【摘要】 目的对ALINITY i免疫发光测定系统检测游离三碘甲状腺原氨酸（free triiodothyronine, FT₃）和总三碘甲腺原氨酸（total triiodothyronine, TT₃）的性能进行验证,并评估新型ALINITY i系统6点校准体系和传统ARCHITECT系统6点校准体系检测对两项甲状腺激素（FT₃和TT₃）检测结果的一致性。方法按照美国临床实验室标准化协会（Clinical and Laboratory Standards Institute, CLSI）制定的指南文件和相关文献,对ALINITY i系统测定的FT₃和TT₃的精密度、最低检出限、线性和生物参考区间进行验证,并参考其中的CLSI EP9-A2文件对雅培ALINITY i系统6点校准体系和雅培ARCHITECT系统6点校准体系两种检测方法间的两项甲状腺激素检测结果进行方法学分析评价,并采用Pearson相关分析和Passing-bablok做数据比对分析。结果 ALINITY i系统6点校准体系检测FT₃和TT₃实验室内各水平总精密度均小于1/3 TEa,在可接受范围。通过线性验证试验证实上述两个项目在厂商声明的范围内呈良好的线性关系。生物参考区间与试剂厂商提供的参考区间数据相符。通过FT₃和TT₃两个检测项目评价两种检测方式的相关性和偏倚情况,FT₃和TT₃在雅培ALINITY i平台6点校准试剂检测和雅培ARCHITECT平台6点校准试剂检测的结果之间相关系数分别为0.996和0.987,斜率分别为0.998和0.924,两者检测结果之间有很强的相关性。结论 ALINITY i的免疫检测游离三碘甲状腺原氨酸（FT₃）和总三碘甲腺原氨酸（TT₃）的性能符合既定的实验室设置标准,且关键性能参数与ARCHITECT高度一致。更多还原

【Abstract】 Objective To validate and evaluate the performance of free triiodothyronine（FT₃） and total triiodothyronine（TT₃） detection based on ALINITY i system.Methods According to the guidelines of Clinical and Laboratory Standards Institute（CLSI） and relevant literatures, the precision, lowest detection limit, linearity and biological reference interval of FT₃ and TT₃ in the immunodiagnostic module of ALINITY i system were verified. The methodology of FT₃ and TT₃ among two detection methods which were Abbott ALINITY i system（6-point calibration） and Abbott ARCHITECT system（6-point calibration） were analyzed referring to EP9-A2 document. Pearson correlation analysis and passing-bablok were conducted for data comparison analysis.Results The total precision of FT₃ and TT₃ on ALINITY i system 6-point calibration reagents was less than 1/3 TEa, which was within the acceptable range. FT₃ and TT₃ were verified to be linear within their analytical measurement ranges. The biological reference interval was consistent with the data provided by manufacture. The correlation and bias of the three detection methods of FT₃ and TT₃ showed that the correlation coefficient was nearly equal to 1.00, and the slope was also close to 1.00. There was a strong correlation between the detection results.Conclusion The performance of FT₃ and TT₃ tested on ALINITY i system can meet the established laboratory setting criteria, and the key performance parameters are consistent with manufacture provided standard.更多还原