Urine sediment analysis: Analytical and diagnostic performance of sediMAX - a new automated microscopy image-based urine sediment analyser.
BACKGROUND
We evaluated the analytical and diagnostic performance of sediMAX (77 Elektronika, Budapest, Hungary), a new automated microscopy image-based urine sediment analyser (which in some countries is also called Urised) in comparison with visual phase-contrast microscopy.


METHODS
Precision, linearity, carry-over and method comparison were carried out according to well-established guidelines. The diagnostic performance with respect to visual phase-contrast microscopy was evaluated with results from two centres (n(1)=910, n(2)=1233). Uncentrifuged urine samples were used in visual microscopy in centre 1, while urine sediments were used in centre 2.


RESULTS
Within-run precision for RBC was 17.8% and 6.7% at 18xE6 RBC/L and 447xE6 RBC/L respectively and for WBC it was 17% and 4.4% at 4xE6 WBC/L and 258xE6/L respectively. Between-run imprecision for RBC was 14.7% for 30xE6/L and 7.2% for 283xE6/L. For WBC it was 5.4% at 25xE6/L and 3% at 166xE6/L. In both studies areas under ROC curves (AUC) were 80-90% for RBC, WBC, squamous epithelial cells, yeast and calcium-oxalate crystals. For non-squamous epithelial cells and pathological and hyaline casts the AUC ranged 73-74%. There was no carry-over.


CONCLUSIONS
The sediMAX is well able to count and identify RBC, WBC, squamous epithelial cells, yeast, bacteria and calcium-oxalate crystals. Recognition of pathological casts and non-squamous epithelial cells is adequate but needs to be improved.
Department of Laboratory Medicine, University Hospital Leuven, Leuven, Belgium. Zahur.Zaman@uz.leuven.be
Zahur
Z
Zaman
Giovanni Battista
GB
Fogazzi
Giuseppe
G
Garigali
Maria Daniela
MD
Croci
Gabor
G
Bayer
Tunde
T
Kránicz
D001331:Automation; D004847:Epithelial Cells / Q000378:metabolism; D004912:Erythrocytes / Q000378:metabolism; D006801:Humans; D006818:Hyalin / Q000378:metabolism; D007962:Leukocytes / Q000378:metabolism; D016014:Linear Models; D008853:Microscopy; D016482:Urinalysis / Q000379:methods*; D014556:Urine / Q000737:chemistry / Q000382:microbiology