Back to Top Skip to main content Skip to sub-navigation

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).

Recommended Content:

Traumatic Brain Injury | Brain Injury Awareness Month | Brain Injury Awareness To Improve Readiness | Brain Injury Awareness To Improve Readiness | Brain Injury Awareness To Improve Readiness | Brain Injury Awareness To Improve Readiness | Traumatic Brain Injury | Brain Injury Awareness To Improve Readiness | Health Innovation Toolkit

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...

2000-2021 DOD Worldwide Numbers for TBI

Report
5/17/2022

TBICoE is the Defense Department’s office of responsibility for tracking traumatic brain injury data in the U.S. military. Here you’ll find data on the number of active-duty service members—anywhere U.S. forces are located—with a first-time TBI diagnosis from calendar year 2000 through the fourth quarter of 2021. The data is also broken down by each branch of the armed services.

Recommended Content:

Traumatic Brain Injury Center of Excellence | TBI Educators | TBI Provider Resources | Traumatic Brain Injury

2021 DOD Worldwide Numbers for TBI

Report
5/17/2022

TBICoE is the Defense Department’s office of responsibility for tracking traumatic brain injury data in the U.S. military. Here you’ll find data on the number of active-duty service members—anywhere U.S. forces are located—with a first-time TBI diagnosis in 2021. The data is also broken down by each branch of the armed services.

Recommended Content:

Traumatic Brain Injury Center of Excellence | TBI Educators | TBI Provider Resources | Traumatic Brain Injury

Neuroimaging Following Mild TBI Clinical Recommendation

Publication
5/16/2022

This TBICoE clinical recommendation allows primary care managers to make an informed, evidenced-based decision regarding whether or not imaging is indicated following a concussion/mild TBI.

Recommended Content:

Traumatic Brain Injury Center of Excellence | TBI Provider Resources | Traumatic Brain Injury

2021 Traumatic Brain Injury Center of Excellence Annual Report

Publication
4/26/2022

The 2021 Traumatic Brain Injury Center of Excellence (TBICoE) Annual Report provides a look at accomplishments and activities from calendar year 2021.

Recommended Content:

Traumatic Brain Injury Center of Excellence | Traumatic Brain Injury | TBI Educators | TBICoE Research | TBI Provider Resources

A History of the Combat Helmet and the Quest to Prevent Injuries

Article
4/25/2022
Lt. Gen. George S. Patton and Brig. Gen. Theodore Roosevelt Jr. are pictured here in 1943 wearing the standard M1 helmet, sometimes called the "steel pot." (Photo: 1st Infantry Division Courtesy Photo)

The combat helmet has evolved over time to improve protection against projectiles and shock waves to reduce the risk of fatal blows and traumatic brain injuries.

Recommended Content:

Traumatic Brain Injury | Military Medical History

Concussion Care Pathway Streamlined for Better Results

Article
4/1/2022
Dr. Gregory Johnson, Tripler Concussion Clinic medical director, conducts a neurological exam on Army Spc. Andrew Karamatic, a combat medic, having him follow his finger with his eyes, at Tripler Army Medical Center, in Honolulu, Hawaii. Neurologic exams are part of the MACE 2 diagnostic tool to assess service members’ Acute Concussion Care Pathway. (Photo: Army Staff Sgt. Christopher Hubenthal, DMA Pacific – Hawaii Media Bureau)

The Defense Health Agency has developed a comprehensive clinical care program (Acute Concussion Care Pathway) to manage concussions based on the military medical community’s many years of experience with injured service members.

Recommended Content:

Traumatic Brain Injury

Brain-Boosting Meal Plans Help Service Members with TBI

Article
3/30/2022
During the NICoE intensive outpatient program (IOP), staff nutritionist Ruth Clark teaches hands-on classes in the on-site patient kitchen. (Photo: Tahira Hayes (Ctr), NICoE/WRNMMC, NSA Bethesda)

Research has shown that dietary changes may help relieve symptoms that might complicate recovery from a traumatic brain injury (TBI), such as chronic pain, anxiety, depression, and sleep problems.

