Army Announces FDA Clearance of Whole Blood Rapid Test to Help with Assessment of Traumatic Brain Injury (IMAGE)
Caption
U.S. Army Sgt. Raymond Calzada, a medical laboratory specialist with 566th Medical Company Area Support, 61st Multifunctional Medical Battalion, 1st Medical Brigade, waits for test results from the Analyzer Traumatic Brain Injury (ATBI) system as part of a simulated casualty scenario during Global Medic, a combat support training exercise, Fort Hunter Liggett, Calif., June 18, 2023. Members of the U.S. Army Medical Materiel Development Activity and the Medical Capability Development Integration Directorate participated in the exercise to gain feedback from end users on the portable, deployable TBI biomarker assessment system. On April 1, 2024, USAMMDA and Abbott announced that the company’s whole blood cartridge for use on the ATBI received clearance from the U.S. Food and Drug Administration. The new test allows clinicians to obtain objective, lab quality, on-the-spot results for TBI assessment using whole blood within 15 minutes. Previous tests for TBI assessment were only cleared for use with plasma or serum, requiring samples to be sent to a laboratory for processing and results. The new test allows for bedside use and can aid in evaluating patients up to 24 hours after injury, a significant improvement over the TBI plasma test.
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U.S. Army Courtesy Photo
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