血浆纤维蛋白原常规测量不确定度的研究

目的探讨测量标准不确定度评价在临床检验常规测定中的应用。方法以血浆纤维蛋白原(Fib)常规测定为例,按测定不确定度评定过程,分析不确定度分量的来源,按A类评定。结果纤维蛋白原测定的不确定度分量来源主要包括:标准不确定度、人体生理变异、厂家提供的标准品、检测的偏倚值等。其中,精密度分量按CLSI EP5A文件评定,分别为2.01%(Fib=2.35g/L)和2.58%(Fib=3.42g/L)。根据厂家的溯源性报告,标准品的不确定度分量为0.5%;根据北京市室间质评回报结果,偏倚所致的不确定度分量为0.61%(Fib=2.52g/L)和1.94%(Fib=3.30g/L)。经合成,单一样本的扩展不确定度为(2.35±0.05)g/L和(3.42±0.11)g/L。结论临床检验常规测定中应根据具体情况分析不确定度分量的来源,用不同方案合成标准不确定度。

Study on measurement uncertainty for Fibrinogen in routine clinical laboratory

Objective To explore the application of evaluation for measurement uncertainty in routine linical laboratory.Methods The routine test of Fibrinogen in plasma was chosen as the example to evaluation the process of measurement uncertainty.The sources of uncertainty were identified,and the component of uncertainty were evaluated as type A.Results Fibrinogen determination uncertainty sources include: standard uncertainty,human physiological variation,manufacturers provide calibrator,test bias.The components of imprecision evaluated on the basis of CLIS EP5A document were2.01%(Fib=2.35g/L) and 2.58%(Fib=3.42g/L).The traceability report from manufacturers showed the uncertainty of calibrator was 0.5%.The bias was 0.61%(Fib=2.52g/L) and 1.94%(Fib=3.30g/L) rspectively,according to the report of external quality assessment from Beijing quality control center.The components of standard uncertainty were(2.35±0.05)g/L and(3.42±0.11)g/L.Conclusions In routine clinical laboratory,the sources of uncertainty should be indentified depended on specific circumstances,and the uncertainty from combined components with various budgets should be applied.