Skip main navigation

Military Health System

Clear Your Browser Cache

This website has recently undergone changes. Users finding unexpected concerns may care to clear their browser's cache to ensure a seamless experience.

Army Announces FDA Clearance of Field Deployable TBI Blood Test

Image of Military personnel standing in the snow preparing to fire a missile . Soldiers from 1st/120th Field Artillery, Wisconsin National Guard, prepare to fire a M-777 Howitzer during Winter Strike 21 at Camp Grayling Maneuver Center, Michigan in Jan. 2021. Soon the Army should have a field-deployable means to detect and evaluate soldiers for TBI (Photo by: Air National Guard photo by Master Sgt. Dan Heaton).

The U.S. Army Medical Materiel Development Activity, in partnership with Abbott, announced the U.S. Food and Drug Administration approval of the Abbott i-STAT™ Alinity™ Traumatic Brain Injury plasma assay, a rapid blood test for TBI in January.

Between 2000 and 2019, more than 400,000 service members experienced a TBI as a result of combat injuries and training accidents, as well as everyday activities such as sporting events.

Developing a field-deployable solution for the detection and evaluation of TBI among our wounded service members serving at home and deployed overseas has been a top priority for the Department of Defense for more than a decade.

"A rapid test for TBI is a critical addition to our downrange capability to care for the brain health of our most important weapon system, the Warfighter, and help maintain a high state of readiness across the Force," said Army Brig. Gen. Michael Talley, commanding general for the U.S. Army Medical Research and Development Command and Fort Detrick, Maryland.

The i-STAT Alinity TBI plasma assay can identify two brain-specific protein markers that rapidly appear in the blood following a TBI. This blood test will provide medical professionals with objective markers that indicate injury to the brain, as opposed to relying on subjective descriptions of the injury-causing incident, reduce the need for head Computed Tomography scans.

"A blood-based biomarker laboratory assay (blood test) for TBI will greatly enhance the ability of DOD medical personnel to objectively assess Service Members who have suffered a suspected TBI. The ability to avoid unnecessary evacuations for head CT scans could really impact the efficiency of TBI management,” said Dr. Krista Caudle, product manager for USAMMDA's Warfighter Brain Health Project Management Office.

The goal for initial implementation of the laboratory assay is to assist with the management of patients with a suspected TBI, particularly focusing on the areas where Service Members would be required to be evacuated from the operational setting to obtain a CT scan of the head. The overall objective is to have a logistically suitable, whole-blood, point-of-care TBI biomarker test with rapid turnaround time.

"The laboratory assay for TBI product development program is an example of how USAMRDC and private industry can share a common vision and achieve a common goal. Over the years, the program progressed through basic science studies at Walter Reed Army Institute of Research and USAMRDC's Combat Casualty Care Research Program, then into product development and clinical trials in USAMMDA, and ultimately U.S. FDA clearance," said Caudle.

The FDA-approved Banyan Biomarkers, Inc., Brain Trauma Indicator™, also funded by USAMMDA, laid the groundwork and served as a foundation for the i-STAT Alinity TBI plasma assay. The DOD partnered with Abbott to develop the TBI biomarkers into a field-deployable laboratory platform, which is an easy-to-use TBI cartridge utilized in the i-STAT Alinity device, the new version of the i-STAT 1 that is currently fielded by the U.S. Army. Recent user assessments have established preliminary suitability of the assay and device in operational laboratory settings for the Army. Future testing will confirm system suitability and enable fielding of this capability.

The laboratory assay for TBI point-of-care biomarker effort has been funded by the U.S. Army and is managed by USAMMDA's Warfighter Brain Health Project Management Office.

You also may be interested in...

Video
Jan 19, 2024

Who is TBICoE?

Who is TBICoE?

The U.S. Congress established TBICoE in 1992 in response to the need to treat service members with TBI from the first Gulf War. TBICoE assists military medical providers in delivering effective and reliable care, crucial for combat readiness. Learn more about their history, mission, and the critical importance they place on protecting, treating, and ...

Video
Jan 19, 2024

What Steps Should A Military Leader Take After A Potentially Concussive Event?

What Steps Should A Military Leader Take After A Potentially Concussive Event?

Military leadership has a responsibility to promote warfighter brain health among service members. That means prompt reporting of potentially concussive events and ensuring service members with TBI get medical attention. This video covers the steps leaders should take after a potential concussion.

