Comparison of Cobas 6500 and Iris IQ200 fully-automated urine analyzers to manual urine microscopy

Introduction: Urine screening is achieved by either automated or manual microscopic analysis. The aim of the study was to compare Cobas 6500 and Iris IQ200 urine analyzers, and manual urine microscopic analysis. Materials and methods: A total of 540 urine samples sent to the laboratory for chemical and sediment analysis were analyzed on Cobas 6500 and Iris IQ200 within 1 hour from sampling. One hundred and fifty three samples were found to have pathological sediment results and were subjected to manual microscopic analysis performed by laboratory staff blinded to the study. Spearman's and Gamma statistics were used for correlation analyses, and the McNemar test for the comparison of the two automated analyzers. Results: The comparison of Cobas u701 to the manual method yielded the following regression equations: y = -0.12 (95% CI: -1.09 to 0.67) + 0.78 (95% CI: 0.65 to 0.95) x for WBC and y = 0.06 (95% CI: -0.09 to 0.25) + 0.66 (95% CI: 0.57 to 0.73) x for RBC. The comparison of IQ200 Elite to manual method the following equations: y = 0.03 (95% CI: -1.00 to 1.00) + 0.88 (95% CI: 0.66 to 1.00) x for WBC and y = -0.22 (95% CI: -0.80 to 0.20) + 0.40 (95% CI: 0.32 to 0.50) x for RBC. IQ200 Elite compared to Cobas u701 yielded the following equations: y = -0.95 (95% CI: -2.13 to 0.11) + 1.25 (95% CI: 1.08 to 1.44) x for WBC and y = -1.20 (95% CI: -1.80 to -0.30) + 0.80 (95% CI: 0.55 to 1.00) x for RBC. Conclusions: The two analyzers showed similar performances and good compatibility to manual microscopy. However, they are still inadequate in the determination of WBC, RBC, and EC in highly-pathological samples. Thus, confirmation by manual microscopic analysis may be useful.