The Food and Drug Administration (FDA) has granted 510 (k) approval for the i-STAT Alinity TBI Plasma Test, a rapid hand blood test used to evaluate people 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 the acid glial fibril protein (GFAP) and the ubiquitin-carboxyl-terminal hydrolase L1 (UCH-L1), biomarkers that are present in increased concentrations in the blood plasma after a brain injury. According to the company, the test showed a sensitivity of 95.8% and a negative predictive value greater than 99%.
The test runs on Abbott’s handheld platform i-STAT Alinity. After a small blood sample is taken from the arm, the plasma is extracted with a centrifuge and applied to the test cartridge, which is then inserted into the hand instrument. Once the plasma has been added to the test cartridge, results are available within 15 minutes. The company is also exploring the use of whole blood on i-STAT at the point of care, eliminating the need for plasma extraction.
“Health care providers have been waiting for a brain blood test and now we have one,” said Dr. Beth McQuiston, medical director for Abbott’s diagnostics business. “You can’t treat what you don’t know, and now clinicians are being provided with critical, objective information that will help them deliver the best possible care so patients can take steps to recover, prevent re-injury, and again the things to do they care most about. “
Visit abbott.com for more information.
Abbott Receives FDA 510 (k) Clearance for First Rapid Hand Blood Test for Concussions. [press release]. Abbott Park, IL: Abbott; January 11, 2021.
This article originally appeared on MPR
Diagnostic Tests Traumatic Brain Injury