Video
Jan 19, 2024

What Happens To The Brain After A TBI?

What Happens To The Brian After A TBI?

What Happens to the Brain After a TBI? This video explores the effects of concussion on a warfighter's brain, commonly caused by falls, sports, or car accidents. It emphasizes the importance of prevention through protective measures like helmets, seatbelts, and safe training practices, which are essential for maintaining brain health.

Article
Dec 15, 2023

Department of Defense Taking Action with Warfighter Brain Health Initiative

Department of Defense Taking Action with Warfighter Brain Health Initiative

"A top priority for the DOD is taking care of our people,” said Dr. Lester Martinez-Lopez, Assistant Secretary of Defense for Health Affairs. “This priority includes promoting brain health and countering traumatic brain injury in all its forms. As the military community’s understanding of brain health has evolved over the years, the Department’s ...

Fact Sheet
Dec 14, 2023

PTSD and Other Stress-Related Disorders Following Concussion/Mild TBI Fact Sheet

.PDF | 542.68 KB

Co-occurring concussion and stress-related disorders, including PTSD, are common among service members. This fact sheet defines concussion, also known as mild traumatic brain injury, and provides an overview of common stress-related disorders, the overlapping symptoms, and how to manage those symptoms.

Fact Sheet
Dec 13, 2023

Low-Level Blast: VA Provider Fact Sheet

.PDF | 820.18 KB

This fact sheet was developed specifically for VA medical providers. Low-level blast is defined as blast generated from firing heavy weapon systems or explosives in combat or training environments. Exposure to low-level blast does not typically result in a clinically diagnosable concussion, also known as mild traumatic brain injury.

Article Around MHS
Dec 5, 2023

When Your Spouse Has a Traumatic Brain Injury

Lorie Falaminiano, an MRI technologist assigned to Naval Medical Center San Diego (NMCSD), conducts an MRI scan of a patient's brain at the NMCSD hospital.

As a spouse of a service member who has suffered a traumatic brain injury, you may be experiencing a range of emotions. It is important to allow yourself to feel every emotion that surfaces and attend to your own needs. Here are some strategies to consider as you prepare to take on your new role as a caregiver to your spouse.

Article Around MHS
Nov 29, 2023

Green Beret Teams Up with the US Southern Command Warrior Care Program Care Coalition Competes in Department of Defenses Warrior Games Challenge and International Invictus Games

U.S. Army Sgt. 1st Class Jacob “Jake” Anthony competing in the 2023 Invictus Games held in Dusseldorf, Germany. (Courtesy photo)

Green Beret U.S. Army Sgt. 1st Class Jacob "Jake” Anthony was deployed to Afghanistan in 2005 on a mission to find a target. His team was breaching a door that turned out to be booby-trapped, resulting in an explosion that killed his teammate in front of him. Anthony would take shrapnel to the right frontal lobe to his brain and had to be initially ...

Infographic
Nov 29, 2023

TBICoE's Low-Level Blast Research Infographic

What is TBICoE doing to help warfighters exposed to low-level blast? Leading the charge: 1. Collaborated on Military weapons training studies and Epidemiology studies 2. Led health and performance efforts in support of the Section 734 Program Advancing the science: 1. Measured LLB exposure effects on performance 2. Provided recommendations on LLB surveillance 3. Advanced DOD’s understanding of LLB health and performance effects Answering the call: 1. Outlined next steps for LLB research 2. Helped to develop guidance for managing brain health risk from blast overexposure 3. Recommended the development of a tool to capture career blast exposure These efforts are in support of the Warfighter Brain Health Initiative LLB Relevant Aims 1. Understand the known and emerging threats and hazards to brain health 2. Monitor warfighters for brain exposures 3. Reduce risk of brain exposures that may negatively impact brain health

This infographic illustrates TBICoE's research activity on understanding how low-level blast influences warfighter brain health. This work directly supports Line of Effort 2 of the Warfighter Brain Health Initiative. Learn more about low-level blast exposure and TBI at health.mil/LLB.

Skip subpage navigation
Refine your search
Last Updated: January 22, 2024
Follow us on Instagram Follow us on LinkedIn Follow us on Facebook Follow us on X Follow us on YouTube Sign up on GovDelivery