采用4种方法评估临床实验室糖化血红蛋白检测的不确定度

valuation of measurement uncertainty for HbA1c by four approaches in clinical laboratory

目的比较4种方法评估临床实验室糖化血红蛋白(HbA1c)检测的不确定度,为临床实验室评估不确定度提供参考。方法根据《CNAS-TRL-001∶2012医学实验室测量不确定度的评定与表达》推荐的4种不确定度评估方法,即利用临床实验室至少6个月的室内质量控制(IQC)数据、1次正确度验证和1次室间质量评价(EQA)数据,分别评估2019年和2020年的33家和35家临床实验室低中高3个HbA1c浓度检测的相对和绝对不确定度。4种不确定度评估方法分别为利用IQC数据和正确度验证数据(方法1)、仅利用正确度验证数据(方法2)、利用IQC和EQA数据(方法3)及仅利用EQA数据(方法4),采用Friedman配对和Wilcoxon符号秩检验进行统计学分析。结果对于方法1,2019和2020年低中高HbA1c检测的相对不确定度和绝对不确定度范围分别为4.21%~9.24%和0.27%~0.64%。与方法1比较,方法2得到的相对和绝对不确定度均较小,差异均有统计学意义(P<0.0167,P<0.05)。与方法1比较,除2020年高浓度水平外,方法3和方法4得到的相对不确定度均较小,在6对(2年低中高浓度)比较中,分别有3对(2019年高浓度,2020年低和中浓度)和2对(2020年低和高浓度)差异有统计学意义(P均<0.0167)。结论临床实验室HbA1c检测不确定度评估应基于IQC和正确度验证数据进行。

Objective To compare results of four glycosylated hemoglobin A1c(HbA1c)detection methods and to evaluate the uncertainty of HbA1C results in clinical laboratory,and to provide method for clinical laboratory on the evaluation of uncertainty.Methods According to the four uncertainty evaluation methods,which were recommended by"CNAS-TRL-001,the evaluation and expression of measurement uncertainty in medical laboratory",the relative and absolute uncertainty of low,medium and high HbA1c in 33 clinical laboratories measured in 2019 and 35 clinical laboratories measured in 2020 was evaluated by more than 6 months of internal quality control(IQC)data,trueness verification and external quality assessment(EQA)data.The four uncertainty evaluation methods were:IQC data and trueness verification data(method 1),only trueness verification data(method 2),IQC and EQA data(method 3)and only EQA data(method 4).The related statistical methods used in this analysis were Friedman and Wilcoxon signed rank test.Results For method 1,the median range of relative and absolute uncertainty of low,medium and high HbA1c detection in 2019 and 2020 ranged from 4.21%to 9.24%and from 0.27%to 0.64%,respectively.Compared to method 1,the relative and absolute uncertainties obtained by method 2 were smaller,and the differences were statistically significant(P<0.0167,P<0.05).Compared to method 1,the relative uncertainties obtained by method 3 and method 4 were smaller,except for the high concentration of HbA1c level in 2020.Among the 6 pairs of comparisons(low,medium and high HbA1c in 2019 and 2020),there were 3 pairs(high HbA1c in 2019,low and medium HbA1c in 2020)and 2 pairs(low and high HbA1c in 2020)of differences with statistical significance(all P<0.0167).Conclusion The uncertainty evaluation of HbA1c detection in clinical laboratory should be evaluated based on IQC and trueness verification data.