Sam Brusco, Associate Editor03.07.23
Abbott Labs has gained U.S. Food and Drug Administration (FDA) for the first commercially available laboratory traumatic brain injury (TBI) blood test, which runs on Abbott’s Alinity i lab instrument.
The Alinity i TBI lab test produces a result in 18 minutes. Those receiving negative results from the test do not need a CT scan. The test measures blood biomarkers that, in elevated concentrations, are correlated to brain injury.
"People sometimes minimize a hit to the head, thinking it's no big deal. Others wonder if a visit to the doctor or emergency room for a possible concussion will provide them with meaningful answers or care," Beth McQuiston, M.D., medical director in Abbott's diagnostics business, told the press. "Now that this test will be widely available in labs across the country, medical centers will be able to offer an objective blood test than can aid in concussion assessment. That's great news for both doctors and people who are trying to find out if they have suffered a traumatic brain injury."
This FDA nod complements Abbott’s i-STAT TBI plasma test—the first rapid blood test for concussion—which is already FDA-cleared. The advancement will broaden access to TBI testing because the Alinity i instrument is widely used in U.S. hospitals and labs.
The test can be administered within 12 hours of suspected TBI. Blood samples are drawn from the arm and sent to the lab for preparation, with results available in as little as 18 minutes.
The Alinity i TBI lab test produces a result in 18 minutes. Those receiving negative results from the test do not need a CT scan. The test measures blood biomarkers that, in elevated concentrations, are correlated to brain injury.
"People sometimes minimize a hit to the head, thinking it's no big deal. Others wonder if a visit to the doctor or emergency room for a possible concussion will provide them with meaningful answers or care," Beth McQuiston, M.D., medical director in Abbott's diagnostics business, told the press. "Now that this test will be widely available in labs across the country, medical centers will be able to offer an objective blood test than can aid in concussion assessment. That's great news for both doctors and people who are trying to find out if they have suffered a traumatic brain injury."
This FDA nod complements Abbott’s i-STAT TBI plasma test—the first rapid blood test for concussion—which is already FDA-cleared. The advancement will broaden access to TBI testing because the Alinity i instrument is widely used in U.S. hospitals and labs.
The test can be administered within 12 hours of suspected TBI. Blood samples are drawn from the arm and sent to the lab for preparation, with results available in as little as 18 minutes.