Dive Brief:
- Abbott received U.S. Food and Drug Administration clearance for what it said will be the first commercially available laboratory blood test to help evaluate traumatic brain injury (TBI), also known as concussion.
- The test offers a result in 18 minutes, allowing clinicians to quickly assess patients with concussion and triage them, the company said Tuesday. A negative test result can rule out the need for a CT scan, eliminating wait time at the hospital.
- The test runs on Abbott's Alinity i laboratory instrument, making it widely available to U.S. hospitals, the Chicago area-based company said.
Dive Insight:
The Abbott test measures two biomarkers in the blood that are tightly correlated to brain injury when found in elevated concentrations, and is for use in patients 18 years of age or older within 12 hours of injury.
It provides test results with 96.7% sensitivity and 99.4% negative predictive value, Abbott said.
There were about 223,135 TBI-related hospitalizations in 2019 and 64,362 TBI-related deaths in 2020, according to the U.S. Centers for Disease Control and Prevention. The figures do not include the many TBIs only treated in the emergency department, primary care or urgent care, or that go untreated, the agency said. People age 75 years and older had the highest rates of TBI-related hospitalizations and deaths.
Abbott said the new test complements its handheld i-STAT TBI plasma test for concussion, which was cleared by the FDA in 2021. With the Alinity i clearance, a blood test for concussion can now be run on Abbott's high throughput Alinity i laboratory instrument.
Broadening the availability of the concussion test for use on lab-based instruments is an important step in Abbott's strategy to ensure its tests are available in all settings where people seek care for head injuries, the company said.
The Alinity i TBI test measures the Ubiquitin C-terminal Hydrolase L1 (UCH-L1) and Glial Fibrillary Acidic Protein biomarkers in blood plasma and serum. The test already has European Union clearance and has been available in markets outside the U.S. since 2021.
