<p>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 (<i>R</i><sup>2</sup> = 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 &lt; 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.</p> Graphical abstract <p></p>

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

  • Rui Feng,
  • Yupeng Wang,
  • Yonghua Chen,
  • Tianxu Li,
  • Houfeng Zhou,
  • Zhenye Zhan,
  • Yuying He,
  • Xialin Tang,
  • Jianfen Su,
  • Yuhuai Guo,
  • Xiaomin Chen,
  • Jie Zan

摘要

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.

Graphical abstract