SULM – Schweizerische Union für Labormedizin | Union Suisse de Médecine de Laboratoire | Swiss Union of Laboratory Medicine

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EI Minder1 , B Raeber1 , K Vesztergomi1 , W Bechel2 , R Bergner2 , M von Wyl2

1Stadtspital Triemli, 8063 Zürich, Switzerland, 2Roche Instrument Center, 6343 Rotkreuz, Switzerland

Urisys® 1800, a new urine analyzer for multiple reagent test strips (Combur10Test® M; Combur9 Test® M) relies on reflectance photometry with improved illumination of test strip areas. Touch screen display, clearly arranged user interface and continuous test strip loading was intended to improve functionality. The study objectives focused on performance and practicability of the new analyzer.
Methods: The assessment included precision, recovery of control material, calibration stability, color rating and result comparison with different reference methods. Practicability in different working scenarios under routine simulating conditions was evaluated by a detailed questionnaire comparing Urisys® 1800 with the currently used routine instrument. Reliability and robustness was checked during the whole evaluation phase.
Results: 99% of results met pre-defined specifications. Calibration was stable for at least four weeks. Daily measurements of controls with normal and abnormal concentration confirmed the stability and accuracy of the analyzer. Results from commercial control material assayed were within claimed ranges. Intra- and inter-assay SD’s for controls and human samples ranged from 0.2 – 5.7% indicating high precision.
Glucose and protein determinations correlated with clinical chemistry analyzers
(Gluc:Y= -15.7 Ln(X)+115, r=0.95, n=550), urine color determinations with visual rating (> 75%). Lower concordance to flow cytometry and microscopic analysis was attributable to limited comparability of methods. The quality of experimental data was equal between the evaluation sites emphasizing reproducibility and robustness of system production. Practicability was rated as highly reliable, robust and easy in off-line and on-line usage.
Conclusion: The evaluation of the new Urisys® 1800 demonstrated accurate, precise and stable performance of the instrument. Higher throughput and convenient operation improves user friendliness compared to previously available analyzers.

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