冰冻人血浆醛固酮标准物质在量值传递中的效果评价

The Effect Evaluation of Aldosterone Reference Material in Frozen Human Plasma in the Quantity Transmission

目的评价冰冻人血浆醛固酮国家二级标准物质在临床实验室血浆醛固酮量值传递中的效果。方法采用同位素稀释液相色谱串联质谱法(ID-LC/MS/MS)和A、B、C 3种免疫法测量原理的常规系统同时测量2个浓度醛固酮标准物质和20份无肉眼可见溶血、乳糜和黄疸的临床单人份血浆样本。以标准物质各常规系统的测量结果为X轴,标准物质的认定值为Y轴作直线回归并计算临床样本经量值递后的值。以ID-LC/MS/MS法测量临床样本结果为X轴,分别以量值传递前后临床样本在A、B、C常规系统与ID-LC/MS/MS法之间结果的相对偏倚为Y轴,绘制改良Bland-Altman图,评价常规系统量值传递前后测量结果的正确性。通过比较量值传递前后平均偏倚及偏倚范围的变化评价醛固酮标准物质在量值传递中的效果。结果根据正确性评价标准判断,A、B、C常规系统量值传递前后测量结果均不正确。量值传递前临床样本在A、B、C常规系统与ID-LC/MS/MS法之间结果的平均偏倚分别为39.34%、41.45%和97.71%,偏倚波动范围分别为16.93%~95.71%、-3.11%~101.5%和4.55%~319.85%。量值传递后的平均偏倚分别为-12.29%、-8.88%和18.49%,偏倚波动范围分别为-26.81%~22.79%、-36.86%~24.00%和-36.08%~138.52%。结论应用冰冻人血浆醛固酮标准物质进行量值传递可以明显改善各常规系统与ID-LC/MS/MS法之间测量结果的偏倚,但是不能完全解决不同测量原理的测量方法间结果的一致性问题。

Objective To evaluate the effect of aldosterone(ALD)national secondary standard material in frozen human plasma in the quantity transmission of clinical laboratory.Methods ALD reference materials of two concentrations and 20 single clinical human plasma samples without visible hemolysis,chyle and jaundice were measured simultaneously by isotope dilution liquid chromatography mass spectrometry(ID-LC/MS/MS)and three types of(A,B,C)routine systems of immunology principle.Linear regression was applied using measurement results of reference materials of each routine system as X axis,while the certified value of reference materials as Y axis.Measurement results of clinical samples after the quantity transmission were then calculated.The improved Bland-Altman diagram was drawn to evaluate the trueness of measurement results before and after the quantity transmission by using results of clinical samples measured by ID-LC/MS/MS method as X axis,while the relative bias of clinical samples among A,B,C routine systems and ID-LC/MS/MS method before and after the quantity transmission as Y axis.The effect of ALD reference material in quantity transmission was evaluated by comparing changes of average bias and bias range before and after the quantity transmission.Results Measurement results of A,B,C routine systems were not true before and after the quantity transmission according to the trueness evaluation criteria.The average biases of clinical samples between routine system A,B and C and ID-LC/MS/MS method before the quantity transmission were 39.34%,41.45%and 97.71%,respectively,and the fluctuation ranges of bias were 16.93%-95.71%,-3.11%-101.5%and 4.55%-319.85%,respectively.The average biases after the quantity transmission were-12.29%,-8.88%and 18.49%,respectively and the fluctuation ranges of bias were-26.81%-22.79%,-36.86%-24.00%and-36.08%-138.52%,respectively.Conclusion The application of ALD reference material in frozen human plasma in the quantity transmission can significantly improve issues of bias of measurement results between routine systems and ID-LC/MS/MS method,but it is not able to fully solve the problem of consistency between measurement methods with different measurement principles.