日立7600-020型全自动生化仪性能验证

Performance test of Hitachi 7600-020 automatic biochemical analyzer

目的对日立7600-020型全自动生化仪装机性能进行验证测试。方法根据美国国家临床实验室标准化委员会(NCCLS)制定的评价标准,用日立7600-020型自动生化仪配套生化试剂对该仪器的精密度、准确性、线性范围、回收率和交叉污染率等进行验证性试验。结果通过对钾(K)、葡萄糖(GLU)、丙氨酸氨基转移酶(ALT)、总蛋白(TP)、三酰甘油(TG)的检测,精密度实验总CV值均小于5%;线性实验相关系数r分别是:0.995 00、.984 90、.989 9、0.995 0、0.984 9;回收率分别为:101.2%、100.7%、98.3%、99.5%、98.9%;交叉污染率为0.63%、0.87%、0.77%、0.82%、0.56%。结论日立7600-020型全自动生化仪交叉携带污染率低,精密度和线性好,各项指标参数均符合仪器设定的要求,达到国家规定的标准。

Objective To test the performance of Hitachi 7600-020 automatic biochemical analyzer.Methods According to the evaluation criteria of the U.S.National Committee for Clinical Laboratory Standards（NCCLS）,we used biological and chemical reagents installed by Hitachi 7600-020 to verify the precision,accuracy,linear range,recovery and cross infection rate of the instrument.Results Based on the test results of the five representative factors including potassium（K＋）,glucose（GLU）,alanine aminotransferase（ALT）,total protein（TP）,as well as triglyceride（TG）,The experimental CV values of precision were all smaller than 5%.The linear correlation coefficients of the experiments were respectively： 0.995 0,0.984 9,0.989 9,0.995 0,0.984 9.The recovery rates of the experiments were as follows： 101.2%,100.7%,98.3%,99.5%,98.9%.The cross infection rate of the experiments were 0.63 %,0.87%,0.77%,0.82%,0.56%.Conclusion The cross infection of Hitachi 7600-020 automatic biochemical analyzer is low,and the precision and linearity of the device is good.All of tested results of parameters are in line with the designed standards as well as national standards.