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Patients can be evaluated up to 24 hours after injury, a significant improvement from previously available tests.

FDA Approves Whole Blood Rapid Test for Assessing Brain Injury

Traumatic brain injury is a major concern in the Army personnel and the new test could drive quick on-field diagnosis

U.S. Army Medical Materiel Development Activity

The U.S. Army Medical Materiel Development Activity is a subordinate element of the U.S. Army Medical Research and Development Command (USAMRDC) and the Army Futures Command.

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Published:Apr 02, 2024
|2 min read
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FORT DETRICK, MD — The U.S. Army officials, in partnership with Abbott, announced recently that the company’s i-STAT® TBI (traumatic brain injury) cartridge has received clearance from the U.S. Food and Drug Administration to be used with whole blood.

The newly cleared device can run whole blood testing at the patient’s bedside, allowing clinicians to obtain lab quality results for patients suspected of concussion in 15 minutes, according to company officials. Also, the patients can be evaluated up to 24 hours after injury, a significant improvement from previously available tests. Previous tests that helped with the assessment of concussion were only cleared for use with plasma or serum, requiring samples to be sent to a laboratory for processing and results.

"TBIs are a major concern for Warfighter health, readiness, and resiliency,” said Brig. Gen. Edward H. Bailey, MD, MA, 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.”

Traumatic brain injury in military personnel

Nearly 500,000 US troops worldwide experienced a TBI resulting from military training, deployment, or day-to-day activities—such as sporting events—between 2000 and 2023, according to DoD statistics. Developing a field-deployable solution for the detection and evaluation of TBIs among service members stationed at home and abroad is, therefore, a top priority for the US military health system.

Abbott developed the i-STAT TBI blood test in collaboration with the U.S. Army Medical Materiel Development Activity (USAMMDA), part of USAMRDC. The command has been dedicated to developing a solution for detecting and evaluating TBIs for more than two decades.

This FDA-approved test measures the presence of two biomarkers that may be released into the bloodstream, indicating a possible brain injury. Testing for these two biomarkers—ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP)—in the aftermath of an injury can provide clinicians with essential information about a patient’s condition and can help healthcare providers decide on an appropriate treatment plan.

U.S. Army Col. James A. (Andy) Nuce, commander of USAMMDA, said the assay will enhance the ability of frontline medical staff to quickly assess service members with suspected TBIs. Since not all patients will require head CT scans, the new method will prevent unnecessary medical evacuations and improve TBI case management in the field.

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

- This press release was originally published on The U.S. Army Medical Materiel Development Activity website