两种干化学生化分析仪血清淀粉酶测定结果的偏倚分析

目的 对SPOTCHEM-4430(SP-4430)半自动干化学生化分析仪与VITROS-350(V350)全自动干化学生化分析仪检测血清淀粉酶(Amy)结果 进行比较分析.方法 收集46份血清标本分别采用两台生化分析仪对Amy测定结果 进行相关分析及偏倚评估.结果 两种干化学生化分析仪检测血清Amy结果 差异无统计学意义(P>0.05),两种分析方法 的结果 一致.相关回归分析r=0.966 3,SP-4430检测系统血清Amy(U/L)在参考值上限(Xc=75)和3个医学决定水平(Xc=50、120、200)处的相对偏差分别为16.23%、 5.90%、23.98%和29.14%.结论 两种检测系统具有较好的精密度;测定血清Amy结果 相对偏差在Xc=50 U/L时临床可接受;另外两个医学决定水平和参考值上限临床不可接受.

Bias comparison of serum amylase results for two kinds of dry chemical analysis systems

Objective TO discuss the comparability of serum amylase（AMY） results between two kinds of dry chemical analysis. Methods VITROS-350 as the comparison method and another kind of SP-4430 as the labora tory method ,were used respectively to detect AMY concentration in 46 clinical plasma samples. Then the coefficient and the equation were used to evaluate the outcome bias between the two systems. Results The correlation coefficient of each detection system was 0. 966 3. The CV value of all detection systems did not exceed T＋ 10 % by precise assessment. Johnson VITROS-350 was regarded as standard detection system and evaluated the acceptability of another detection system. As a result,the deviation of the reference value supper limit and three medical decision level （Xc=50,120,200）of the SP-4430 were 16.23% and 5.90%,23.98% and 29.14%. Conclusion Two different bio chemical analysis systems have good reproducibility. The bias of serum amylase results measured by two kinds of dry chemical analysis systems exists,which could be acceptable at the medical decision level of 50 U/L,but not at 120 U/ L and 200 U/L.