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 | Health Innovation Month

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...

Progressive Return to Activity After Concussion Video

Video
2/25/2021
DHA Seal

The PRA is an evidence-based, easy-to-use approach to help providers return service members with mild TBIs back to duty safely. TBICoE researchers have found that, if medical providers completed a two-hour, in-person training on the use of the PRA, their patients saw an overall reduction in symptoms after one week, one month, and three months, when compared to patients treated by providers who had not received the training.

Recommended Content:

Traumatic Brain Injury Center of Excellence | Provider Resources | TBI Educators | Traumatic Brain Injury | Brain Injury Awareness Month | TBI Resources | TBI Screening

Brain Injury Awareness Month "Be TBI Ready" Infographic

Infographic
2/24/2021
March is Brain Injury Awareness Month. Be TBI Ready. A traumatic brain injury—or TBI—is a blow or jolt to the head that disrupts the normal function of the brain. The severity of the TBI is determined at the time of the injury and may be classified as: mild, moderate, severe, or penetrating.

During Brain Injury Awareness Month, TBICoE and the MHS will promote the theme “Be TBI Ready” — recognizing that health care providers and others in the military community need to be aware of the latest educational trainings, research, fact sheets, and other available resources to prevent, diagnose, and treat TBI.

Recommended Content:

Brain Injury Awareness Month | Traumatic Brain Injury | Traumatic Brain Injury Center of Excellence | TBI Educators | Brain Injury Awareness Toolkit

Returning to Duty After Concussion

Infographic
2/24/2021
What's the best way to recover from a concussion? Returning to duty too soon after a concussion can lead to prolonged symptoms, decreased readiness, poor marksmanship, accidents and falls, and increased risk of more concussions. Progressively increasing activity in a step-wise manner can help you resolve your symptoms and return to duty safely. Ask your primary health care provider about TBICoE's Progressive Return to Activity to help you return to duty as quickly and safely as possible. Visit health.mil/TBICoE.

This TBICoE infographic gives an overview of the risks of returning to duty too soon after a concussion and explains how a progressive increase in activity can help get you back to duty safely. Returning to duty too soon after concussion can lead to prolonged symptoms, poor marksmanship, decreased readiness, accidents and falls, and increased risk of more concussions.

Recommended Content:

Traumatic Brain Injury | Brain Injury Awareness Month | Traumatic Brain Injury Center of Excellence | Patient and Family Resources | TBI Educators | Provider Resources | Brain Injury Awareness Toolkit

Progressive Return to Activity Following Acute Concussion/Mild TBI Provider Training

Publication
2/23/2021

The TBICoE revised the Progressive Return to Activity Following Acute Concussion/Mild Traumatic Brain Injury Clinical Recommendation (PRA) and this updated provider training slide deck. The trainings objectives will help providers to identify the key changes to the updated 2021 PRA; explain the rationale for using a PRA protocol for service members post-concussion; understand the criteria for progression following a concussion or mild traumatic brain injury; identify appropriate activities at each stage of progression; understand how to apply primary care management strategies and specialty referral considerations to treat concussed service members who are not progressing as expected; utilize the Tri-Service Workflow mild TBI Alternate Input Method Form to document the PRA in the Armed Forces Health Longitudinal Application.

Recommended Content:

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

Progressive Return to Activity Following Acute Concussion/Mild TBI

Publication
2/23/2021

The 2021 Progressive Return to Activity (PRA) Following Acute Concussion/Mild Traumatic Brain Injury 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 | Provider Resources | Traumatic Brain Injury | TBI Resources

March 2021 Toolkit

Publication
2/22/2021

March is nationally recognized as Brain Injury Awareness Month, with the goal of increasing traumatic brain injury (TBI) awareness and improve health care providers’ ability to identify, care for, and treat all those who are affected by TBI. A TBI is a blow or jolt to the head that disrupts the normal function of the brain. According to the Defense Health Agency Traumatic Brain Injury Center of Excellence, 430,720 service members have been diagnosed with a first-time TBI since 2000. The toolkit also contains information on patient Safety Awareness Week, National Nutrition Month and many other graphics and messages you can use for holidays and observances during March.

