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 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...

TBI Caregiver Support Forms

Form/Template
6/29/2021

This is a fillable and printer-friendly version of the forms available in the "Traumatic Brain Injury: A Guide for Caregivers of Service Members and Veterans."

Recommended Content:

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

Medical Advances Since Gulf War Boil Down to Increased Lives Saved

Article
6/25/2021
Medical personnel training on how to treat a neck wound

Not all medical advances since the first Gulf War are highly technical.

Recommended Content:

Health Readiness & Combat Support | Research and Innovation | Health Innovation Toolkit

NICoE Education Webinar Series: July Poster

Publication
6/25/2021

Service Members and TBI: The Not So Invisible Wound

Recommended Content:

Traumatic Brain Injury | TBI Education and Training Events | Centers of Excellence

NICoE Education Webinar Series: June Poster

Publication
6/23/2021

Combat-related Concussion: Understanding Trajectories of Long-term Clinical and Imaging Outcomes

Recommended Content:

Traumatic Brain Injury | TBI Education and Training Events

TBICoE Virtual Quarterly Education Series: July 2021

Publication
6/22/2021

The Traumatic Brain Injury Center of Excellence is hosting a caregiver education series to learn about TBI caregiver resources, mind-body wellness exercises, and current research in the field.

Recommended Content:

Traumatic Brain Injury Center of Excellence | TBI Educators | Traumatic Brain Injury | TBI Education and Training Events

Progressive Return to Activity Following Concussion/mTBI Patient and Leadership Guide

Publication
6/22/2021

The Progressive Return to Activity Following Concussion/mTBI Patient and Leadership Guide alerts command and line leaders about the PRA process and provides service members with appropriate activities for each stage of their recovery.

Recommended Content:

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

30 Years after Desert Storm, Military Medicine Evolving ‘Phenomenally’

Article
6/9/2021
Military health personnel surrounding an operating table

Thirty years after the Persian Gulf War, technical advances in military medicine are saving lives and improving post-trauma quality of life.

Recommended Content:

Our History | Health Innovation Toolkit

Health Innovation: COVID-19 Vaccine Clinics at the PX

Infographic
6/2/2021
Health Innovation: COVID-19 Vaccine Clinics at the PX

Health Innovation Month. Placing COVID-19 vaccination clinics in the PX brings vaccines to the people

Recommended Content:

Health Innovation Toolkit | Health Innovations across the MHS Enterprise | Health Innovation Toolkit

Health Innovation: Decide + Be Ready App

Infographic
6/2/2021
Health Innovation: Decide + Be Ready App

Health Innovation Month. Developed app to help female service members make informed contraception decisions

Recommended Content:

Health Innovation Toolkit | Health Innovations across the MHS Enterprise | Health Innovation Toolkit

Health Innovation: Joint Health Information Exchange

Infographic
6/2/2021
Health Innovation: Joint Health Information Exchange

Health Innovation Month Securely connecting DOD electronic health records with civilian networks through the Joint Health Information Exchange

Recommended Content:

Health Innovation Toolkit | Health Innovations across the MHS Enterprise | Health Innovation Toolkit

Health Innovation: DIY Ventilators

Infographic
6/2/2021
Health Innovation: DIY Ventilators

Health Innovation Month Developing inexpensive DIY ventilators to meet demand and patient need

Recommended Content:

Health Innovation Toolkit | Health Innovations across the MHS Enterprise | Health Innovation Toolkit

Health Innovation July 2021 v2

Infographic
6/2/2021
Health Innovation July 2021 v2

Health Innovation Month

Recommended Content:

Health Innovation Toolkit | Health Innovations across the MHS Enterprise

Health Innovation: Drive-Up Pharmacies

Infographic
6/2/2021
Health Innovation: Drive-Up Pharmacies

Health Innovation Month Opening drive-up pharmacies kept access to prescriptions and lowered COVID-19 risk

Recommended Content:

Health Innovation Toolkit | Health Innovations across the MHS Enterprise | Health Innovation Toolkit

Health Innovation July 2021 Spotlight

Infographic
6/2/2021
Health Innovation July 2021 Spotlight

Health Innovation Month

Recommended Content:

Health Innovation Toolkit | Health Innovations across the MHS Enterprise

RRC Tri Service Carousel Slide Graphic

Infographic
6/2/2021
RRC Tri Service Carousel Slide Graphic

#ReadyReliableCare is the DHA-led effort to advance #HighReliability across the MHS.

Recommended Content:

Health Innovation Toolkit | Health Innovation – Pathways to Ready Reliable Care
<< < 1 2 3 4 5  ... > >> 
Showing results 61 - 75 Page 5 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.