Abbott FDA-Cleared Blood Test Evaluates Need for CT scans in Patients with Head Injury

Abbott’s newly FDA-cleared blood test is the first commercially available diagnostic that assesses whether a patient with a mild traumatic brain injury (mTBI) — commonly known as a concussion — needs further evaluation with a computed tomography (CT) scan.

The Alinity i TBI test, taken within 12 hours of injury, shows whether two complementary biomarkers correlated to brain injury have elevated concentrations. A negative result rules out the need for the CT scan. The test, which delivers results in as few as 18 minutes, has 96.7 percent sensitivity and 99.4 percent negative predictive value.

The Alinity i TBI could eliminate up to 40 percent of CT scans to rule out concussion, the company said.

The test is CE-marked and has been available outside the U.S. since 2021.