Haselmann Verena, Schamberger Christian, Trifonova Feodora, Ast Volker, Froelich Matthias F, Strauß Maximilian, Kittel Maximilian, Jaruschewski Sabine, Eschmann David, Neumaier Michael, Neumaier-Probst Eva
Department of Clinical Chemistry, University Medicine Mannheim, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.
Orthopaedic-Trauma Surgery Centre, University Medicine Mannheim, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.
Pract Lab Med. 2021 May 12;26:e00236. doi: 10.1016/j.plabm.2021.e00236. eCollection 2021 Aug.
Serum biomarker S100B has been explored for its potential benefit to improve clinical decision-making in the management of patients suffering from traumatic brain injury (TBI), especially as a pre-head computed-tomography screening test for patients with mild TBI. Although being already included into some guidelines, its implementation into standard care is still lacking. This might be explained by a turnaround time (TAT) too long for serum S100B to be used in clinical decision-making in emergency settings.
S100B concentrations were determined in 136 matching pairs of serum and lithium heparin blood samples. The concordance of the test results was assessed by linear regression, Passing Pablok regression and Bland-Altman analysis. Bias and within- and between-run imprecision were determined by a 5 × 4 model using pooled patient samples. CT scans were performed as clinically indicated.
Overall, S100B levels between both blood constituents correlated very well. The suitability of S100B testing from plasma was verified according to ISO15189 requirements. Using a cut-off of 0.105 ng/ml, a sensitivity and negative predictive value of 100% were obtained for identifying patients with pathologic CT scans. Importantly, plasma-based testing reduced the TAT to 26 min allowing for quicker clinical decision-making. The clinical utility of integrating S100B in TBI management is highlighted by two case reports.
Plasma-based S100B testing compares favorably with serum-based testing, substantially reducing processing times as the prerequisite for integrating S100B level into management of TBI patients. The proposed new clinical decision algorithm for TBI management needs to be validated in further prospective large-scale studies.
血清生物标志物S100B已被探索其在改善创伤性脑损伤(TBI)患者管理中的临床决策方面的潜在益处,特别是作为轻度TBI患者头部计算机断层扫描前的筛查测试。尽管已被纳入一些指南,但将其纳入标准治疗仍缺乏相关实践。这可能是因为血清S100B的周转时间(TAT)过长,无法在紧急情况下用于临床决策。
对136对匹配的血清和肝素锂血样测定S100B浓度。通过线性回归、Passing Pablok回归和Bland-Altman分析评估测试结果的一致性。使用混合患者样本的5×4模型确定偏差以及批内和批间不精密度。根据临床指征进行CT扫描。
总体而言,两种血液成分中的S100B水平相关性非常好。根据ISO15189要求验证了血浆S100B检测的适用性。使用0.105 ng/ml的临界值,在识别CT扫描异常的患者时,敏感性和阴性预测值均为100%。重要的是,基于血浆的检测将TAT缩短至26分钟,从而能够更快地做出临床决策。两个病例报告突出了将S100B纳入TBI管理的临床实用性。
基于血浆的S100B检测与基于血清的检测相比具有优势,大幅缩短了处理时间,这是将S100B水平纳入TBI患者管理的前提条件。所提出的新的TBI管理临床决策算法需要在进一步的前瞻性大规模研究中得到验证。