Blood test can detect brain injuries


A new blood test approved by the U.S. Food and Drug Administration to detect brain injuries might reduce the number of potentially unnecessary brain scans, according to a new study.
Traumatic brain injuries (TBIs) — which can range from relatively mild conditions (such as a concussion) to severe ones (such as bleeding in the brain) — can be difficult to diagnose. One way to diagnose the injuries is a CT scan, but these imaging tests can be very costly and expose patients to radiation.
In the new study, published July 24 in the journal The Lancet Neurology, the researchers argue that the blood test could reduce the number of unnecessary CT scans performed on patients suspected of having a TBI. However, several experts told Live Science that they weren’t convinced the new test would be a significant boon to patients.
The blood test, which was developed by Banyan Biomarkers Inc., works by looking for two proteins that indicate brain injury has occurred, according to the study. The proteins, called UCH-L1 and GFAP, are thought to be released mostly with brain injuries. (The company also provided funding for the study.)
The new study details the clinical trial that led the FDA to approve the test — the first of its kind to be approved in the U.S., though a similar test is already widely used in Europe. The clinical trial, which ran from 2012 to 2014, included nearly 2,000 patients with suspected brain injuries at 22 sites in Europe and the U.S. The patients in the trial had both the blood test and a CT scan within 12 hours of their injury (when the two proteins are most elevated). The blood test indicated a positive result if either one or both proteins were above a certain threshold and a negative result if both were below the limit.
The CT scan was used in the trial as the “gold standard” for determining how well the blood test found such injuries. The researchers found that the blood test had a nearly 98-percent specificity. In other words, it missed very few injuries. The blood test “missed” only three patients who’d had a CT scan that indicated injury but also had a negative blood-test result.
The findings suggest that the blood test could reduce the number of CT scans by 35 percent, said study co-author Dr. Robert Welch, an emergency-medicine physician and professor of emergency medicine at Wayne State University, in Detroit.

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