Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Department of Neurological Surgery, Mayo Clinic, Rochester, Minnesota, USA.
J Neurotrauma. 2020 Dec 1;37(23):2460-2467. doi: 10.1089/neu.2020.7140. Epub 2020 Sep 14.
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 ( = 122; median = 13 pg/mL, IQR: 7-20), < 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), < 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; < 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.
胶质纤维酸性蛋白（GFAP）已通过美国食品和药物管理局（FDA）批准，用于在轻度创伤性脑损伤（TBI）后 12 小时内确定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）；在欧洲，S100 钙结合蛋白 B（S100B）则用于此功能。这项多中心观察性转化研究和临床知识在创伤性脑损伤（TRACK-TBI）研究的 1 期生物标志物队列分析比较了 GFAP 的诊断性能，该性能是在快速床边检测平台上测量的，用于预测 GCS 为 3-15 的 TBI 患者在受伤后 24 小时内 CT 上颅内异常的情况。在出现 TBI 的患者中进行头部 CT 扫描，并在所有同意的患者中采集血液，这些患者均来自 18 个美国 1 级创伤中心。在床边原型检测设备上对血浆进行 GFAP 分析，对血清进行 S100B 分析。在 1359 名 GCS 为 3-15 的 TBI 患者中，平均（标准差[SD]）年龄为 40.1（17.0）岁；68%为男性。CT+TBI 患者的血浆 GFAP 水平明显高于 CT-TBI 患者（中位数=1358pg/ml，四分位距[IQR]：472-3803）和骨科创伤对照组（中位数=122pg/ml，IQR：13-20）， < 0.001。CT+TBI 患者的血清 S100B 水平也高于 CT-TBI 患者（中位数=0.17μg/L，IQR：0.09-0.38）， < 0.001。为预测入院 CT 扫描中的颅内损伤，生成了受试者工作特征曲线；在同一队列中，GFAP 的曲线下面积（AUC）明显高于 S100B（GFAP AUC-0.85，95%置信区间[CI]0.83-0.87；S100B AUC-0.67，95%CI0.64-0.70； < 0.001）。在 GCS 为 3-15 的 TBI 患者中，使用床边原型检测设备检测 GFAP，具有较高的鉴别能力，可预测受伤后 24 小时内 CT 扫描上的颅内异常。GFAP 显著优于 S100B。
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