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
Within-run precision for RBC was 17.8 % and 6.7 % at 18 × E6 RBC/L and 447 × E6 RBC/L respectively and for WBC it was 17 % and 4.4 % at 4 × E6 WBC/L and 258 × E6/L respectively. Between-run imprecision for RBC was 14.7 % for 30 × E6/L and 7.2 % for 283 × E6/L. For WBC it was 5.4 % at 25 × E6/L and 3 % at 166 × E6/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.
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.