BECKMAN DXI800全自动化学发光仪检测心肌三项的性能验证  

Analytical performance verification of BECKMAN DxI 800 automated chemiluminescence analyzer for the detection of three cardiac markers

作　　者：刘伟丽[1] 张云[1] 阳剑[1] 赵强元[1] 

机构地区：[1]中国人民解放军海军总医院检验科,北京100048

出　　处：《检验医学与临床》2015年第A01期172-173,共2页Laboratory Medicine and Clinic

摘　　要：目的对BECKMAN DXI800全自动化学发光仪检测心肌项目进行性能验证。方法参照美国临床实验室标准化协会（CLSI）文件，对BECKMAN DXI800全自动化学发光仪检测3项原装试剂肌酸激酶同工酶（CK—MB）、心肌肌钙蛋白I（cTnI）、肌红蛋白（MYO）的精密度、携带污染率、线性范围等方面进行验证，并与厂商声明的性能标准进行比较。结果心肌三项的携带污染率符合厂商声明。高、低两水平质控品的批内精密度和批间精密度即变异系数（Cv）均小于厂家声明的CV值，均在允许范围内；线性范围验证结果显示，各检测项目的斜率（a值）均在（1±0．05）范围内，相关系数（r2值）≥0．95，均在仪器要求范围内，并具有良好的线性。结论BECKMAN DXI800全自动化学发光仪通过了性能验证，精密度、携带污染率、线性范围均在相关要求范围内，符合临床实验室要求，可应用于临床心肌项目的检测。Objective To verificate the analytical performance of BECKMAN DxI 800 automated chemiluminescence analyzer in myocardial detection project. Methods The precision, rate of carry contamination, linear range and other aspects of the BECKMAN DXI800 automated chemiluminescence analyzer in detecting the three original reagent CK-MB,TNI and MYO referring to the American Clinical and Laboratory Standards Institute（CLSI） file were tested,and then compared with manufacturer＇s standards）. Results The carry contamination rate of 3 indexes of cardiac was in accordance with manufacturer＇s statement. The precision within-batch and between batches,namely coefficient of variation（CV） of the high and low levels cardic markers plus control were less than the CV value stated by the manufacturer, and all of them were in the range permitted; As the linear range verification results showed, the slope（a） values of each test project were in the range of（1±0.05）,the correlation coefficient（r2 ） ≥ 0.95,each of them was Within the required range and had a good linearity. Conclusion The BECKMAN DxI 800 automated chemiluminescence analyzer has passed the test, all the properties including precision, rate of carry contamination and linear range are within the range of requirements and satisfied the clinical laboratory requirement, so it can be applied to detection of clinical myocardial project.

关 键 词：全自动化学发光仪 性能验证 精密度 携带污染率 线性范围 

分 类 号：R512.8[医药卫生—内科学]