Roh, Yeonjeong Baek, Yujin Kim, Myoung Gyu Koo, Bonhan Seo, Ramin Lee, Joonseok Jung, Seungwon Kim, Sang Kyung Bae, Moonsuk Lee, Chang-Seop Kim, Il-Hwan Shin, Yong 2025-03-23T12:00:14Z 2025-03-23T12:00:14Z 2025-03-19 2025-06 0925-4005 https://pubs.kist.re.kr/handle/201004/152082 Severe Fever with Thrombocytopenia Syndrome (SFTS), caused by the SFTS virus (SFTSV), is a tick-borne infectious disease prevalent in East Asia, characterized by acute fever and significant thrombocytopenia. Early and accurate diagnosis of SFTS is critical, particularly in rural areas where laboratory facilities are limited. Current diagnostic approaches, including RT-qPCR and immunological tests, face challenges due to their complexity, low sensitivity and the need for laboratory infrastructure. To address this, we developed a semi-automated diagnostic system for on-site testing of SFTS, integrating nucleic acid extraction with rapid, naked-eye detection using a reverse transcription loop-mediated isothermal amplification coupled with lateral flow assay. This system uses innovative SFTSV RNA reference materials encapsulated in virus-like particles, ensuring both stability and homogeneity, making them ideal for calibrating and validating diagnostic assays. Additionally, the semi-automated system, equipped with a microfluidic chip and optimized extraction processes, demonstrates a limit of detection (LOD) of 1.82 x 102 copies/mu L with SFTSV RNA reference materials. Finally, this system allows for the rapid and accurate detection of SFTSV RNA from 12 clinical specimens within 100 minutes, with results visible to the naked eye in just 2 minutes post-amplification. This system offers a practical solution for on-site SFTS diagnosis, particularly in resource-limited settings, and represents a significant advancement in the field of molecular diagnostics. English Elsevier BV Semi-automated diagnostic system and severe fever with thrombocytopenia syndrome (SFTS) viral RNA reference materials encapsulated in virus-like particles for on-site diagnosis of SFTS Article 10.1016/j.snb.2025.137530 1 Sensors and Actuators, B: Chemical, v.433 Sensors and Actuators, B: Chemical 433 N scie scopus 001437445000001 2-s2.0-85218916828 Chemistry, Analytical Electrochemistry Instruments & Instrumentation Chemistry Electrochemistry Instruments & Instrumentation Article DROPLET DIGITAL PCR LENTIVIRUS VECTOR INTERNATIONAL STANDARDS 1ST QUANTIFICATION OPTIMIZATION BUNYAVIRUS ESTABLISH QUALITY DNA Severe fever with thrombocytopenia syndrome Reference materials Virus-like particle On-site test Molecular diagnostics Naked-eye detection