临床生物化学指标测量不确定度的评估

目的通过对临床生物化学指标测量不确定度的评估，探讨医学实验室认可工作中测量不确定度的评估方法和程序。方法利用室内质控数据计算批内变异及批问变异系数，卫生部临检中心室间质评数据计算偏倚不确定度，利用3个来源的不确定度综合评估丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶、乳酸脱氢酶、肌酸激酶、碱性磷酸酶（ALP）、γ-谷氨酰转移酶（GGT）、总蛋白、血清清蛋白、葡萄糖、尿素、肌酐、尿酸、三酰甘油、总胆固醇、钠（Na）、钾、氯（C1）、钙、磷（P）等指标的测量不确定度。结果19项临床生物化学指标中，低浓度C1及高浓度Na扩展不确定度值最小，低浓度P及高浓度ALP扩展不确定度值最大。低浓度ALT、ALP、P及高浓度ALP扩展不确定度大于10％，检测结果与真实值差波动较大，其他各项指标扩展不确定度均较小。结论本研究采用的测量不确定度评估方法简单方便，能分析不同因素对测量结果的影响程度，可用于医学实验室认可工作。

Evaluation on measurement uncertainty of clinical biochemical indicator

Objective To explore a method for evaluation of measurement uncertainty of clinical biochemical indicator. Methods The laboratory internal quality control data and the National Center for clinical laboratory EQA data were analyzed, the measurement uncertainty of ALT, AST, LDH, CK, ALP, 7 -GT, TP, ALB, Glu, Urea, Cr, UA,TG,TC,Na,K,C1,Ca and P were evaluated,respectively. Results CL of low concentration and Na of high con- centration in 19 clinical biochemistry indicators expanded minimum value, and P of low concentration and ALP of high concentration expanded maximum value. The measurement uncertainty in ALT, ALP, P of low concentration and ALP of high concentration were greater than 10%. The larger fluctuations were between the testing results and the true value of measurement uncertainty,and measurement uncertainty of another indexes were small. Conclusion This evaluation method of measurement uncertainty is simple and convenient, and can analyze the influence of different fac- tors on the measurement results. It can be used for the medical laboratory.