Abbott’s concussion-detecting blood test approved by FDA

pharmafile | March 8, 2023 | News story | Medical Communications  

US-based Abbott, a medical technology company, has received FDA approval for its laboratory blood test which detects traumatic brain injury (TBI) in patients with mild TBIs, also known as concussions.


i-STAT TBI helps determine if patients ‒ 18 years old or over ‒ with suspected mild TBI within 12 hours of injury, need a CT scan. The test is used in conjunction with the company’s Alinity i laboratory instrument and 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 ‒ their elevated concentrations indicate brain injury.


The i-STAT TBI has already proven its effectiveness, delivering 96.7% sensitivity and 99.4% negative predictive value within 18 minutes of the test being taken. It is approved in the EU and has been available to markets outside of the US since 2021.


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.”


James Spargo

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