两台全自动电化学发光分析仪检测结果的可比性分析.docVIP

两台全自动电化学发光分析仪检测结果的可比性分析 　　【摘要】 目的：了解本实验室罗氏E601与西门子ADVIA Centaur CP两台电化学发光仪检测结果的可比性，以分析两套系统检测肿瘤标志物与甲状腺激素结果的准确性和一致性。方法：分析对比两部仪器一个月的室内质控结果。参考美国临床和实验室标准协会（CLSI）EP9-A2文件，以E601为比对仪器，ADVIA Centaur CP为实验仪器，同时检测患者样本中甲胎蛋白（AFP）、癌胚抗原（CEA）、促甲状腺激素（TSH）、游离三碘甲状腺原氨酸（FT3）和游离甲状腺素（FT4）的含量。对实验数据进行统计学分析，比较两台仪器的相关性。结果：两台仪器测定AFP、CEA、TSH、FT3、FT4结果稳定，偏倚结果均符合相关要求。检测结果相关性显著（P0.05），符合临床要求。结论：两部仪器性能良好，检测结果准确可靠，具有较好的一致性。各检测项目（AFP、CEA、TSH、FT3、FT4）结果具有可比性 【关键词】 E601； 比对分析； 化学发光 中图分类号 R446 文献标识码 B 文章编号 1674-6805（2016）16-0048-02 【Abstract】 Objective：To explore the laboratory Roche E601 and Siemens ADVIA Centaur CP those two electrochemiluminescence testing result can be compared in order to analyze the accuracy and consistency of the two sets of analysis system for detection of tumor markers and thyroid hormone results.Method：Analysis and comparison of the results of indoor quality control of two instruments in one month.Reference to the clinical and Laboratory Standards Institute（CLSI） EP9-A2 document，with E601 as the comparison instrument，and Centaur CP as experiment instrument，simultaneous detection of alphafetoprotein（AFP），carcinoembryonic antigen（CEA）， thyroid stimulating hormone（TSH），free triiodothyronine（FT3） and free thyroxine（FT4） in the patients.The experimental data were statistically analyzed.The correlation between the two instruments was compared.Result：The results of AFP，CEA，TSH，FT3，FT4 were stable， and the bias results were in accordance with the relevant requirements.The detection results were significantly correlated（P0.05），which was consistent with the clinical requirements.Conclusion：The performance of the two instruments are good，the test results are accurate and reliable，and they have good consistency.The results of each test item（AFP，CEA，TSH，FT3，FT4） are comparable. 【Key words】 E601； Comparative analysis； Chemiluminescence First-author’s address：Xinhui Hospital Affiliated to Southern Medical University，Jiangmen 529100，China doi：10.14033/j.cnki.cfmr.2016.16.023