Concussion faculty member assists on FDA cleared TBI blood test

Dr. Fred Korley and the i-STAT Alinity blood test
Dr. Fred Korley and the i-STAT Alinity blood test

“For the very first time, we have a blood test for the brain,” said Dr. Fred Korley, associate professor of Emergency Medicine at Michigan Medicine and faculty member at the Michigan Concussion Center.

On January 11, Abbott, a global healthcare technology leader, announced they had received 510(k) clearance from the FDA for the i-STAT Alinity blood test, the first rapid handheld traumatic brain injury (TBI) blood test. This test will help clinicians assess individuals with suspected TBI by allowing them to measure blood levels of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1), two complementary biomarkers that, in elevated concentrations, are strongly associated with brain injury.

According to Korley, GFAP and UCH-L1 are found within two of the most common types of brain cells, astrocytes, and neurons. When brain cells are damaged, GFAP and UCH-L1 are released into the brain, where they are picked up by blood vessels and circulated throughout the body. 

i-STAT Alinity requires a small blood sample drawn from which plasma is extracted with a centrifuge and applied to the test’s cartridge. The cartridge is then inserted into the handheld instrument, with results returning in 15 minutes. A negative result can be used to rule out the need for a brain CT scan, which is commonly used to help diagnose TBI and identify life-threatening bleeding in the brain. 

For those testing positive, this test result complements a brain CT scan by providing additional information regarding the extent of brain injury. 

Korley said this handheld device has the potential to be a “game-changer.” He noted that only nine percent of TBI patients evaluated in the emergency department have a positive brain CT scan. “With this test, we can identify those who need a brain CT scan a lot sooner and save some people from getting the associated radiation, and financial costs, and send them home quicker,” he said. “Furthermore, down the line, we may be able to provide additional information that we cannot provide right now.” 

The TBI blood test was developed in collaboration with the U.S. Department of Defense (DoD),  which has been dedicated to developing a solution for the objective detection and evaluation of TBI for more than a decade. The DoD, through U.S. Army Medical Research and Development Command’s (USAMRDC) U.S. Army Medical Materiel Development Activity (USAMMDA), played a critical role in funding the development of these tests that run on Abbott’s i-STAT Alinity platform. The Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) research team has led a number of cutting-edge studies that demonstrate how this TBI blood test can be used for the benefit of TBI patients in clinical care.

TRACK-TBI, of which Korley is an investigator, is an 18-center research network conducting the largest observational study on TBI across the United States. The study collects blood samples from patients who come into the emergency room for TBI care, including control subjects (healthy patients, friends of TBI patients, etc.), and follows them longitudinally for up to 12 months after they leave. 

Korley serves on the Biomarker Committee for TRACK-TBI, where he helps analyze blood-based biomarker data and guides data interpretation. He also helps write manuscripts to share the group’s findings and improve clinical care.

Currently, the biggest problem for diagnosing TBI, according to Korley, is that there isn’t an objective way to tell how severe the TBI is. “Only a small portion of TBI patients have an injury that results in bleeding into their brain, however, there are a lot of people who suffer injuries that put them out of work for more than six months, however, they don’t have significant findings on their brain CT,” he said.

Korley is optimistic that there may be opportunities to use the i-STAT beyond the TBI space, for detecting brain injury from non-trauma-related conditions. “It’s a whole new world,” he said.