基于纳米场效应晶体管生物传感器对临床样本中乳腺癌相关miRNA的高通量早期检测研究

The breast cancer shows a rising trend, the early symptoms are not typical and easy to be ignored, which will lead to poor prognosis and even death, thus early detection and diagnosis of breast cancer is crucial. In order to realize the early diagnosis of breast cancer with rapidity, sensitivity, specificity and low cost, this project is aimed at realizing the multiplex and high-through early detection of miRNA related to breast cancer by utilizing the novel nanomaterial-based field-effect transistor (FET) biosensor. To synthesize nanomaterials with high quality and unique FET chips as designed, then fabricating the functionalized nanomaterial-based FET biosensor with high performance. The specific aims of the project are as the following: 1) Exploring the electrical detection property of the biosensor to miRNA related to breast cancer to fabricate nanomaterial-based FET biosensor with high-through, high sensitivity and selectivity; 2) The biosensor will be used to detect miRNA in serum of breast cancer patients compared with traditional detection methods, to explore its efficiency, sensitivity, specificity, cost and so on; 3) To directly detect relevant miRNA in cell lysate of patients with breast cancer by the biosensor, making a comparison with traditional detection methods. In this project, it’s the first study making attempts to utilize the nanomaterial-based FET biosensor to detect multiple miRNAs with high sensitivity and high-through at one time and to directly detect miRNA in clinical samples of patients, such as serum samples and cell lysate of breast cancer patients. Thus the nanomaterial-based FET biosensor shows huge potential for early detection and diagnosis of cancer.

乳腺癌的发病率逐年上升，早期症状不典型而易忽视，导致预后差甚至危及生命，因此乳腺癌的早期检测诊断至关重要。为实现乳腺癌的快速、灵敏、特异、低成本的早期诊断，本项目拟利用纳米场效应晶体管（FET）生物传感器实现乳腺癌相关miRNA的高通量早期检测。在制备高质量纳米材料的基础上，以设计独特的FET芯片为基底，构建高性能的纳米FET芯片，进行表面修饰和功能化改性后：1)研究其对乳腺癌相关miRNA识别检测性能，研制高通量、高灵敏和特异性的纳米FET生物传感器；2)将该传感器用于乳腺癌患者血清中miRNA的检测，与传统检测方法进行比对，探究其时效性、灵敏度、特异性及人工成本等性能；3)该传感器直接检测乳腺癌细胞裂解液中相关miRNA，探讨比对传统方法的结果及性能。项目首次提出将该传感器用于多元、高通量的miRNA检测，并直接检测临床样本，这将为纳米FET生物传感器用于癌症的早期检测诊断提供新思路。

乳腺癌作为女性最常见的一种恶性肿瘤，其发病率、死亡率呈继续增长趋势，乳腺癌的早期症状隐匿，比较容易被忽视，乳腺癌的中晚期往往会因为错过了最佳的治疗时期而导致预后差甚至危及生命。因此，迫切地需要提高乳腺癌的早期诊断，从而改善预后、降低死亡率。为实现乳腺癌的快速、灵敏、特异、低成本的早期诊断，本项目利用新型纳米场效应晶体管（FET）生物传感器检测乳腺癌相关miRNA的表达。首先制备高质量纳米材料石墨烯，将石墨烯与FET芯片结合构建高性能的纳米FET芯片，然后对芯片进行表面修饰和功能化改性后：1)检测乳腺癌相关miRNA-21，实验证明研制的纳米FET生物传感器具有很高的灵敏度和特异性；2)该传感器直接用于乳腺癌患者和体检乳腺正常人群血浆中miRNA-21的检测，检测结果有统计学差异，表明该生物传感器通过血样检测能够区分乳腺癌患者与正常人群。3)该生物传感器检测miRNA-21与传统的qRT-PCR方法进行比对，研究结果表明石墨烯FET生物传感器在时效性、灵敏度、特异性及人工成本等性能方面均有一定的优势。本项目实现了纳米FET生物传感器直接用于临床样本血浆中miRNA-21的检测，这将为纳米FET生物传感器用于癌症的早期检测诊断提供新思路。

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