Comparative performance analysis of urised 3 and DIRUI FUS-200 automated urine sediment analyzers and manual microscopic method

Abstract

Objective: Microscopic examination of urine sediment is necessary for evaluation of renal and urinary tract diseases. In this study, we evaluated and compared analytic and diagnostic performances of DIRUI FUS-200 and a new image-based automated urine sediment analyzer Urised 3. Method: A total of 440 urine samples, submitted to our laboratory, were evaluated by two automated urine sediment analyzers and a standardized manual microscopy. Precision, linearity and method comparison studies were performed according to CLSI guidelines. Results: Considering the red blood cell (RBC) and white blood cell (WBC) counts, strong correlations existed between FUS-200 and manual microscopy (r=0.993 vs 0.861), Urised 3 and manual microscopy (r=0.962 vs 0.818), FUS200 and Urised 3 (r=0.961 vs 0.961). Clinical non-concordance ranged from 7% to 14.16% among all methods. Conclusions: The concordance between the analyzers and manual microscopy for WBC was better than that of RBC. The concordance between the two analyzers was better for WBC and RBC, with respect to the manual microscopy. Although the Urised 3, FUS-200 and manual microscopy counts were in agreement; confirmation of the results of automated analyzers with manual microscopy is particularly helpful, for pathological samples with near cut-off values.