Department of Laboratory Medicine, University Hospital Leuven, Leuven, Belgium.
Clin Chim Acta. 2010 Feb;411(3-4):147-54. doi: 10.1016/j.cca.2009.10.018. Epub 2009 Oct 25.
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.
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.
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.
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.
我们评估了 sediMAX（77 Elektronika，布达佩斯，匈牙利）的分析和诊断性能，这是一种新的基于自动化显微镜图像的尿液沉淀物分析仪（在某些国家也称为 Urised），并将其与视觉相差显微镜进行了比较。
根据既定的指南进行了精密度、线性、携带污染和方法比较。使用来自两个中心（n(1)=910，n(2)=1233）的结果评估了与视觉相差显微镜的诊断性能。在中心 1 中使用未经离心的尿液样本进行视觉显微镜检查，而在中心 2 中使用尿液沉淀物。
在 18xE6 RBC/L 和 447xE6 RBC/L 时，RBC 的批内精密度分别为 17.8%和 6.7%，在 4xE6 WBC/L 和 258xE6/L 时，WBC 的批内精密度分别为 17%和 4.4%。在 30xE6/L 时，RBC 的批间不精密度为 14.7%，在 283xE6/L 时为 7.2%。在 25xE6/L 时，WBC 的批间不精密度为 5.4%，在 166xE6/L 时为 3%。在两项研究中，RBC、WBC、鳞状上皮细胞、酵母和草酸钙晶体的 ROC 曲线下面积（AUC）均为 80-90%。非鳞状上皮细胞和病理性透明管型的 AUC 范围为 73-74%。没有携带污染。
sediMAX 能够很好地计数和识别 RBC、WBC、鳞状上皮细胞、酵母、细菌和草酸钙晶体。对病理性管型和非鳞状上皮细胞的识别是足够的，但需要改进。
