Background: Clinical laboratories provide essential diagnostic services that are essential in clinical decision making, contributing to the quality of healthcare. The performance of two Siemens ADVIA 1800 analyzers was characterized in a hospital Biochemistry laboratory in order to evaluate the analytical characteristics of such automated analyzer systems using nonoriginal assay reagents attempting to support laboratory quality service and crucial clinical decision making. Methods: We independently completed performance validation studies including trueness, precision, sensitivity as well as measurement of uncertainty and sigma metrics calculation for 25 biochemical parameters. Results: Trueness expressed as bias was less than 20% for both ADVIA 1800 analyzers. Within run and total precisions expressed as CV% were ≤9.85% on both analyzers for most parameters studied with few exceptions (Mg, TB, DB, Cl, HDL and UA) observed either in low or in high level samples and between the two analyzers. LoB, LoD and LoQ values produced by the two analyzers were comparable except Cl. Uncertainty values produced by the two analyzers were comparable with no significant differences. Quality performance of reagent assays was studied using the sigma metrics system. The sigma values were plotted on normalized method decision charts for graphical representation of assay performances for each analyzer. Conclusions: The two ADVIA systems, independently evaluated, showed consistent performance characteristics with certain discrepancies by several reagents. Sigma analysis was helpful for revealing the quality performance of non-original reagents supporting the need for strict assessment of quality assurance and in some instances optimization/improvement of assay methods.

中文翻译：

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使用商业化验试剂的自动化临床化学分析仪的性能特征有助于医院实验室的质量保证和临床决策。

背景：临床实验室提供必要的诊断服务，这对于临床决策至关重要，有助于提高医疗质量。在一家医院生物化学实验室中，对两个西门子ADVIA 1800分析仪的性能进行了表征，目的是使用非原始的分析试剂评估此类自动化分析仪系统的分析特性，以尝试支持实验室质量服务和关键的临床决策。方法：我们独立完成了性能验证研究，包括真实性，精确度，敏感性以及不确定性的测量和25个生化参数的sigma度量计算。结果：两种ADVIA 1800分析仪均以偏差表示的真实度小于20％。在运行内，表示为CV％的总精度≤9。在两个分析仪上，大多数参数的研究都达到了85％，但在低水平或高水平样品中以及两个分析仪之间都观察到了很少的例外（Mg，TB，DB，Cl，HDL和UA）。除Cl外，两个分析仪产生的LoB，LoD和LoQ值可比。两种分析仪产生的不确定度值是可比较的，没有显着差异。使用sigma指标系统研究了试剂分析的质量性能。将sigma值绘制在归一化方法决策图上，以图形方式表示每个分析仪的测定性能。结论：两个独立评估的ADVIA系统显示出一致的性能特征，几种试剂存在一定差异。