两台生化分析仪多项目测定结果比对分析与偏倚评估.docVIP

两台生化分析仪多项目测定结果比对分析与偏倚评估 　　[摘要]目的 对HITACHI7600-020和BS-380两个不同的检测系统的多个项目进行方法比对和偏倚评估,探讨同一医院不同检测系统间测定的结果是否具有可比性。方法依据美国国家临床实验室标准委员会(NCCLS) EP9-A2文件要求,每天收集8份不同浓度的患者新鲜血清,分别用两种检测系统进行6个生化项目的测定,连续测定5天,记录测定结果,计算相关系数和直线回归方程,根据回归方程计算在某医学决定水平上的预期偏倚()和预期偏倚的95%置信区间并判断偏倚是否可以接受。结果Cl- 预期偏倚的95%置信区间大于美国临床实验室修正法规(CLIA′88)规定的允许误差范围,不可接受。其余5个项目测定结果的预期偏倚均可以接受。结论 检测系统应定期进行方法比对和偏倚评估,以确保检测结果的可比性。 　　[关键词]EP9-A2; 方法比对; 偏倚评估 　　[中图分类号]R446.1[文献标识码]A [文章编号] 1005-0515(2010)-8-216-02 　　 　　Comparative Study and Bias Evaluation on the Results of Serum Biochemical Marker 　　with Different Biochemical Detecting System 　　XUE Chun-ping 　　(Department of Clinical laboratory, Macheng peoples hospital, Macheng Hubei 431600, China) 　　 　　[Abstract]ObjectiveHITACHI7600-020 and BS-380 two different detection systems methodology comparison analysis of test results between the two detection systems is comparable. Methods According to the U.S. National Committee for Clinical Laboratory Standards (NCCLS) EP9-A2 document requested daily from the clinical samples were collected in eight different concentrations of serum samples, respectively, with two kinds of detection systems for a number of biochemical determination of the project were determined 5 days, record test results, to compare the two detection systems analysis and bias estimates. Results The two detection systems detected K+, Na+, Cl-, Bun, Crea, Glu correlation coefficient r = 0.9975,0.9869,0.9843,0.9994,0.9977,0.9978, in addition to Cl-, the results of the projects measured deviation 1 /4 CLIA88 allowable error range. Conclusion The two kinds of detection systems for various projects (Cl-excluding) the determination to get consistent test results, Cl-adjusted two systems also enable the determination of the results comparable. 　　[Keywords]EP9-A2; method comparison;bias estimation 　　 　　目前, 各类全自动生化分析仪广泛应用于临床,往往同一医院会采用不同的仪器、方法检测相同项目,以满足不同功能分区的需求。由不同的仪器、试剂、校准品及质控品所构成的检测系统其结果是不完全一致的,但这样的结果势必影响到临床判断及对患者病情变化的监测。因此,定期对不同检测系统进行测定结果的比对,以确保结果的可比性是目前检验医学