Objective To verify the comparability of patients results of glucose by two analysers in one hospital. Methods The procedures of the studentized range test include:selecting analyte for comparison,selecting instruments, identify an approximate analyte concentration for comparison testing,calculating the desired concentration or activity to be used for comparison sample selection, selecting comparable samples, selecting the appropriate level of acceptance criteria that can be applied to the comparison test,setting critical difference of comparability tests,determining the number of replicates to be run. Results The imprecision levels of two analysers were 1. 17% ,0. 92% ;1. 47% and 1. 44% respectively. Control 1 pooled CV was 1. 76% , control 2 pooled CV was 1. 46%. Sample ranges were 5. 41 mmol/L 20% (4. 33 mmol/L～6. 49 mmol/L) and 13. 10 mmol/L 20% (10. 48 mmol/L～15. 72 mmol/L). Selected 5. 54 mmol/L (sample 1) and 13. 25 mmol/L (sample 2) as the initial values of major analysis instruments. The acceptability criteria of critical difference was intended to be 1. 90%. According to the critical difference (%) of studentized range tests and the pooled CV we could choose patient samples of two different levels,and four replicates were chosen for the comparisons. The ranges for two analyzers' results of each kind of samples were 1. 83% and 1. 30% respectively,the ranges were less than the critical differences,the comparability of methods was considered acceptable. Conclusion Range test method provides guidance on how to verify comparability of quantitative laboratory results for individual patients within one hospital.%目的 对同一医院内血清葡萄糖在两台生化分析仪上检测可比性进行验证.方法 极差检验可比性方法包括:选择比对的分析物,选择比对的仪器,确定可比性检验接近的分析物浓度,计算用于比对样本选择的期望的浓度,选择可比性的样本,设定可比性检验的临界差值,患者结果可比性检验可接受标准,确定检测重复的次数.结果 两台生化分析仪(仪器A和B)在两个浓度水平质控制物(质控物1和2)的不精密度(CV%)分别为:1.17%,0.92%;1.47%,1.44%.质控物1合成的CV为1.76%,质控物2合成的CV为1.46%.患者样本范围计算为控制物均值的20%,即为4.33～6.49 mmol/L和10.48～15.72 mmol/L.对于比对试验选择在分析仪器A上样本最初的值为5.54 mmol/L (样本1)和13.25 mmol/L(样本2).临界差值可接受标准定为1.90%.根据极差检验的临界差值(%)以及上述的信息可选择两个不同水平的患者样本,且每一样本只作三次检测来检验两台仪器之间是否存在差异.两台检测系统对于两个浓度水平的患者样本的极差值分别为1.83%和1.30%,因为极差值小于临界差值,对于两样本方法的可比性对于给定的已知的差值是可接受的.结论 极差检验方法为评估在一个医疗机构内检测同一患者样本的不同系统的可比性提供了指南,比传统的方法比对试验简单、易实施.
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