Automation and performance validation of the pooled donor basophil activation test for chronic urticaria using the...

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.