Bringing Biomarkers to the Bedside: The Clinical Promise of Abbott’s TBI Test

The diagnosis of mild traumatic brain injury (TBI) and concussion has long relied on clinical judgment, symptom checklists, and imaging decisions often made under uncertainty. Despite growing awareness of concussion in both athletic and non-athletic populations, standard evaluation methods remain largely subjective and time-consuming, with limited access to rapid, objective diagnostic tools. The clinical challenge is compounded by the need to balance safety with resource stewardship—identifying which patients truly require neuroimaging while avoiding unnecessary exposure and cost.

Abbott’s i-STAT TBI test, the first rapid blood test for concussion approved by the FDA, aims to change that paradigm. Recently recognized on TIME’s 2025 Best Inventions list, the test measures two brain injury biomarkers to help clinicians assess mild TBI in just 15 minutes—potentially reducing the need for CT scans and supporting evidence-based decision-making. In this interview with NeurologyLive^®, Beth McQuiston, MD, neurologist and medical director in Abbott’s diagnostics business, discussed how this tool integrates into clinical care, its broader implications for TBI assessment, and where concussion diagnostics may be headed next. Furthermore, McQuiston reflected on the test’s recognition by TIME, and Abbott’s vision to expand its use beyond the hospital setting.

NeurologyLive: What should clinicians/neurologists know about the function of Abbott’s i-STAT TBI test? What advantages does this tool offer?

Beth McQuiston, MD: Abbott’s blood test helps clinicians assess concussions and was approved by the U.S. FDA last year, marking an important step forward in advancing the standard of care for concussions. We have seen concussion evaluation remain the same for decades—utilizing tools that are largely subjective to assess concussion. Now, our blood test helps provide rapid, objective, and science-backed information to help doctors determine the next steps for care.

The Abbott i-STAT TBI test does this by providing results in 15 minutes by checking a patient’s blood for two biomarkers that may be present at elevated levels, after suffering a mild traumatic brain injury or concussion. If the blood test results show non-elevated levels, this can help clinicians rule out the need for a CT scan of the head and assist in determining the best next steps for patient care.

Is there any adjustment to using this tool? Discuss how it can be seamlessly integrated into clinical care?

Concussion evaluation has been the same for decades—utilizing the Glasgow Coma Scale to subjectively assess concussion. Our test helps provide rapid, objective information to clinicians and helps take away some of the ambiguity of concussion assessment, which is a benefit to both doctors and people seeking answers about their injury.

In addition, hospitals are now utilizing a new framework for characterizing acute traumatic brain injuries, published this year in The Lancet Neurology and spearheaded by the US National Institutes of Health – National Institute of Neurological Disorders and Stroke (NIH-NINDS). This new framework enables fast, accurate assessment, personalized treatment planning, and customized follow-up care for patients with traumatic brain injury. By replacing the outdated “mild/moderate/severe” labels with a multidimensional system, it reduces subjectivity and ambiguity while embracing objective, evidence-based tools such as Abbott’s FDA-cleared biomarker test.

What does it mean to see the i-STAT TBI test named among TIME’s Best Inventions List?

We know what a game changer this test can be for doctors and patients and we are proud to see it earn this recognition! More than 300 Abbott scientists as well as medical and clinical team members have contributed to the development of this test. We know how critical this test is for the world, so anything that helps us raise awareness of this issue is of great value.

For example, each year in the United States, almost 5 million people seek help for a concussion. And while the majority of concussions —97%— are a non-sports related injury, 84% of people believe athletes are most at risk. But it’s tripping on the corner of the rug, falling on the sidewalk or hitting your head during the activities of everyday life that cause the most concussions. So everything that helps to raise awareness of this issue is of great value.

Does the company have any plans to continue to optimize this test or its platforms in the future?

We’re aiming for our i-STAT Alinity TBI test to eventually be available for use on the sidelines of athletic events or the scenes of car crashes, collisions or falls. Currently the test needs to be used within a healthcare setting or medical tent and the test, itself, needs to be conducted while the i-STAT is stationary, which can include medical facilities at a sports stadium or athletic complex if conducted by trained medical staff. However, it’s important to remember that the majority of concussions happen as a result of activities other than sports, such as falls and accidents. We are also exploring the use of this test in the pediatric population.

Our vision for the future is that concussion testing is available wherever it’s needed, whether that’s in the lab or urgent care or on the playground or the sidelines.