FDA Clears Rapid Blood Test for Mild Traumatic Brain Injury

The Food and Drug Administration (FDA) has granted 510(k) clearance for i-STAT Alinity TBI plasma test, a rapid handheld blood test to evaluate individuals with suspected mild traumatic brain injuries (TBIs), including concussions.

The i-STAT Alinity TBI plasma test was developed in collaboration with the US Department of Defense. The test simultaneously measures glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1), biomarkers present in blood plasma at elevated concentrations after a brain injury. According to the Company, the test has demonstrated 95.8% sensitivity and greater than 99% negative predictive value.

The test runs on Abbott’s handheld i-STAT Alinity platform. After a small blood sample is drawn from the arm, the plasma is extracted with a centrifuge and applied to the test’s cartridge, which is then inserted into the handheld instrument. Once the plasma is placed in the test cartridge, results are available within 15 minutes. The Company is also investigating the use of whole blood on i-STAT at the point of care, which would eliminate the need for plasma extraction.

“Health care 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.”

For more information visit abbott.com.

Reference

Abbott receives FDA 510(k) clearance for the first rapid handheld blood test for concussions. [press release]. Abbott Park, IL: Abbott; January 11, 2021.