Giannakos Georgios, Marka Sofia, Georgoulia Konstantina, Kintzios Spyridon, Moschopoulou Georgia
Laboratory of Cell Technology, Faculty of Biotechnology, Agricultural University of Athens, Iera Odos 75, 118 55 Athens, Greece.
Biosensors (Basel). 2025 Aug 3;15(8):503. doi: 10.3390/bios15080503.
Prostate cancer is among the most prevalent malignancies in men worldwide, underscoring the need for early and accurate diagnostic tools. This study presents a proof-of-concept and pilot clinical validation of a novel bioelectric impedance-based biosensor for the detection of prostate-specific antigen (PSA) in human serum. The system integrates Molecular Identification through Membrane Engineering (MIME) with the xCELLigence real-time cell analysis platform, employing Vero cells electroinserted with anti-PSA antibodies. Optimization experiments identified 15,000 cells/well as the optimal configuration for impedance response. The biosensor exhibited specific, concentration-dependent changes in impedance upon exposure to PSA standard solutions and demonstrated significant differentiation between PSA-positive and PSA-negative human serum samples relative to the clinical threshold of 4 ng/mL. The biosensor offered rapid results within one minute, unlike standard immunoradiometric assay (IRMA), while showing strong diagnostic agreement. The system's specificity, sensitivity, and reproducibility support its potential for integration into point-of-care screening workflows. This bioelectric assay represents one of the fastest PSA detection approaches reported to date and offers a promising solution for reducing overdiagnosis while improving clinical decision-making and patient outcomes.
前列腺癌是全球男性中最常见的恶性肿瘤之一，这凸显了对早期准确诊断工具的需求。本研究展示了一种基于生物电阻抗的新型生物传感器用于检测人血清中前列腺特异性抗原（PSA）的概念验证和初步临床验证。该系统将通过膜工程进行分子识别（MIME）与xCELLigence实时细胞分析平台相结合，采用电插入抗PSA抗体的非洲绿猴肾细胞（Vero细胞）。优化实验确定每孔15,000个细胞为阻抗响应的最佳配置。该生物传感器在暴露于PSA标准溶液时表现出特定的、浓度依赖性的阻抗变化，并且相对于4 ng/mL的临床阈值，PSA阳性和PSA阴性人血清样本之间显示出显著差异。与标准免疫放射分析（IRMA）不同，该生物传感器在一分钟内即可得出快速结果，同时显示出很强的诊断一致性。该系统的特异性、灵敏度和可重复性支持其整合到即时检测筛查工作流程中的潜力。这种生物电检测方法是迄今为止报道的最快的PSA检测方法之一，为减少过度诊断、改善临床决策和患者预后提供了一个有前景的解决方案。
