Supporting data for “Development and Clinical Validation of Novel Biomarkers for Early Diagnosis of Advanced Liver Fibrosis”

This study encompasses two principal objectives. The primary objective is to generate high-affinity monoclonal antibody pairs with optimal specificity for the establishment of a robust and reproducible immunoassay platform targeting human thrombospondin-2 (TSP2/THBS2) and CDCP1 (CUB domain-containing protein 1). The secondary objective involves validating the clinical utility of these biomarkers in discriminating advanced fibrosis stages, while concurrently integrating them with established clinical parameters to develop a multi-dimensional predictive algorithm. This translational research will be implemented across three distinct metabolic disorder cohorts: the HKWD-MASLD derivation cohort (n=846), the SPEED-Shunde validation cohort 1 (n=784), and the OCLH validation cohort 2 (n=223). The dataset includes monoclonal antibody development for immunoassay optimization, clinical validation of biomarker panels for metabolic associated steatohepatitis (MASH) diagnosis, and the creation of a hierarchical diagnostic algorithm for early detection of MASH progression.