医学实验室血清球蛋白不确定度评定

Evaluation of measurement uncertainty of serum globulin in medical laboratory

目的以医学实验室血清球蛋白为例,研究如何用top-down法评定测量不确定度,为临床决策提供一定依据。方法应用top-down法评定不确定度,先评定出有证参考物质(CRM)总蛋白(TP)和白蛋白(Alb)的不确定度,再把这两项的不确定度合成,即为球蛋白(Glb)不确定度。结果浓度为70.10 g/L的TP、37.2 g/L的Alb的相对合成不确定度分别为1.77%、1.83%。Glb相对合成不确定度为2.55%,相对扩展不确定度为5.10%(k=2)。结论用top-down法评定Glb不确定度具有可行性,其可判断患者两次测量结果是否具有统计学差异,对患者的临床诊断和治疗具有潜在指导作用。

Objective To study how to use the top-down method to evaluate the measurement uncertainty based on the seroglobulin in medical laboratories in order to provide certain reference for clinical decision making. Methods The top-down method was used to evaluate the uncertainty, which included evaluating the uncertainties of certified reference materials（CRM） such as total protein（TP） and albumin（Alb） at first and then combining the two uncertainties to get the uncertainty of globulin（Glb）. Results The relative combined uncertainties of 70.10 g/L of TP and 37.2 g/L of Alb were 1.77% and 1.83% respectively. The relative combined uncertainty of Glb was 2.55% and its relative expanded uncertainty was 5.10%（k=2）. Conclusion The application of the top-down method in evaluating Glb uncertainty is feasible, can determine if there exists statistical difference between patient＇s two measurements, and it is of potential guiding effect on the clinical diagnosis and treatment for patients.