蒙特卡罗法对血清淀粉酶活性不确定度的评定

Evaluation of serum amylase uncertainty by Monte Carlo method

目的:探讨参考实验室测量血清淀粉酶(amylase,AMY)的不确定度评定方法。方法:利用参考测量程序测定血清AMY催化活性浓度,分别采用测量不确定度表达指南为框架的不确定度评定方法(GUM Uncertainty Framework,GUF)和蒙特卡罗法(Monte Carlo method,MCM)评定不确定度,通过分析不确定度来源,并对各分量进行定量,计算合成标准不确定度,进而计算扩展不确定度。用自适应蒙特卡罗法(adaptive MCM)对GUF评定结果进行确认。结果:GUF评定样品A测量结果为(85.8450±1.1026)U/L(k=1. 9 6), 9 5%CI8 4.7424～86.9476U/L;样品B测量结果为(225.5625±2.9312)U/L(k=1.96),95%CI222.6313～228.4937U/L。MCM评定样品A测量结果为(85.8350±1.0864)U/L,95%CI84.7596～86.9215U/L;样品B测量结果为(225.5847±2.8571)U/L,95%CI222.7570～228.4499U/L。样本A数值容差取0.05时,用自适应MCM对GUF确认,通过验证;数值容差取0.01时,用自适应MCM对GUF确认时,未通过。样本B数值容差取0.5时,用自适应MCM对GUF确认,通过验证;数值容差取0.1时,用自适应MCM对GUF确认,未通过。结论:依据JJF1059.2～2011《用蒙特卡罗法评定测量不确定度》推荐的adaptive MCM可作为GUF的确认方法。

Objective:To explore the uncertainty evaluation method of serum amylase measured by reference laboratory.Methods:The concentration of amylase(AMY)catalytic activity in serum was determined by reference measurement procedure.GUM Uncertainty Framework(GUF)and Monte Carlo method(MCM)were used to assess uncertainty,which includes the sources of uncertainty,quantifying each component,calculating the synthetic standard uncertainty and calculating extended uncertainty.Adaptive MCM was used to confirm the GUF assessment results.Results:Sample A measurement results assessed by GUF was(85.8450±1.1026)U/L(k=1.96),95%CI 84.7424–86.9476 U/L;sample B measurement results assessed by GUF was(225.5625±2.9312)U/L(k=1.96),95%CI 222.6313–228.4937 U/L.Sample A measurement results assessed by MCM was(85.8350±1.0864)U/L,95%CI 84.7596–86.9215 U/L.Sample B measurement results assessed by MCM was(225.5847±2.8571)U/L,95%CI 222.7570–228.4499 U/L.When the tolerance value of sample A was 0.05,the GUF was confirmed with adaptive MCM and verified.When the tolerance value of sample A was 0.01,the self-adaptive MCM was used to confirm GUF,and it did not pass.When the tolerance value of sample B was 0.5,the GUF was confirmed with adaptive MCM and verified.When the tolerance value of sample B was 0.1,the self-adaptive MCM was used to confirm GUF,and it did not pass.Conclusion:According to JJF1059.2–2011“Assessment of Measurement Uncertainty by Monte Carlo Method”,adaptive MCM can be used as the confirmation or supplement method of GUF.