分析变异和个体内生物学变异与检验结果的关系

Relationship between analytical variation and individual biological variation with testing results

目的利用生物学变异建立差值显著性评价方法,并用于检验结果评价。方法通过室内质量控制数据获得贝克曼AU68全自动生化仪的累计在控变异系数,结合个体内生物学变异计算肝肾功能和电解质等12项生化项目的参考变化值,并评价慢性肾炎患者连续监测的检验结果。结果仪器的分析变异相对固定,总的分析变异与个体内生物学变异相关。差值显著性计算后慢性肾炎患者治疗3个月时的总蛋白、清蛋白、丙氨酸氨基转移酶和肌酐有显著性改变;治疗后8个月肾功能的指标变化没有显著性。结论临床实验室可以使用差值显著性评价方法对患者检验结果和监测指标的系列结果变化进行评价,帮助临床医生科学解读检验报告。

Objective To establish the difference significant evaluation method by using the biological variation and to apply it in the testing results evaluation .Methods The accumulated controlling variation coefficient of the Beckman AU680 automatic biochemical analyzer was obtained by the internal quality control data ,the reference change values（RCV） of 12 biochemical items of hepatorenal function and electrolytes were calculated by combining with the individual biological variation .Then series testing results of a chronic nephritis patient were evaluated .Re‐sults The anatyical variation of the instrument was relatively stable .The total analytical variation was correlated with the individual biological variation .After difference value significant calculation ,the results of TP ,ALB ,ALT and CREA in the chronic nephritis patient were changed significantly after 3 months treatment ;the change of renal func‐tion indexes after 8 - month treatment had no significance .Conclusion Clinical laboratories can apply the RCV meth‐od and the significance probability to evaluate the changes in the detection results and the series results change of mo‐nitoring indexes for helping clinical doctors to interpreting the testing report .