FDA Clears First Commercially Available Blood Test to Evaluate for TBI, Concussion

20 Mar 2023 • U.S. Food and Drug Administration has given clearance for what will be the first commercially available laboratory traumatic brain injury (TBI) blood test, making it widely available to hospitals in the United States. The test will provide clinicians with an objective way to quickly assess individuals with mild TBIs, also known as concussions. It offers a new reliable result in 18 minutes to help clinicians quickly assess concussion and triage patients. For those with negative results, it rules out the need for a CT scan and can eliminate wait time at the hospital. The test measures two biomarkers in the blood that, in elevated concentrations, are tightly correlated to brain injury.

How does it do that?

  • The Alinity i test(Abbott) can be used when a patient shows up to the hospital with a suspected mTBI within 12 hours of injury. Results from the blood sample are available in as little as 18 minutes and shared with the treating healthcare provider for evaluation.

  • The Alinity i TBI test measures complementary biomarkers in blood plasma and serum - Ubiquitin C-terminal Hydrolase L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP), that, in elevated concentrations, are tightly correlated to brain injury. It provides test results with 96.7% sensitivity and 99.4% negative predictive value.

  • The test is for use to aid in the evaluation of patients, 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head.

The availability of this blood test removes the subjectivity in concussion diagnosis and eliminates the need for costly CT scans in patients who test negative, reducing both health care system and patient costs.

This FDA clearance complements Abbott's i-STAT TBI Plasma test, the first rapid blood test for concussion, which is already cleared by the FDA in 2021.

Source: DT | Read full story

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