CAJ | 학술논문

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。
목적：평고아과자건검측계통측정혈청총단백적측량불학정도。방법근거혈청총단백적의학결정수평(MDL)배제량개농도수평적시험양본，분별정의위저치MDL양본、고치MDL양본。선평고혈청총단백재저치MDL급고치MDL적비내중복성、비간중복성、방법편의등인자，재근거상술인자학정혈청총단백재상술량개MDL수평처적확전불학정도(EU)。결과(1)자건검측계통측정혈청총단백재저치MDL적비내변이계수(CVw)、비간변이계수(CVB)、방법편의변이계수(CVBias)분별위0.86%、1.37%、2.31%，EU위5.64%。(2)자건검측계통측정혈청총단백재고치MDL적CVw、CVB、CVBias분별위0.74%、1.41%、3.29%，EU위7.31%。결론본연구평고측량불학정도적방법간단、역행，시험소득적EU가이준학지반영림상검험결과적분산성。
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.