基于个体内生物学变异评估同一样本系列复测值差异的方法

Method to Evaluate the Differences between Repeat Measurements of the Same Sample Based on Within-Subject Biological Variation

目的基于生物学变异评估同一样本系列复测结果可接受的临界差异(critical difference,CD)。方法通过参考改变值(reference change value,RCV)公式转化为CD公式,分别计算95%和99%概率下同一台仪器上复测和不同仪器上复测的CDs(critical difference,same instrument)和CD_D(critical difference,different instrument),建立CD与个体内生物学变异(within-subject biological variation,CV_I)的关系,评估实验室生化、激素、血细胞检测以及肿瘤标志物等检测项目分别于95%和99%概率下相同和不同仪器的最优、期望及最低质量规范的CD,判断同一样本系列复测值差异的可接受性。结果 CDs在最优、期望和最低质量规范下对应CV_I的系数分别为0.7,1.4和2.1(P=95%);0.9,1.8和2.7(P=99%);CD_D在最优、期望和最低质量规范下对应CV_I的系数分别为0.8,1.7和2.8(P=95%);1.0,2.3和3.6(P=99%)。结论基于CV_I评估同一样本系列复测值CD的方法计算简单,实用性强,为检验工作人员提供了又一新量化的判断标准。

Objective To evaluate critical differences （CD） in a series of results of the same sample based on biological varia- tion. Methods Converted the formula of reference difference value （RCV） into CD,and calculate CD between repeat meas- urements on the same instrument and different instruments as CDs （critical difference, same instrument） and CDD （critical difference,different instrument） under 95 % and 99 % probability,respectively. Then the relationship between CD and with- in-subject biological variation （CVD was established. Calculated CDs and CDD of the optimal,expected and minimum quality specifications for the detection of biochemistry,hormones, blood routine and tumor markers at 95 % and 99 % probability and determined the acceptability of differences between repeat measurements. Results Corresponding to the optimal, expected and minimum quality specifications,the coefficients of CVI were 0. 7,1. 4,2.1 （P= 95%） and 0.9,1.8,2.7 （P=99%） for CDs,the coefficients of CVI were 0.8,1.7,2.8 （P=95%） and 1.0,2.3,3.6 （P=99%） for CDo. Conclusion The meth- od of assessing CD of the same sample based on CVI is simple and practicable, which provides another quantitative criteria for laboratory staff.