糖化血红蛋白液相色谱-质谱参考测量程序测量结果的不确定度评定

Evaluation of uncertainty of reference measurement procedure(liquid chromatography-mass spectrography) for hemoglobin A_(1c)

目的探讨液相色谱-质谱(LC-MS)参考测量程序(又称:参考方法)测量人全血中糖化血红蛋白(HbA_(1c))结果的不确定度评定方法。方法建立国际检验医学溯源联合委员会(JCTLM)推荐的HbA_(1c)参考测量程序——LC-MS法,按照国际临床化学与检验医学联合会(IFCC)HbA_(1c)标准化工作组实验方案对样品进行测量,分析测量不确定度分量来源,评定各分量,合成标准不确定度,计算扩展不确定度,确定校准和测量能力(CMC)。结果人全血HbA_(1c)浓度为32.8 mmol/mol、71.8 mmol/mol、52.4 mmol/mol、100.9 mmol/mol、59.6 mmol/mol时,其相对扩展不确定度分别为2.9%、1.5%、1.9%、1.3%和1.7%(95%置信区间,包含因子k=2)。参考测量能力范围为32.8 mmol/mol至100.9 mmol/mol时,其CMC为1.3%。结论该参考实验室评定了LC-MS参考测量程序HbA_(1c)检测结果的测量不确定度,满足了对HbA_(1c)参考测量能力的要求。

Objective To evaluate the uncertainty of reference measurement procedure(reference method)for hemoglobin A1c(HbA1c)in whole blood by liquid chromatography mass spectrometry(LC MS). Methods We set up the HbA1creference method recommended by the Joint Committee for Traceability in Laboratory Medicine(JCTLM),liquid chromatography mass spectrography(LC MS). The samples were measured according to HbA1cstandardization working group′s protocol of the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC). The sources of uncertainty were analyzed and evaluated,and then the standard uncertainty was composed and the expended uncertainty was calculated. The reference measurement capacity range and calibration and measurement capacity(CMC)were determined. Results The relative expanded uncertainties were 2.9%,1.5%,1.9%,1.3% and 1.7%(95% confidence interval,k= 2)for the HbA1clevels of 32.8,71.8,52.4,100.9 and 59.6 mmol/mol in whole human blood,re spectively.When the capacity ranges of reference measurement were from 32.8 to 100.9 mmol/mol,the CMC was determined as 1.3%.Conclusion On this basis,the evaluation of measured uncertainty met the requirement of HbA1c reference measurement capability.