Objective To reduce the variability in detection results and enhance the stability of product quality in fully automated flow cytometric fluorescence immunoassay analyzers by introducing robust parameter design.

Methods Applying the principles of robust parameter design, magnetic bead transfer rate was selected as the target characteristic. Magnetic rod retraction distance (A), adsorption cycles (B), and cleaning solution volume (C) were chosen as controllable factors, while environmental factors (temperature and humidity) served as noise factors and the tests were carried out by using orthogonal experimental design combined with the composite noise factor method. Results and Conclusion After optimizing the product design using robust design methods, the coefficient of variation (CV) in detection results decreased from approximately 3.08%~5.72% to 1.63%~2.93%. Robust parameter design substantially improved the stability of detection results, enhanced the overall quality of the product at the design stage, and proved to be a systematic, effective, and easily mastered design approach.