New TBI blood test provides rapid results
The i-STAT TBI test was developed in collaboration with Abbott, the U.S. Department of Defense U.S. Army Medical Research and Development Command’s (USAMRDC) and U.S. Army Medical Materiel Development Activity (USAMMDA). The USAMRDC has been dedicated to developing a solution for the objective detection and evaluation of TBI for more than two decades and has played a critical role in developing the TBI test on Abbott’s i-STAT Alinity system.
Abbott’s i-STAT TBI test provides results in just 15 minutes by checking a patient’s blood for two biomarkers that may be present after suffering a brain injury. Dr. Papa was a pioneer in identifying the biomarkers used in the TBI blood test and her over two decades of innovative research played a pivotal role in test development.
“During a head trauma, a person’s brain gets jostled. Damaged brain cells release two proteins: GFAP and UCH-L1 into their blood,” said Dr. Papa. “The higher the concentrations of these proteins, the more severe the brain injury. The quicker doctors can detect these brain injuries, the quicker a patient can get life-saving treatment. On the flip side, if we find these biomarkers are not elevated in their blood within 24 hours of trauma, that may indicate that they do not need to have a CT scan.”
The new TBI blood test is now an innovative tool in a doctor’s toolbox. Currently, CT scans are the most common way to diagnose brain lesions. However, they are time-consuming, expensive and associated with radiation exposure. The TBI blood test could cut down on the need for CT scans. For decades, concussion evaluation has been the same — utilizing a physical examination of a patient to subjectively assess a concussion and imaging to detect brain tissue damage or lesions.
“TBI patients can sometimes be challenging to assess in an emergency department,” said Chris Davlantes, M.D., senior director of Global Medical & Scientific Affairs in Abbott’s Point of Care Diagnostics division and practicing ER physician. “During critical moments of uncertainty, a blood test can add objective information to quickly assess which patients can be safely sent home without imaging. We’re thrilled to collaborate withOrlandoHealth, a pioneer in concussion management, to introduce this important test for traumatic brain injuries—marking a significant advancement in the standard of care for patients.”
OrlandoHealthLeads the Way
Each month,OrlandoHealthORMC’s emergency department sees an average of 125 patients who have sustained a traumatic brain injury.OrlandoHealthORMC is proud to be home to Central Florida’s only Level One Trauma Center.
“We are incredibly proud to be the first hospital in the world to roll out this new blood test for traumatic brain injuries,” said Kelly Nierstedt, President and CEO ofOrlandoHealthOrlandoRegional Medical Center. “Dr. Papa is a visionary. Her decades of trailblazing TBI research highlightsOrlandoHealth’s commitment to patient care and strategic innovation. We are honored to be on the leading edge of healthcare throughout the entire journey from the research lab to the patient’s bedside.”
Now, Dr. Papa is working on evaluating the test in children. She also continues to be actively involved inOrlandoHealth’s clinical implementation of the blood test to help adult patients with suspected TBIs.
“It was a humble beginning. I started this research by going around the emergency department asking patients to participate in our study and collecting blood samples to test for brain injury biomarkers,” said Dr. Papa, “We owe a debt of gratitude to all the patients and families who agreed to participate in this research because they helped make this test possible.”
Abbott’s i-STAT TBI cartridge received clearance from the U.S. Food and Drug Administration (FDA) to be used with venous whole blood in early 2024. This test can be used to help evaluate patients 18 years and older, up to 24 hours after injury. The i-STAT TBI cartridge is the latest addition to Abbott’s TBI test portfolio, which also includes the i-STAT TBI Plasma cartridge and the ARCHITECT® and Alinity i lab test (serum and plasma).
The ability to use whole blood to help assess TBI is an important step in Abbott’s vision to make its tests available in all settings where people seek care for head injuries including outside traditional healthcare settings, such as at athletic facilities. Abbott is engaged in ongoing research and planning that may, in the future, allow the test to be used with a broader population including teens and pediatrics.The test is currently being evaluated for use in the pediatric population age 17 and under.
