US-based medical device maker Abbott has received Health Canada authorisation for its i-STAT TBI test cartridge, which uses whole blood to assess suspected concussions.
The test, performed on Abbott’s portable i-STAT Alinity instrument, provides lab-quality results within 15 minutes.
It facilitates rapid evaluation of mild traumatic brain injuries (mTBI) at the patient’s bedside.
The i-STAT TBI test cartridge can now be used up to 24 hours post-injury, a significant improvement against the common delay in seeking care, said Abbott.
The approval broadens Abbott’s TBI test offerings, complementing its existing i-STAT TBI Plasma test and ARCHITECT and Alinity i lab tests.
Abbott diagnostics business senior medical director Beth McQuiston said: “Abbott has pioneered breakthroughs in TBI testing technology for more than a decade.
“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.”
The regulatory approval enables testing in diverse healthcare settings, such as urgent care clinics, and potentially in pharmacies and at sporting event sidelines.
It enables clinicians to evaluate patients aged 18 and older with suspected mTBI, potentially reducing the need for computer tomography (CT) scans.
The test requires a small venous blood sample, which is applied to the cartridge and inserted into the i-STAT Alinity instrument.
It measures two brain-specific biomarkers, ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP), which are released during significant brain injuries.
If these biomarkers are below established thresholds, a CT scan may be unnecessary, supporting effective patient care decisions.
University of Toronto associate professor and St. Michael’s Hospital trauma surgeon and medical director Andrew Beckett said: “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.
“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.”
Recently, Abbott secured the US Food and Drug Administration (FDA) approval for its Tendyne transcatheter mitral valve replacement (TMVR) system.
Tendyne is a minimally invasive device that addresses mitral valve malfunction due to severe mitral annular calcification (MAC), a condition where calcium builds up in the annulus.
