两种化学发光免疫检测系统AMH测定结果的可比性研究  

A Comparability Research on anti-Müllerian Hormone Results Between Two Chemiluminescence Immune Detection Systems

作　　者：曾玉[1] 许烨[1] 蒋翠莲[1] 陈亚军[1] ZENG Yu;XU Ye;JIANG Cuilian;CHEN Yajun(Department of Clinical Laboratary, Nanjing Obstetric and Gynecology Hospital, Nanjing 210003, China)

机构地区：[1]江苏省南京市妇幼保健院检验科,江苏南京210000

出　　处：《标记免疫分析与临床》2020年第11期2003-2006,2010,共5页Labeled Immunoassays and Clinical Medicine

摘　　要：目的探讨贝克曼DXI800化学发光仪和罗氏Cobase e602电化学发光仪针对人血清中抗缪勒管激素(anti-Müllerian hormone,AMH)的检测能力是否等效以及检测结果的可比性。方法分别以贝克曼DXI800化学发光仪和罗氏Cobase e602电化学发光仪为目标系统和待测系统。收集均匀分布于试剂说明书所标注的线性区间(0.02~24ng/mL)内的133例女性血清标本,且排除脂血、溶血及黄疸标本,分别在两个检测系统内检测AMH数值。依据NCCLS EP9-A2文件并运用SPSS 20.0或EXCEL软件进行离群点检查,绘制绝对偏倚图和相对偏倚图,计算相关系数和回归方程,统计符合率和Kappa值,并进行偏倚分析,综合评估2个检测系统检测AMH的检验效能和可比性。结果纳入的133例标本中无离群值;罗氏Cobase e602检测系统与贝克曼DXI800检测系统相比,检测AMH绝对差值和相对差值超过限值的点所占比例分别为4.51%和3.76%;两个检测系统所测得的AMH水平的回归方程为:Y=0.802X-0.109,r为0.991(r≥0.975,P<0.001),相关性和线性良好。两个检测系统在AMH参考值上限和均值两个水平处的偏倚SE%均超出1/2TEa,临床不接受。AMH各年龄分段的总符合率均大于90%,Kappa值均大于0.75。结论贝克曼DXI800化学发光仪和罗氏Cobase e602电化学发光仪检测AMH的相关性和线性良好;一致性和符合率均一致,即两者的检验效能一致,均能满足临床检测需求,但两个检测系统检测AMH的具体结果数值不具有可比性。Objective To evaluate the comparability of anti-Müllerian hormone(AMH)results between Beckman DXI800 chemiluminescence instrument and Roche Cobase e602 electrochemiluminescence instrument.Methods 133 female serum samples were tested with both Beckman DXI800 instrument(target system)and Roche Cobase e602 instrument(test system).AMH results were distributed in the linear range(0.02-24ng/mL).According to the profile of NCCLS EP9-A2 and using SPSS20.0 or Excel software to check outliers,we drew an absolute and relative bias map,calculated correlation coefficient and regression equation,counted coincidence rate and Kappa value,and conducted a bias analysis.Finally,the test efficiency and comparability of the two detection systems for AMH detection were evaluated.Results There were no outliers in 133 cases.Compared with Beckman DXI800,Roche Cobase e602 accounted for 4.51%of absolute difference and 3.76%of relative difference exceeded the limit.The regression equation of AMH levels was:Y=0.802X-0.109,R=0.991(R≥0.975,P<0.001),indication that the correlation and linearity were good.The biases exceeded 1/2TEa(12.5%),which was not acceptable.The total coincidence rate of AMH was more than 90%,and Kappa value was greater than 0.75.Conclusion The correlation and linearity of Beckman DXI800 and Roche Cobase e602 are good.The consistency and coincidence rate are consistent,that is to say,the test efficiency of the two methods is consistent,and both can meet with the needs of clinical testing.However,the specific results of AMH detected by the two detection systems are not comparable.

关 键 词：检测系统 抗缪勒管激素 可比性 检验效能 

分 类 号：R446.1[医药卫生—诊断学]