The US Food and Drug Administration (FDA) has given clearance for the first-ever handheld point-of-care blood testing device that can be used to evaluate mild traumatic brain injury (TBI) within just 15 minutes. In previously published data, the device has shown that it predicts TBIs better than a CT scan and might potentially be much cheaper.
Abbott's i-STAT™ Alinity™ handheld blood analyzer tests blood samples for two important biomarkers associated with TBI, UCH-L1 and GFAP. These proteins are normally elevated in the blood of patients that have experienced a concussion or head trauma.
"Healthcare providers have been waiting for a blood test for the brain and now we have one," Beth McQuiston, M.D., medical director for Abbott's diagnostics business said in a press release. "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."
TBIs are very common in contact sports such as American football, rugby, and soccer, where players hit the ball with their heads, as well as other physical contact sport like wrestling or mixed martial arts. However, quickly evaluating if someone has experienced a TBI has been challenging. Patients usually end up going to hospital a fair period of time after experiencing the injury, as there is no current immediate evaluation test available. The diagnosis of a TBI currently requires a person to go to hospital for a CT scan after they experience symptoms of a concussion, and then receive the scan to rule on whether they have a TBI.
"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," said Geoffrey Manley, MD, PhD, vice chair of neurological surgery at the University of California, San Francisco in the statement released by Abbott. "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."
Now the Abbott handheld device is set to change that, allowing for rapid testing after a suspected concussion that could deliver the results within 15 minutes. A negative test using the handheld device could rule out the requirement of getting a CT scan to test for a TBI, a positive result would mean they should get a CT scan to confirm if it is a TBI and how severe it is so that they can get the clinical care they need.
TBIs are generally concerning. Research has shown that repeated head injuries or concussions could lead to major mental impairment, as well as increasing the chances of developing dementia, hence more needs to be done to tackle clinical care and diagnosing patients with TBI faster.
That is why the new testing approach using the Abbott handheld device holds real promise, as it would rapidly speed up predicting who has a concussion and help patients get faster clinical care when they need it, which could improve their outcomes in the future.