The Performance evaluation of the Dirui MUS3600 and FUS3000Plus automated urine analyzers utilized in the AMS CMU EQA unit's urinalysis proficiency testing program

Background: Urinalysis is one of the essential laboratory tests for health checks, which requires highly skilled personnel. In medical laboratories, automated urine analyzers are crucial for reducing workloads compared to human methods. However, quality control is necessary to ensure their accuracy and precision. The Dirui MUS3600 and FUS3000Plus automated urinalysis analyzer models are also interested in taking part in the proficiency testing program, and the AMS CMU EQA unit has developed urine control materials for the Thai medical laboratory's urinalysis EQA program. Objective: The goal of this study was to evaluate the performance of the Dirui 3600 and FUS3000Plus urine analyzer models for usage in the AMS CMU EQA unit laboratory using method validation items. Materials and methods: Total of 724 urine samples were collected, and three in-house urine control levels were prepared. Imprecision, accuracy, comparison, and diagnostic performance tests were determined by using MUS3600 and FUS3000Plus compared with the microscopic examination as the standard method. Results: Both automated models provided excellent results of %CV of within day and between day running shows less than 10%. The agreement between automation and standard methods in physical, chemical, and sediment evaluation was 70-100%. The correlation coefficient for the RBC and WBC parameters compared with the manual microscope method ranged from r=0.88 to 0.93. Linearity results of both models show r=0.99 for RBCs and WBCs, respectively. Results of carry-over also show good reliability results below 0.005%. Moreover, the results of sensitivity and specificity in important urinary diseases indicate sediment for example RBC and WBC show more than 83% of overall results. Conclusion:The Dirui MUS3600 and FUS3000Plus models of urinalysis analyzers yielded good results, indicating that they are suitable for use in the future for the collection and preparation of specimens for QC material used in the proficiency program that should follow the standard procedure for EQA participants. In addition, both models can produce good urinalysis results in clinical laboratories.