流动相单分子免疫检测系统的设计

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中图分类号：0439 文献标志码：A doi：10.37188/CO.2025-0045 CSTR：32171.14.CO.2025-0045

Design of flow-phase single-molecule immunoassay detection system

HU Peng-tao 1，2 ，GAO Ruo-qian 1* ，GE Ming-feng1，DONG Wen-fei 1，2 ，LILi 1 ， SU Xin-ran 1，2

（1.Suzhou Institute of Biomedical Engineering and Technology， ChineseAcademyofSciences，Suzhou215163，China; 2.School ofMechanical and Electrical Engineering， Changchun University of Science and Technology， Changchun 130022， China） * Corresponding author，E-mail： gaorq@sibet.ac.cn

Abstract： We develop a single-molecule immunoassay detection system for flow-phase samples to enable early diagnosis of tumor biomarkers. The system includes an optical fluorescence imaging platform and an image processng algorithm. First， we developed a flow-phase single-molecule immunoassay detection method suitable forreal-time detectionof low-concentration，high-throughput samples.Second，we designed a set of fluorescence imaging detection platform compatible with microfluidic chips. Through the rational configuration of optical filters and beam spliters， high-resolution fluorescence imaging was achieved by utilizing multi-module integration. Finally， based on the image detection and counting algorithm for out-of-focus particles， we optimized a feature-matching algorithm to effctively detect out-of-focus fluorescent particles. Experimental results demonstrate a detection limit of 0.001pg/mL within a linear range of 0.001-1pg/mL with coefficient of variation below 10% . The system can process up to 10 samples per hour. These findings indicate that our system meets the requirements for stable，sensitive，and high-throughput single-molecule immunoassay detection， showing promising potential for early cancer screening.

Key words： early diagnosis; single-molecule immunodetection; fluorescence imaging; optical platform; feature matching

1引言

随着疾病诊断技术的不断发展，精准医疗已成为前沿研究领域，其中生物分子的高灵敏度定量检测在疾病诊断中发挥着至关重要的作用。（剩余15164字）