Impedimetric affinity biosensors are, without any doubt, among the most sensitive analytical devices available, offering low limits of detection and wide linear response ranges. There are, however, only a few papers detailing the application of impedimetric biosensors for the analysis of clinically relevant samples with due clinical performance. The fact that these devices have not found their way to any commercial or clinical use to date might be surprising, since an electrochemical assay platform based on portable potentiostats is a success story for monitoring a range of clinical parameters such as ions, haematological indicators and glucose. This review discusses the reasons behind this discrepancy and addresses the barriers to be overcome in order to achieve the point‐of‐care diagnostics using such devices for detection of protein oncomarkers approved by FDA. The final part of the review covers the most recent progress in the area.

中文翻译：

---

基于电化学阻抗谱的生物传感器：机理，分析实例和商业化的蛋白质癌症生物标志物分析面临的挑战

阻抗亲和力生物传感器毫无疑问是可用的最灵敏的分析设备之一，提供了低检测限和宽线性响应范围。但是，只有少数几篇论文详细介绍了阻抗测量生物传感器在具有适当临床表现的临床相关样品分析中的应用。这些设备迄今尚未发现可用于任何商业或临床用途的事实，这可能令人惊讶，因为基于便携式恒电位仪的电化学测定平台是监测一系列临床参数（如离子，血液学指标和葡萄糖）的成功案例。 。这篇综述讨论了这种差异背后的原因，并解决了要克服的障碍，以便使用此类设备来实现由FDA批准的用于检测蛋白分析仪的即时诊断。审查的最后部分涵盖了该领域的最新进展。