罗氏e602不同仪器间乙肝标志物检测结果的一致性  

Evaluation on the consistency of detection results of hepatitis B markers among different instruments of Roche e602

作　　者：赵秀丽[1] 赵钦[1] ZHAO Xiuli;ZHAO Qin(Department of Clinical Laboratory,Central Hospital Affiliated to Shenyang Medical College,Shenyang 110024,China)

机构地区：[1]沈阳医学院附属中心医院检验科,辽宁沈阳110024

出　　处：《中国现代医生》2021年第1期106-109,共4页China Modern Doctor

摘　　要：目的对罗氏cobas 8000 e602乙肝标志物的试剂在Au1和Au2检测两仪器间检测结果的一致性进行评价。方法参照CLSI EP9A3方案,各取40例样本同时在Au1和Au2间单次检测,对其结果进行一致性分析,计算医学决定水平处的偏移值,以≤1/2室间质评(±10%)作为可接受标准。结果罗氏e602 Au1和Au2间乙肝标志物结果95%在Bland-Altman一致性界限内,Passing-Bablok回归方程分别为HBsAg:Y=-0.0036+1.0458X,HBsAb:Y=0.6364+1.0043X;HBeAg:Y=-0.0096+1.0063X;HBeAb:Y=-0.0011+1.0203X;HBcAb:Y=-0.0002+0.9160X。医学决定水平的偏移值分别为4.13%、6.57%、-0.33%、1.88%、-8.79%,比对结果可接受。结论罗氏cobas 8000 e602 Au1和Au2检测乙肝标志物的比对结果一致,检测结果无差异。Objective To evaluate the consistency of detection results of hepatitis B markers between two instruments of Au1 and Au2 of Roche cobas 8000 e602.Methods According to CLSI EP9A3 scheme,40 samples were taken from each group and were detected singly between Au1 and Au2 at the same time.The consistency analysis was carried out on the results,and the deviation value at the medical decision level was calculated.The acceptable standard was≤1/2 interlaboratory quality assessment(±10%).Results The results of hepatitis B markers between Au1 and Au2 of Roche e602 were 95%within the consistency limit of Bland-Altman,and the Passing-Bablok regression equations were HBsAg:Y=-0.0036+1.0458X,HBsAb:Y=0.6364+1.0043X,HBeAg:Y=-0.0096+1.0063X,HBeAb:Y=-0.0011+1.0203X,HBcAb:Y=-0.0002+0.9160X,respectively.The offset values of medical decision level were 4.13%,6.57%,-0.33%,1.88%and-8.79%,respectively,and the comparison results were acceptable.Conclusion Au1 and Au2 of Roche cobas 8000 e602 have the same comparison results in detecting hepatitis B markers,and there is no significant difference in detection results.

关 键 词：乙肝标志物 电化学发光 Bland-Altman 方法学比对 一致性分析 

分 类 号：R526[医药卫生—内科学]