A Performance Evaluation of Sysmex UF-4000 Automated Urine Sediment Analyzer and Advances and Applications of Comparison Schemes on Urine Cell Counting
Objective To evaluate the performance of UF-4000 automated urine sediment analyzer,and to evaluate the consistency of urine red blood cell(RBC)and white blood cell(WBC)counts between the two methods,and to further provide a reference basis for the establishment of a comparison protocol in our laboratory.Methods According to the requirements of CNAS-CL02-A002:2018:Accreditation Criteria for the Quality and Ability of Medical Laboratories,the performance evaluation of UF-4000 automated urine sediment analyzer was validated.According to the urine cell counting guidance scheme of the National Clinical Laboratory Operating Procedures,120 fresh midstream urine samples were collected from Outpatients and Inpatients Departments in Maanshan People's Hospital from October,2021 to July,2022.For the comparative analysis,the quantitative method of non-centrifugal fresh urine counter plate was used as the reference method,and the urine sediment analyzer method was used as the evaluation method.Passing-Bablok regression analysis was used for model fitting,and Wilcoxon signed rank test and Spearman correlation analysis were performed,and Bland-Altmen difference plots was used to evaluate levels of agreement.Results The precision,accuracy,carrying contamination rate,linear and clinically reportable range,and reference interval validation of UF-4000 urine sediment analyzer met the standard requirements.In the range of 22.50-1075.47/μL,the results of RBC detected by the two methods were consistent(Y=3.077+0.966X,r=0.993).There was no statistically significant difference between results of the two groups(Z=-1.298,P=0.194).The ratio Bland-Altmen method was used to analyze RBC data,and 100％of the points were within the 95％limits of agreement.In the range of 27.97-603.76/μL,the results of WBC detected by the two methods were consistent(Y=-2.387+1.037X,r=0.993).There was no statistically significant difference between results of the two groups(Z=-0.935,P=0.350).The ratio Bland-Altmen method was used to analyze WBC data,and 98.33％of the points were within the 95％limits of agreement.Conclusion The UF-4000 automated urine sediment analyzer exhibits commendable performance in this study,demonstrating comparable detection capability of RBC and WBC to the reference method,thereby ensuring a high accuracy and consistency.Consequently,it can adequately fulfill the requirements of clinical testing.
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