February 6, 2021
With the close of the NFL season we’ve seen some big hits, and weekly examples of the ever-evolving concussion testing and safety protocols in place. Simultaneously, in the first few weeks of 2021 there have been publications linking sports practices to brain trauma given the cumulative risk associated with the number of practices and athletes participating. But what we’ve not heard a lot about is the almost 5 million people a year that end up in the emergency room for traumatic brain injuries sustained from accidents, falls and other normal activities of daily life. Visits that in 2021 also put people at high risk for contracting Covid-19.
Add in warfighters on the battlefield, victims of domestic violence, the elderly, and other populations that face increased risk of traumatic brain injury (TBI), and the need for fast, reliable tests that let us know if we’ve suffered head trauma becomes clear. Not to mention the long-term costs associated with an estimated 13.5 million Americans living with a disability due to TBI, or the nearly $77 billion annual (direct and indirect) costs of TBI in the U.S.
But now, thanks to long standing partnerships and cross-sector research there is a handheld device that claims to objectively measure a brain injury within 15 minutes. Days ago, Abbott received 510(k) clearance for the first ever rapid handheld TBI blood test, which will help clinicians assess individuals with suspected TBIs, including concussions. The test will run on Abbott’s handheld i-STAT Alinity platform, with results available within 15 minutes after plasma is placed in the test cartridge.
Until now, tests like this have sometimes taken days, leaving doctors and families without complete information, and patients without proper treatment plans. But a 15-minute test can be run on a sideline, on the battlefield or quickly in an emergency room or urgent care center. It’s even estimated that this kind of testing can reduce the need for CT scans by 40%. “A blood test that can rule out the need for a CT scan has huge implications from both a time and cost perspective for patients. The sooner we can diagnose TBI, the sooner we can begin treatment, which is paramount in helping patients return to their normal lives,” says Geoffrey Manley, M.D., Ph.D., vice chair of neurological surgery at the University of California, San Francisco.
The i-STAT Alinity TBI test simultaneously measures two biomarkers: glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in blood plasma. These are two complementary biomarkers, that in elevated concentrations, are tightly correlated to brain injury. It provides test results with 95.8% sensitivity and greater than 99% negative predictive value. Because it’s impossible to treat what you don’t know, this kind of objective information can literally change the care and treatment plans for patients within minutes of their injury.
The TBI blood test was a true collaboration, having been developed in partnership with the U.S. Department of Defense, through U.S. Army Medical Research and Development Command’s (USAMRDC). The U.S. Army Medical Materiel Development Activity (USAMMDA), also played a critical role in developing the test run on Abbott’s i-STAT Alinity platform. And, the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) research team were the first to demonstrate how this TBI blood test can be used for the benefit of TBI patients in clinical care.
With survivors of TBI experiencing a range of impairments to memory, movement, sensation (e.g., vision and hearing), and emotional functioning (e.g., personality changes, psychological symptoms) early diagnosis and treatment is essential to recovery. Further, misdiagnosis or lack of diagnosis can worsen the effects of a TBI and open people up to sustain more injuries as they return too early to their daily routines or practices. “Your brain health is everything,” says Beth McQuiston, M.D., medical director for Abbott’s diagnostics business. Adding, “As a neuroscientist, it’s clear we’re long overdue for an objective blood test for the brain. We have them for the heart, for the pancreas – for pretty much every other organ. Now, if you injure your head we can tell, within 15 minutes, whether further evaluation is needed. That’s groundbreaking.”
While the i-STAT Alinity won’t be available for the 2021 Super Bowl in Tampa, Florida, its 510(k) clearance from the FDA does mean that it can be on the market for public and private use in the near future – 90 days from FDA notification. And with the right uptake, we could see the device on sidelines in coming seasons, and maybe in the 2022 Super Bowl in LA.