不同溯源的两台血凝仪测定纤维蛋白原方法学比较

Methodology comparison of fibrinogen level detection by two coagulation analyzer in different traceability

目的比较SYSMEX CA6000与STA Compact 2台血凝仪测定纤维蛋白原的结果,了解其偏倚的可接受性。方法根据美国临床实验室标准化委员会(NCCLS)EP9-A2文件,用2台血凝仪同时测定40例患者的纤维蛋白原,检查离群点并进行直线相关分析,计算医学决定水平处的预期偏倚。结果2台仪器测定结果均无离群点。直线回归方程为YΛ=0.851 6X-0.048 7,r=0.992。3个医学决定水平处预期偏倚分别为0.093、0.197、0.791 g/L。结论纤维蛋白原的3个医学决定水平处预期偏倚95%置信区间下限均低于允许偏倚,SYSMEX CA6000测定结果与STA Compact测定结果相当,偏倚可接受。

Objective To compare the fibrinogen level detected by two coagulation analyzer, SYSMEX CA6000 and STA Compact, and comprehend the acceptability on bias. Methods According to the relevant document EP9-A2 of National Committee for Clinical Laboratory Standards （NCCLS） , fibrinogen level of 40 samples of patients were detected respectively by two different coagulation analyzers. Outliers＇ detection and the correlation between two sets of results were analyzed. The expected bias at medical decision levels were calculated. Results There was no outlier in two re- sults. The regression equation was Y = 0. 851 6X -0. 048 7, r = 0. 992. The expected bias of fibrinogen at three medical decision levels were 0.093,0. 197 and 0. 791 g/L respectively. Conclusions The upper limits of 95% confidence in- terval of expected bias at three medical decision levels were all lower than acceptable bias. So the results between SYS- MEX CA6000 and STA COMPACT were equal, the bias was accepted.