应用有证参考物质评定常规医学实验室分析中不确定度

Evaluation of the Uncertainty in Routine Medical Laboratory Analysis Using Certified Reference Material

应用有证参考物质(CRM)评定8个生化项目不确定度,将标准量值传递至常规测量系统中,通过对测量程序的标准化研究,使不同测量程序测量结果具有可比性.参照EP15-A2文件评定批间不精密度引入的不确定度相对值;应用8个项目CRM及常规校准品分别校准常规仪器,并分别检测20份标本,参照EP15-A2、EP29-A评定偏移引入的不确定度,并合成扩展不确定度U.研究发现:两种校准状态下测量值有较好的相关性及一致性;修正偏移时,Urea、TC、Cr、Glu、HDL-C、LDL-C、TG、UA低浓度时不确定度分别为2.18%、2.03%、3.21%、1.73%、4.27%、5.22%、2.59%、2.55%,高浓度时分别为2.05%、1.62%、2.50%、1.97%、3.17%、3.19%、2.26%、3.02%;未修正偏移时,低浓度不确定度分别为5.96%、4.77%、7.41%、4.60%、7.30%、10.07%、8.05%、3.70%,高浓度不确定度分别为5.91%、4.61%、7.13%、4.69%、6.71%、9.18%、7.95%、4.04%.结果表明:应用CRM校准常规测量程序,可避免直接测量CRM时存在的基质效应等问题,实现非配套系统量值溯源,理论上缩短溯源链,同时也为不确定度评定相关研究赋予了新的思路.

The uncertainty of 8 biochemical items by using certified reference material（CRM） was evaluated, the standard value to the routine measurement procedures was passed. The standard study of the measurement system made the measurement results from different measurement procedures comparable. ubwas used to assess the uncertainty of inter batch imprecision introduced by EP15-A2;routine instruments by 8 items of CRM and routine calibration were calibrated, and 20 specimens were detected respectively. The uncertainty ubias introduced by EP15-A2 and EP29-A was evaluated, the uncertainty U was extended and synthesized. The measured values in the two calibration states have preferable correlation and consistency;while correcting the deviation, the uncertainties of Urea, TC, Cr,Glu, HDL-C, LDL-C, TG and UA in low concentration were 2.18%, 2.03%, 3.21%, 1.73%, 4.27%, 5.22%,2.59%, 2.55%, respectively, and in high concentration were 2.05%, 1.62%, 2.50%, 1.97%, 3.17%, 3.19%, 2.26%and 3.02%;without correcting the deviation, the uncertainties in low concentration were 5.96%, 4.77%, 7.41%,4.60%, 7.30%, 10.07%, 8.05% and 3.70%, the uncertainties in high concentration were 5.91%, 4.61%, 7.13%,4.69%, 6.71%, 9.18%, 7.95% and 4.04%. Using the CRM calibration conventional instrument can avoid some problems such as the matrix effects and so on when directly measuring the CRM, and realize the measurement traceability of the non-matching testing system, theoretically shorten the traceability chain. At the same time, it provides new perspectives for uncertainty evaluation research.