应用Westgard方法决定图判断非配套生化试剂使用性能的临床可接受性  

Clinical acceptability of performance of non-matching biochemical reagents by applying Westgard method decision chart

作　　者：陈泳 苏镜 何志亮[2] 何寿富 赵可伟[2] 

机构地区：[1]韶关市职业病防治院,广东韶关512026 [2]广州中医药大学附属骨伤科医院,广东广州510240

出　　处：《国际检验医学杂志》2016年第1期55-57,共3页International Journal of Laboratory Medicine

摘　　要：目的应用Westgard方法决定图判断非配套生化试剂使用性能的临床可接受性。方法通过非配套生化试剂在AU480生化仪上定量测定各个实验项目,计算出允许不精密度变异系数(CV%)和允许不准确度偏倚(Bias%),与要求的允许总误差(TEa)作比较,并应用Westgard方法评价决定图,将22个常规生化项目的变异系数(CV)和偏倚(Bias%)以图像形式表达,进而判断各个实验项目的分析性能可否接受。结果 22个常规生化项目的允许不精密度CV%和允许不准确度Bias%在Westgard方法决定图上判断显示,Mg、DB、ALP、TG的CV%和Bias%分别是3.63%和3.45%、4.24%和4.45%、4.23%和2.98%、4.80%和1.74%,分析性能为不符合;CK、AMY、P、ALT、GGT、BUN的CV%和Bias%分别是1.52%和6.67%、2.19%和4.15%、2.65%和2.73%、2.99%和2.83%、3.34%和0.32%、3.56%和1.41%,分析性能为临界;TB、AST、ALB、UA、TC的CV%和Bias%分别是1.98%和3.20%、2.09%和2.28%、2.26%和1.62%、2.30%和1.80%、2.51%和1.77%,分析性能为良好;其他项目分析性能为优秀。结论除了Mg、DB、ALP、TG项目性能较差外,其他项目均具有较好的精密度和准确度,分析性能可以接受。应用Westgard方法决定图可简单、准确、直观地判断非配套试剂的性能。Objective To apply the Westgard method decision chart to judge the clinical acceptability of performance of nonmatching biochemical reagents.Methods The various experimental items were quantitatively detected by applying the non-matching biochemical reagents in the AU480 biochemical analyzer,the coefficient of variation（CV%）of allowable imprecision and the bias% of allowable inaccuracy were calculated,which were compared with the required allowable total error（TEa）,and the Westgard method decision chart was used.The CV%and Bias% of 22 conventional biochemical items were expressed by image form,thus the acceptability of the analytic performance of each experimental item was judged.Results The CV% of allowable imprecision and Bias% of allowable inaccuracy in 22 conventional biochemical items judged by the Westgard method decision chart for Mg,DB,ALP,TG were 3.63% and 3.45%,4.24% and 4.45%,4.23% and 2.98%,4.80% and 1.74% respectively,the analytic performances were inconformity;CV% and Bias%for CK,AMY,P,ALT,GGT and BUN were 1.52% and 6.67%,2.19% and 4.15%,2.65%and 2.73%,2.99% and 2.83%,3.34% and 0.32%,3.56%and 1.41% respectively,the analytic performance was critical;the CV% and Bias%for TB,AST,ALB,UA and TC were 1.98% and 3.20%,2.09% and 2.28%,2.26% and 1.62%,2.30% and1.80%,2.51% and 1.77% respectively,the analytic performance was good;the analytic performance for the other itmes were excellent.Conclusion Except for the poor performance for Mg,DB,ALP and TG,the other items all have better precision and accuracy,the analytic performance is acceptable.Applying the Westgard method decision chart can judge the performance of non-matching reagents simply,accurately and intuitively.

关 键 词：方法决定图 非配套试剂 性能验证 临床可接受性 

分 类 号：R446.1[医药卫生—诊断学]