Development of a Lateral Flow Immunoassay Strips for Rapid Antigen Detection of Dabie bandavirus

This study reports the development of a point-of-care (POC) serological assay for the detection of the Dabie bandavirus (DBV) infection. Specifically, this assay is based on the principle of lateral flow immunoassay (LFIA) strips. Two monoclonal antibodies against DBV were generated. They showed an optimal pairing. One mAb, named NP-10, was immobilized on the strip surface as the capture antibody. The other mAb, named NP-20, was labeled with colloidal gold nanoparticles (AuNPs) and used as the detector antibody. A series of parameters of this method were optimized during the AuNPs-mAb immune complex conjugating process, including the different pairing of antigens and antibodies, pH value, and the amount of coupled antibody. The whole detection process was completed within 15 min using 70 μL of the analyte solution, which consisted of 10 μL of sample and 60 μL of dilution buffer. The performance of the established assay was evaluated by using serum samples of DBV-infected individuals. It showed 90.9% clinical diagnostic sensitivity and 100% specificity with a κ coefficient of 0.929. The results demonstrated that our designed LFIA strips (LFIAs) used for DBV infection detection exhibited stable performance and reproducible outcomes. Consequently, this rapid and user-friendly LFIA can furnish physicians with preliminary test results. This enables them to make accurate diagnoses of DBV infections by integrating these results with other testing methods and clinical manifestations.