Skip to main content

Military Health System

Test of Sitewide Banner

This is a test of the sitewide banner capability. In the case of an emergency, site visitors would be able to visit the news page for addition information.

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...

Dizziness and Visual Problems After Concussion

Infographic
5/22/2023
Graphic containing general information on dizziness and vision  problems after a traumatic brain injury. Visit health.mil/TBIFactSheets and download related fact sheets for information.

More than 80% of all concussions—also known as mild traumatic brain injury—in the military are considered mild. Dizziness and visual problems are among the most common symptoms after concussion and often resolve within days or weeks

Changes in Behavior, Personality or Mood Following Concussion/mTBI Fact Sheet

Fact Sheet
5/22/2023

This TBICoE fact sheet can be used by health care providers to educate patients with a concussion, or mild TBI, on how to manage changes in mood related to their injury. Patients and caregivers would also find this information useful.

Application of Acute Concussion Care Pathway: MACE 2 & PRA Training

Calendar Event
5/16/2023

The Traumatic Brain Injury Center of Excellence is hosting a combined Military Acute Concussion Evaluation 2 and Progressive Return to Activity clinical recommendation virtual training. Attendees may earn two CEUs through the Defense Health Agency Continuing Education Program Office.

Acute Concussion Care Pathway: MACE 2 and PRA Training

Publication
5/12/2023

The Traumatic Brain Injury Center of Excellence is hosting a combined Military Acute Concussion Evaluation 2 and Progressive Return to Activity clinical recommendation virtual training.

TBICoE Spotlight: Lisa Moy Martin

Video
5/11/2023
TBICoE Spotlight: Lisa Moy Martin

In this edition of TBICoE Connect Employee Spotlight, we dive into Lisa Moy Martin's inspiring journey in TBI research, her dedication to the mission and the unique opportunities that helped shape her decades long career.

Vestibular Assessment and Rehab Course Focuses on Dizziness from TBI

Article
5/5/2023
Vestibular Assessment and Rehab Course Focuses on Dizziness from TBI

Hearing Center of Excellence offers training for dizziness related to concussion.

Cognitive Rehabilitation Therapy

FAQs
4/19/2023

The complexity of the brain and brain injuries has led to questions about the nature of cognitive rehabilitation therapy and its availability to service members who have sustained TBIs.

Concussion Protocols Aid Diagnosis, Treatment, and Recovery

Article
4/17/2023
Concussion Protocols Aid Diagnosis, Treatment, and Recovery

Whether on the sport field or the battlefield, the Defense Health Agency is the global leader in research on the effects of concussion—known as mild traumatic brain injury—in the military. Its research has fueled the development of protocols to help providers assess and treat concussion from initial injury to acute and post-acute medical settings, rehabilitation, and, ultimately, a return to family, community, work, continued duty, or recreation.

Anomalous Health Incident Acute Assessment Training

Publication
4/17/2023

This virtual training, hosted by the Traumatic Brain Injury Center of Excellence, will introduce MHS health care providers to Anomalous Health Incidents and review assessment and treatment strategies. Detailed guidance on how to complete a medical evaluation using Anomalous Health Incident (AHI) Acute Assessment (DHA Form 244), will be provided.

2023 TBICoE Quarterly Education Series Schedule

Publication
4/14/2023

The Traumatic Brain Injury Center of Excellence's Quarterly Education Series is an enterprise-wide learning opportunity for Military Health System stakeholders. Since inception, the QES provides trainings and events that are relevant to the MHS, discussing specialty topics and current research related to TBI.

2022 TBICoE Publication Catalog

Publication
4/7/2023

TBICoE publication citations and summaries are organized by category, or overarching research topic. The purpose of this document is to (1) summarize key findings and potential clinical implications of calendar year 2022 TBICoE publications, (2) increase awareness, and (3) assist in planning of future efforts.

TBI—The Female Experience

Publication
4/6/2023

Join the Traumatic Brain Injury Center of Excellence for an exploration of the unique ways in which brain injury manifests in the female population at the next Quarterly Education Series virtual event. Etiology, symptomatology, and diagnosis can be nuanced and have long gone unstudied in women. Experts will discuss a new wave of research, clinical support, and barriers for females with TBI. TBICoE's QES is an enterprise-wide learning opportunity for Military Health System stakeholders.

Traumatic Brain Injury Awareness

Article Around MHS
4/6/2023
A patient receives an MRI. Rachel Mote, the regional educational coordinator at the Landstuhl Regional Medical Center traumatic brain injury clinic talk about TBIs during the Kaiserslautern Military Community News Update. (Photo by U.S. Air Force Sgt. Jared Kindlespire, Regional Media Center AFN Europe)

Symptoms of traumatic brain injuries aren't always physical, or even recognizable. Listen to our audio newscast and get potentially lifesaving advice from the experts.

Highlighting the Intrepid Spirit Concussion Recovery Clinic

Article Around MHS
4/6/2023
U.S. Navy Commander Diana Fu explains the physical therapy room at Intrepid Spirit Concussion Recovery Clinic to Marine Corps Installations East Commander on Aug. 2, 2021. (Photo by Naval Medical Center Camp Lejeune)

Would you be able to recognize the symptoms of a brain injury in yourself or someone close to you? Even the slightest head injury may not just "go way", and we've got some important tips that could save your life.

Traumatic Brain Injury Center of Excellence FAQs

FAQs
3/31/2023

The Traumatic Brain Injury Center of Excellence FAQs provides answers to questions we are regularly asked about the organization and its mission.

Page 1 of 21 , showing items 1 - 15
First < 1 2 3 4 5  ... > Last 
Refine your search
Last Updated: December 28, 2022
Follow us on Instagram Follow us on LinkedIn Follow us on Facebook Follow us on Twitter Follow us on YouTube Sign up on GovDelivery