Abbott Receives Health Canada Authorization for Whole Blood Rapid Test to Help Assess Suspected Concussions Français
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), otherwise known as concussion
The test produces lab-quality results in 15 minutes
Clinicians can get a result at the patient's bedside, making the test accessible at urgent care clinics and healthcare settings outside of the hospital emergency room
The test can be used to help evaluate patients up to 24 hours after injury
MISSISSAUGA, ON, June 16, 2025 /CNW/ -- Abbott (NYSE: ABT) 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.
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 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 T ransforming R esearch and C linical K nowledge in T raumatic B rain I njury (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.
1 Brain Injury Canada. Statistics: Traumatic brain injury (TBI) general statistics. Available at https://braininjurycanada.ca/en/statistics/. Accessed on April 29, 2025.
2 Government 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.
3 Statistics 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.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Global News
an hour ago
- Global News
A baby toothbrush sold at Dollarama is being recalled over ‘defect'
A brand of baby toothbrush is being recalled due to a potential choking hazard, Health Canada said in a public advisory on Friday. The Oracare Baby Brush, sold across the country at Dollarama, is being recalled after a consumer complaint concerning a manufacturing 'defect' that can cause the product to break into two pieces. According to Health Canada, there have been no reported incidents of choking to date, but Dollarama says it will no longer import or sell the product. Get daily National news Get the day's top news, political, economic, and current affairs headlines, delivered to your inbox once a day. Sign up for daily National newsletter Sign Up By providing your email address, you have read and agree to Global News' Terms and Conditions and Privacy Policy Canadians, parents and caregivers of children are being advised to stop using the product and return it to Dollarama for a refund. While no choking incidents have been reported to Health Canada or Dollarama, people are still being advised to seek immediate medical attention from a health-care professional if injury has occurred from using the toothbrush.
Cision Canada
5 hours ago
- Cision Canada
Global Action to End Smoking Welcomes Nataliia Toropova as Chief Development Officer Français
Toropova brings decades of experience in international public health and tobacco harm reduction to Global Action's team of experts committed to funding work to end the smoking epidemic. NEW YORK, June 16, 2025 /CNW/ -- Global Action to End Smoking is pleased to announce the appointment of Nataliia "Natasha" Toropova as its new Chief Development Officer, effective immediately. "I'm honored to join Global Action, an organization that shares my own values of compassion for those who smoke and my vision of a world without smoking-related deaths," said Toropova. Natasha will lead Global Action's efforts to expand its philanthropic reach by funding critical research and initiatives that accelerate progress toward ending smoking worldwide. She brings decades of experience in public health, tobacco control, and fundraising including as a Programme Manager for the World Health Organization (WHO) and as an Advocacy Coordinator at Campaign for Tobacco Free Kids in Eastern Europe. In these roles, she not only promoted public health initiatives but also led successful fundraising campaigns to support their missions. Most recently, Natasha completed her six-year tenure as CEO of Healthy Initiatives, a nonprofit organization committed to strengthening public health by addressing the risk of non-communicable diseases in countries including Ukraine, Eastern Europe, and Central Asia. As a grantee of Global Action, Healthy Initiatives has educated hundreds of health care providers across nine countries in Eastern Europe and Central Asia on the benefits of tobacco harm reduction for people who cannot or will not quit smoking—especially amid the stress of global conflict. The team has also provided critical aid—including CAT tourniquets, ambulances, and mental health support—to the areas most impacted by the ongoing war in Ukraine. "Natasha brings a bold vision, deep expertise, and an unwavering commitment to public health," said Pam Parizek, Executive Board Chair of Global Action. "She's seen firsthand the positive impact Global Action's support can have to accelerate smoking cessation and is the perfect person to grow our partnerships and lead our efforts to expand our funding for this life-saving work." Natasha joins Global Action at a pivotal time as the organization reinvigorates its commitment to grantees. Through a recent reorganization, Global Action has ensured its ability to exist until its mission to end smoking is completed, allowing it to honor existing commitments and fund future grants. Natasha's development work will directly support Global Action's grantees, which currently include projects with organizations such as Northwell Health, the National Harm Reduction Coalition and ECLAT, a research-based spinoff of the University of Catania. She will work closely with the executive leadership team to carry out her fundraising and outreach duties. "Global Action remains steadfast in its commitment to its mission," said Heidi Goldstein, President and Chief Legal Officer of Global Action. "We have now guaranteed that our organization will last to see the end of the global smoking epidemic." About Global Action to End Smoking Global Action to End Smoking is an independent U.S. nonprofit 501(c)(3) grantmaking organization whose charitable mission is to end combustible tobacco use, which remains the leading preventable cause of death globally. Historically, Global Action received funding from PMI Global Services, Inc. (PMI). As of September 2023, Global Action and PMI terminated their original funding agreement, and Global Action formally adopted a policy not to seek or accept funding from companies that produce tobacco or non-medicinal nicotine products.
Cision Canada
7 hours ago
- Cision Canada
Abbott Receives Health Canada Authorization for Whole Blood Rapid Test to Help Assess Suspected Concussions Français
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), otherwise known as concussion The test produces lab-quality results in 15 minutes Clinicians can get a result at the patient's bedside, making the test accessible at urgent care clinics and healthcare settings outside of the hospital emergency room The test can be used to help evaluate patients up to 24 hours after injury MISSISSAUGA, ON, June 16, 2025 /CNW/ -- Abbott (NYSE: ABT) 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. 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 and on LinkedIn, Facebook, Instagram, X and YouTube. 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 T ransforming R esearch and C linical K nowledge in T raumatic B rain I njury (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. 1 Brain Injury Canada. Statistics: Traumatic brain injury (TBI) general statistics. Available at Accessed on April 29, 2025. 2 Government of Canada. Injury in review, 2020 edition: Spotlight on traumatic brain injuries across the life course. Available at Accessed November 2024. 3 Statistics Canada. Self-reported concussions in Canada: A cross-sectional study. Available at Accessed November 2024.
