The Food and Drug Administration has approved a blood test to detect concussion that produces results in minutes rather than hours -- a breakthrough that could help expedite treatment for service members with traumatic brain injuries, according to the U.S. Army and Abbott Laboratories, the diagnostic's developer.
The i-STAT mild traumatic brain injury cartridge is designed to detect the existence of biomarkers that signal brain damage within 12 hours of an injury to determine whether a patient requires a follow-on CT scan.
Given that roughly 1,600 service members experience a head injury each month as the result of training, accidents or military operations, and more than 5 million Americans visit an emergency room each year for possible head injury, the rapid test could be a game changer in treatment and response, officials say.
Read Next: New Cold-Assignment Incentive Pay Coming for Airmen and Guardians at 7 Bases
"This can help get the most severely injured service members to neurosurgeons faster and ultimately save lives," Lt. Col. Bradley Dengler, neurosurgical consultant to the U.S. Army Office of the Surgeon General, said in a release.
The test was developed by Abbott with the U.S. Army Medical Materiel Development Activity, part of U.S. Army Medical Research and Development Command. It measures the levels of two head injury biomarkers -- glial fibrillary acidic protein and ubiquitin carboxyl-terminal hydrolase -- in a blood sample, with results produced bedside within 15 minutes.
The test previously was approved only for use with blood plasma or serum, with samples shipped to a lab and results available in about 24 hours.
Dr. Geoffrey Manley, chief of neurosurgery at Zuckerberg San Francisco General Hospital, said that assessment for traumatic brain injury has been highly subjective for decades, with physicians making initial determinations based on a coma scale and using CT scans to detect brain damage.
"Emergency departments can be a busy place. It's important to be able to triage patients quickly," Manley said in a release from Abbott. "With the help of this whole blood test, we can quickly and objectively determine whether or not a patient needs a CT scan or additional evaluation, right at the point of care. It's an incredibly helpful tool that advances the treatment of traumatic brain injury."
The Department of Defense has worked with Abbott for more than a decade to develop portable blood tests to evaluate concussions. In 2019, it awarded the company $35.2 million to develop a test that would detect TBI biomarkers.
The FDA formally cleared the test for marketing on March 27. Army officials said development of a test for early detection and evaluation of TBI has been a priority for two decades, and the service believes the test will not only help troops but improve case management in the field.
"Given the large numbers of expected casualties with all severities of traumatic brain injury in future large-scale combat operations, this test can help maintain combat power far forward by helping to eliminate unnecessary evacuations," Dengler said.
Abbott said the approval will allow its product to be used to test patients in health care settings beyond emergency rooms, such as advanced urgent care clinics.
Officials also described it as an important step toward testing outside health care settings, "such as on the sidelines of sporting events," according to a release.
Related: Risk of Brain Cancer Higher in Troops with Moderate to Severe Brain Injuries, Large Study Shows
