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用于全自动即时分子诊断设备的物联网医疗架构。

IoMT Architecture for Fully Automated Point-of-Care Molecular Diagnostic Device.

作者信息

Kim Min-Gin, Kil Byeong-Heon, Ryu Mun-Ho, Kim Jong-Dae

机构信息

Thermo Fisher Scientific, South San Francisco, CA 90080, USA.

School of Software, Hallym University, Chuncheon-si 24252, Republic of Korea.

出版信息

Sensors (Basel). 2025 Jul 16;25(14):4426. doi: 10.3390/s25144426.


DOI:10.3390/s25144426
PMID:40732552
Abstract

The Internet of Medical Things (IoMT) is revolutionizing healthcare by integrating smart diagnostic devices with cloud computing and real-time data analytics. The emergence of infectious diseases, including COVID-19, underscores the need for rapid and decentralized diagnostics to facilitate early intervention. Traditional centralized laboratory testing introduces delays, limiting timely medical responses. While point-of-care molecular diagnostic (POC-MD) systems offer an alternative, challenges remain in cost, accessibility, and network inefficiencies. This study proposes an IoMT-based architecture for fully automated POC-MD devices, leveraging WebSockets for optimized communication, enhancing microfluidic cartridge efficiency, and integrating a hardware-based emulator for real-time validation. The system incorporates DNA extraction and real-time polymerase chain reaction functionalities into modular, networked components, improving flexibility and scalability. Although the system itself has not yet undergone clinical validation, it builds upon the core cartridge and detection architecture of a previously validated cartridge-based platform for and (CT/NG). These pathogens were selected due to their global prevalence, high asymptomatic transmission rates, and clinical importance in reproductive health. In a previous clinical study involving 510 patient specimens, the system demonstrated high concordance with a commercial assay with limits of detection below 10 copies/μL, supporting the feasibility of this architecture for point-of-care molecular diagnostics. By addressing existing limitations, this system establishes a new standard for next-generation diagnostics, ensuring rapid, reliable, and accessible disease detection.

摘要

医疗物联网(IoMT)正在通过将智能诊断设备与云计算和实时数据分析相结合,彻底改变医疗保健行业。包括COVID-19在内的传染病的出现,凸显了快速和分散诊断以促进早期干预的必要性。传统的集中式实验室检测会带来延迟,限制及时的医疗响应。虽然即时分子诊断(POC-MD)系统提供了一种替代方案,但在成本、可及性和网络效率方面仍存在挑战。本研究提出了一种基于IoMT的全自动POC-MD设备架构,利用WebSocket进行优化通信,提高微流控芯片效率,并集成基于硬件的模拟器进行实时验证。该系统将DNA提取和实时聚合酶链反应功能整合到模块化、网络化组件中,提高了灵活性和可扩展性。尽管该系统本身尚未经过临床验证,但它基于先前经过验证的基于芯片的 和 (CT/NG)平台的核心芯片和检测架构构建。选择这些病原体是因为它们在全球的流行情况、高无症状传播率以及在生殖健康中的临床重要性。在先前一项涉及510份患者样本的临床研究中,该系统与一种商业检测方法显示出高度一致性,检测限低于10拷贝/μL,支持了这种架构用于即时分子诊断的可行性。通过解决现有局限性,该系统为下一代诊断建立了新标准,确保快速、可靠且可及的疾病检测。

相似文献

[1]
IoMT Architecture for Fully Automated Point-of-Care Molecular Diagnostic Device.

Sensors (Basel). 2025-7-16

[2]
Technologies for Interoperable Internet of Medical Things Platforms to Manage Medical Emergencies in Home and Prehospital Care: Scoping Review.

J Med Internet Res. 2025-1-23

[3]
A hybrid fog-edge computing architecture for real-time health monitoring in IoMT systems with optimized latency and threat resilience.

Sci Rep. 2025-7-15

[4]
Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.

Cochrane Database Syst Rev. 2022-7-22

[5]
The effect of sample site and collection procedure on identification of SARS-CoV-2 infection.

Cochrane Database Syst Rev. 2024-12-16

[6]
Enhancing remote patient monitoring with AI-driven IoMT and cloud computing technologies.

Sci Rep. 2025-7-5

[7]
Clinical evaluation of two commercial PCR kits for the detection of nonviral sexually transmitted infections.

J Med Microbiol. 2025-7

[8]
Blockchain-Based Trust Management Framework for Cloud Computing-Based Internet of Medical Things (IoMT): A Systematic Review.

Comput Intell Neurosci. 2022

[9]
PD-LAMP smartphone detection of SARS-CoV-2 on chip.

Anal Chim Acta. 2022-4-22

[10]
A secured remote patient monitoring framework for IoMT ecosystems.

Sci Rep. 2025-7-2

本文引用的文献

[1]
Performance Evaluation of the LabGenius C-CT/NG-BMX Assay for and Detection.

Ann Lab Med. 2025-3-1

[2]
Microfluidic methods for the diagnosis of acute respiratory tract infections.

Analyst. 2024-12-16

[3]
Molecular point-of-care devices for the diagnosis of infectious diseases in resource-limited settings - A review of the current landscape, technical challenges, and clinical impact.

J Clin Virol. 2023-12

[4]
Current Technologies for Detection of COVID-19: Biosensors, Artificial Intelligence and Internet of Medical Things (IoMT): Review.

Sensors (Basel). 2022-12-30

[5]
Artificial Intelligence (AI) and Internet of Medical Things (IoMT) Assisted Biomedical Systems for Intelligent Healthcare.

Biosensors (Basel). 2022-7-25

[6]
REASSURED Multiplex Diagnostics: A Critical Review and Forecast.

Biosensors (Basel). 2022-2-16

[7]
Cloud-Based Software Architecture for Fully Automated Point-of-Care Molecular Diagnostic Device.

Sensors (Basel). 2021-10-21

[8]
An internet of things-based point-of-care device for direct reverse-transcription-loop mediated isothermal amplification to identify SARS-CoV-2.

Biosens Bioelectron. 2022-1-1

[9]
Point of care testing for infectious disease: ownership and quality.

J Antimicrob Chemother. 2021-9-23

[10]
Economic impact of COVID-19 pandemic on healthcare facilities and systems: International perspectives.

Best Pract Res Clin Anaesthesiol. 2021-10

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