Orlando Health first in the world to use Abbott's new blood test for traumatic brain injuries

(Press-News.org) Orlando, FL (Aug. 13, 2024) – Orlando Health Orlando Regional Medical Center (ORMC) is the first hospital in the world to use a new, groundbreaking blood test to help assess patients with suspected mild traumatic brain injuries (TBIs), or concussions. The rapid TBI blood test provides results in just 15 minutes and was developed by Abbott, in collaboration with the Department of Defense, and built upon innovative research that Orlando Health’s Dr. Linda Papa and others helped pioneer over 20 years ago.

According to the National Institutes of Health, traumatic brain injury from accidents or sports is a leading cause of death and disability in the United States. And the CDC estimates that 2.5 million people visited the emergency department for TBIs in one year.

Nearly 25 years ago, Dr. Papa noticed as an emergency medicine physician that doctors had blood tests to help diagnose and treat conditions for many major organs like the heart, liver and kidneys. But there was no blood test for the brain. She was inspired by her patients to find a way to blunt the impacts of TBIs through science, and her research and body of work reflect her dedication to helping patients with TBIs. This is why it is particularly noteworthy that Orlando Health, led by Dr. Papa, will be the first hospital system in the world to roll out Abbott’s i-STAT TBI blood test. With this new test at their fingertips, Orlando Health emergency room physicians can now more quickly assess patients during those critical moments when every second counts.

“Now, doctors are finally armed with a blood test to check your brain,” said Dr. Linda Papa, Director of Clinical Research at Orlando Health. “This is a game-changer, and we are just getting started.”

New TBI blood test provides rapid results 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. Test results can help rule out the need for a CT scan of the head and assist in determining the best next steps for patient care. 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, MD, 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 with Orlando Health, 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."

Orlando Health Leads the Way Each month, Orlando Health ORMC’s emergency department sees an average of 125 patients who have sustained a traumatic brain injury. Orlando Health ORMC is 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, Senior Vice President of Orlando Health and President of Orlando Health Orlando Regional Medical Center. “Dr. Papa is a visionary. Her decades of trailblazing TBI research highlight Orlando Health’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 in Orlando Health’s clinical implementation of Abbott’s 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.”

Dr. Papa has evaluated different aspects of the blood test through various studies and has been the lead author of many studies published in journals such as JAMA Neurology, JAMA Network Open, Nature Scientific Reports, Journal of Neurotrauma, BMJ Paediatrics Open, Academic Emergency Medicine, Annals of Emergency Medicine and Journal of Trauma. 

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About Abbott’s i-STAT TBI Test 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.

The i-STAT TBI test was developed in collaboration with 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.

The Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) research team was the first to demonstrate how this TBI blood test can be used for the benefit of TBI patients in clinical care. All clinical trials for the test were run through the TRACK consortium.

About Orlando Health Orlando Health is a private, not-for-profit healthcare organization with $10.5 billion of assets under management.

The healthcare system is recognized around the world for Central Florida’s only pediatric and adult Level I Trauma program as well as the only state-accredited Level II Adult Trauma Center in Pinellas County, Florida. It is the home of one of the nation’s largest neonatal intensive care units, one of the only systems in the Southeast to offer open fetal surgery to repair the most severe forms of spina bifida, the site of an Olympic athlete training facility and operator of one of the largest and highest performing clinically integrated networks in the region. Orlando Health has pioneered life-changing medical research and its Graduate Medical Education program hosts more than 350 residents and fellows.

In FY 23, Orlando Health cared for 197,000 inpatients and 6.6 million outpatients. The healthcare system provided nearly $1.3 billion in economic impact to the communities it serves in the form of community benefit programs and services, Medicare shortfalls, bad debt, community-building activities and capital investments in FY 22, the most recent period for which this information is available.

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