Device relies on two protein biomarkers to indicate traumatic injury

U.S. Army medics in Europe are testing a new handheld diagnostic tool that can identify traumatic brain injuries in as little as 15 minutes, the service announced Thursday.

Military officials said the i-STAT Alinity device, made by Abbott Laboratories, can revolutionize how medics detect and treat such injuries on the battlefield. Rather than relying on subjective cognitive evaluations that ask patients questions to assess a concussion, the device provides objective results by measuring unique biomarkers in the blood of the injured.

Lt. Col. Bradley Dengler, the neurosurgery consultant to the Army Surgeon General and director of the Military Traumatic Brain Injury Initiative at the Uniformed Services University, described the development as a major advance in battlefield medicine.

“This is probably the single most important advancement in traumatic brain injury care in the last 15 to 20 years,” Dengler said in an Army release. “Historically, we’ve missed a lot of these injuries.”

The i-STAT device measures two biomarkers released into the bloodstream that can indicate a possible brain injury: ubiquitin C-terminal hydrolase L1, or UCH-L1, and glial fibrillary acidic protein, or GFAP. Dengler said the test carries high predictive value — if the blood biomarkers are not elevated, there is a 99% chance that no bleeding is occurring in the brain.

The Army is integrating the devices into air defense forward units under the 10th Army Air and Missile Defense Command. These units were selected because they often operate in remote locations, hours away from advanced medical facilities and sophisticated brain scanners.

The device represents a significant upgrade from the Military Acute Concussion Evaluation, a 15-minute standardized cognitive assessment involving memory lists and concentration exercises that has been the Army’s standard tool.

Abbott Laboratories received clearance from the Food and Drug Administration to use the device with whole blood two years ago, according to the company. The expanded clearance allows doctors to assess patients with suspected concussion at the bedside and obtain lab-quality results in 15 minutes. Prior to that approval, the tests were only cleared for use with plasma or serum, requiring samples to be sent to a laboratory for processing.