PITTSBURGH (TNS) — Earlier this month, a Pitt professor of neurological surgery celebrated with his team as their research cleared a major hurdle: FDA approval.
The device they helped create is poised to push the detection of concussions forward immeasurably, with availability in some hospitals and urgent care centers as early as the summer.
Dr. David Okonkwo, director of the Neurotrauma Clinical Trials Center, and his team’s efforts have resulted in the first lab-quality test capable of detecting concussions rapidly and accessibly, right at patients’ bedsides and, someday, on the sidelines of sporting events.
The instrument, known as i-STAT Alinity, builds on another Dr. Okonkwo-researched tool: The i-STAT TBI, approved by the FDA in 2021, was the first handheld, rapid and objective blood test for concussions in history.
Both devices, developed and manufactured by Abbott, add objectivity to a somewhat subjective diagnostic process that includes neurological exams and patient questionnaires. The key difference is practicality.
While available around the world and used at “a few hospitals in the U.S.,” an Abbott spokesperson said in an email, i-STAT TBI relies on blood serum — a component of blood that requires professionals to first draw blood from patients, then process it via centrifuge, a clunky laboratory tool.
Its offspring conducts the same test but on whole blood: no lab or centrifuge required.
“It’s almost like trying to measure something in tap water versus measuring something from a river,” Dr. Okonkwo told the Post-Gazette. “There are countless things in a river that aren’t in tap water, by the time it’s processed through numerous steps, goes through a pipe, ends up in your house, comes out of your tap and into a glass that you drink.
“When you go to whole blood, you’re having to test river water instead of tap water.”
Concussions are a type of traumatic brain injury (TBI) caused by a direct blow or bump to the head, or by a hit to the body that causes powerful movement of the head or neck, forcing the brain to move rapidly inside of the skull.
When that occurs, proteins are released into the blood. The detection of two of those — UCH-L1 and GFAP — is how i-STAT Alinity is able to rule out concussion with a 96.5% predictive value, when assessed within 24 hours of injury, per statistics provided by Abbott, which indicates that a CT scan (to rule out a brain bleed) is likely unnecessary.
Abbott expects i-STAT Alinity to be available by summer 2024 to emergency rooms and urgent care centers, but it also has important implications for the U.S. military.
“What it instantly allows our nation’s military to do is to get this as close as possible to the point of injury to improve our ability to help wounded warriors in the civilian world,” Dr. Okonkwo said.
Because the newly cleared test — approved just on April 1 — hasn’t yet been adopted by health care systems, Abbott cannot confirm insurance participation, though the company anticipates coverage similar to other routine diagnostic blood tests, at a wholesale cost similar to other types of diagnostic blood tests already performed in those centers.
Use on the sidelines, where Dr. Okonkwo finds himself weekly during the fall and winter as the Pittsburgh Steelers’ team neurosurgeon, will have to wait, however.
“The nature of the studies performed to gain FDA clearance for these tests were done in patients brought to level one trauma centers,” Dr. Okonkwo said. “We have every reason to believe there is significant overlap with the injuries to athletes who sustain a concussion, but we need to do studies specifically in that patient population to confirm that use.”
Dr. Okonkwo and his team — which includes research partner Ava Puccio, a doctorally prepared nurse and associate professor at Pitt’s School of Medicine with expertise in neuroscience — anticipate taking another step toward practicality before truly reaching the sidelines: removing the need for a needle-and-syringe blood draw in favor of a finger-stick test, much like a glucometer.
The final hurdle to use at live sporting events will include another level of approval, by professional sports leagues and players’ unions, as individual teams are unable to adopt medical diagnostics such as this.
With current approval for use in those 18 years and older, further research is also underway in the pediatric population, which, if successful and awarded FDA approval, could capture around 2.3 million concussions or brain injuries diagnosed in kids under 18, should 2022 data hold.
But concussion prevalence statistics are riddled with folly, as it is well understood that around half of all sustained concussions go undiagnosed.
That understanding emphasizes the importance of the 10-year-old Department of Defense-funded TBI biorepository — a collection of TBI-affected brains — at Pitt’s School of Medicine, which “allows us to study things from a number of perspectives including diagnosis, identification of best treatments and monitoring the impact of TBI,” Dr. Okonkwo said.
And as concussion assessment becomes more objective and easier to access — someday with a finger-prick on a sideline, if all goes as planned — it all leads to yet more reasons to celebrate.
“Every journey begins with a step, and that first step, of proving that you could measure proteins in blood and diagnose an injury to the brain, was not considered possible 20 years ago,” Dr. Okonkwo said. “We have, collectively, made the impossible possible.”
