Department of Biological Science and Technology, National Chiao Tung University, Hsinchu, Taiwan; Institute of Molecular Medicine and Bioengineering, National Chiao Tung University, Hsinchu, Taiwan.
Department of Biological Science and Technology, National Chiao Tung University, Hsinchu, Taiwan.
Biosens Bioelectron. 2020 May 1;155:112111. doi: 10.1016/j.bios.2020.112111. Epub 2020 Feb 20.
Electrochemical biosensors possess numerous desirable qualities for target detection, such as portability and ease of use, and are often considered for point-of-care (POC) development. Label-free affinity electrochemical biosensors constructed with semiconductor manufacturing technology (SMT)-produced electrodes and a streptavidin biomediator currently display the highest reproducibility, accuracy, and stability in modern biosensors. However, such biosensors still do not meet POC guidelines regarding these three characteristics. The purpose of this research was to resolve the limitations in reproducibility and accuracy caused by problems with production of the biosensors, with the aim of developing a platform capable of producing devices that exceed POC standards. SMT production settings were optimized and bioreceptor immobilization was improved through the use of a unique linker, producing a biosensor with exceptional reproducibility, impressive accuracy, and high stability. Importantly, the three characteristics of the sensors produced using the proposed platform all meet POC standards set by the Clinical and Laboratory Standards Institute (CLSI). This suggests possible approval of the biosensors for POC development. Furthermore, the detection range of the platform was demonstrated by constructing biosensors capable of detecting common POC targets, including circulating tumor cells (CTCs), DNA/RNA, and curcumin, and the devices were optimized for POC use. Overall, the platform developed in this study shows high potential for production of POC biosensors.
电化学生物传感器在目标检测方面具有许多理想的特性，例如便携性和易用性，因此常被考虑用于即时检测（POC）的开发。使用半导体制造技术（SMT）生产的电极和链霉亲和素生物介质构建的无标记亲和电化学生物传感器在现代生物传感器中显示出最高的重现性、准确性和稳定性。然而，这些生物传感器在这三个特性方面仍不符合 POC 指南。本研究的目的是解决生物传感器生产过程中出现的重现性和准确性问题，旨在开发一个能够生产出超过 POC 标准的设备的平台。通过优化 SMT 生产设置和使用独特的连接子来改善生物受体固定化，生产出具有出色重现性、令人印象深刻的准确性和高稳定性的生物传感器。重要的是，使用所提出的平台生产的传感器的三个特性均符合临床和实验室标准协会（CLSI）设定的 POC 标准。这表明该生物传感器可能获得 POC 开发的批准。此外，该平台的检测范围通过构建能够检测常见 POC 靶标（包括循环肿瘤细胞（CTC）、DNA/RNA 和姜黄素）的生物传感器得到了证明，并且这些设备已针对 POC 使用进行了优化。总体而言，本研究中开发的平台在生产 POC 生物传感器方面具有很高的潜力。
