From lab to clinic: A portable and automated microfluidic nucleic acid detection instrument for rapid STI pathogen identification

IF 10.7 1区生物学 Q1 BIOPHYSICS

Biosensors and Bioelectronics Pub Date : 2025-04-24 DOI:10.1016/j.bios.2025.117498

Shutao Liu , Feifei Zhou , Kailin Li , Sunyi Chen , Binfen Hu , Yixuan Feng , Hao Song , Xiaonian Lu , Dou Wang , Chenchen Ge

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引用次数: 0

Abstract

Sexually transmitted infections (STIs) remain a significant global public health challenge. The rapid and precise identification of these pathogens is crucial for effective diagnosis and treatment. Current polymerase chain reaction (PCR)-based assays, despite their widespread use, present several limitations in clinical settings, including high costs and technical complexity. To address these challenges, we developed a portable and automated microfluidic nucleic acid detection device for multiplex detection of three sexually transmitted pathogens via the fluorescence quantitative PCR (qPCR) assay. This integrated platform combines automated sample processing, multiplex qPCR amplification, and fluorescence detection within a single device. The entire closed-loop testing procedure, from automated nucleic acid extraction to result generation, requires only 40 min. The system demonstrates detection limits of 360 copies/ml for Neisseria gonorrhoeae (NG), 140 copies/ml for Ureaplasma urealyticum (UU), and 290 copies/ml for Chlamydia trachomatis (CT). Clinical validation revealed exceptional performance in multiplex detection of infected specimens, showing complete concordance (100 %) with standard diagnostic results while maintaining high specificity. These findings highlight the instrument's clinical potential and establish a new paradigm for automated, multiplex pathogen detection.

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从实验室到临床：用于STI病原体快速鉴定的便携式自动微流控核酸检测仪器

性传播感染仍然是一项重大的全球公共卫生挑战。快速和准确地识别这些病原体对于有效的诊断和治疗至关重要。目前基于聚合酶链反应（PCR）的检测方法尽管被广泛使用，但在临床环境中存在一些局限性，包括高成本和技术复杂性。为了解决这些挑战，我们开发了一种便携式、自动化的微流控核酸检测装置，通过荧光定量PCR （qPCR）检测三种性传播病原体。该集成平台将自动化样品处理，多重qPCR扩增和荧光检测结合在一个设备内。整个闭环检测过程，从自动核酸提取到结果生成，只需要40分钟。该系统显示淋病奈瑟菌（NG）的检测限为360拷贝/ml，解脲支原体（UU）的检测限为140拷贝/ml，沙眼衣原体（CT）的检测限为290拷贝/ml。临床验证显示，在多重检测感染标本方面表现出色，与标准诊断结果完全一致（100%），同时保持高特异性。这些发现突出了该仪器的临床潜力，并为自动化、多重病原体检测建立了新的范例。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Biosensors and Bioelectronics 工程技术-电化学

CiteScore

20.80

自引率

7.10%

发文量

1006

审稿时长

29 days

期刊介绍： Biosensors & Bioelectronics, along with its open access companion journal Biosensors & Bioelectronics: X, is the leading international publication in the field of biosensors and bioelectronics. It covers research, design, development, and application of biosensors, which are analytical devices incorporating biological materials with physicochemical transducers. These devices, including sensors, DNA chips, electronic noses, and lab-on-a-chip, produce digital signals proportional to specific analytes. Examples include immunosensors and enzyme-based biosensors, applied in various fields such as medicine, environmental monitoring, and food industry. The journal also focuses on molecular and supramolecular structures for enhancing device performance.