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

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M SIKIRICA1 , T BOBETIC-VRANIC1 , Z FLEGAR-MESTRIC1

1Institute of Clinical Chemistry, «Merkur» University Hospital, Zagreb, Croatia

Objective. Quality specifications of iQ 200 Automated Urine Microscopy Analyzer and comparison with Manual Microscopy of Supravitally Stained Specimens.
Methods. iQ 200 Microscopy Analyzer, FDA and TÜV (EN ISO 13485:2000) certified, uses digital imaging and Auto Particle Recognition (APR) software to autoclassify urine particles into twelve categories: erythrocytes (RBC), leukocytes (WBC), leukocytes –clump, squamous epithelial cells (SEC), non-squamos epithelial cells as small round cells (SRC), hyaline casts, unclacssified casts, crystals, sperm, yeast, bacteria and mucus. 350 specimens were compared in most frequent clinically relevant urine particles by iQ 200 Micriscopy Analyzer with manual microscopy of stained specimens according to the European Urinalysis Guidelines.
Results. Regression statistics: for RBC y=0.691x+2.70 r=0.973; for WBC y=0.838x -1.42 r=0.977; for SEC y=1.107x+4.13 r=0.936; for SRC y=1.147x+0.99 r=0.703 and for casts y=0.936x+0.69, r=0.845. The within-run imprecision based on ten measurements of suspension of fixed red blood cells was for positive control (1000 particles/µL) CV=1,80%, for mean control (500 particles /µL) CV=2,70%, while it was in the declared ranges for the negative control. Between-days imprecision measured during 40 days was for the positive control CV=1.87% while it was in the declared ranges for the negative control. The linearity was estimated in five concentration ranges and it was higher than 1000 particles /µL. Carryover was negligible.
Conclusion. Analyzer is capable of performing the quantification of microscopic elements in urine on basic level of differentiation on user-defined criteria but subclassification of cell types is rough estimation. Further improvement of software is needed for subclassification of special urine particles. For now, visual microscopic review should be performed. iQ 200 Microscopy Analyzer offers considerable savings in time and achieve a high degree of standardization in urinalysis.

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