Department of Chemistry, Life Sciences and Environmental Sustainability, University of Parma, Parco Area Delle Scienze, 17/A, 43124, Parma, Italy.
Department of Chemistry, Life Sciences and Environmental Sustainability, University of Parma, Parco Area Delle Scienze, 17/A, 43124, Parma, Italy.
Talanta. 2020 Sep 1;217:120991. doi: 10.1016/j.talanta.2020.120991. Epub 2020 Apr 6.
Prompt cancer diagnosis and treatment represent fundamental aspects to significantly improve patient survival rate. Human epididymis protein 4 (HE4) has recently been identified as promising single serum biomarker of epithelial ovarian cancer with improved diagnostic performances respect to current reference biomarkers. In this study we present the first competitive immunosensing strategy for HE4 determination implemented on magnetic microbeads functionalized with HE4 antigen. A full factorial design and multiple linear regression allowed to find the optimal experimental conditions providing the maximum inhibition rate within the explored domain. Method validation was performed in serum to ensure reliable data to support decision in clinical practice. This method allowed matching the clinically relevant concentration values for the serum biomarker, limits of detection and quantification being 2.8 and 23.0 pM, respectively. Also recovery rate in the 89 ± 7-103 ± 5% range resulted suitable for method applicability for diagnostic purposes.
提示癌症的诊断和治疗是显著提高患者生存率的基本方面。人附睾蛋白 4（HE4）最近被确定为一种有前途的上皮性卵巢癌单一血清生物标志物，与目前的参考生物标志物相比，具有更好的诊断性能。在这项研究中，我们提出了一种基于磁性微球的用于 HE4 测定的竞争性免疫传感策略，该微球用 HE4 抗原功能化。全因子设计和多元线性回归允许找到最佳的实验条件，在探索的范围内提供最大的抑制率。在血清中进行方法验证，以确保可靠的数据支持临床实践中的决策。该方法能够匹配与临床相关的血清生物标志物浓度值，检测限和定量限分别为 2.8 和 23.0 pM。回收率在 89±7-103±5%范围内也适合用于诊断目的的方法适用性。
