Performance evaluation of the new fully automated urine particle analyser UF-5000 compared to the reference method of the Fuchs-Rosenthal chamber

•Urine particles analysis•Automated analysis of urine sediment•Verification of UF-5000 diagnostic performance•Comparison between UF-5000 and Fuchs Rosenthal chamber count

BackgroundUF-5000 is the new fully automated urine particle analyser. We validated its performance.Methods736 urines were analysed and results were compared by two pathologists on uncentrifuged samples, using Fuchs-Rosenthal chamber.ResultsAUC of ROC curve ranged between 0.86 and 0.99. Sensitivity was > 0.90 for all the elements and similar for RBC and yeasts. Specificity ranged between 0.74 and 0.89 for total cast, epithelial/non-squamous/renal-tubular cells and RBC. For all the other parameters specificity was > 0.90. Comparison with Fuchs-Rosenthal chamber was very good for all the parameters; r ranged between 0.52 and 0.99 except for pathological cast because of the lack of the pathological samples in medium and higher ranges. Linearity performance (R2) was 1.00, 1.00 and 0.99 respectively for RBC, WBC and epithelial cells (EC). No carry-over was observed. The within-run imprecision was 25.42%,13.81%,1.36% for RBC; 37.50%,10.16%,1.41% for WBC and 35.25%, 17.85%,6.30% for EC at low, near the cut off level and high concentrations, respectively. The between-run imprecision was 6.90%,1.60% for RBC, 4.10%,1.90% for WBC and 7.60%,7.30% for EC, using low and high positive quality controls, respectively.ConclusionUF-5000 is an analyser of great interest to detect urine particle related to pathological process of kidney and urinary tract.