FDA Gives Clearance for the First 15-Minute Handheld Blood Test for Concussions

The Food and Drug Administration (FDA) has given clearance for a 15-minute handheld traumatic brain injury (TBI) blood test, which will be available on a handheld diagnostic device (i-STAT Alinity; Abbott, Abbott Park, IL) to asses TBIs including mild TBIs (mTBIs) also known as concussions. The blood test can eliminate time spent waiting for an emergency room and could reduce the number of unnecessary CT scans by up to 40%.

"Healthcare providers have been waiting for a blood test for the brain and now we have one," said Beth McQuiston, MD, medical director for Abbott's diagnostics business. "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."

The TBI blood test measures levels of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1), which, when bother are elevated, have a 99% predictive value for TBI. The test has 95.8% sensitivity for identifying TBIs. GFAP is known to be a marker of glial cell damage and UCH-L1 is specific to neurons.The test requires a blood sample, which is taken from the arm. Plasma is extracted with a centrifuge and applied to the test's cartridge. The cartridge is then inserted into the handheld instrument for testing. The FDA also granted a breakthrough designation for a TBI test that would run on core laboratory instruments. 

"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. "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."