Latest news with #i-STAT®Alinity
Cision Canada
13 hours ago
- Health
- 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.
Yahoo
13 hours ago
- Health
- Yahoo
Abbott Receives Health Canada Authorization for Whole Blood Rapid Test to Help Assess Suspected Concussions
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 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. References 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. SOURCE Abbott View original content to download multimedia: Sign in to access your portfolio
Yahoo
01-05-2025
- Health
- Yahoo
MotoAmerica Becomes First Sports Organization to Use Abbott's Rapid Blood Test for Concussion Evaluation On-site at Races
The test, run on Abbott's portable i-STAT® Alinity® hand-held instrument, uses whole blood to help evaluate patients 18 years of age and older with a suspected mild traumatic brain injury, or concussion, producing lab-quality results in 15 minutes The test will be used by healthcare professionals in the medical facilities at all MotoAmerica races in 2025 ABBOTT PARK, Ill., and IRVINE, Calif., May 1, 2025 /PRNewswire/ -- Abbott (NYSE: ABT), the global healthcare company, and MotoAmerica, the premier motorcycle road racing series in North America, announced today that MotoAmerica is the first professional sports organization worldwide to use Abbott's groundbreaking blood test to help assess suspected concussions for riders in the on-site medical facilities at all races. Abbott's test, the i-STAT TBI test cartridge, is used to evaluate patients 18 years of age and older who present with suspected mild traumatic brain injury (mTBI). It provides results in 15 minutes and may be used up to 24 hours after injury to help determine the need for a CT scan of the head. In 2024, Abbott's i-STAT TBI test received clearance from the U.S. Food and Drug Administration (FDA) to be used with whole blood, allowing doctors to quickly assess patients with suspected mTBI on the handheld i-STAT Alinity analyzer at the patient's side. "This is the first ever objective test that physicians have had at the point-of-care to assist in the assessment of concussions – it changes the game," said Carl Price, M.D., chief medical officer for MotoAmerica. "If a crash or fall does happen, the ability to quickly and objectively determine whether or not a rider needs a CT scan or additional evaluation, right there on-site, provides us—and our riders—with peace of mind." The i-STAT TBI test cartridge will be available in on-site medical facilities for all MotoAmerica races across the U.S. during the 2025 season, beginning with the race at Michelin Raceway Road in Atlanta, Ga. (May 2-4). "As both a neurologist and licensed physician, I know firsthand the limitations of relying on a subjective tool like the Glasgow Coma Scale in the assessment of brain injury," said Beth McQuiston, M.D., medical director in Abbott's diagnostics business. "The ability to objectively assess the need for a head CT scan following potential brain injury right at the point of care, whether that be at a hospital bedside or an on-site medical facility at a sporting event, means quick assessment and a quick path to the right treatment." At MotoAmerica, riders wear comprehensive protection, including airbag-equipped suits that inflate on impact, helmets tested for multiple impact forces, and full-body armor. The tracks also feature air fence barriers and a dedicated medical safety car. In the event of a crash or fall, immediate on-site assessment adds an extra layer of safety to determine if a rider requires a CT scan or further evaluation. "The standard of competition and performance in MotoAmerica continues to increase," said Chuck Aksland, chief operating officer, MotoAmerica. "Between the riders, the motorcycles, their gear, and now accessibility to the most innovative medical equipment, we continue to push our standards and practices to better protect our racers. Our use of Abbott's rapid blood test for concussion assessment furthers this commitment and will help us evaluate medical needs quickly and on location." According to the National Institutes of Health (NIH), traumatic brain injury from accidents or sports is a leading cause of death and disability in the United States. The Centers for Disease Control and Prevention (CDC) estimates 2.5 million people visit the emergency department for TBIs every year. How the test worksThe 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. The test was developed by Abbott, with support from the U.S. Army Medical Research and Development Command's (USAMRDC) U.S. Army Medical Materiel Development Activity (USAMMDA) and in collaboration with Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI). The ability to use whole blood to help assess patients with suspected mTBI is an important step in Abbott's vision to make its tests available in all settings where people seek care for head injuries. Today, the test is available to be used by hospitals, clinics, and any athletic organization with trained medical staff on-site and the ability to run moderately complex testing. Research and planning are ongoing to determine the feasibility of using these biomarkers similarly in teens and children. About MotoAmerica:MotoAmerica is officially sanctioned by the American Motorcyclist Association (AMA) and the Fédération Internationale de Motocyclisme (FIM), and it features nine classes of motorcycle road racing: Superbike, Supersport, King of the Baggers, Talent Cup, Super Hooligan, Stock 1000, Twins Cup, Build. Train. Race. and Mini Cup. 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 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. View original content: SOURCE Abbott Sign in to access your portfolio
