Performance verification of the new UF-1500 urine particle analyser: a new opportunity for small and medium laboratories.

BACKGROUND

The UF-1500 is the new fully automated urine particle analyser by Sysmex specifically tailored for small and medium laboratories. This study aim to validate its analytical and diagnostic performance.

METHODS

754 first morning mid-stream urines were analysed on UF-1500; 550 samples were used for the UF-5000 comparison and 204 were used for the correlation with manual count on Fuchs-Rosenthal chamber. Carry-over, linearity and imprecision of the UF-1500 were also assessed.

RESULTS

Correlation with the UF-5000 was excellent, with coefficient range between 0.88 and 1.00. Correlation with Fuchs-Rosenthal chamber was very good for all the parameters; ranged between 0.67 and 0.94. Linearity regression coefficient of determination (R) was excellent for almost all the parameters. No carry-over was observed. The within-run imprecision range between 2.93 % for RBC and 35.63 % for WBC. The between-run imprecision ranged between 2.1 % for RBC and 23.9 % for CAST, using low and high positive quality controls, respectively.

CONCLUSION

The analytical and diagnostic performance is satisfactory for almost all the parameters, when compared with the UF-5000; the correlation with the reference method is equally good.