Clinical evaluation and comparative study of a fully automated erythrocyte osmotic fragility analysis system based on...

Accurate assessment of erythrocyte osmotic fragility (EOF) is essential for diagnosing hemolytic disorders, yet traditional methods are labor-intensive and time-consuming, limiting their clinical efficiency. This study aimed to evaluate the performance of a fully automated EOF analysis system developed by Shenzhen Pumen Technology Co., Ltd., which utilizes scatter turbidimetry, and to determine its accuracy and consistency compared with the conventional spectrophotometric method. A total of 114 whole blood samples were analyzed using the automated system with reagents from Changchun Huili Biotechnology Co., Ltd., and results were compared with those obtained from the Shimadzu UV-2450 spectrophotometer as the reference method. Consistency between the two systems was assessed using linear regression, Kappa statistics, Bland-Altman analysis, and medical decision level bias evaluation. The automated EOF system demonstrated a strong linear correlation with the reference method, achieving a Kappa value of 1.00, indicating complete agreement in classification results. Moreover, 99.11% of data points fell within acceptable ranges, and bias confidence intervals at the medical decision level were below threshold values. These findings indicate that the fully automated EOF system provides stable and reliable results that align with clinical needs and offer high consistency with traditional methods, supporting its potential for broader clinical application and promotion.