摘要
目的评估我科自建检测系统测定血清总蛋白的测量不确定度。方法根据血清总蛋白的医学决定水平(MDL)配制两个浓度水平的试验样本,分别定义为低值MDL样本、高值MDL样本。先评估血清总蛋白在低值MDL及高值MDL的批内重复性、批间重复性、方法偏倚等因子,再根据上述因子确定血清总蛋白在上述两个MDL水平处的扩展不确定度(EU)。结果 (1)自建检测系统测定血清总蛋白在低值MDL的批内变异系数(CVw)、批间变异系数(CVB)、方法偏倚变异系数(CVBias)分别为0.86%、1.37%、2.31%,EU为5.64%。(2)自建检测系统测定血清总蛋白在高值MDL的CVw、CVB、CVBias分别为0.74%、1.41%、3.29%,EU为7.31%。结论本研究评估测量不确定度的方法简单、易行,试验所得的EU可以准确地反映临床检验结果的分散性。
Objective To evaluate the measurement uncertainty of serum total protein detected by the self-developed detecting system in our department. Methods Two groups of samples were prepared according to medical decision levels(MDL) of serum total protein, which were defined as low-value MDL sample and high-value MDL sample respectively. The within-run repeatability, between-run repeatability and method biases of serum total protein at the 2 levels of MDLs were evaluated firstly, and then the corresponding expanded uncertainties (EU) were confirmed. Results (1)The within-run coefficient of variation(CVw), between-run coefficient of variation(CVB) and methods bias coefficient of variation(CVBias) of serum total protein at the low-value MDL were 0.86%, 1.37% and 2.31% respectively, and the EU was 5.64%. (2)The CVw , CVB and CVBias of serum total protein at the high-value MDL were 0.74%, 1.41% and 3.29% respectively, and the EU was 7.31%. Conclusion This method for evaluating measurement uncertainty in this study is of convenience and feasibility, and the EU can reflect the dispersion of clinical test results accurately.
出处
《实验与检验医学》
CAS
2014年第2期137-138,149,共3页
Experimental and Laboratory Medicine
关键词
检测系统
总蛋白
测量不确定度
医学决定水平
变异系数
Detecting system
Total protein
Measurement uncertainty
Medical decision level
Coefficient of variation