Abbott has proudly announced the FDA clearance of its pioneering rapid blood test for concussions, which operates with whole blood samples on the company’s cutting-edge, portable i-STAT® Alinity® instrument. This significant advancement offers a promising leap forward in the management and assessment of patients with a suspected mild traumatic brain injury (mTBI), commonly referred to as a concussion, directly at the patient’s bedside. The capability to deliver lab-quality results in a mere 15 minutes stands to revolutionize the way healthcare providers approach the evaluation of such injuries, extending the utility of this technology to settings well beyond the emergency department, including urgent care clinics and potentially even to the sidelines of athletic events.
Previously, the assessment tools for concussions were limited to plasma or serum samples and necessitated laboratory processing, which could delay critical decision-making regarding patient care. However, with the new FDA clearance, Abbott’s rapid blood test can now be administered using a whole blood sample. This enhancement dramatically broadens the scope of healthcare environments where rapid, accurate concussion assessment can be performed, offering a more immediate and accessible solution for patient care.
FDA-Approved Rapid Blood Test Transforms Concussion Diagnosis with Biomarker Analysis
Employing a small venous blood sample, the rapid blood test leverages the i-STAT TBI cartridge within the portable i-STAT Alinity system to analyze two brain-specific biomarkers, ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP). These biomarkers, when detected, may indicate a brain injury, providing essential information that can guide healthcare professionals in deciding the most appropriate treatment pathway. This rapid testing method not only facilitates an expedited assessment process but also contributes significantly to a more objective evaluation of head traumas, potentially ruling out the need for a CT scan and thereby streamlining the patient care journey.
The clearance of this rapid blood test marks a monumental step in Abbott’s ongoing commitment to improving the management of traumatic brain injuries through innovative diagnostic solutions. It paves the way for testing in a variety of new healthcare and potentially non-healthcare settings, opening up possibilities for quicker and more efficient evaluations of concussions at the point of care. This is particularly relevant given the statistics indicating that nearly 5 million people visit the emergency department for TBI in the U.S. each year, with a significant portion of individuals suspecting a concussion not seeking the necessary medical evaluation.
Abbott’s Groundbreaking TBI Test, Developed with the U.S. Army, Sets New Standards in Concussion Care
Developed in collaboration with the U.S. Department of Defense’s U.S. Army Medical Research and Development Command and the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) team, this rapid blood test embodies over two decades of dedicated research aimed at enhancing the detection and management of TBIs. This collaboration highlights the critical role of cross-sector partnerships in advancing medical technology for the benefit of patients worldwide.
With its latest FDA clearance, Abbott continues to lead in the development of diagnostic tools that address critical healthcare needs. The company is actively engaged in research and planning efforts that aim to extend the use of the test to broader populations, including teens and pediatrics, and into various settings outside of traditional healthcare facilities. This endeavor underscores Abbott’s vision of making advanced diagnostic tests accessible wherever they are needed, ultimately fostering a future where the swift and accurate assessment of concussions can significantly impact the health and well-being of individuals across the globe.
Resource: Abbott, April 01, 2024
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