Clinical researchers at the University of Pittsburgh have been instrumental in developing a new blood test that can identify a concussion within 15 minutes—much faster than the previous iteration, which needed to be sent to a lab.

It received Food and Drug Administration approval April 1.

The whole blood test manufactured by medical device and health care company Abbott can confirm a concussion or other mild traumatic brain injury within 24 hours of an injury and requires only a small venous blood draw. It has shown to be nearly 97% accurate.

The i-STAT TBI blood test measures two biomarkers from the brain—UCH-L1 and GFAP—that may be released into the bloodstream, indicating a possible brain injury. Until now, measuring those proteins had to be done using blood plasma or serum, which required sending blood samples to a lab for processing and testing.

“Getting FDA approval for whole blood radically changes the landscape for clinical practice,” says David Okonkwo, Pitt professor of neurological surgery, who was a primary investigator on the project. Okonkwo directs the University of Pittsburgh Neurotrauma Clinical Trials Center.

He says the test can be used in health care settings outside a hospital emergency room and soon could be found in urgent care centers and in primary care facilities.

He expects it won’t be too far in the future before the test can be used on the sidelines at sporting events or at the scene of a car accident. The U.S. military is already using it to evaluate soldiers overseas, he says.

The “monumental” story of getting FDA approval for a whole-blood TBI test, says Okonkwo, “can’t be told without the University of Pittsburgh School of Medicine,” which played a critical role in creating a consortium dedicated to diagnosing and treating TBI that includes partners such as Abbott, the University of California, San Francisco and the Department of Defense.

Read more in the Pittsburgh Post-Gazette.