BeadWatch: Automated Longitudinal Quality Control Monitoring for Luminex Bead-Based Immunoassays in...

Luminex bead-based immunoassays are central to HLA antibody testing in histocompatibility laboratories, yet QC monitoring remains largely manual. Although ISO 15189, EFI and ASHI standards require statistical trend analysis, laboratories typically rely on spreadsheet tracking or periodic visual inspection; these approaches can detect gross run failures but are poorly suited to surfacing gradual trends in instrument, reagent and operator performance. We developed BeadWatch, an open-source automated QC dashboard application that reads directly from vendor databases, applies Levey-Jennings charts with optional I-MR views, and includes cross-instrument and cross-operator comparison dashboards and configurable alerting. BeadWatch currently supports OneLambda HLA Fusion and deploys as a single portable application with no installation steps. Single-site deployment in our laboratory ingested approximately 20 years of historical data, revealing instrument lifecycle trajectories and a step change in instrument MFI following a platform transition-patterns consistent with known instrument behaviour but not previously documented. During prospective monitoring, an automated alert identified a pipetting error before the responsible operator had independently recognised the issue. BeadWatch is freely available at https://github.com/oxfordgenes/BeadWatch.