- The test, run on Abbott's portable i-STAT®
Alinity® instrument, uses whole blood to help evaluate
patients with a suspected mild traumatic brain injury (mTBI), or
concussion
- The test produces lab-quality results in 15 minutes
- Clinicians are now able to get a result at the patient's
bedside, making the test accessible at urgent care clinics and
other healthcare settings outside the hospital emergency room
- The test can be used to help evaluate patients up to 24 hours
after injury
ABBOTT
PARK, Ill., April 1,
2024 /PRNewswire/ -- Abbott's i-STAT TBI cartridge
has received clearance from the U.S. Food and Drug Administration
(FDA) to be used with whole blood, allowing doctors to help assess
patients with suspected concussion at the patient's bedside and
obtain lab-quality results in 15 minutes. Previously, the tests to
help with the assessment of TBI were only cleared for use with
plasma or serum, requiring samples to be sent to a lab for
processing and testing.
This new clearance will enable testing to be performed in an
array of new healthcare settings beyond hospital emergency
departments including urgent care clinics with a certificate to
perform moderate complexity tests. This is an important step toward
a future where testing could be done outside traditional healthcare
settings, such as on the sidelines of sporting events.
The whole blood test on a portable instrument helps clinicians
evaluate patients 18 years of age and older who present with
suspected mild traumatic brain injury or mTBI, commonly known as
concussion. Test results can help rule out the need for a CT scan
of the head and assist in determining the best next steps for
patient care. The ability to perform the test with a whole blood
sample means testing can take place at healthcare settings without
a lab which helps to accelerate the evaluation of head traumas.
With this clearance, the i-STAT TBI test can be used to help
evaluate patients up to 24 hours after injury, an important
advancement since those injured often wait before seeking care.
Nearly 5 million people go to the emergency department
for a TBI in the U.S. each year, but more than half of
people who suspect they have a concussion never get it
checked.
For decades, standard TBI 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.
"Emergency departments can be a busy place. It's important to be
able to triage patients quickly," said Geoffrey Manley, M.D., PhD, Chief of
Neurosurgery at Zuckerberg San Francisco General Hospital,
Professor of Neurosurgery at the University of
California San Francisco and contact principal investigator
for the TRACK-TBI Network. "Historically, that process for
suspected concussions was largely subjective. With the help of this
whole blood test, we can quickly and objectively determine whether
or not a patient needs a CT scan or additional evaluation, right at
the point of care. It's an incredibly helpful tool that advances
the treatment of traumatic brain injury."
How the test works
The i-STAT TBI cartridge with
the i-STAT Alinity System requires a small venous blood sample,
which is applied to the test cartridge. The cartridge is then
inserted into the portable i-STAT Alinity instrument. The test
measures two biomarkers from the brain that may be released into
the bloodstream, indicating a possible brain injury. Testing for
these two biomarkers – ubiquitin C-terminal hydrolase L1 (UCH-L1)
and glial fibrillary acidic protein (GFAP) – in the aftermath of an
injury can provide clinicians with essential information about a
patient's condition and can help healthcare providers decide an
appropriate treatment plan.
"Clinicians have needed an objective way to assess patients with
concussions," said Beth
McQuiston, M.D., medical director in Abbott's diagnostics
business. "When you look at all the other diseases, or other organs
in the body, they all have blood tests to help assess what's
happening. Now, we have a whole blood test that can help assess the
brain right at the patient's bedside – expanding access to more
health providers and therefore patients."
The newly cleared test expands Abbott's TBI test offerings,
which includes the i-STAT TBI Plasma test and the
ARCHITECT® and Alinity i lab test (serum and plasma),
which were all cleared previously.
The ability to use whole blood to help assess TBI is an
important step in Abbott's vision to make its tests available in
all settings where people seek care for head injuries. Abbott is
engaged in ongoing research and planning that may, in the future,
allow the test to be used in non-healthcare settings and with a
broader population including teens and pediatrics.
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
114,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com and on LinkedIn, Facebook,
Instagram, X and Youtube.
The i-STAT TBI blood test was developed in collaboration with
the U.S. Department of Defense U.S. Army Medical Research and
Development Command's (USAMRDC) U.S. Army Medical Materiel
Development Activity (USAMMDA). The USAMRDC has been dedicated to
developing a solution for the objective detection and evaluation of
TBI for more than two decades and has played a critical role in
developing the TBI test on Abbott's i-STAT Alinity
platform.
The Transforming Research and Clinical Knowledge in Traumatic
Brain Injury (TRACK-TBI) research team was the first to demonstrate
how this TBI blood test can be used for the benefit of TBI patients
in clinical care.
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SOURCE Abbott