Skip to main content

Military Health System

Army Announces FDA Clearance of Field Deployable TBI Blood Test

Image of Military personnel standing in the snow preparing to fire a missile . Military personnel standing in the snow preparing to fire a missile

Recommended Content:

Traumatic Brain Injury Center of Excellence | Brain Injury Awareness

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...

Anomalous Health Incident (AHI) Acute Assessment Training

Publication
3/15/2023

This virtual training, hosted by the Traumatic Brain Injury Center of Excellence, will introduce MHS health care providers to Anomalous Health Incidents (AHI) 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.

Recommended Content:

Traumatic Brain Injury Center of Excellence | Education & Training Events | TBI Provider Resources | TBI Educators

INFORMATION PAPER: The Impact of Mild Traumatic Brain Injury on the Autonomic Nervous System

Publication
3/15/2023

The purpose of this information paper by TBICoE is to provide a general overview of the current evidence related to the impact of concussion/mild traumatic brain injury (mTBI) on the autonomic nervous system (ANS). This paper will focus on heart rate variability (HRV), pupillary light reflex (PLR), and hyperhidrosis within the military and civilian populations.

Recommended Content:

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

2023 NICoE Brain Injury Awareness Month Events

Publication
2/28/2023

Downloadable PDF of the 2023 NICoE Brain Injury Awareness Month events they are hosting or participating in.

Recommended Content:

The National Intrepid Center of Excellence | Arts in Health Program | Brain Injury Awareness | Traumatic Brain Injury Center of Excellence | Be a Brain Warrior: Protect. Treat. Optimize.

FEB 2023 TBICoE Quarterly Education Series Flyer

Publication
2/8/2023

TBICoE Quarterly Education Series: TBI Across the Lifespan. Join TBICoE at this virtual event to explore clinical best practices for prevention, assessment, and treatment of mild TBI, also known as concussion, for military dependents. Download the flyer for details.

Recommended Content:

Traumatic Brain Injury Center of Excellence | TBI Provider Resources | TBI Educators | Education & Training Events

TBICoE Brain Injury Awareness Month 2023 Events Flyer

Publication
1/29/2023

2023 Brain Injury Awareness Month training and education events hosted by the Traumatic Brain Injury Center of Excellence

Recommended Content:

Traumatic Brain Injury Center of Excellence | TBI Provider Resources | TBI Educators | Education & Training Events | Vision Center of Excellence

Progressive Return to Activity: Primary Care for Acute Concussion Management

Publication
1/23/2023

The Progressive Return to Activity (PRA): Primary Care for Acute Concussion Management clinical recommendation is an evidence-based return to activity protocol for primary care managers and concussion/traumatic brain injury (TBI) clinic providers. The PRA is a six-step approach that begins after the provider performs the Military Acute Concussion Evaluation 2 (MACE 2) and diagnoses the patient with a concussion/TBI. The PRA stages start with relative rest and allow service members to gradually increase activities until they receive clearance for return to full duty or activity. In each stage, it offers general and military specific activities and options to help providers manage their patients’ primary symptom clusters. The PRA also offers recommendations on specialty referrals and handouts are available for providers to give patients and leadership.

Recommended Content:

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

DOD TBI Worldwide Numbers At-A-Glance

Publication
8/24/2022

TBICoE is the Defense Department’s office of responsibility for tracking traumatic brain injury data in the U.S. military. The "DOD TBI Numbers At-A-Glance" provide a high level overview of TBI's sustained since 2000 and also show the data by severity and service branch.

Recommended Content:

Traumatic Brain Injury Center of Excellence | DOD TBI Worldwide Numbers

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

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 | TBI Educators | TBICoE Research | TBI Provider Resources

References and Acknowledgements: Neuroimaging Following Concussion Clinical Recommendation

Publication
4/6/2022

This document acknowledges those who participated in the expert working group with the Traumatic Brain Injury Center of Excellence and provides the resources and references used to develop the Neuroimaging Following Concussion/Mild Traumatic Brain Injury: Guidance for the Primary Care Manager.

Recommended Content:

Traumatic Brain Injury Center of Excellence

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

Assessment and Management of Dizziness and Visual Disturbances Following Concussion/Mild Traumatic Brain Injury

Publication
10/22/2021

This clinical recommendation provides medical staff with a single, comprehensive reference for the assessment and management of dizziness and visual disturbances following mild TBI/concussion. Dizziness and visual disturbances often present with overlapping symptoms and should prompt a provider to perform a visual and dizziness—or vestibular—assessment.

Recommended Content:

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

Improving Relationships after TBI

Publication
10/21/2021

Flier for the Interactive Relationship Building Workshop for Active-Duty Military and Veteran TBI Caregivers and Families: This flier provides information on TBICoE's educational session for caregivers of active-duty service members and veterans who have sustained a TBI. In addition to sharing caregiver resources and current research initiatives, webinar topics will also include relationship building strategies, improving communication and addressing intimacy after TBI.

Recommended Content:

Traumatic Brain Injury Center of Excellence | Patient and Family Resources | TBI Provider Resources | Centers of Excellence

2000-Q2 2021 DOD Worldwide Numbers for TBI

Publication
10/14/2021

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 second quarter of 2021. The data is also broken down by each branch of the armed services.

Recommended Content:

Traumatic Brain Injury Center of Excellence | DOD TBI Worldwide Numbers | Centers of Excellence

2021 Q2 DOD Worldwide Numbers for TBI

Publication
10/14/2021

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 the second quarter of calendar year 2021. The data is also broken down by each branch of the armed services.

Recommended Content:

Traumatic Brain Injury Center of Excellence | DOD TBI Worldwide Numbers
<< < 1 2 3 4 5  ... > >> 
Showing results 1 - 15 Page 1 of 6
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