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

Army Announces FDA Clearance of Field Deployable TBI Blood Test

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 Toolkit | Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit | TBI Information | Brain Injury Awareness 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...

Vision Problems After Concussion Fact Sheet

Fact Sheet
3/30/2021

This fact sheet helps concussed service members understand vision problems and provides insight into treatment options.

Recommended Content:

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

Dover Air Force Base features ‘Park ‘N Pickup’ pharmacy

Article
3/26/2021
Picture of prescription sitting on a counter

Due to the increased need for patient safety, the 436th Medical Group pharmacy at Dover Air Force Base has implemented a Park ‘N Pickup process.

Recommended Content:

Brain Injury Awareness Toolkit | Coronavirus | Patient Safety

Historic observance celebrates the achievements of women

Article
3/25/2021
A flyer of three women in three separate pictures smiling

The DHA held a virtual observance—featuring a panel discussion on women’s history— in honor of Women’s History Month.

Recommended Content:

Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit | Women's Health

TBI Hot Topics Bulletin March 2021

Publication
3/24/2021

Are you a busy health care provider? Not enough time to keep up with the latest TBI research trends and news? Stay informed with the TBI Hot Topics Bulletin. TBICoE tracks the latest TBI scientific studies, advances, and discoveries most relevant to health care providers. This issue covers the fourth quarter of calendar year 2020.

Recommended Content:

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

Course improves patient care by identifying cause of errors

Article
3/19/2021
Military Personnel wearing face mask and posing for a picture

Knowing where problems may arise ultimately results in higher quality of patient care.

Recommended Content:

Patient Safety | Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit | Patient Safety Awareness Week

DODs Patient Safety Program works to eliminate preventable harm

Article
3/18/2021
Picture of a vital sign machine

The Joint Patient Safety Reporting System and TeamSTEPPS play a major role in the DOD’s Patient Safety Program

Recommended Content:

Patient Safety | Quality and Safety of Health Care (for Healthcare Professionals) | Patient Safety Awareness Week | Patient Safety Awareness Week | Brain Injury Awareness Toolkit

Balancing rest, activity key to recovering from concussion

Article
3/17/2021
Two football teams facing off in the middle of a play

A newly revised suite of tools and resources for military health care providers will help improve the treatment of service members with concussions, and ensure their safe return to full duty.

Recommended Content:

Traumatic Brain Injury | Brain Injury Awareness Month | Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit

Military researchers gain new insights into brain injuries

Article
3/16/2021
Military personnel sitting at a table collecting data

Blast injury research helps to fill knowledge gaps about brain injury.

Recommended Content:

Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit | Traumatic Brain Injury | Brain Injury Awareness Month | Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit

Patient Safety Awareness Week 2021 highlights role of technology

Article
3/12/2021
A graphic with the words "Patient Safety Awareness Week 2021 March 14-20

Patient Safety Awareness Week brings awareness to health care safety and promotes patient safety practices.

Recommended Content:

Patient Safety | Technology | Patient Safety Awards Program | Patient Safety Awareness Week | HRO Awards - Previous Winners | Brain Injury Awareness Toolkit | Patient Safety Awareness Week

HEADS: Protect Your Strongest Weapon

Publication
3/11/2021

This flyer promotes awareness of the key symptoms of concussion/mild TBI.

Recommended Content:

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

Distinguishing between TBIs, psychological conditions key to treatment

Article
3/10/2021
Military personnel holding a gun

Expert says long-lasting symptoms may be a sign of another issue.

Recommended Content:

Traumatic Brain Injury Center of Excellence | A Head for the Future | Traumatic Brain Injury | Brain Injury Awareness Month | Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit | TBI and Total Force Fitness

New NICoE director sets an ambitious agenda for the future

Article
3/8/2021
Military personnel wearing face mask while talking to each other

The accomplished new leader of the NICoE and Intrepid Spirit Center network has plans for increased services and a higher profile for the unique care center.

Recommended Content:

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

Traumatic Brain Injury Awareness

Video
3/8/2021
DHA Seal

A TBI is a blow or jolt to the brain that can be life-altering if the symptoms are not recognized. If you or a loved one experience the symptoms mentioned in this video, speak to a health care professional for more information.

Recommended Content:

Traumatic Brain Injury | Brain Injury Awareness Month | Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit

Proper nutrition impacts overall health & readiness

Article
3/4/2021
Man wearing a face mask restocking fruit at a store

Nutritional fitness implications for Total Force Fitness are far reaching.

Recommended Content:

Total Force Fitness | Nutritional Fitness | Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit

Updated tools and training improve TBI and concussion recovery

Article
3/3/2021
A group of military personnel wearing face mask working on laptop computers

Up-to-date clinical tools help diagnose and manage TBI on and off the battlefield.

Recommended Content:

Traumatic Brain Injury | Traumatic Brain Injury Center of Excellence | TBICoE Podcasts | Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit | Brain Injury Awareness Month | Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit
<< < 1 2 3 4 5  ... > >> 
Showing results 16 - 30 Page 2 of 14

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.