• Posted April 3, 2024

FDA Clears 15-Minute Bedside Test to Gauge Soldiers' Brain Injury

When a soldier is rushed to medical care following a blast or other injury to the head, time is crucial in deciding just how extensive that injury is.

Now, the U.S. Army has announced that the U.S. Food and Drug Administration has cleared a bedside whole blood test that can answer that question in about 15 minutes.

Prior tests relied on blood plasma or serum, and that meant sending samples to a lab for analysis.

The new test, made by Abbott and called the  i-STAT TBI (Traumatic Brain Injury) cartridge, sidesteps that issue.

It could be an advance for the care of traumatic brain injuries (TBIs) on the battlefield, U.S. Army Brig. Gen. Edward Bailey said in an Army news release.

"TBIs are a major concern for Warfighter health, readiness and resiliency," said Bailey, who is commanding general of the U.S. Army Medical Research and Development Command (USAMRDC). "This milestone accomplishment demonstrates how Army medical developers can partner with industry to deliver solutions for frontline medical personnel caring for our injured service members."

According to background data supplied by the Army, about half a million U.S. troops have experienced some form of TBI during their training, deployment or even sporting events, between 2000 and 2023.

That's why the Army teamed up with Abbott to develop a quicker test when TBIs occur.

Here's how the i-STAT test works. First, doctors draw a whole blood sample from a vein of the affected soldier, which fills a small cartridge. That cartridge is then popped into a portable i-STAT instrument that "measures the presence of two biomarkers that may be released into the bloodstream, indicating a possible brain injury," according to the Army.

The results from that analysis arrive quickly, "provide clinicians with essential information about a patient's condition, and can help healthcare providers decide on an appropriate treatment plan," the Army added.

Besides helping speed treatment decisions, the test should also help rule out other off-site tests, such as CT scans. That could lessen the need for medical evacuations, said U.S. Army Col. Andy Nuce, commander of the U.S. Army Medical Material Development Activity (USAMMDA).

"During future large-scale combat operations, enemy weapons and exposure to blast or concussive events will present challenges to frontline medical providers," Nuce said.  "We are constantly working to investigate, develop and field modern medical solutions to protect the Warfighters of 2030, 2040 and beyond."

According to U.S. Army Lt. Col. Bradley Dengler, Neurosurgical Consultant to the Office of the Surgeon General, the ultimate goal is the safety of those who serve.

"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,"he said. "This can help get the most severely injured service members to neurosurgeons faster and ultimately save lives."

More information

Find out more about TBIs at the U.S. National Institute of Neurological Disorders and Stroke.

SOURCE: U.S. Army, news release, April 1, 2024