Automation and performance validation of the pooled donor basophil activation test for chronic urticaria using the Hamilton STAR system

This study presents the automation of the pooled donor basophil activation test (PD-BAT) for chronic urticaria, transitioning from a previously published manual assay in tubes to an automated 96-well plate format using the Hamilton Microlab STAR system. The primary aim is to enhance throughput and robustness in a commercial lab environment while maintaining assay accuracy and reproducibility. Donor screening included 36 individuals, of which 16 were selected for pooled assays. A total of 90 sera were analyzed in parallel by manual and automated methods. The automated PD-BAT demonstrated 93.3% qualitative agreement (r > 0.97) with the manual assay. Throughput improved through automation, a 66% reduction in hands-on time was observed between the manual (9 h/batch) and automated (3 h/batch) methods. Discordant results (6.7%) occurred only near the technical cutoff, highlighting both the robustness and limitations of the method. This automation represents a valuable advancement over the manual assay, optimizing laboratory workflows.