曲妥珠单抗是一种靶向人表皮生长因子受体 2 的重组人源化单克隆抗体，是人表皮生长因子受体2 阳性乳腺癌治疗中的核心药物。大量研究表明，曲妥珠单抗在不同患者体内的药代动力学行为存在显著个体差异，其血清浓度水平与治疗疗效及心脏毒性等不良反应密切相关。因此，建立快速、灵敏、可靠的曲妥珠单抗血清检测方法，对于实现治疗药物监测和个体化精准用药具有重要意义。传统检测方法如酶联免疫吸附法和液相色谱 – 质谱联用技术在临床和科研中应用广泛，但普遍存在检测周期长、操作复杂、难以实现床旁检测等局限。近年来，随着电化学生物传感、纳米材料及微流控技术的发展，多种面向床旁检测的曲妥珠单抗速检测方法不断涌现。本文在系统梳理传统检测技术的基础上，重点综述近 5 年来基于电化学传感与床旁检测平台的曲妥珠单抗快速检测方法，并对其应用前景进行展望。

乳腺癌；曲妥珠单抗；电化学生物传感；POCT；血清检测

[1]国家肿瘤质控中心乳腺癌专家委员会,中国抗癌协会肿瘤药物临床研究专业委员会,中国抗癌协会乳腺癌专业委员会,徐兵河.HR+/HER-2-早期乳腺癌复发风险与临床管理专家共识(2025版)[J].中华肿瘤杂志,2025,47(7):599-616

[2]莫淼,王泽洲,郑莹,等.2022年全球及中国乳腺癌流行病学特征分析[J].海军军医大学学报,2025,46(04):497-503.

[3]Li L, Zhang D, Liu B, Lv D, Zhai J, Guan X, Yi Z, Ma F. Antibody-drug conjugates in HER2-positive breast cancer. Chin Med J (Engl). 2021 Dec 22;135(3):261-267.

[4]Early Breast Cancer Trialists’ Collaborative group (EBCTCG). Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomised trials. Lancet Oncol. 2021 Aug;22(8):1139-1150.

[5]Luo X, Wang N, Xing Y, Gao X, Yu Y, Liu T, Jiang S, Dong M. Pharmacokinetics of trastuzumab and its efficacy and safety in HER2-positive cancer patients. Cancer Chemother Pharmacol. 2024 Nov;94(5):721-732.

[6]Sheikh, A.A.; Alam, O.; Rub, R.A.; Iqbal, M.; Medhi, K.; Alsalman, A.J.; Imran, M.; Alshehri, S.; Ghoneim, M.M.; Shakeel, F. UPLC-MS/MS-Based Analysis of Trastuzumab in Plasma Samples: Application in Breast Cancer Patients Sample Monitoring. Processes 2022, 10, 509.

[7]Zhao,Shuxia,et al.Rapid quantification of trastuzumab and bevacizumab in serum using magnetic bead immuno-enrichment coupled with LC–MS/MS.Journal of Analytical Science and Technology 17.1(2026):3.

[8]Regiart M, Gimenez AM, Ortega FG, Gómez GE, Sainz J, Tortella GR, Fernández-Baldo MA. Nanomaterials-Enhanced Electrochemical Biosensors for Epithelial Cancer Diagnosis: Recent Advances. Biosensors (Basel). 2025 Nov 22;15(12):766.

[9]Aydin S, Emre E, Ugur K, Aydin MA, Sahin İ, Cinar V, Akbulut T. An overview of ELISA: a review and update on best laboratory practices for quantifying peptides and proteins in biological fluids. J Int Med Res. 2025 Feb;53(2):3000605251315913.

[10]Alez-Martin, L., Hirschler, E., Houzé, P., Potier, N., Mignet, N., Leize-Wagner, E., François, Y.-N., & Gahoual, R. (2025). Characterization and quantification of therapeutic monoclonal antibodies, anti-drug antibodies and their interactions for clinical applications. TrAC Trends in Analytical Chemistry, 192, 118385.

[11]Ma X, Wang R, Wei L, Liu P, Jing L, Wang J, Dong W, Tian X, Fu R. A comparison of chemiluminescent immunoassay and enzyme-linked immunosorbent assay for detecting phospholipase A2 receptor antibody in primary membranous nephropathy. Pract Lab Med. 2024 Feb 29;39:e00385.

[12]Sun B, Liu J, Cai P, Wu J, Liu W, Hu H, Liu L. Aptamer-based sample purification for mass spectrometric quantification of trastuzumab in human serum. Talanta. 2023 May 15;257:124349.

[13]Jug A , Bratkovi T , Ila J .Biolayer interferometry and its applications in drug discovery and development[J].Trends in Analytical Chemistry, 2024, 176(000):13.

[14]Van Zant W, Ray P. Democratization of Point-of-Care Viral Biosensors: Bridging the Gap from Academia to the Clinic. Biosensors (Basel). 2025 Jul 7;15(7):436.

[15]Guo L, Zhao Y, Huang Q, Huang J, Tao Y, Chen J, Li HY, Liu H. Electrochemical protein biosensors for disease marker detection: progress and opportunities. Microsyst Nanoeng. 2024 May 22;10:65.

[16]Kim, J.Y., Kim, M.Y., Song, Y. et al. Recent Strategies in Nanomaterials-Based Signal Amplification of Electrochemical Biosensors. BioChip J (2026).

[17]Gaba,Smriti,and Utkarsh Jain.Electrochemical Immunosensor Based on Screen-Printed Electrodes Modified with Gold Nanoparticles for Highly Sensitive Detection of TGF-α.Talanta Open(2025):100590.

[18]Cancelliere,R.,et al.Label-free electrochemical immunosensors:A practical guide.TrAC Trends in Analytical Chemistry 180(2024):117949.

[19]Shoute, L.C.T., Abdelrasoul, G.N., Ma, Y. et al. Label-free impedimetric immunosensor for point-of-care detection of COVID-19 antibodies. Microsyst Nanoeng 9, 3 (2023).

[20]Domsicova,Michaela,et al.New insights into aptamers:An alternative to antibodies in the detection of molecular biomarkers.International Journal of Molecular Sciences 25.13(2024):6833.

[21]Reaño,Resmond L.,and Erwin C.Escobar.A review of antibody,aptamer,and nanomaterials synergistic systems for an amplified electrochemical signal.Frontiers in Bioengineering and Biotechnology 12(2024):1361469.

[22]Mazzaracchio,Vincenzo,and Fabiana Arduini.Smart microfluidic devices integrated in electrochemical point-of-care platforms for biomarker detection in biological fluids.Analytical and Bioanalytical Chemistry(2025):1-23.

[23]Wang,Siyue,Xiaotian Guan,and Shuqing Sun.Microfluidic biosensors:enabling advanced disease detection.Sensors 25.6(2025):1936.