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...

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.

Video
Nov 6, 2023

The Warfighter Brain Health for Leaders Training Video

The Warfighter Brain Health for Leaders Training Video

The Warfighter Brain Health for Leaders Training video is an essential resource for enhancing the Department of Defense's Warfighter Brain Health Initiative. It empowers military leaders with strategies for preventing, protecting against, and managing brain injuries. Additionally, the video enhances leaders' abilities to assess and recognize symptoms ...

Fact Sheet
Nov 6, 2023

Warfighter Brain Health After TBI: Guidance for Leaders

.PDF | 895.85 KB

This TBICoE fact sheet, Warfighter Brain Health After TBI: Guidance for Leaders, condenses the basics of recognizing, reporting, and preventing TBI in service members. It updates and supersedes the Line Leader Policy Guidance fact sheet and includes a list of what the DOD has defined as potentially concussive events and outlines leaders’ ...

Publication
Sep 29, 2023

TBICoE Research Review: Mild TBI and PTSD

.PDF | 435.28 KB

This research review provides an in-depth summary of the available clinical research on the topic of co-morbid mild traumatic brain injury and posttraumatic stress disorder. Specifically, this review will address symptoms, anatomy, diagnosis, and treatment of mild TBI, PTSD, and the unique circumstances associated with the presentation of both.

Publication
Sep 29, 2023

Mild TBI and PTSD Clinical Pearls

.PDF | 924.82 KB

TBICoE's "Mild Traumatic Brain Injury and Posttraumatic Stress Disorder Clinical Pearls," is a new supplemental product to the detailed research review. This resource is designed to be brief and provide key actionable “clinical pearls” that should be considered in the treatment of service members with comorbid mild TBI and PTSD.

Video
Sep 21, 2023

TBI and Low-Level Blast Exposure: What Medical Providers Need to Know

TBI and Low-Level Blast Exposure: What Medical Providers Need to Know

This educational video, produced by the Traumatic Brain Injury Center of Excellence, focuses on the effects of low-level blast and traumatic brain injury. Its purpose is to provide supplemental information on low-level blast to health care providers and beneficiaries.

Technical Document
Jul 20, 2023

Infographic: What is the Acute Concussion Care Pathway?

.PDF | 714.95 KB

TBICoE developed this infographic as a quick reference tool that demonstrates application of the standardized acute concussion assessment and care process. By adhering to this established pathway of care for mild TBI, providers across the MHS can ensure a reduction in unwarranted variation and foster an integrated, standardized system of readiness and ...

Fact Sheet
Jul 18, 2023

Low-Level Blast: Fact Sheet for Service Members

.PDF | 867.41 KB

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. Both providers and service members should be aware of the potential effects of low ...

Fact Sheet
Jul 18, 2023

Low-Level Blast: Fact Sheet for Providers

.PDF | 1.26 MB

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. Both providers and service members should be aware of the potential effects of low ...

Video
Jul 13, 2023

Acute Concussion Care Pathway Overview

What is the Acute Concussion Care Pathway thumbnail of educational video for providers.

The Acute Concussion Care Pathway standardizes acute concussion care in the Military Health System. This video is designed to educate medical providers on the ACC Pathway, improving their understanding and application of evidence-based clinical tools. This video covers aspects of the ACC Pathway in detail, providing explanations and guidance on using ...

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