目的:对生化检测系统的20项常规检测项目的精密度性能进行评价,以确定其是否满足临床需要.方法:应用美国临床和实验室标准化协会(CLSI)EP15-A2"精密度和真实度性能的用户验证指南"文件,选用2个不同批次、不同浓度水平的室内质控物,采用AU2700生化仪连续测定3~5 d,计算批内精密度(σ批内)和总的室内精密度(σ总),并与厂商声明的精密度进行比较,同时也分别与卫生与计划生育委员会临检中心室间质量评价标准(EQa)、WS/T403-2012:"临床生物化学检验常规项目分析质量指标"进行比较.结果:所检测的20个常规项目的σ批内和σ总100%小于厂商声明的精密度.同时,σ批内均<1/4的卫生与计划生育委员会临检中心室间质量评价标准,σ总均<1/3的卫生与计划生育委员会临检中心室间质量评价标准,也小于临床生物化学检验常规项目分析质量指标中规定的不精密度.结论:应用EP15-A2指南文件验证厂商声明的精密度性能操作简便,经济实用,适合临床实验室对精密度进行核实,所评价的检测系统的精密度性能既符合厂商声明的精密度,也符合国家相关规定要求,该生化检测系统精密度可以满足临床需要.%Objective:To evaluate the performance precisions of 20 routine test items of biochemical analyzer system so as to confirm whether they can meet clinical demands. Methods: 2 quality control materials ( different concentration, different lot) according to "verification guidance of precision and validity for user " of EP15-A2 were continuously detected 3-5d by using AU2700, and the within-run precision(σw) and total precision (σt)were calculated and compared with the declarations of manufacturers. At the same time, it also be compared with National Center for Clinical Laboratories's EQa standard and WS/T403-2012: Analytical quality specification for routine analytes in clinical biochemistry.Results: The within-run precisions and total precisions of the 20 routine items were less than that of the declaration of manufacturers. At the same time, all of the within-run precisions were less than 25% of EQa standard, and all of total precisions were less than one third of EQa standard. Besides, they also less than the relative standards of WS/T403-2012.Conclusion: It is easy and economic in practice that EP15-A2 is applied to verify the precisions of the declaration of manufacturer, and it suits to the verification for precision of clinical laboratory. As this method, the precision performance of the detection system not only accords with the precision of the declaration of manufacturers, but also accords with the national requirements. Finally, the precision of this biochemistry detection system can satisfy the clinical demands.
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