College of Life Sciences, Northwest University, Xi'an, 710069, China.
College of Agronomy, Henan University of Science and Technology, Luoyang 471003, China.
Analyst. 2023 Dec 4;148(24):6369-6374. doi: 10.1039/d2an01562e.
S100B is an essential biomarker in the early diagnosis and treatment monitoring of brain injury. However, the traditional clinical diagnostic assay for S100B detection requires a complex operation or large equipment, which limits its application for rapid point-of-care tests (POCT). This study aimed to establish a lateral-flow immunoassay (LFIA) strip test system for S100B determination. PSS-MA-GoldMag nanoparticles were conjugated with anti-S100B antibodies as probes. Using this antibody-nanoparticle composite, an LFIA system based on magnetic quantification was established for S100B detection. For the evaluation of the performance of this LFIA system in clinical practice, 216 clinical samples were assayed using the LFIA test system and a commercial ECLI kit. Using the LFIA system, reliable results could be obtained in 30 min with a detection limit of 0.05 ng mL. The coefficient of variation (CV) was <13.8% and <14.03% for intra- and inter-assay precision, respectively. The recoveries were between 95.1 and 107.3%. The relative deviation of the interference experiments was <10%. In the analysis of clinical samples, the result indicated that the sera level of S100B in the detection group did not correlate with gender ( = 0.564 > 0.05) or age ( = 0.083 > 0.05). There is a good correlation between the novel method and the Elecsys®, with a determination coefficient of 0.9566, > 0.05. The Bland-Altman analysis between the two ways shows that the 95% confidence bands between the two methods in measuring S100B were -0.27 ng mL to +0.29 ng mL with a mean difference of +0.006 ng mL. These results indicated that the novel LFIA system could be a simple, rapid, convenient, and accurate method for S100B determination.
S100B 是脑损伤早期诊断和治疗监测的重要生物标志物。然而，传统的 S100B 检测临床诊断检测方法需要复杂的操作或大型设备，限制了其在快速即时检验（POCT）中的应用。本研究旨在建立一种用于 S100B 测定的侧向流免疫分析（LFIA）条带测试系统。PSS-MA-GoldMag 纳米颗粒与抗 S100B 抗体偶联作为探针。使用这种抗体-纳米颗粒复合物，建立了基于磁性定量的 S100B 检测 LFIA 系统。为了评估该 LFIA 系统在临床实践中的性能，使用 LFIA 测试系统和商业 ECLI 试剂盒对 216 份临床样本进行了测定。使用 LFIA 系统，在 30 分钟内可获得可靠的结果，检测限为 0.05ngmL。内和间分析精度的变异系数（CV）分别<13.8%和<14.03%。回收率在 95.1%至 107.3%之间。干扰实验的相对偏差<10%。在临床样本分析中，结果表明检测组血清 S100B 水平与性别（ = 0.564 > 0.05）或年龄（ = 0.083 > 0.05）无关。新方法与 Elecsys®有很好的相关性，决定系数为 0.9566，>0.05。两种方法之间的 Bland-Altman 分析显示，两种方法测量 S100B 时的 95%置信带分别为-0.27ngmL 至+0.29ngmL，平均差值为+0.006ngmL。这些结果表明，新型 LFIA 系统可能是一种简单、快速、方便、准确的 S100B 测定方法。
