缺血修饰清蛋白全自动分析法的建立及初步性能评价

目的建立缺血修饰清蛋白(IMA)全自动生化分析仪检测方法 ,并对该方法进行初步性能评价。方法采用清蛋白钴结合试验(ACB)测定IMA,利用在分光光度法检测中寻找的高、低浓度样本,在HITACHI-7170A全自动生化分析仪上设计合理参数,建立ACB的校准曲线,并对所建立的方法进行性能分析评价。结果建立的7170A全自动生化分析法测定IMA其健康体检组混合血清和急性冠状动脉综合征(ACS)组混合血清的批内和批间变异系数分别为0.97%和1.46%,1.01%和1.73%,实验的重复性较好。把高、低值按一定比例混合后进行线性回归分析显示,线性回归方程式为:Y=0.1794X+0.029,相关系数(r)=0.9959,线性良好。检测健康对照组和ACS组IMA浓度,检测结果显示,ACS组IMA明显高于健康对照组。结论在HITACHI-7170A全自动生化分析仪成功建立ACB测定IMA的方法 ,本法具有准确性高、重复性好、反应稳定及操作简单等优点,可作为辅助ACS诊断的早期心肌缺血标志物。

Establishment of the test of ischemia modified albumin by HITACHI-7170 auto-biochemical analyzer and evaluation of its analytical performance

Objective To establish ischemia modified albumin（IMA） automatic biochemical analyzer detection method,and validate its preliminary performance. Methods IMA were detected with albumin cobalt binding test （ACB）. A reasonable parameters of the high and low concentration values searched with speetrophotometry was designed on the bases of IMA. HITACHI-7170A automatic biochemical analyzer. The performance of established meth od was evaluated by precision and linearity. Results Precision evaluation indicates that the ACB test possesses very good performance. The intra-CV and the intevCV of the healthy control serum were 0.97% and 1.01% respectively. The intrmCV and the inter-CV of the serum of the patients with ACS were 1. 46% and 1.73% respectively. A series of different concentration of serum mixed by certain proportion of samples shows the linear analysis equation is Y= 0. 1794X＋0. 029 and the correlation coefficient r=0. 9959 with the regression test qualified. The concentration of IMA in ACS group is higher than that in healthy control group. Conclusion The approach of establishing ACB test on HITACHI - 7170A automatic biochemical analyzer is of high accuracy,good repeatability and stability of reaction. And all the advantages of ACB test indicate that it can be applied in early clinical diagnosis.