依据CLSI EP9-A3文件评价两种方法学检测降钙素原的可比性  

A Comparability Evaluation of Procalcitonin Detected by Two MethodologiesAccording to CLSI EP9-A3 Guideline

作　　者：时磊 刘晨 欧红玲 张旺 朱凡 马盈盈 王岩 刘永飞 王欣茹 SHI Lei;LIU Chen;OU Hongling;ZHANG Wang;ZHU Fan;MA Yingying;WANG Yan;LIU Yongfei;WANG Xinru(Department of Clinical Laboratory,PLA Rocket Characteristic Medical Center,Beijing 100088,China;Intensive Care Unit,PLA Rocket Characteristic Medical Center,Beijing 100088,China)

机构地区：[1]火箭军特色医学中心检验科,北京100088 [2]火箭军特色医学中心重症医学科,北京100088

出　　处：《标记免疫分析与临床》2022年第7期1184-1188,共5页Labeled Immunoassays and Clinical Medicine

基　　金：军事医学创新工程项目(编号:18CXZ023)。

摘　　要：目的评价磁微粒化学发光法和电化学发光法检测降钙素原(PCT)结果的一致性,以评估磁微粒化学发光法检测PCT是否能够满足临床的需求。方法根据美国临床和实验室标准协会(CLSI)新指南EP9-A3文件要求,收集2021年10月至12月火箭军特色医学中心患者检测剩余的新鲜血清标本79例,以罗氏电化学发光法为参比方法,迈瑞磁微粒化学发光法为评估方法,对两种方法检测PCT的结果进行相关性和一致性检验。选择普通线性回归(ordinary linear regression,OLR)、加权最小二乘法(weighted least squares,WLS)、Deming回归、Passing-Bablok回归,4种回归模型对两种方法学的检测结果进行拟合分析。结果2种方法学的PCT检测结果具有显著相关性(r=0.99,P<0.001)。参照方法和评估方法比较,结果显示4种回归模型,均在可接受范围内。根据四截距和斜率判断,Passing-Bablok回归为最佳模型。将PCT的医学决定水平代入回归模型拟合方程,计算得到的相对偏移<1/2 TEa±15%(TEa为国家卫生健康委临床检验中心室间质量评价允许总误差),满足要求。结论罗氏电化学发光法和迈瑞磁微粒化学发光法检测PCT结果具有显著相关性和一致性,能够满足临床检测需要。Objective To assess the consistency of magnetic particle chemiluminescence method and electrochemiluminescence method in detecting serum procalcitonin(PCT).Methods Seventy-nine fresh serum samples were collected in our center from October to December,2021.With Roche electrochemiluminescence method as the reference,we assessed the accuracy and stability of the Mindray magnetic particle chemiluminescence method in detecting serum PCT.The consistency and correlation between the results of the two methods were analyzed.Furthermore,the ordinary linear regression(OLR),weighted least squares(WLS),Deming regression,and Passing-Bablok regression were applied for fitting analysis between two methods.Results There was a significant correlation between PCT test results of the two methods(r=0.99,P<0.001).The effects of four regression models were all within the acceptable range.Passing-Bablok regression was the best model.When we substituted the medical decision level of PCT into the fitting equation of the regression model,the calculated relative deviation was less than 1/2TEa±15%,which met the requirements(TEa was the total allowable error of inter-room quality evaluation of National Center for Clinical Laboratories).Conclusion PCT detection results of Roche electrochemiluminescence method and Mindray magnetic particle chemiluminescence method are significantly correlated and consistent.

关 键 词：降钙素原 电化学发光法 磁微粒化学发光法 方法学 

分 类 号：R446.1[医药卫生—诊断学]