SP-4430干式生化分析仪血清淀粉酶测定结果的可比性分析评估

目的：通过对SP-4430干式生化分析仪与日立7170A生化分析仪进行方法对比分析,探讨不同系统之间检测血淀粉酶（Amy）结果偏倚是否可以接受。方法：先检测两台仪器重复性及线性分析后,再以总院日立7170A全自动生化分析仪结果作为比较方法的测定值（X）,以SP-4430干式生化分析仪和分院日立7170A全自动生化分析仪测定结果作为实验方法的测定值（Y）,对46例血淀粉酶测定结果进行相关分析及偏倚的评估。结果：各检测系统测定Amy的精密度、变异系数均小于10%、3个不同生化分析系统新鲜血清淀粉酶测定结果相关系数分别为0.981 31（总院7170A与SP-4430）;0.981 34（分院7170A与SP-4430）;0.999 42（总院7170A与分院7170A）和可靠性系数为0.985 6。SP-4430干式生化分析仪和分院日立7170A全自动生化分析仪血清淀粉酶（U/L）在3个医学决定水平（Xc=50,120,200）处相对偏差分别为35.54%、30.84%、29.50%和0.78%、1.27%、0.41%。结论：各检测系统具有较好的精密度和线性;测定血清淀粉酶结果相对偏差在3个医学决定水平处,SP-4430临床不可接受,分院日立7170A临床可接受。

A comparative analysis of amylase results for SP-4430 dry chemical analysis systems

Objective:Compare the bias of amylase(Amy) results of three analytic methods(SP-4430 dry chemistry and two Hitachi 7170A analyzer).Methods: To evaluate the precision and liner range of the following three analyzers,the three analyzer were used respectively to detect 46 clinical plasma Amy concentrations.Then the coefficient and the equation were used to evaluate the outcome bias among three systems.Results: The CV value of all detection systems did not excel 10%.The correlation co efficiency of each detecti...