两种化学发光免疫分析系统检测促甲状腺素的性能分析  

A Performance Analysis of Two Chemiluminescence Immunoassay Systemsfor the Detection of Thyroid Stimulating Hormone

作　　者：孙雪 冯苏 刘思阳 王薇 梁翠娟 赵东兰 SUN Xue;FENG Su;LIU Siyang;WANG Wei;LIANG Cuijuan;ZHAO Donglan(Shijiazhuang People’s Hospital,Shijiazhuang 050000,China)

机构地区：[1]石家庄市人民医院检验科,河北石家庄050000

出　　处：《标记免疫分析与临床》2023年第8期1416-1419,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：目的 分析两种化学发光检测系统测定促甲状腺素(TSH)性能,探讨两种化学发光检测系统的临床适用性。方法以罗氏Cobas-E601自动免疫分析仪测试结果为参比系统(X),以新产业Maglumi 2000全自动化学发光测定仪测定结果为需考核系统(Y),收集石家庄市人民医院2018年5月29日至2018年6月25日的519例样本,分别使用新产业Maglumi 2000和罗氏Cobas-E601全自动化学发光仪进行TSH的检测,参考美国临床实验室标准要求化协会(CLSI)指南EP9-A2文件的规定,进行两个系统间TSH的方法学分析,对这两个系统的结果进行比对分析及偏倚的评估。结果 TSH在两套检测系统的测试结果相关性良好,相关系数>0.975;预期偏差均在可接受范围内,具有较好的一致性。结论 国内新产业Maglumi 2000全自动化学发光测定仪检测TSH可以满足临床的需要。Objective To evaluate the performance of thyroid stimulating hormone(TSH)in two chemiluminescence detection systems and to explore the clinical applicability of two chemiluminescence detection systems.Methods Taking the test results of Roche Cobas-E601 autoimmune analyzer as the reference system(X),and taking the measurement results of the new industry Maglumi 2000 automatic chemiluminescence analyzer as the assessment system(Y),519 specimens of Shijiazhuang People’s Hospital from May,29,2018 to June,25,2018 were collected for the study.TSH detection was carried out using the new industry Maglumi 2000 and Roche Cobas-E601 automatic chemiluminescence analyzer,respectively.Referring to the provisions of the US(CLSI)EP9-A2 document,a methodological analysis of TSH between the two systems was performed,and the results of the two systems were compared and the bias was evaluated.Results The test results of TSH in the two test systems showed a good correlation,with the correlation coefficient>0.975.The expected deviations were within the acceptable range,which showed a good consistency.Conclusion The domestic new industry Maglumi 2000 automatic chemiluminescence analyzer detection TSH can meet the needs of clinical practice.

关 键 词：促甲状腺素 免疫分析 化学发光测定仪 性能验证 

分 类 号：R-331[医药卫生]