The new blood test will run on Abbott's Alinity i laboratory instrument and helps doctors evaluate patients with mild traumatic brain injury (mTBI), commonly known as concussion, by ruling out the need for a CT scan
Abbott’s blood test evaluates TBI. (Credit: Tatiana from Pixabay)
US-based medical technology company Abbott has received the US Food and Drug Administration (FDA) approval for its new laboratory blood test that measures traumatic brain injury (TBI).
The blood test, dubbed i-STAT TBI, runs on the company’s Alinity i laboratory instrument and allows clinicians to rapidly assess individuals with mild TBIs, also known as concussions.
It measures the levels of Ubiquitin C-terminal Hydrolase L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) in blood plasma and serum.
UCH-L1 and GFAP are two complementary biomarkers, whose elevated concentrations are closely associated with brain injury.
The test is intended to help determine if patients, aged 18 years and above, with suspected mild traumatic brain injury within 12 hours of injury, need a CT scan of the head.
The i-STAT TBI blood test is designed to provide test results within 18 minutes, with 96.7% sensitivity and 99.4% negative predictive value.
It is already approved in the European Union (EU) and has been available in markets outside the US since 2021, said the medical technology firm.
Abbott diagnostics business medical director Beth McQuiston said: “People sometimes minimise 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.
“Now that this test will be widely available in labs across the country, medical centres 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.”
Abbott developed the blood-based lab test in collaboration with the US Department of Defence (DoD), which has been developing a solution for TBI detection.
The DoD, through US Army Medical Research and Development Command’s (USAMRDC) US Army Medical Materiel Development Activity (USAMMDA), supported the test run on the i-STAT Alinity platform.
According to the company, i-STAT TBI Plasma is the first rapid blood test for concussion, and its FDA approval will enhance TBI testing in hospitals and laboratories across the US.