The US FDA has approved the first commercially available blood test for traumatic brain injury, eliminating the need for CT scans to evaluate such patients.
Industry giant Abbott announced a breakthrough on Tuesday, noting that the product will be widely available in US hospitals. The Alinity i TBI lab test gives him results in 18 minutes, allowing physicians to quickly assess and triage concussion patients.
Abbott estimates that the test can reduce the number of unnecessary CT scans by up to 40%, reducing wait times and lowering costs for the health system and patients.
“Now that the test is widely available in laboratories around the country, medical centers will be able to provide an objective blood test to help assess concussions,” said Abbott’s medical director of diagnostics. Neurologist Beth McKiston, M.D., said: statement“This is great news for both doctors and people trying to find out if they’ve had a traumatic brain injury.”
Ratings for concussion have been constant for decades, with doctors using the Glasgow Coma Scale along with computed tomography to detect lesions and damage to brain tissue.
Abbott says the test works by measuring complementary biomarkers in plasma and serum. Previous Youth demonstrated a sensitivity of 96.7% and a negative predictive value of 99.4% for his case. Alinity i TBI is intended for patients over the age of 18 with suspected mild traumatic brain injury (on the Glasgow scale he scores 13-15) within 12 hours of injury.
European regulators have previously approved the lab test, which will be available in markets outside the United States from 2021, Abbott said.
