22项生化检测项目测量不确定度的评价

Evaluation of Measurement Uncertainty of 2 2 Clinical Chemistry Assays

目的：根据临床实验室室内质量控制和室间质量评价的累积数据评价22项生化检测项目的测量不确定度。方法收集检验科2013年1～6月22项生化检测项目的室内质量控制数据和2012～2014年间常规化学室内质控和室间质评的数据，依据 Nordtest准则，分别计算与精密度和偏倚相关的不确定度分量，然后评估合成标准不确定度和扩展不确定度。结果利用室内质控与室间质评数据可以逐步计算出22项生化检测项目的不确定度范围为4.24～24.88，其中 ALP的扩展不确定度最大，达到24.88；Na＋的扩展不确定度最小，仅为4.24。各类指标的扩展不确定度范围如下：电解质（4.27～18.16，Na＋最低，Mg最高）；酶类（8.12～24.88，GGT最低，ALP最高）；小分子物质（4.88～12.44，GLU最低，Cr最高）；蛋白与脂类（4.78～13.1，TC最低，TG最高）。结论使用累积的室内质控与室间质评数据评定生化定量检测项目的不确定度简便可行，可用于定期评估检验结果准确性。

Objective To calculate the measurement uncertainty of clinical chemical analytes according to the internal quality control （IQC）and external quality assessment （EQA）data in clinical laboratory.Methods Collected the IQC data from January to June 2013 and EQA data between 2012～2014 of clinical chemistry in clinical laboratory.Calculated the measure-ment uncertainty and extended uncertainty according to the Nordtest criteria.Results It was effective to evaluate the uncer-tainty using IQC and EQA data.ALP ranked the highest extended uncertainty and Na^＋ ranked the lowest uncertainty.The range of uncertainty varies greatly,electrolyte 4.27～18.16,enzyme 8.12～24.88,small molecular 4.88～12.44,protein and lipids 4.78～13.1.Conclusion The evaluation of clinical chemistry uncertainty by IQC and EQA data is simple and practi-cal,which is beneficial for assurancing the measurement accuracy.