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. 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.

中文翻译：

---

胶质纤维酸性蛋白与 S100 钙结合蛋白 B 的护理点平台血液生物标志物测试用于预测创伤性脑损伤：创伤性脑损伤研究中的变革性研究和临床知识。

胶质纤维酸性蛋白 (GFAP) 经美国食品药品监督管理局 (FDA) 批准，用于确定轻度创伤性脑损伤 (TBI) 后 12 小时内是否需要进行头部计算机断层扫描 (CT)（格拉斯哥昏迷评分 [GCS] 13-15） ; S100 钙结合蛋白 B (S100B) 在欧洲发挥此功能。这项多中心、观察性脑损伤转化研究和临床知识 (TRACK-TBI) 研究的 1 期生物标志物队列分析将在快速护理点平台上测量的 GFAP 的诊断性能与蛋白质 S100B 进行比较，以预测颅内损伤受伤后 24 小时内 CT 异常（GCS 3-15）。对 TBI 受试者进行头部 CT 扫描，并为所有同意前往 18 个美国 1 级创伤中心就诊的受试者采集血液。使用即时检测设备原型测定法分析血浆中的 GFAP，并分析血清中的 S100B。在 1359 名 TBI 患者 (GCS 3-15) 中，平均（标准差 [SD]）年龄 = 40.1 (17.0) 岁；68%为男性。CT+ TBI 受试者（中位数 = 1358 pg/mL，四分位数范围 [IQR]：472–3803）的血浆 GFAP 水平显着高于 CT- TBI 受试者（中位数 = 116 pg/mL，IQR：26–397）或骨科受试者创伤对照（n  = 122；中位数 = 13 pg/mL，IQR：7-20），p  < 0.001。CT+ TBI 受试者的血清 S100B 水平（中位数 = 0.17 μg/L，IQR：0.09–0.38）同样高于 CT- TBI 受试者（中位数 = 0.10 μg/L，IQR：0.06–0.18），p < 0.001  。生成受试者操作特征曲线，用于预测入院 CT 扫描时的颅内损伤；同一队列中 GFAP 的曲线下面积 (AUC) 显着高于 S100B（GFAP AUC – 0.85，95% 置信区间 [CI] 0.83–0.87；S100B AUC – 0.67，95% CI 0.64-0.70；p  < 0.001）。GFAP 是在护理点平台原型测定上测量的，具有很高的辨别能力，可以预测 TBI 患者在 GCS 3-15 到受伤后 24 小时的整个损伤范围内 CT 扫描的颅内异常。GFAP 的性能明显优于 S100B。