A new rapid test that checks for traumatic brain injuries (TBI) using a single drop of blood is expected to make its debut in the military in the coming months.
The product marks one of the most significant steps forward for TBI patients’ care in the past 20 years, Lt. Col. Bradley Dengler, an Army neuroscientist who directs the Military Traumatic Brain Initiative at the Uniformed Services University in Bethesda, Maryland, said in a recent release announcing the product’s approval by the Food and Drug Administration.
U.S. Army officials, in partnership with medical device manufacturer Abbott, jointly announced April 1, 2024, that the company’s i-STAT® TBI whole blood cartridge had received FDA marketing clearance. Abbott developed the blood test in collaboration with USAMMDA.
Previous tests to help diagnose concussion or more severe TBI were cleared by FDA in early 2021 only for use with blood plasma or serum. This required samples to be sent to a laboratory for processing and results.
The new test, which takes only 15 minutes for results and is run on a portable device, also can be used to evaluate patients up to 24 hours after injury, a significant improvement from previously available tests. The device therefore could aid in decisions on priority evacuations from forward deployments in a future conflict where rapid evacuation (the “golden hour”) is not possible.
“Given the large numbers of expected casualties with all severities of traumatic brain injury in future large-scale combat operations, this test can help maintain combat power far forward by helping to eliminate unnecessary evacuations,” Dengler said.
“Additionally, and just as important, given the limited number of neurosurgeons available in-theater, ongoing research demonstrates that a future version of this test could be used to triage more severely injured patients, as the blood biomarker elevations correlate with the severity of their intracranial injuries,” Dengler commented. “This can help get the most severely injured service members to neurosurgeons faster and ultimately save lives.”
The U.S. Army Medical Research and Development Command, headquartered at Fort Detrick in Frederick, Maryland, has been dedicated to developing a solution for detecting and evaluating TBIs for more than two decades.
The new diagnostic method will prevent unnecessary medical evacuations and improve TBI case management in the field since not all patients will require head CT scans, said U.S. Army Col. Andy Nuce, commander of the U.S. Army Medical Materiel Development Activity part of USAMRDC.
In July 2023, the technology was tested in simulated battle conditions during a soldier “touchpoint” as part of the Global Medic combat support training exercise at the U.S. Army’s Fort Hunter Liggett, California, which is known as the military’s premier total force training center.
“TBIs are a major concern for warfighter health, readiness, and resiliency,” said U.S. Army Brig. Gen. (Dr.) Edward H. Bailey, commanding general of USAMRDC. “This milestone demonstrates how Army medical developers can partner with industry to deliver solutions for frontline medical personnel caring for our injured service members.”