First Commercially Available Lab-Based Blood Test to Help Evaluate Concussion

A bump, blow, or whiplash to the head is the main cause of traumatic brain injury (TBI), which can lead to short- and long-term detrimental effects. People affected by TBI may experience impaired memory, movement, sensation (such as hearing and vision), and emotional function (such as psychological symptoms and personality changes). The effects of TBI can last for a few days post-injury or become permanent. For a long time, the process for standard concussion evaluation has remained the same, where the physician relies on subjective Glasgow Coma Scale assessments and CT scans to detect brain tissue damage or lesions. Now, the first commercially available laboratory TBI blood test in the U.S. helps doctors evaluate patients with concussion by ruling out the need for a CT scan.

Abbott Diagnostics (Lake Bluff, IL, USA) has received U.S. Food and Drug Administration clearance for the first commercially available laboratory TBI blood test, making it widely available to hospitals in the U.S. The Alinity i TBI test measures complementary biomarkers in blood plasma and serum - Ubiquitin C-terminal Hydrolase L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP), that, in elevated concentrations, are tightly correlated to brain injury. It provides test results with 96.7% sensitivity and 99.4% negative predictive value. By testing for these two biomarkers immediately after an injury, health care providers can decide on the appropriate next steps and devise a treatment plan for the patients. The test is for use to aid in the evaluation of patients, 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head. The test had earlier received European Union clearance and has been available in markets outside the U.S. since 2021.

The test, which runs on Abbott's Alinity i laboratory instrument, will help clinicians quickly and objectively evaluate people with mild TBIs (concussions). A patient visiting the hospital within 12 hours of suspected mTBI can be administered the Alinity i test. The process involves obtaining a blood sample from the arm, sending it to the lab for preparation and running the test on the Alinity i instrument. The test results are usually available in 18 minutes, and can be shared with the relevant healthcare providers for immediate evaluation. Negative results on the test prevent additional CT scans and eliminate waiting time at the hospital, thus reducing the cost burden on the healthcare system and patients, as well as reducing time spent in the emergency department.

"People sometimes minimize a hit to the head, thinking it's no big deal. Others wonder if a visit to the doctor or emergency room for a possible concussion will provide them with meaningful answers or care," said Beth McQuiston, M.D., medical director in Abbott's diagnostics business. "Now that this test will be widely available in labs across the country, medical centers will be able to offer an objective blood test than can aid in concussion assessment. That's great news for both doctors and people who are trying to find out if they have suffered a traumatic brain injury."

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