依据CLSIEP9-A2对两种降钙素原检测系统进行方法学比对和偏差分析  

Methodological Assessment and Bias Estimation of Two Procalcitonin Analysis Systems According to EP9-A2

作　　者：郑秀娥 李晋[3] 夏文龙[1] 于素芳[2] ZHENG Xiu-e;LI Jin;XIA Wen-long;YU Su-fang(Center for Certifcation and Evaluation,SDFDA Shandong Jinan 250014;Shandong Provincial Center for Disease Control and Prevention Shandong Jinan 250014;School of Public Health,Shandong University Shandong Jinan 250012)

机构地区：[1]山东省食品药品监督管理局审评认证中心,山东济南250014 [2]山东大学公共卫生学院,山东济南250012 [3]山东省疾病预防控制中心,山东济南250014

出　　处：《中国医疗器械信息》2018年第21期13-15,150,共4页China Medical Device Information

摘　　要：目的:通过对两种降钙素原(PCT)检测系统进行方法学比对和预期偏差评估,探讨不同检测系统间PCT检测结果是否具有可比性和检测结果的偏差是否在允许范围内。方法:参照美国临床实验室标准化协会(CLSI)EP9-A2文件要求,Roche-e601全自动电化学发光免疫分析检测系统作为参考方法,Mlabs-m-101型定量免疫荧光检测系统作为比对方法,对患者血清PCT进行检测,计算相关系数和直线回归方程,评估两种检测系统之间的预期偏差。结果:两种检测系统所得的结果相关性良好(r=0.998,P<0.05),医学决定水平处的系统误差(SE%)为10.8%,在可接受范围内。结论:两种检测系统PCT结果具有可比性,能够满足临床检测要求。Objective： To evaluate the comparability and bias of the test results of two detection systems for serum procalcitonin（PCT）. Methods： According to the profle NCCLS-EP9-A2, the two systems were used to detect PCT to obtain the correlation coefcient and the liner equation for evaluation of the test result bias. Results： The results of the two groups were correlated（r2=0.998）, The system-atic error （SE%） at the medically determined level was 10.8%, which was within the acceptable range. Conclusion： The PCT results of the two detection systems are comparable and can meet the clinical testing requirements.

关 键 词：方法比对 偏差评估 降钙素原 

分 类 号：R197.39[医药卫生—卫生事业管理]