Bioanalysis Laboratory, Faculty of Chemistry, University of Bialystok, Ciolkowskiego 1K, 15-245 Bialystok, Poland.
Faculty of Chemical Technology, Poznan University of Technology, pl. Sklodowskiej-Curie 5, 60-965 Poznan, Poland.
Sensors (Basel). 2021 May 20;21(10):3567. doi: 10.3390/s21103567.
Human epididymis protein 4 (HE4) is an ovarian cancer marker. Various cut-off values of the marker in blood are recommended, depending on the method used for its determination. An alternative biosensor for HE4 determination in blood plasma has been developed. It consists of rabbit polyclonal antibody against HE4, covalently attached to a gold chip via cysteamine linker. The biosensor is used with the non-fluidic array SPRi technique. The linear range of the analytical signal response was found to be 2-120 pM, and the biosensor can be used for the determination of the HE4 marker in the plasma of both healthy subjects and ovarian cancer patients after suitable dilution with a PBS buffer. Precision (6-10%) and recovery (101.8-103.5%) were found to be acceptable, and the LOD was equal to 2 pM. The biosensor was validated by the parallel determination of a series of plasma samples from ovarian cancer patients using the Elecsys HE4 test and the developed biosensor, with a good agreement of the results (a Pearson coefficient of 0.989). An example of the diagnostic application of the developed biosensor is given-the influence of ovarian tumor resection on the level of HE4 in blood serum.
人附睾蛋白 4（HE4）是一种卵巢癌标志物。根据用于测定它的方法，推荐了血液中该标志物的各种临界值。已经开发出一种用于测定血浆中 HE4 的替代生物传感器。它由针对 HE4 的兔多克隆抗体组成，通过半胱氨酸接头共价连接到金芯片上。生物传感器与无流动阵列 SPRi 技术一起使用。分析信号响应的线性范围被发现为 2-120 pM，并且可以在适当稀释 PBS 缓冲液后，用于测定健康受试者和卵巢癌患者的血浆中的 HE4 标志物。发现精度（6-10%）和回收率（101.8-103.5%）可以接受，LOD 等于 2 pM。使用 Elecsys HE4 测试和开发的生物传感器平行测定一系列卵巢癌患者的血浆样本，验证了生物传感器，结果具有良好的一致性（Pearson 系数为 0.989）。给出了开发的生物传感器的诊断应用示例 - 卵巢肿瘤切除对血液中 HE4 水平的影响。
