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Abbott Rapid Handheld TBI Blood Test Gets 510(k) Clearance From FDA

NEW YORK – Abbott announced on Monday its rapid handheld blood test for traumatic brain injury has received 510(k) clearance from the US Food and Drug Administration.

The test can help physicians assess people with suspected mild TBIs, including concussions, and returns results in 15 minutes on the firm's handheld i-Stat Alinity platform, the company said in a statement. It measures the biomarkers glial fibrillary acidic protein and ubiquitin carboxyl-terminal hydrolase L1 present in the blood after a brain injury, and negative results can be used to rule out the need for a head CT scan. Positive results can complement CT scans to determine whether a patient has a TBI. 

The test, which was developed in collaboration with the US Department of Defense, has nearly 96 percent sensitivity and more than 99 percent negative predictive value, Abbott said.

In addition to this test, which uses plasma extracted from the sample using a centrifuge, the Abbott Park, Illinois-based firm is working on a rapid whole-blood test for head injuries that would not require plasma extraction. The firm also received breakthrough designation from the FDA for a TBI test running on its Alinity I and Architect core lab instruments.