Dias V C, Moschopedis T, Prosser C, Yatscoff R W
Department of Laboratory Medicine and Pathology, Faculty of Medicine, University of Alberta, Edmonton, Canada.
Clin Biochem. 1996 Jun;29(3):217-23. doi: 10.1016/0009-9120(96)84727-9.
To evaluate the performance of a new, benchtop, fully automated urine analyzer the CLINITEK ATLAS and compare it with the URICHEM 1000 CHEMSTRIP UA analyzer. Macroscopic analysis included measurement of 8 urine analyte chemistries and specific gravity by the refractive index method (SgRl).
The analytical performance studies conducted were calibration stability, precision (within-run and day-to-day), comparison of results of 437 fresh patient urine specimens, analysis of time performance, and problem logging over a 16-day evaluation period.
Satisfactory calibration reproducibility, within-run (n = 10), and day-to-day (n = 16) precision was found because results fell within the +/- one color-block by the proposed National Committee for Clinical Laboratory Standards (NCCLS) criteria. Patient results (n = 437) from the 2 analyzers giving the same color-block agreement was found to be for pH, 52%; glucose, 92%; ketones, 86%; protein, 79%; bilirubin, 97%; leukocytes, 72%; blood, 80%; and nitrite, 98%. The concordance defined by the NCCLS criteria as the agreement of results +/- one color-block between the 2 analyzers was found to be for pH, 96%; glucose, 99%; ketones, 100%; protein, 95%; bilirubin, 100%; leukocytes, 97%; and blood 86%. The SgRl determined on ATLAS was correlated with the RD-10 Rapid Density analyzer with the following results: slope = 0.97, intercept = 0.033, r = 0.94, Syx = 0.003, for a range of values from 1.002 to 1.070.
Our preliminary data indicate that the analytical performance, and automatable features for complete walk-away function of this analyzer can significantly increase the overall testing efficiency in the urinalysis laboratory.
评估新型台式全自动尿液分析仪CLINITEK ATLAS的性能，并将其与URICHEM 1000 CHEMSTRIP UA分析仪进行比较。宏观分析包括通过折射指数法（SgRl）测量8种尿液分析物化学指标和比重。
进行的分析性能研究包括校准稳定性、精密度（批内和日间）、437份新鲜患者尿液标本结果的比较、时间性能分析以及在16天评估期内的问题记录。
校准再现性、批内（n = 10）和日间（n = 16）精密度令人满意，因为根据美国国家临床实验室标准委员会（NCCLS）提议的标准，结果落在±一个色阶范围内。发现两台分析仪对患者结果（n = 437）给出相同色阶一致率的情况为：pH为52%；葡萄糖为92%；酮体为86%；蛋白质为79%；胆红素为97%；白细胞为72%；血液为80%；亚硝酸盐为98%。NCCLS标准定义的两台分析仪结果在±一个色阶内一致的符合率为：pH为96%；葡萄糖为99%；酮体为100%；蛋白质为95%；胆红素为100%；白细胞为97%；血液为86%。在ATLAS上测定的SgRl与RD - 10快速密度分析仪相关，结果如下：斜率 = 0.97，截距 = 0.033，r = 0.94，Syx = 0.003，取值范围为1.002至1.070。
我们的初步数据表明，该分析仪的分析性能以及完全无需人工干预功能的自动化特性可显著提高尿液分析实验室的整体检测效率。
