Abbott's i-STAT TBI cartridge has received clearance from the U.S. Food and Drug Administration (FDA) to be used with whole blood, enabling doctors to assess patients with suspected concussion at the bedside and obtain lab-quality results in just 15 minutes. Previously, tests aiding in traumatic brain injury (TBI) assessment were only cleared for use with plasma or serum, necessitating samples to be sent to labs for processing and testing.

This milestone allows testing to be conducted in various healthcare settings, including urgent care clinics certified to perform moderate complexity tests, and potentially even on the sidelines of sporting events, streamlining the evaluation of head traumas.

The i-STAT TBI test, performed on Abbott's portable Alinity System, assists clinicians in evaluating patients aged 18 and older presenting with suspected mild traumatic brain injury or mTBI, commonly known as concussion. The results help rule out the necessity for a CT scan of the head and guide further patient care decisions. Conducting the test with whole blood samples facilitates assessment in healthcare settings without labs, expediting the evaluation of head traumas.

This clearance also extends the window for testing to up to 24 hours after injury, a crucial advancement given that many individuals with suspected concussions delay seeking medical attention.

Approximately 5 million people in the U.S. visit emergency departments for TBI annually, yet over half of those suspecting they have a concussion do not seek medical evaluation.

Traditionally, TBI assessment relied on subjective methods like the Glasgow Coma Scale and CT scans. The i-STAT TBI cartridge measures two biomarkers, ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP), which may indicate brain injury when released into the bloodstream post-injury. This objective assessment aids in determining treatment plans.

Dr. Geoffrey Manley, Chief of Neurosurgery at Zuckerberg San Francisco General Hospital and Professor at the University of California San Francisco, remarked, "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."

The i-STAT TBI cartridge, utilized with the Alinity System, requires a small venous blood sample, which is then applied to the test cartridge. Inserting the cartridge into the portable instrument yields results in minutes, aiding clinicians in making critical decisions swiftly.

Dr. Beth McQuiston, Medical Director in Abbott's diagnostics business, noted, "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."

This clearance broadens Abbott's TBI test offerings, complementing the i-STAT TBI Plasma test and the ARCHITECT® and Alinity i lab test (serum and plasma) previously cleared.

Abbott continues to explore opportunities to extend the test's use beyond healthcare settings and potentially to adolescent and pediatric populations, aligning with its vision to make tests available wherever people seek care for head injuries.