.S. and is
not yet commercially available in the U.S.