TY  - JOUR
PY  - 2021//
TI  - Accuracy of a rapid GFAP/UCH-L1 test for the prediction of intracranial injuries on head CT after mild traumatic brain injury
JO  - Academic emergency medicine
A1  - Bazarian, Jeffrey J.
A1  - Welch, Robert D.
A1  - Caudle, Krista
A1  - Jeffrey, Craig A.
A1  - Chen, James Y.
A1  - Chandran, Raj
A1  - McCaw, Tamara
A1  - Datwyler, Saul A.
A1  - Zhang, Hongwei
A1  - McQuiston, Beth
SP  - ePub
EP  - ePub
VL  - ePub
IS  - ePub
N2  - STUDY OBJECTIVE: To determine the accuracy of a new, rapid blood test combining measurements of both glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) for predicting acute traumatic intracranial injury (TII) on head CT scan after mild traumatic brain injury (mTBI). <br><br>METHODS: Analysis of banked venous plasma samples from subjects completing the Prospective Clinical Evaluation of Biomarkers of Traumatic Brain Injury (ALERT-TBI) trial, enrolled 2012-14 at 22 investigational sites in the US and Europe. All subjects were ≥18 years old, presented to an emergency department (ED) with a non-penetrating head injury and Glasgow Coma Scale score (GCS) 9-15 (mild to moderate TBI), underwent head CT scanning as part of their clinical care, and had blood sampling within 12 hours of injury. Plasma concentrations of GFAP and UCH-L1 were measured using i-STAT Alinity and TBI plasma cartridge and compared to acute TII on head CT scan. <br><br>RESULTS: Of the 2,011 subjects enrolled in ALERT-TBI, 1,918 had valid CT scans and plasma specimens for testing and 1,901 (99.1%) had GCS 13-15 (mTBI), for which the rapid test was intended. Among these subjects, the rapid test had a sensitivity of 0.958 (95%CI: 0.906, 0.982), specificity of 0.404 (0.382, 0.427), negative predictive value (NPV) of 0.993 (0.985, 0.997), and positive predictive value of 0.098 (0.082, 0.116) for acute TII. <br><br>CONCLUSIONS: A rapid i-STAT-based test had high sensitivity for prediction of acute TII, comparable to lab-based platforms. The speed, portability and high accuracy of this test may facilitate clinical adoption of brain biomarker testing as an aid to head CT decision-making in EDs.<p />  <p>Language: en</p>
LA  - en
SN  - 1069-6563
UR  - http://dx.doi.org/10.1111/acem.14366
ID  - ref1
ER  -