Advances in Immunoassays for detection of pancreatitis biomarkers

Abstract

Pancreatitis is a predominant cause of gastrointestinal morbidity. However, the early and accurate detection of biomarkers, which is essential for guiding risk stratification and therapeutic decision-making, is constrained by the sensitivity and throughput limitations of conventional assays. This review critically examines advances in immunoassay technologies, including high-sensitivity lipase and amylase ELISAs, chemiluminescence and time-resolved fluorescence formats, label-free plasmonic sensors, digital single-molecule platforms, and multiplex bead-based and microarray systems, as applied to pancreatitis biomarker quantitation. This study synthesizes data on classical enzymatic markers, such as lipase and amylase, established proteins, including C-reactive protein and trypsinogen activation peptide, and emerging molecular targets, such as cytokines, DAMPs, and microRNAs. The focus is on evaluating analytical performance metrics, including sensitivity, specificity, dynamic range, precision, and robustness, along with preanalytical factors and clinical applications. These components are analyzed in relation to early diagnosis, assessment of severity, and evaluation of therapeutic response. Current challenges in assay standardization, head-to-head validation, and preanalytical variability are highlighted, and the potential of microfluidic “lab-on-a-chip” and point-of-care platforms is explored. This review effectively integrates advanced immunoassay modalities with the performance of pancreatitis-specific biomarkers, thereby uniquely linking technological innovation to clinical applicability. This study aims to offer a prioritized roadmap for the development and implementation of standardized multiplexed assays in personalized pancreatitis diagnostics.