Rapid Concussion Blood Test Researched by Steelers' Neurologist Approved by FDA

The FDA has approved a rapid blood test that can detect concussions quickly and in an easily accessible manner.

Per Abby Mackey of the Pittsburgh Post-Gazette, the test built on the efforts of Dr. David Okonkwo, a professor of neurological surgery at the University of Pittsburgh and neurosurgeon for the Pittsburgh Steelers, and his research team.

The test uses an i-STAT Alinity device that can be used anywhere and provides results within minutes.

Mackey noted the work done by Okonkwo and his team has 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."

Abbott, the company that manufactures the device, believes the i-STAT Alinity could be available in emergency rooms and urgent care centers as soon as this summer.

Dr. Okonkwo also cited its benefits for United States military members.

"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 told Mackey.

Despite receiving FDA approval, Dr. Okonkwo did note it's unlikely to be used to diagnose concussions in football players anytime soon because of the types of patients they used to gain clearance.

"The nature of the studies performed to gain FDA clearance for these tests were done in patients brought to level one trauma centers," he 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."

The FDA previously approved the i-STAT TBI test in 2021 that relies on a blood serum to detect concussions. Dr. Okonkwo explained the i-STAT Alinity uses the same test on whole blood, so it doesn't require a lab or centrifuge to examine the results:

"It's almost like trying to measure something in tap water versus measuring something from a river. 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."

According to Mackey, the next step for Dr. Okonkwo and his research team to clear before the test can be put to use in football games will be "removing the need for a needle-and-syringe blood draw in favor of a finger-stick test, much like a glucometer."

The testing will also require approval from sports leagues and unions before it could be implemented. The current approval for the test is only in people aged 18 years or older, but research is ongoing for the pediatric population.

Per the NFL's injury tracking data, there have been a total of 2,028 diagnosed concussions between the preseason and regular season from 2015 to '23. There have been 161 diagnosed concussions in the regular season in each of the past two seasons.