Welch Robert D, Bazarian Jeffrey J, Chen James Y, Chandran Raj, Datwyler Saul A, McQuiston Beth, Caudle Krista
Wayne State University, Department of Emergency Medicine, Detroit Receiving Hospital, 6G-UHC, 4201 St. Antoine, Detroit, MI 48201, USA.
University of Rochester, 601 Elmwood Ave, Rochester, NY 14642, USA.
Am J Emerg Med. 2025 Mar;89:129-134. doi: 10.1016/j.ajem.2024.12.005. Epub 2024 Dec 7.
A glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) blood biomarker panel can reliably eliminate the need to perform a head computed tomography (CT) scan in selected patients with traumatic brain injury (TBI). Currently, this FDA cleared panel can be run both on a core laboratory platform or a hand-held single-sample point of care platform. This study examined test characteristics of the panel as analyzed on a core lab-based fast high-throughput platform.
This secondary analysis of clinical data and banked blood samples obtained for the ALERT-TBI study included patients ≥18 years old with nonpenetrating head injury, a presenting Glasgow Coma Scale score 9-15, and a head CT was indicated. Included were patients with a GCS 13-15 who had sufficient banked blood for analysis. Test characteristics of the biomarker panel were determined relative to head CT findings for traumatic intracranial injury.
Among the 1899 included subjects, mean age was 49.1 yrs. (18 to 98 yrs), 56.5 % male, and 70.6 % were Caucasian. The most common mechanism of injury was a fall (51.9 %) and 94.1 % presented with a GCS of 15. Head CT was positive for traumatic intracranial injury in 120 patients (6.3 %) of which the biomarker panel was a false negative in four patients. Sensitivity (95 % confidence interval) of the biomarker panel was 96.7 (91.7, 98.7), specificity 40.1 (37.8, 42.4), negative predictive value 99.4 (98.6, 99.8), and the negative likelihood ratio was 0.08 (0.03, 0.22).
The biomarker panel, measured on this core lab-based fast high-throughput platform, had high sensitivity and negative predictive values. The core laboratory platform has the advantage of speed and the ability to analyze multiple samples simultaneously suggesting additional utility when there is high need for CT imaging such as mass casualty or emergency department volume overload situations.
胶质纤维酸性蛋白（GFAP）和泛素羧基末端水解酶L1（UCH-L1）血液生物标志物组合能够可靠地使部分创伤性脑损伤（TBI）患者无需进行头部计算机断层扫描（CT）。目前，这个获得美国食品药品监督管理局（FDA）批准的组合可以在核心实验室平台或手持式单样本即时检验平台上进行检测。本研究检测了该组合在基于核心实验室的快速高通量平台上分析时的检测特性。
对为ALERT-TBI研究获取的临床数据和储存血样进行的二次分析纳入了年龄≥18岁、有非穿透性头部损伤、初始格拉斯哥昏迷量表评分为9-15分且需进行头部CT检查的患者。纳入的患者为格拉斯哥昏迷量表评分为13-15分且有足够储存血样用于分析的患者。相对于创伤性颅内损伤的头部CT检查结果，确定生物标志物组合的检测特性。
在纳入的1899名受试者中，平均年龄为49.1岁（18至98岁），男性占56.5%，白种人占70.6%。最常见的损伤机制是跌倒（51.9%），94.1%的患者格拉斯哥昏迷量表评分为15分。120例患者（6.3%）的头部CT检查显示创伤性颅内损伤阳性，其中生物标志物组合在4例患者中为假阴性。生物标志物组合的敏感性（95%置信区间）为96.7（91.7, 98.7），特异性为40.1（37.8, 42.4），阴性预测值为99.4（98.6, 99.8），阴性似然比为0.08（0.03, 0.22）。
在这个基于核心实验室的快速高通量平台上检测的生物标志物组合具有高敏感性和阴性预测值。核心实验室平台具有速度快以及能够同时分析多个样本的优势，这表明在对CT成像有高需求的情况下，如大规模伤亡或急诊科容量过载情况时，该平台具有额外的实用价值。
