Background: Urinalysis is a high demand procedure, with a large amount of manual labor and poorly standardized. Recently a new walk-away automated urine analyzer has been introduced. The aim of this study was to evaluate the performance of UriSed as an alternative to the microscopic analysis of urine samples. Methods: Four hundred mid-stream urine samples from patients with several clinical conditions were analyzed by bright field microscopy and by UriSed. The validation protocol included studies of precision, carryover, and comparison with the gold standard microscopy. Results: Our data showed that UriSed is a precise method. Repeatability and reproducibility ranged from 8 to 15%. Carryover was negligible. All the elements showed good agreement between both methods, with an extremely high correlation between the erythrocyte and leukocyte counts (r > 0.95) Conclusions: UriSed is a precise and accurate alternative to microscopy that allows a better workflow and may significantly improve turnaround time.604693697Winkel, P., Statland, B.E., Jorgenson, J., Urine microscopy: An ill-defined method examined by a multifactorial technique (1974) Clin Chem, 20, pp. 436-439Delanghe, J.R., Kouri, T.T., Huber, A.R., The role of automated urine particle flow cytometry in clinical practice (2000) Clinica Chimica Acta, 301, pp. 1-18Langlois, M.R., Delanghe, J.R., Steyaert, S.R., Everaert, K.C., De Buyzere, M.L., Automated flow cytometry compared with an automated dipstick reader for urinalysis (1999) Clinical Chemistry, 45, pp. 1118-1122Block, D.R., Lieske, J.C., Automated urinalysis in the clinical lab (2012) Medical Laboratory Observer, 44 (10), pp. 8-10Barta, Z., Tünde, K., Bayer, G., UriSed technology - A standardised automatic method of urine sediment analysis (2011) European Infectious Disease, 5 (2), pp. 139-142Evaluation of precision performance of quantitative measurement methods (2004) CLSI Document EP05-A2, , Clinical and Laboratory Standards Institute. Wayne, PA, USA: CLSIUser verification of performance for precision and truenessapproved guideline (2005) CLSI Document EP15-A2, , Clinical and Laboratory Standards Institute. second edition. Wayne, PA, USA: CLSIGuidelines for the evaluation of blood cell analysers including those used for differential leucocyte and reticulocyte counting and cell marker applications (1994) Clin Lab Haemat, 16, pp. 157-174. , International Council for Standardization in HaematologySzwed, J.J., Schaust, C., The Importance of microscopic examination of the urinary sediment (1982) American Journal of Medical Technology, 48 (2), pp. 141-143Shaw Jr., S.T., Poon, S.Y., Wong, E.T., "Routine urinalysis": Is the dipstick enough? (1985) JAMA, 253, pp. 1596-1600Resnick, M., Comment on simplifying urinalysis (1985) Clin Chem, 31, pp. 450-451Wald, R., Bell, C.M., Nisenbaum, R., Interobserver reliability of urine sediment interpretation (2009) Clin J Am Soc Nephrol, 4, pp. 567-571Tsai, J.J., Yeun, J.Y., Kumar, V.A., Don, B.R., Comparison and interpretation of urinalysis performed by a nephrologist versus a hospital-based clinical laboratory (2005) American Journal of Kidney Diseases, 46 (5), pp. 820-829Akin, O.K., Serdat, M.A., Cizmeci, Z., Comparison of LabUMat-with-UriSed and iQ®200 fully automatic urine sediment analysers with manual urine analysis (2009) Biotechnol Appl Biochem, 53, pp. 139-144Block, D.R., Lieske, J.C., Automated urinalysis in the clinical lab (2012) MLO Med Lab Obs, 44 (10), pp. 8-10+12. , quiz 14Mayo, S., Acevedo, D., Quiñones-Torrelo, C., Canós, I., Sancho, M., Clinical laboratory automated urinalysis: Comparison among automated microscopy, flow cytometry, two test strips analyzers, and manual microscopic examination of the urine sediments (2008) J Clin Lab Anal, 22 (4), pp. 262-270Zaman, Z., Fogazzi, G.B., Garigali, G., Urine sediment analysis: Analytical and diagnostic performance of sediMAX® - A new automated microscopy image-based urine sediment analyser (2010) Clinica Chimica Acta, 411, pp. 147-154Jiang, T., Chen, P., Ouyang, J., Zhang, S., Cai, D., Urine particles analysis: Performance evaluation of Sysmex UF-1000i and comparison among urine flow cytometer, dipstick, and visual microscopic examination (2011) Scand J Clin Lab Invest, 71 (1), pp. 30-37Manoni, F., Tinello, A., Fornasiero, L., Urine particle evaluation: A comparison between the UF-1000i and quantitative microscopy (2010) Clin Chem Lab Med, 48 (8), pp. 1107-1111Manoni, F., Gessoni, G., Alessio, M.G., Mid-stream vs. first-voided urine collection by using automated analyzers for particle examination in healthy subjects: An Italian multicenter study (2011) Clin Chem Lab Med, 50 (4), pp. 679-684