Abbott has received clearance from the US Food and Drug Administration (FDA) for its i-STAT TBI cartridge to be used with whole blood, marking a significant advancement in assessing traumatic brain injury (TBI) at the patient's bedside. 

This clearance enables doctors to obtain lab-quality results within 15 minutes, facilitating timely diagnosis and treatment decisions for patients with suspected concussion.

Previously, TBI tests were only cleared for use with plasma or serum, necessitating sample processing in a laboratory. With this new clearance, testing can now be performed with whole blood samples, expanding the accessibility of TBI assessment beyond traditional healthcare settings.

The i-STAT TBI cartridge, utilized with the portable i-STAT Alinity System, allows clinicians to evaluate patients aged 18 and older presenting with suspected mild traumatic brain injury, commonly known as concussion. By measuring biomarkers released into the bloodstream, such as ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP), the test aids in ruling out the need for a CT scan and guiding patient care decisions.

Dr. Geoffrey Manley, Chief of Neurosurgery at Zuckerberg San Francisco General Hospital, lauded the significance of the whole blood test in expediting patient triage and assessment. "With the help of this whole blood test, we can quickly and objectively determine whether or not a patient needs a CT scan or additional evaluation, right at the point of care. It's an incredibly helpful tool that advances the treatment of traumatic brain injury," remarked Dr. Manley.

The i-STAT TBI cartridge's clearance underscores Abbott's commitment to enhancing TBI assessment and expanding access to care. Dr. Beth McQuiston, Medical Director in Abbott's diagnostics business, emphasized the importance of providing clinicians with an objective tool for assessing concussions, stating, "Now, we have a whole blood test that can help assess the brain right at the patient's bedside – expanding access to more health providers and therefore patients."

The clearance of the i-STAT TBI cartridge for whole blood testing complements Abbott's existing TBI test offerings, including the i-STAT TBI Plasma test and the ARCHITECT® and Alinity i lab tests for serum and plasma. Abbott continues its research and planning efforts to potentially extend the use of the test to non-healthcare settings and a broader patient population, including teenagers and pediatric patients, in the future.