Health Canada has granted approval for Abbott’s i-STAT TBI test cartridge, enabling clinicians to evaluate suspected concussions more effectively.
The authorisation allows for the use of the test cartridge with whole blood, enabling clinicians to get lab-quality results in 15 minutes.
Previously, mild traumatic brain injury (mTBI) assessment tests were authorised only for plasma or serum samples, necessitating lab processing.
The approval facilitates testing in diverse healthcare settings, potentially expanding to pharmacies, clinics without radiology, and even sporting event sidelines.
The i-STAT TBI test is designed to assess those who are 18 years and above with suspected mTBI (commonly referred to as concussion).
It can help rule out the requirement for a head computed tomography (CT) scan and guide the further steps for individual care, using other clinical information.
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By GlobalDataThe authorisation also extends the test’s utility to assess individuals up to 24 hours post-injury, addressing situations where individuals may delay seeking medical attention.
Abbott’s market offerings for TBI testing already include the i-STAT TBI Plasma test and the ARCHITECT and Alinity i lab tests for serum and plasma.
To be used with the i-STAT Alinity System, the i-STAT TBI test cartridge needs only a small blood sample.
It measures two brain-specific biomarkers, ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP), released into the bloodstream after brain injury.
If levels of these biomarkers are below a certain threshold, a serious injury is unlikely, and a CT scan may be avoided.
Abbott diagnostics business senior medical director Beth McQuiston said: “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 optimise patient care.”
In April 2025, the company reported new data from its Volt CE Mark Study, indicating that individuals treated with pulsed field ablation (PFA) therapy using the Volt PFA System for atrial fibrillation (AFib) showed efficacy and safety up to 12 months.
