The COVID-19 pandemic greatly impacted the in vitro diagnostic market, leading to the development of new technologies such as point-of-care testing (POCT), multiplex testing, and digital health platforms. In this study, we present a self-contained microfluidic chip integrated with an internet-of-things (IoT)-based point-of-care (POC) device for rapid and sensitive diagnosis of respiratory viruses. Our platform enables sample-to-answer diagnostics within 70 min by automating RNA extraction, reverse transcription-loop-mediated isothermal amplification (RT-LAMP), and fluorescence detection. The microfluidic chip is designed to store all the necessary reagents for the entire diagnostic assay, including a lysis buffer, a washing buffer, an elution buffer, and a lyophilized RT-LAMP cocktail. It can perform nucleic acid extraction, aliquoting, and gene amplification in multiple reaction chambers without cross-contamination. The IoT-based POC device consists of a Raspberry Pi 4 for device control and data processing, a CMOS sensor for measuring fluorescence signals, a resistive heater panel for temperature control, and solenoid valves for controlling the movement of on-chip reagent solutions. The proposed device is portable and features a touchscreen for user control and result display. We evaluated the performance of the platform using 11 clinical respiratory virus samples, including 5 SARS-CoV-2 samples, 2 influenza A samples, and 4 influenza B samples. All tested clinical samples were accurately identified with high specificity and fidelity, demonstrating the ability to simultaneously detect multiple respiratory viruses. The combination of the integrated microfluidic chip with the POC device offers a simple, cost-effective, and scalable solution for rapid molecular diagnosis of respiratory viruses in resource-limited settings.

中文翻译：

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开发独立的微流控芯片和基于物联网的护理点设备，用于自动识别呼吸道病毒

COVID-19 大流行极大地影响了体外诊断市场，促进了即时检测 (POCT)、多重检测和数字健康平台等新技术的发展。在这项研究中，我们提出了一种独立的微流控芯片，与基于物联网 (IoT) 的护理点 (POC) 设备集成，用于快速、灵敏地诊断呼吸道病毒。我们的平台通过自动化 RNA 提取、逆转录环介导的等温扩增 (RT-LAMP) 和荧光检测，可在 70 分钟内实现从样本到答案的诊断。微流控芯片旨在存储整个诊断测定所需的所有试剂，包括裂解缓冲液、洗涤缓冲液、洗脱缓冲液和冻干 RT-LAMP 混合物。它可以在多个反应室中进行核酸提取、等分和基因扩增，而不会交叉污染。基于物联网的 POC 设备由用于设备控制和数据处理的 Raspberry Pi 4、用于测量荧光信号的 CMOS 传感器、用于温度控制的电阻加热器面板以及用于控制片上试剂溶液运动的电磁阀组成。所提出的设备是便携式的，并具有用于用户控制和结果显示的触摸屏。我们使用 11 个临床呼吸道病毒样本评估了该平台的性能，其中包括 5 个 SARS-CoV-2 样本、2 个甲型流感样本和 4 个乙型流感样本。所有测试的临床样本均被准确识别，具有高特异性和保真度，证明了同时检测多种呼吸道病毒的能力。集成微流控芯片与 POC 设备的结合提供了一种简单、经济高效且可扩展的解决方案，可在资源有限的环境中对呼吸道病毒进行快速分子诊断。