Health Canada has granted approval for Abbott's i-STAT TBI test cartridge for use with whole blood, marking a significant advancement in concussion assessment capabilities. The authorization enables clinicians to evaluate suspected mild traumatic brain injury (mTBI) at the patient's bedside and obtain lab-quality results within 15 minutes.
Previously, mild traumatic brain injury assessment tests were authorized only for plasma or serum samples, necessitating laboratory processing. This new whole blood capability eliminates the need for sample processing in a laboratory setting, dramatically expanding the test's accessibility across healthcare environments.
Expanded Healthcare Settings
The approval facilitates testing in diverse healthcare settings beyond traditional hospital emergency departments. According to Abbott, this advancement opens possibilities for testing in urgent care clinics, pharmacies, clinics without radiology capabilities, and potentially even at sporting event sidelines.
"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. "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."
Clinical Impact and Patient Population
The i-STAT TBI test is designed to assess individuals 18 years and older with suspected mTBI, commonly referred to as concussion. Test results can help rule out the requirement for a head computed tomography (CT) scan and guide further steps for individual care when used in conjunction with other clinical information.
The authorization extends the test's utility to assess individuals up to 24 hours post-injury, addressing situations where patients may delay seeking medical attention after head trauma. This timing flexibility is particularly important given that injured individuals often wait to seek care.
According to Canadian statistics, an estimated 165,000 Canadians will experience a traumatic brain injury this year, with more than 20,000 people hospitalized annually for TBI. Among all types of TBIs, concussions are the most common, accounting for approximately 80 to 95 percent of such injuries.
Biomarker Technology
The i-STAT TBI test cartridge, used with the i-STAT Alinity System, requires only a small venous blood sample. The test measures two brain-specific biomarkers that are released into the bloodstream following brain injury: ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP).
If levels of these biomarkers are below established thresholds, a serious injury is unlikely, and a CT scan may be avoided. This objective measurement provides clinicians with essential information about a patient's condition and helps determine appropriate treatment plans.
Clinical Significance
"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."
For decades, standard TBI assessment has relied on tools such as the Canadian CT Head Rule, which uses the Glasgow Coma Scale and subjective assessments alongside CT scans to detect brain tissue damage or lesions. The blood test provides objective information and helps remove the ambiguity of standard concussion assessments.
This approval expands Abbott's TBI testing portfolio, which already includes the i-STAT TBI Plasma test and the ARCHITECT and Alinity i laboratory tests for serum and plasma samples. The development of the i-STAT TBI test cartridge was supported by the U.S. Department of Defense U.S. Army Medical Research and Development Command, which has been dedicated to developing objective TBI detection solutions for more than two decades.
