参考测量程序测定血清总胆红素浓度的不确定度评定

摘要

目的：探讨参考实验室测定血清总胆红素（TBil）的不确定度评定方法。方法应用国际检验医学溯源联合委员会（JCTLM）推荐的Doumas血清TBil参考测量程序测定国际临床化学和检验医学联合会（IFCC）参考实验室外部质量评价计划（RELA）样本，分析各不确定度分量的来源，并对各不确定度分量分别进行评定，计算合成标准不确定度，进而计算出扩展不确定度。结果2013年RELA-A样本TBil平均浓度为52.30μmol/L，合成标准不确定度为0.67μmol/L，取包含因子（k）=2、95%置信区间，则扩展不确定度为1.34μmol/L；2013年RELA-B样本TBil平均浓度为81.60μmol/L，合成标准不确定度为0.70μmol/L，取k=2、95%置信区间，则扩展不确定度为1.40μmol/L。结论依据JCTLM推荐的Doumas血清TBil参考测量程序建立的测量不确定度评定方法可满足临床实验室对血清TBil参考测量系统的要求。%ObjectiveTo investigate the evaluation method for measurement uncertainty of serum total bilirubin (TBil) concentration in clinical reference laboratories.MethodsThe International Federation of Clinical Chemistry and Laboratory Medicine(IFCC) external quality assessment scheme for reference laboratories in laboratory medicine(RELA)sample was measured by Doumas serum TBil reference procedure of the Joint Committee for Traceability in Laboratory Medicine(JCTLM),and the sources of uncertainty components were identified. The evaluation of uncertainty components was processed,and then a combined standard uncertainty was calculated. Finally,an expanded uncertainty was obtained.ResultsThe TBil average concentration of 2013 RELA-A sample was 52.30μmol/L,the combined standard uncertainty was 0.67μmol/L,the 95% confidence interval was taken,and the coverage factor(k)was 2. The expanded uncertainty was 1.34μmol/L. The TBil average concentration of 2013 RELA-B sample was 81.60μmol/L,the combined standard uncertainty was 0.70μmol/L,the 95% confidence interval was taken,and thek was 2. The expanded uncertainty was 1.40μmol/L.ConclusionsThe established method can meet the requirements of clinical laboratories for serum TBil reference procedure.