We must increase public awareness of concussions and how they are treated. — Dr. Vincent Schaller, M.D. DABFM, CIC, Director of MAC Alliance

What to Know About the First FDA-Cleared Blood Test for Concussions and TBIs

FDA-cleared blood test for concussions & TBI

It’s official: emergency rooms and urgent care centers around the country now have a rapid-result blood test for concussions and traumatic brain injuries (TBIs) available for screening patients. This is a game-changer, allowing for earlier diagnosis, which leads to better recovery outcomes.

The test runs on a handheld device by Abbott called the i-STAT™ Alinity™, and results are available within 15 minutes after plasma is placed in the test cartridge. The test measures specific proteins present in the blood after a TBI. A positive test result complements other objective and neurocognitive screenings to help medical professionals evaluate someone whom they suspect has suffered a brain injury.

You Can’t Treat What You Don’t Know

“This is very exciting for those of us in the concussion and TBI field of specialty,” says Vincent Schaller, MD, DABFM, CIC, medical director and founder of Mid-Atlantic Concussion (MAC) Alliance. “Being able to detect the presence of a TBI via blood test within 15 minutes in an emergency room or urgent care setting means more people can get treated without delay and potentially make a quicker recovery. Less people will suffer with prolonged invisible symptoms due to a concussion not being diagnosed from their first evaluation in an acute environment, like the ER or Urgent Care Center.”

“You can’t treat what you don’t know and now physicians will be equipped with critical, objective information that will help them provide the best care possible, allowing patients to take steps to recover, prevent reinjury and get back to doing the things they care about most,” according to Beth McQuiston, M.D., medical director for Abbott’s diagnostics business.

How the i-STAT Alinity TBI plasma test Works

i-stat alinity blood test for concussions and TBIs

i-STAT Alinity from Abbott
(Photo: Abbott 2023)

The i-STAT Alinity blood test for concussion and TBI requires only a small blood sample drawn from the arm, from which plasma is extracted and applied to a cartridge that is then inserted into the handheld instrument. The test simultaneously measures biomarkers glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in blood plasma. When these two complementary biomarkers are found in elevated concentrations there is a tight correlated to brain injury. The i-STAT Alinity blood test for TBI provides test results with 95.8% sensitivity and greater than 99% negative predictive value.

The TBI blood test was developed in collaboration with the U.S. Department of Defense (DoD), through U.S. Army Medical Research and Development Command’s (USAMRDC) U.S. Army Medical Materiel Development Activity (USAMMDA). In addition, the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) research team was the first to demonstrate how this TBI blood test can be used for the benefit of TBI patients in clinical care.

Abbott is also working on a whole blood test, which would eliminate the need for separation of plasma and could be used at the patient’s side in a healthcare setting. The company envisions a portable test in the future that can be used wherever people experience head injuries and need a quick evaluation, like sporting events or in military settings.

Why Is Immediate, Accurate Concussion Diagnosis Is So Important

Studies have reported that nearly 5 million people end up in the emergency room for a TBI in the United State each year. “Evaluating brain injuries is complex – and research shows that we only catch about half of those who show up to the hospital with a suspected TBI,” according to Geoffrey Manley, M.D., Ph.D., vice chair of neurological surgery at the University of California, San Francisco. “And beyond those who go to the hospital for a suspected TBI, many more never do. A test like this could encourage more people to get tested after a head trauma, which is important, because not receiving a diagnosis can be dangerous and may prevent people from taking the necessary steps to recover safely.”

Dr. Schaller could not agree more. “The symptoms of an undiagnosed concussion or TBI can worsen over time or lead to long term issues like migraine headaches, cognitive deficits, visual deficits, etc. And if the diagnosis of a concussion is missed in the ER or urgent care, then an athlete may return to their sport unsafely creating a threefold increased risk of a back-to-back concussion that can also result in worsened outcomes including the avoidable second impact syndrome,” he says. The risks of worsened outcomes holds true for non-athletes as well. Early diagnosis using a rapid objective blood test will lead people to proper treatment sooner.

 People living with TBIs may experience symptoms such as:

Taking the Guess Work Out of Concussion Diagnosis and Treatment

In assessing TBIs in our concussion specialty clinics, MAC Alliance uses advanced brain health testing technologies and concussion protocols. The testing tools include:

We also use these tools to monitor how patients’ recovery programs are working, and allow us to customize each to address individual needs. “We also utilize Brain SPECT Scan technology in some of our toughest concussion and TBI cases,” says Dr. Schaller.

Through a partnership with Amen Clinics, we now can provide Single Photon Emission Computed Tomography, or SPECT, to our patients. Amen Clinics has built the world’s largest database of SPECT brain scans (over 200,000 to date) to help patients with a wide variety of cognitive and mental health issues, as well as detecting areas of brain injury from trauma, hypoxia, toxic exposure, etc.

Where to Find a Concussion Specialist in the Mid-Atlantic Region

To date, MAC Alliance has treated over 15,000 patients in Delaware, Pennsylvania, Maryland, New Jersey, Virginia, New York, Georgia and beyond. To find a MAC Alliance Concussion Care Center near you, please use our easy-to-use location finder or call (302) 235-8808.

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Concussion Protocol Guidelines | MAC Alliance

DR. SCHALLER DISCUSSES CONCUSSION CARE ON ESPN


Dr. Vincent Schaller joins OTL to give his feedback on how we are not properly caring for concussions long term.

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