Development and Application of a Time-Resolved Fluorescence Immunoassay for Quantification of Rabies Virus Glycoprotein Antigen

Abstract

Objective: To establish and validate a time-resolved fluorescence immunoassay (TRFIA) for quantifying rabies virus glycoprotein antigen, thereby enhancing the quality control capabilities of rabies vaccines. Methods: A novel detection method was developed using a TRFIA-based kit. The kit's performance was comprehensively evaluated through method validation and comparative analysis against results obtained from an enzyme-linked immunosorbent assay (ELISA) kit. Results: The TRFIA method met all predetermined validation criteria. Assay results demonstrated a strong correlation with ELISA outcomes, while providing a broader quantitative range, greater resistance to interference, and superior methodological robustness. Conclusion: The TRFIA-based method for rabies virus glycoprotein quantification delivers reliable quality control results when applied to in-process samples and final rabies vaccine products..