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Abbott Secures FDA Approval for Rapid Whole Blood Test Enabling Concussion Evaluation at the Patient's Bedside

Monday, April 01, 2024

Abbott's i-STAT TBI cartridge has obtained FDA approval for whole blood usage, marking a significant breakthrough in traumatic brain injury (TBI) assessment. Previously, TBI tests were limited to plasma or serum samples, necessitating laboratory analysis. This new clearance allows for rapid bedside assessment with high-quality results in just 15 minutes.

Expanding beyond traditional hospital settings, this clearance enables assessment in urgent care clinics with moderate complexity testing certification. It also hints at the potential for testing in unconventional locations such as sports sidelines.

The whole blood test, usable on a portable instrument, can now aid clinicians in evaluating patients aged 18 and above presenting with suspected mild traumatic brain injury or concussion. Test results can help guide patient care decisions, potentially avoiding unnecessary CT scans of the head.

By utilizing whole blood samples, this clearance facilitates testing in healthcare facilities lacking laboratory infrastructure, thereby expediting head trauma evaluation. Moreover, it extends the assessment window to up to 24 hours post-injury, addressing delays often observed in seeking care after a head injury.

Complementing Abbott's existing TBI test portfolio, which includes the i-STAT TBI Plasma test and the ARCHITECT® and Alinity i lab tests for serum and plasma, this newly cleared test aligns with the company's vision of making TBI assessment accessible across various care settings.

Abbott remains committed to ongoing research and development, with future plans aimed at expanding the test's utility to non-healthcare settings and a broader demographic, including adolescents and pediatric patients.


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