Design and fabrication of a disposable arc-shaped reagent cassette and an integrated nucleic acid rapid diagnostic device

Against the backdrop of accelerated globalization and aggravated climate change, the frequency and transmission risks of infectious disease outbreaks have significantly increased, posing a severe threat to public health security. Traditional pathogen diagnostic technologies, which rely on high-precision instruments, specialized personnel, and high-cost consumables, struggle to meet the demands for rapid response and on-site testing during public health emergencies. To address this challenge, this study proposes a low-cost, portable pathogen diagnostic system aimed at enhancing the capability of on-site detection for infectious diseases. The system consists of a disposable arc-shaped assay disc (DASRC) and an integrated nucleic acid rapid diagnostic device (INARDD), which integrates magnetic bead-based nucleic acid extraction technology and loop-mediated isothermal amplification (LAMP) to achieve full-process automation from sample processing to result determination. The system completes nucleic acid extraction, transfer, purification, amplification, and detection within 60 minutes, with no manual intervention required. It achieves a detection sensitivity of 10 2 copies/μL. Key components of the system can be rapidly prototyped using small-scale CNC milling machines and 3D printing technology, significantly reducing production barriers. The total system cost is approximately 560 CNY, with consumables for a single test costing only 10 CNY. The device weighs about 2 kilograms and operates without an external power source. Its compact size and operational simplicity markedly enhance the feasibility of on-site testing, offering an efficient and cost-effective solution for combating infectious disease transmission.