Recommended Content:

Brain Injury Awareness Toolkit | Total Force Fitness | Traumatic Brain Injury | Brain Injury Awareness Month

Sleep After Concussion

Infographic
2/18/2021
Sleep After Concussion. Service members with TBI report 3 times more sleep problems. TBIs can happen anywhere, only 16.9 percent of TBIs happen while deployed. Visit health.mil/TBIFactSheets to learn more about sleep problems and how to improve them

"Sleep After Concussion" is intended for patients and caregivers of those who have sustained a TBI. The infographic reviews general information of sleep-related concerns and points towards additional educational resources.

Recommended Content:

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

Sleep and TBI

Video
2/8/2021
DHA Seal

Sleep disturbances are common for service members and veterans following a mild TBI, also known as concussion.

Recommended Content:

Traumatic Brain Injury Center of Excellence | TBI Educators | Patient and Family Resources | Provider Resources | Traumatic Brain Injury | Brain Injury Awareness Toolkit | Brain Injury Awareness Toolkit | Total Force Fitness

MHS operational innovations continue in battle against COVID-19

Article
1/5/2021
Two medical personnel, wearing full PPE, in an operating room

MHS innovations in 2020 include a new registry for real-time COVID-19 data and a system to free up hospital beds and protect patients from the disease.

Recommended Content:

Coronavirus | Research and Innovation | Innovation | Technology | COVID-19 Vaccine Toolkit | Health Innovation Month

Caregivers share their stories of support for TBI recovery

Article
11/23/2020
Group of people walking and on wheelchairs through the forest

"Recovery is possible to help lead a normal life."

Recommended Content:

Warrior Care Toolkit | Warrior Care Toolkit | Warrior Care Toolkit | Traumatic Brain Injury | Warrior Care Toolkit

Sleep After mTBI

Infographic
11/19/2020
Sleep After mTBI

"Sleep After mTBI" is intended for providers to show the importance of screening and treating service members affected by sleep issues following mTBI.

Recommended Content:

Traumatic Brain Injury | Traumatic Brain Injury Center of Excellence | Provider Resources | Brain Injury Awareness Toolkit | Sleep

NICoE & ISC Network maintain TBI care during COVID-19

Article
11/19/2020
Image of United States map with locations noted

The Network leveraged their geographic distribution to help each other quickly adapt to changing times.

Recommended Content:

Coronavirus | Traumatic Brain Injury | COVID-19 Vaccine Toolkit | Centers of Excellence

TBI Champions Roxana Delgado & Victor Medina

Video
11/17/2020
TBI Champions Roxana Delgado & Victor Medina

While he was deployed, retired Army Sgt. 1st Class Victor Medina was in a vehicle that was hit by an explosive device. He sustained a traumatic brain injury (TBI) that severely impaired some of his physical functions and ability to speak. Medina’s wife, Roxana Delgado, continued her pursuit of a Ph.D. in health sciences and became his caregiver. As they adjusted to a life neither one of them had imagined, their marriage became a new kind of partnership.

Recommended Content:

Traumatic Brain Injury Center of Excellence | Patient and Family Resources | A Head for the Future | Traumatic Brain Injury

TBI Champion Gary Moran

Video
11/17/2020
TBI Champion Gary Moran

SGM Gary D. Moran shares his TBI recovery story, and tips for talking to kids about TBI.

Recommended Content:

Traumatic Brain Injury Center of Excellence | A Head for the Future | Patient and Family Resources | Traumatic Brain Injury

TBI Champion Micah Norgard

Video
11/16/2020
TBI Champion Micah Norgard

After 12 years as an infantryman, Norgard's biggest battle was recognizing the cumulative effects of multiple TBIs.

Recommended Content:

Traumatic Brain Injury | Traumatic Brain Injury Center of Excellence | A Head for the Future
<< < ... 6 7 8 9 10  ... > >> 
Showing results 76 - 90 Page 6 of 17

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.