MISSISSAUGA, Ontario, June 16, 2025 – Abbott announced today that Health Canada has approved the company’s i-STAT TBI test cartridge for use with whole blood, helping clinicians to assess suspected concussion at the patient's bedside and obtain lab-quality results in 15 minutes. Previously, the tests used to help assess mild traumatic brain injury (mTBI) were only authorized for use with plasma or serum, requiring samples to be sent to a lab for processing.
This new authorization will enable testing to be performed in an array of new healthcare settings beyond hospital emergency departments, including urgent care clinics. This is an important step toward a future where testing could be done in settings such as in pharmacies, clinics without radiology or even in locations such as the sidelines of a sporting event.
"Particularly in the emergency setting, we have long needed a reliable and expedient way to assess and triage patients for urgent computed tomography (CT) imaging of the brain after head trauma," said Andrew Beckett, M.D., a trauma surgeon and medical director of the Trauma Program at St. Michael’s Hospital, Unity Health Toronto, and an associate professor at the University of Toronto. "The availability of a rapid point of care and objective test for traumatic brain injury will be a major advancement in emergency care as it can help facilitate immediate and precise diagnosis, ensuring prompt, appropriate treatment."
The whole blood test on a portable instrument helps clinicians evaluate patients 18 years of age and older who present with suspected mTBI, commonly known as a 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 in conjunction with other clinical information. The ability to perform the test with a whole blood sample means testing can take place in healthcare settings without a lab, which helps to accelerate head trauma evaluation.
With this authorization, the i-STAT TBI test cartridge can be used to help evaluate patients up to 24 hours after injury, an important advancement since those injured often wait to seek care.
It is estimated that 165,000 Canadians will experience a TBI this year.1 Likewise, each year in Canada, more than 20,000 people are hospitalized for TBI, which can range from mild to severe and include concussions.2
Among all types of TBIs, concussions are the most common, accounting for approximately 80 to 95 percent of such injuries.3 Even a mild form of TBI can have long-term consequences.2
For decades, standard TBI assessment has remained the same, with doctors leveraging tools such as the Canadian CT Head Rule which uses the Glasgow Coma Scale, a subjective assessment as well as CT scans, to detect brain tissue damage or lesions. A blood test provides objective information and helps remove the ambiguity of a standard concussion assessment.
"Abbott has pioneered breakthroughs in TBI testing technology for more than a decade," said Beth McQuiston, M.D., senior medical director in Abbott's diagnostics business. "We’re proud of this important step forward in advancing the standard of care for concussions. With this approval, right from the patient’s bedside, clinicians are now able to order a rapid blood test that can provide powerful objective information, quickly. This dramatically changes the efficiency in the emergency room and helps optimize patient care."
This approval expands Abbott's TBI test on market offerings, which already includes the i-STAT TBI Plasma test and the ARCHITECT® and Alinity i lab test (serum and plasma).
How the test works:
The i-STAT TBI test cartridge with the i-STAT Alinity System requires a small venous blood sample – just a few drops applied to the test cartridge. The cartridge is then inserted into the portable i-STAT Alinity instrument. The test measures two brain-specific biomarkers that are released into the blood stream when there is a significant brain injury. If neither of these biomarkers measured are above an established cutoff, a significant injury has likely not occurred, and a CT scan can likely be avoided. Testing for these two biomarkers – ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) – following an injury can provide essential and objective information about a patient’s condition and can help healthcare providers decide an appropriate treatment plan.
ABBOTT RECEIVES HEALTH CANADA AUTHORIZATION FOR WHOLE BLOOD RAPID TEST TO HELP ASSESS SUSPECTED CONCUSSIONS
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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.
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The i-STAT TBI test cartridge was developed with support by 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. (Reference to USAMRDC and USAMMDA does not imply or constitute endorsement by these organizations or by the Department of Defense or the U.S. Army.)
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.
Abbott Media:
Stacey Brown
stacey.brown2@abbott.com
References:
1Brain Injury Canada. Statistics: Traumatic brain injury (TBI) general statistics. Available at https://braininjurycanada.ca/en/statistics/. Accessed on April 29, 2025.
2Government of Canada. Injury in review, 2020 edition: Spotlight on traumatic brain injuries across the life course. Available at www.canada.ca/en/public-health/services/injury-prevention/canadian-hospitals-injury-reporting-prevention-program/injury-reports/2020-spotlight-traumatic-brain-injuries-life-course.html. Accessed November 2024.
3Statistics Canada. Self-reported concussions in Canada: A cross-sectional study. Available at https://www150.statcan.gc.ca/n1/pub/82-003-x/2023006/article/00002-eng.htm. Accessed November 2024.
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