乳腺癌是全世界女性癌症相关死亡的第二大原因，在美国亦如此，每年造成约57.1万人死亡。早期发现乳腺癌可以提高治疗效果和治愈的可能性。尽管目前已存在乳腺癌的诊断方法，如乳房X线摄影、超声波和活体组织检查，但其中一些方法价格昂贵、不舒适、耗时，并且具有有限的敏感性，因此需要开发一种经济实惠、快速、高灵敏度的方法，例如电化学生物传感器。我们的研究重点是利用ECM1生物标志物来检测乳腺癌患者，该标志物在合成尿液中表达更高。我们的研究有两个主要目标：(i) 使用电化学阻抗谱法和酶联免疫吸附测定法测量不同ECM1蛋白浓度。通过使用电化学阻抗谱法校准ECM-1蛋白水平来建立电化学生物传感器的标准曲线。(ii) 验证电化学生物传感器的有效性。此目标涉及测试合成尿液中ECM1的未知浓度，以确保生物传感器在早期阶段检测生物标志物的效率。结果显示，合成尿液中的ECM-1检测范围为1 pg/mL 至500ng/mL。这表明通过检测患者尿液中ECM-1蛋白水平的变化，电化学生物传感器能够始终准确诊断乳腺癌的早期阶段或增加复发。我们的研究结果突出了电化学生物传感器在患者尿液中检测早期乳腺癌生物标志物(ECM-1)的效力。我们计划进一步对患者样本进行研究，并开发便携式硬件供患者使用。版权所有 © 2023。由Elsevier B.V.出版。

Breast cancer is the second highest cause of cancer-related mortality in women worldwide and in the United States, accounting for around 571,000 deaths per year. Early detection of breast cancer increases treatment results and the possibility of a cure. While existing diagnostic modalities such as mammography, ultrasound, and biopsy exist, some are prohibitively expensive, uncomfortable, time-consuming, and have limited sensitivity, necessitating the development of a cost-effective, rapid, and highly sensitive approach such as an electrochemical biosensor. Our research focuses on detecting breast cancer patients using the ECM1 biomarker, which has higher expression in synthetic urine. Our study has two primary objectives: (i) Diverse ECM1 protein concentrations are measured using electrochemical impedance spectroscopy and ELISA. Establishing a standard curve for the electrochemical biosensor by calibrating ECM-1 protein levels using electrochemical impedance spectroscopy. (ii) Validation of the effectiveness of the electrochemical biosensor. This aim entails testing the unknown concentration of ECM1 in the synthetic urine to ensure the efficiency of the biosensor to detect the biomarker in the early stages. The results show that the synthetic urine solution's ECM-1 detection range ranges from 1 pg/ml to 500 ng/ml. This shows that by detecting changes in ECM-1 protein levels in patient urine, the electrochemical biosensor can consistently diagnose breast cancer in its early stages or during increasing recurrence. Our findings highlight the electrochemical biosensor's efficacy in detecting early-stage breast cancer biomarkers (ECM-1) in patient urine. Further studies will be conducted with patient samples and develop handheld hardware for patient usage.Copyright © 2023. Published by Elsevier B.V.