Development of a monoclonal antibody-based time-resolved fluorescence immunochromatographic assay strip for rapid and quantitative determination of S100B in serum.

Traumatic brain injury (TBI) represents a significant global health challenge requiring rapid and accurate diagnostic tools. S100 calcium-binding protein B (S100B) serves as a consensus-endorsed serum biomarker for TBI, but current detection methods lack the speed and simplicity needed for on-site clinical applications. This study reports the development of a time-resolved fluorescence immunochromatographic test strip (TRFIS) for rapid and quantitative serum S100B detection. High-affinity monoclonal antibodies against S100B were generated via hybridoma technology, and time-resolved fluorescent microspheres (TRFMs) were integrated with lateral flow immunoassay. The TRFIS demonstrated excellent analytical performance with a linear range of 15.6-1000 pg/mL (R2 = 0.9885), a detection limit of 12.6 pg/mL, and a test time of approximately 13 min. Intra- and inter-batch coefficients of variation were both < 10.0%, confirming high reproducibility. This platform offers high sensitivity, accuracy, and simplicity, making it potentially suitable for on-site TBI diagnosis in resource-limited healthcare settings.