The FDA granted clearance for the first rapid, handheld blood test to diagnose traumatic brain injuries, including concussions. The test, which is made by Abbott and runs on its i-STAT Alinity device, takes about 15 minutes to complete; it could help athletic trainers and physicians make sideline determinations about the care an injured player needs.
The TBI blood test analyzes plasma for the presence of the proteins UCH-L1 and GFAP, biomarkers that indicate head trauma. The current assessment requires plasma to be extracted with a centrifuge, but Abbott is working to develop a whole blood test as well.
In announcing the FDA 510(k) approval—a designation for fast-tracked clearance—Abbott noted that its test can help eliminate unnecessary CT scans, if a patient tests negative, or it can complement a CT scan and a clinician’s evaluation in diagnosing a concussion. Abbott, which developed the test in conjunction with the U.S. Department of Defense, said its test has 95.8% sensitivity and greater than 99% negative predictive value.
