Westgard方法决定图在生化检测系统性能评价中的应用研究

目的:利用Westgard方法决定图判定Olympus AU2700生化检测系统的性能。方法:依据NCCLS EP5-A文件进行精密度实验操作,应用EXCEL软件对Olympus AU2700生化分析仪测定19个常规生化项目的结果进行统计分析,得到批内、批间、日间和总不精密度。不准确度根据2009年卫生部临床检验中心第3次全国常规化学室间质评统计结果确定。计算各项目的不精密度、不准确度相对于CLIA88总允许误差(TEa)的百分比,并利用Westgard方法决定图判断生化检测系统性能的可接受性。结果:钠(Na)和尿素氯(Bun)性能差,钙(Ca)、总胆红素(T-Bil)和肌酐(Cr)性能边缘,氯(C1)、白蛋白(ALB)、碱性磷酸酶(AKP)和直接胆红素(D-Bil)性能良好,其余10个项目的性能优秀。结论:Na和Bun性能差,需要对其进行方法改进和性能的重新评估。应用Westgard方法决定图可简单、准确、直观地判断检测系统性能。

Performance Evaluation of Olympus AU2700 Biochemical Analyzer Based on Westgard Method Decision Chart

Objective To evaluate the performance of Olympus AU2700 biochemical analyzer based on Westgard method decision chart.Methods The precision evaluation was conducted according to the profile EP5-A described by the NCCLS, Microsoft Office Excel was used for the data analysis,and the inner,intra,between day and total imprecision of 19 routine biochemical items determined by AU2700 biochemical analyzer were collected.The inaccuracy evaluation was based on the data in 2009 of external quality assessment（EQA） from National Center for Clinical Laboratory（NCCL）.Then the total imprecision（s%of TEa） and the mean inaccuracy（bias%of TEa） were marked in the Westgard method decision chart to judge the biochemical analyzer performance.Results The performances of Na and Bun were poor,the performances of Ca, T-Bil and Cr were marginal,the performances of Cl,ALB and AKP were good,and the performances of the rest items were excellent.Conclusion Some effective means,such as systematic maintenance and improved method,must be taken to improve and reevaluate the performance of Na and Bun,and Westgard method decision chart,which is simple,accurate and intuitionistic,can be used for detection system performance evaluation.