- New test will run on Abbott's Alinity® i laboratory instrument,
complementing Abbott's rapid i-STAT TBI Plasma test, cleared by the
FDA in 2021
- Given the significant number of Alinity i instruments in use in
labs across the U.S., Abbott's lab test will make concussion
testing available to more people across the country
- Test helps doctors evaluate patients with mild traumatic brain
injury (mTBI), commonly known as concussion, by ruling out the need
for a CT scan
ABBOTT
PARK, Ill., March 7,
2023 /PRNewswire/ -- Abbott (NYSE: ABT) has received
U.S. Food and Drug Administration clearance for what will be the
first commercially available laboratory traumatic brain injury
(TBI) blood test, making it widely available to hospitals in
the United States. The test, which
runs on Abbott's Alinity® i laboratory instrument, will provide
clinicians with an objective way to quickly assess individuals with
mild TBIs, also known as concussions.
Abbott's Alinity i TBI lab test offers a new reliable result in
18 minutes to help clinicians quickly assess concussion and triage
patients. For those with negative results, it rules out the need
for a CT scan and can eliminate wait time at the hospital. The test
measures two biomarkers in the blood that, in elevated
concentrations, are tightly correlated to brain injury.
For decades, standard concussion assessment has remained the
same, with doctors leveraging the Glasgow Coma Scale, a subjective
doctor assessment, and CT scans to detect brain tissue damage or
lesions. Having a blood test available could help reduce the number
of unnecessary CT scans by up to 40%, potentially reducing costs to
the healthcare system and the patient as well as the amount of time
they spend in the emergency department.
Millions of people in the U.S. suffer a concussion each year,
but more than half of people who suspect they have a
concussion never get it checked.
"People sometimes minimize a hit to the head, thinking it's no
big deal. Others wonder if a visit to the doctor or emergency room
for a possible concussion will provide them with meaningful answers
or care," said Beth McQuiston, M.D.,
medical director in Abbott's diagnostics business. "Now that this
test will be widely available in labs across the country, medical
centers will be able to offer an objective blood test than can aid
in concussion assessment. That's great news for both doctors and
people who are trying to find out if they have suffered a traumatic
brain injury."
TBIs are caused by a bump, blow or whiplash to the head and can
pose risk of both short- and long-term effects. People who
experience a TBI may experience impairment of memory, movement,
sensation (e.g., vision and hearing), and emotional functioning
(e.g., personality changes, psychological symptoms). Effects of TBI
can last anywhere from a few days post-injury or may be permanent.
People who sustain a TBI are more likely to have another one –
similarly to how a sprained ankle or torn ligament is more
susceptible to future injury.
These effects are worsened by misdiagnosis or lack of diagnosis,
so providing tools that can objectively aid in the evaluation of a
TBI or concussion is essential to giving people the answers and
treatment they need.
Abbott has been pioneering breakthroughs in TBI testing
technology for over a decade. This FDA clearance complements
Abbott's i-STAT TBI Plasma test, the first rapid blood test for
concussion, which is already cleared by the FDA. With the Alinity i
clearance, a TBI blood test can now be run on Abbott's high
throughput Alinity i laboratory instrument. The advancement will
make TBI testing more available because the Alinity i instrument is
widely used in hospitals and laboratories across the U.S.
The Alinity i test can be used when a patient shows up to the
hospital with a suspected mTBI within 12 hours of injury. A blood
sample is drawn from the arm and sent to the lab for preparation
and the test is run on the Alinity i instrument. Results are
available in as little as 18 minutes and shared with the treating
healthcare provider for evaluation.
Broadening the availability of the TBI blood test for use on
lab-based instruments is an important step in Abbott's strategy to
ensure its tests are available in all settings where people seek
care for head injuries.
About Alinity i laboratory test for TBI
The Alinity i TBI test measures complementary biomarkers in
blood plasma and serum - Ubiquitin C-terminal Hydrolase L1
(UCH-L1) and Glial Fibrillary Acidic Protein (GFAP), that, in
elevated concentrations, are tightly correlated to brain injury. It
provides test results with 96.7% sensitivity and 99.4% negative
predictive value.
Testing for these two biomarkers in the immediate aftermath of
an injury can help health care providers decide appropriate next
steps and develop a plan to care for patients. The test is for use
to aid in the evaluation of patients, 18 years of age or older,
presenting with suspected mild traumatic brain injury (Glasgow Coma
Scale score 13-15) within 12 hours of injury, to assist in
determining the need for a CT (computed tomography) scan of the
head.
The test previously received European Union clearance and has
been available in markets outside the U.S. since 2021.
About Abbott
Abbott 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 115,000 colleagues
serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter
@AbbottNews.
The i-STAT 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 Alinity
platform.
The Transforming Research and Clinical Knowledge
in Traumatic Brain Injury (TRACK-TBI) research team
were the first to demonstrate how this TBI blood test can be used
for the benefit of TBI patients in clinical care.
View original
content:https://www.prnewswire.com/news-releases/abbott-receives-fda-clearance-for-first-commercially-available-lab-based-blood-test-to-help-evaluate-concussion-301764488.html
SOURCE Abbott