Recommended Content:

Traumatic Brain Injury | Nutritional Fitness | Total Force Fitness

Immediate Testing: How the Military Evaluates Risk For Brain Injuries

Article
3/28/2022
Pfc. Thomas Icenogle, a student in the Army’s Combat Medic Specialist Training Program at the Medical Education and Training Campus on Joint Base San Antonio-Fort Sam Houston, Texas, conducts a Military Acute Concussion Evaluation 2 (MACE 2) on Pvt. Alejandro Leija, while Pvt. Dominic Dubois refers to the MACE 2 card. (Photo: Lisa Braun, Medical Education and Training Campus Public Affairs)

MACE 2 allows for a quick assessment of traumatic brain injuries in the field and is similar to sports concussion checks.

Recommended Content:

Traumatic Brain Injury

One Airmans Recovery from TBI

Video
3/28/2022
One Airmans Recovery from TBI

After a motorcycle accident, Master Sergeant Stalnaker started having symptoms of traumatic brain injury, or TBI. He tells his story about his symptoms and his road to recovery from physical and emotional wounds as a result.

Recommended Content:

Traumatic Brain Injury

Five Clinical Tools To Help Assess and Treat TBI

Article
3/17/2022
An Army 'gun team' brace for the concussion of a 105mm howitzer during operations in Iraq in 2008. (Photo: Master Sgt. Kevin Doheny)

Here are five new ways that doctors can diagnose and treat mild concussions.

Recommended Content:

Traumatic Brain Injury

Ask the Doc: Can a Concussion Affect Hearing and Vision?

Article
3/16/2022
Elizabeth Kirkpatrick, a physical therapist for the Fort Drum Traumatic Brain Injury (TBI) Clinic, New York, uses a model of the inner ear on Feb. 27, 2019, to demonstrate how a concussion can cause inner ear, or vestibular, damage which may result in dizziness, anxiety, depression, moodiness, balance problems and irritability to name a few. (Photo: Warren W. Wright Jr., Fort Drum MEDDAC)

Even a mild concussion can lead to hearing and vision problems.

Recommended Content:

Traumatic Brain Injury | Traumatic Brain Injury Center of Excellence | Vision and Hearing Loss Prevention | Hearing Center of Excellence | Vision Center of Excellence | Vision and Hearing Loss Prevention | Ask The Doc

TBICoE 2021 Publications

Publication
3/16/2022

Master list of 2021 TBICoE articles published in research journals

Recommended Content:

Traumatic Brain Injury Center of Excellence | Patient and Family Resources | TBICoE Research | Traumatic Brain Injury

One Airman's Recovery from TBI

Video
3/9/2022
One Airman's Recovery from TBI

After a motorcycle accident, Master Sergeant Stalnaker started having symptoms of traumatic brain injury, or TBI. He tells his story about his symptoms and his road to recovery from physical and emotional wounds as a result. If you’re experiencing symptoms of TBI, visit health.mil/TBI to learn about the resources available to you.

Recommended Content:

Brain Injury Awareness To Improve Readiness | Traumatic Brain Injury | Brain Injury Awareness Month

A Retired Navy SEAL Discusses his TBI

Video
3/9/2022
A Retired Navy SEAL Discusses his TBI

Retired Navy SEAL Edward Rasmussen discusses his TBI, and urges others to seek treatment if they have symptoms. If you’re experiencing symptoms of TBI, visit health.mil/TBI to learn about the resources available to you.

Recommended Content:

Brain Injury Awareness To Improve Readiness | Traumatic Brain Injury | Brain Injury Awareness Month

BIAM Caregivers

Infographic
2/17/2022
BIAM Caregivers

#DYK? Family support helps TBI recovery? Learn how to support your loved one here: https://www.health.mil/News/Articles/2021/07/22/Caregiver-Guide-supports-service-members-and-veterans-with-TBI #BeTBIReady #BIAMonth

Recommended Content:

Brain Injury Awareness To Improve Readiness | Traumatic Brain Injury Center of Excellence | Traumatic Brain Injury | Brain Injury Awareness Month
<< < 1 2 3 4 5  ... > >> 
Showing results 1 - 15 Page 1 of 18
Refine your search
Last Updated: February 18, 2022

DHA Address: 7700 Arlington Boulevard | Suite 5101 | Falls Church, VA | 22042-5101

Some documents are presented in Portable Document Format (PDF). A PDF reader is required for viewing. Download a PDF Reader or learn more about PDFs.