摘要
目的利用分析性能西格玛(σ)值、不精密度及分析总误差,评价相同项目使用不同参考区间的检测系统分析性能或评估检测系统分析性能的衰减。方法收集2011年实验室干、湿化学分析系统室内质控及室间质评项目的部分数据,依据美国临床实验室改进修正法案(CLIA′88)的允许总误差(TE),应用公式分析性能σ=[允许总误差(TE)-Bias(%)]/CV计算σ值,同时使用TE=|Bias|+Z×CV(%)计算项目的分析总误差,统计分析不精密度(CV),进行质量控制方案的选择和质量改进,评价两种分析系统的分析性能。结果统计15项检测项目,干、湿化学两种分析系统的分析总误差,差异无统计学意义(P>0.05);不精密度干化学分析系统(x,3.63%)好于湿化学分析系统(x,2.42%),P<0.05,差异有统计学意义;分析性能σ值,干化学分析系统(x,5.16;σ>4为10项,占66.7%)好于湿化学分析系统(x,3.40;σ>4为3项,占20%),P<0.05,差异有统计学意义。结论该室干化学分析系统的分析性能稍好于湿化学分析系统。6σ质量管理方式不仅是实验室进行质量管理的重要工具,其分析性能σ值与不精密度、分析总误差共同在评价同一实验室相同项目使用不同参考区间的检测系统或评估检测系统分析性能的衰减方面具有重要的参考价值。
Objective To evaluate the performance of different detection systems with different reference intervals for the same item or to evaluate the attenuation of performance of detection systems by using analytical performance of Sigma（σ） values,imprecision and analytical total error.Methods Partial data of internal quality control and external quality assessment of dry and wet chemical analyzing systems in 2011 were collected.According to allowed total error（TE） claimed by the American Society of Clinical Laboratory Improvement Amendments Act（CLIA’88）,the performance value of σwas calculated with formula of σ=（TE-Bias%）/CV.The total error was calculated with formula of TE=｜Bias｜＋Z×CV（%）.Analysis imprecision（CV） was statistically analyzed.Quality control program was selected to amend quality.The analytical performance of the two analysis systems was evaluated.Results 15 test items,detected by the two kinds chemical analyzing systems,were with no statistical difference of total error（P〉0.05）.Imprecision of dry chemical system（x=3.63%） was better than wet chemical system（x=2.42%）,P〈0.05.Mean value of performance value of σ about dry chemical system was 5.16,with 10 items（66.7%） σ〉4,which was better than wet chemical system[x=3.40,with 3 items（20.0%）σ〉4],P〈0.05.Conclusion Dry chemical system in this laboratory might be with better analytical performance than wet chemical system.6σ quality management could not only be an important tool for laboratory quality management,but also be with important reference value for evaluating the performance of different detection systems with different reference intervals for the same item and the attenuation of performance of detection systems,when combined with imprecision and total error.
出处
《国际检验医学杂志》
CAS
2012年第13期1561-1564,共4页
International Journal of Laboratory Medicine
关键词
分析性能西格玛
不精密度
总误差
检测系统
analyze the performance of sigma； imprecision； total error； detection system
