Linko Solveig, Kouri Timo T, Toivonen Eila, Ranta Paivi H, Chapoulaud Eric, Lalla Martti
Hospital District of Helsinki and Uusimaa, Helsinki University Central Hospital, HUSLAB, Helsinki, Finland.
Clin Chim Acta. 2006 Oct;372(1-2):54-64. doi: 10.1016/j.cca.2006.03.015. Epub 2006 May 11.
We evaluated the Iris iQ200 Automated Urine Microscopy Analyzer to find out if the instrument performed better than traditional visual bright field microscopy in detecting basic urine particles, as assessed against reference phase contrast microscopy.
The HUSLAB quality system was followed in planning and completing the evaluation process. The iQ200 instrument results from 167 mid-stream, uncentrifuged urine specimens were compared to those obtained with phase contrast reference microscopy, and to those with routine bright field microscopy. Linearity, carry-over and precision were tested according to well-established protocols.
The iQ200 counted erythrocytes (RBC) at r=0.894 (R(2)=0.799) with Automated Particle Recognition (APR) software alone and at r=0.948 (R(2)=0.898) after re-classification. The performance for leukocytes (WBC) was r=0.885 with APR and r=0.978 after re-classification. The correlations of counting after user re-classification were r=0.927 for squamous epithelial cells (SQEP), r=0.856 for casts, and r=0.706 for non-squamous epithelial cells. The iQ200 showed good linearity and precision and no carry-over was detected.
The Iris iQ200 was capable to count reliably RBC, WBC, and SQEP cells and to identify a fraction of bacteria and renal elements. Counting results equalled or exceeded that of routine bright field microscopy or earlier flow cytometric technology. The instrument eliminates manual sample preparation but requires a well-trained technologist for re-grouping of findings.
我们对Iris iQ200全自动尿液显微镜分析仪进行了评估，以确定该仪器在检测基本尿液颗粒方面是否比传统的视觉明场显微镜表现更好，并以参考相差显微镜进行评估。
在规划和完成评估过程时遵循了HUSLAB质量体系。将167份中段未离心尿液标本的iQ200仪器结果与相差参考显微镜以及常规明场显微镜获得的结果进行比较。根据既定方案测试线性、残留和精密度。
仅使用自动颗粒识别（APR）软件时，iQ200对红细胞（RBC）计数的相关系数r = 0.894（R² = 0.799），重新分类后为r = 0.948（R² = 0.898）。对白细胞（WBC）计数的性能，APR时r = 0.885，重新分类后为r = 0.978。用户重新分类后计数的相关性，鳞状上皮细胞（SQEP）为r = 0.927，管型为r = 0.856，非鳞状上皮细胞为r = 0.706。iQ200显示出良好的线性和精密度，未检测到残留。
Iris iQ200能够可靠地计数红细胞、白细胞和鳞状上皮细胞，并识别一部分细菌和肾脏成分。计数结果等于或超过常规明场显微镜或早期流式细胞术技术。该仪器无需手动样本制备，但需要训练有素的技术人员对结果进行重新分组。
