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

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 Chlamydia trachomatis and Neisseria gonorrhoeae (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.