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Rapid blood test could detect brain injury in minutes, study shows

A blood protein test could detect the severity of head trauma in under 15 minutes, according to research published recently in the Journal of Neurotrauma.

By showing that glial fibrillary acidic protein (GFAP) can accurately determine the severity of a brain injury through a blood test, the research team working on this study, led by author David Okonkwo, M.D., Ph.D., director of the Neurotrauma Clinical Trials Center at UPMC and professor of neurological surgery at the University of Pittsburgh School of Medicine, advanced the development of a point-of-care testing device designed to help clinicians assess traumatic brain injury (TBI) in minutes.

For the rapid test, the vision included using a hand-held device with a cartridge that would measure GFAP in a patient’s blood. Researchers at Abbott Laboratories, a global health care company, will need to finalize the test for the i-STAT device, which already is used by the military and health care providers around the world to perform several common blood tests within minutes. The blood test would reveal a patient’s GFAP level.


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“This would eliminate guesswork in diagnosing TBIs and learn whether a person needs further treatment,” said Okonkwo. “Whether you’re testing a soldier injured in combat or testing a patient in a small rural hospital with limited resources, health care providers could have critical information they need–in minutes–to treat each patient’s brain injury.”

For this study, which expanded upon previous GFAP findings, researchers enrolled 1,497 people who sought care at one of the 18 Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) level 1 trauma centers nationwide over four years. GFAP is a Food and Drug Administration-approved marker for ruling out whether a patient needs a head computed tomography (CT) scan within 12 hours after a mild TBI.

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For years, scientists have studied blood tests involving GFAP. They also have studied a similar protein called S100B. Both proteins are released in the bloodstream in response to specific injuries, including TBI. But this study showed that GFAP substantially outperformed S100B as a TBI diagnostic marker.

“Knowing this protein can show the severity of a TBI through a simple blood test is promising when considering we can use a device that already is in widespread use in hospitals, doctors’ offices and urgent care facilities.


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All we would need to do is add an extra cartridge to the device to analyze blood for the GFAP protein,” said Okonkwo. He estimates this device could potentially decrease unnecessary CT scans by 20% or more, saving nearly $100 million in medical expenses annually.

Source:

University of Pittsburgh

Journal Reference:

Point-of-Care Platform Blood Biomarker Testing of Glial Fibrillary Acidic Protein versus S100 Calcium-Binding Protein B for Prediction of Traumatic Brain Injuries: A Transforming Research and Clinical Knowledge in Traumatic Brain Injury Study

Abstract:

Glial fibrillary acidic protein (GFAP) is cleared by the Food and Drug Administration (FDA) to determine need for head computed tomography (CT) within 12 h after mild traumatic brain injury (TBI) (Glasgow Coma Score [GCS] 13–15); S100 calcium-binding protein B (S100B) serves this function in Europe.

This phase 1 biomarker cohort analysis of the multi-center, observational Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study compares GFAP’s diagnostic performance, measured on a rapid point-of-care platform, against protein S100B to predict intracranial abnormalities on CT within 24 h post-injury across the spectrum of TBI (GCS 3–15). Head CT scan performed in TBI subjects and blood was collected for all consenting subjects presenting to 18 United States level 1 trauma centers.


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Plasma was analyzed on a point-of-care device prototype assay for GFAP and serum was analyzed for S100B. In 1359 patients with TBI (GCS 3–15), mean (standard deviation [SD]) age = 40.1 (17.0) years; 68% were male. Plasma GFAP levels were significantly higher in CT+ TBI subjects (median = 1358 pg/mL, interquartile range [IQR]: 472–3803) than in CT- TBI subjects (median = 116 pg/mL, IQR: 26–397) or orthopedic trauma controls (n = 122; median = 13 pg/mL, IQR: 7–20), p < 0.001.

Serum S100B levels were likewise higher in CT+ TBI subjects (median = 0.17 μg/L, IQR: 0.09–0.38) than in CT- TBI subjects (median = 0.10 μg/L, IQR: 0.06–0.18), p < 0.001. Receiver operating characteristic curves were generated for prediction of intracranial injury on admission CT scan; area under the curve (AUC) for GFAP was significantly higher than for S100B in the same cohort (GFAP AUC – 0.85, 95% confidence interval [CI] 0.83–0.87; S100B AUC – 0.67, 95% CI 0.64-0.70; p < 0.001). GFAP, measured on a point-of-care platform prototype assay, has high discriminative ability to predict intracranial abnormalities on CT scan in patients with TBI across the full injury spectrum of GCS 3–15 through 24 h post-injury. GFAP substantially outperforms S100B.

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