Establishment of a rapid detection method for severe fever with thrombocytopenia syndrome virus based on reverse transcription-recombinase polymerase amplification with lateral flow nucleic acid chromatography assay technology.

INTRODUCTION: Severe fever with thrombocytopenia syndrome virus (SFTSV), a novel bunyavirus associated with febrile illness, thrombocytopenia, and leukopenia, represents a considerable public health threat. METHODS: In this study, we developed a visual detection platform for SFTSV by integrating reverse transcription-recombinase polymerase amplification (RT-RPA) with lateral flow nucleic acid chromatography assay (LFNA). The method operates under isothermal conditions, and delivers results within 40 minutes. Using a conserved region of the S segment as the amplification target. RESULTS: The assay demonstrated a detection limit of 101 copies/μL and showed no cross-reactivity with 12 other common clinical pathogens or 6 less common clinical pathogens. An evaluation of 80 SFTSV-positive clinical samples and 16 SFTSV-negative clinical samples showed that, compared with quantitative PCR (qPCR), the method demonstrated excellent sensitivity and specificity. DISCUSSION: The RT-RPA-LFNA platform is easy to operate, provides rapid results and is cost-effective, and therefore has potential for use in point-of-care testing (POCT), particularly in resource-limited primary healthcare settings. This approach not only provides a reliable tool for SFTSV diagnosis but also holds potential for the detection of other pathogens.