Roche E601免疫分析仪检测甲功三项性能评价  

Performance Evaluation Analysis of FT3,FT4,TSH Projects

作　　者：黄玮[1] 郭旭霞[1] 燕学强[1] 史盟浩 乔慧[1] Huang Wei;Guo Xuxia;Yan Xueqiang(Department of Laboratory,Peace Hospital Affiliated to Changzhi Medical College)

机构地区：[1]长治医学院附属和平医院检验科,046000

出　　处：《长治医学院学报》2018年第2期103-106,共4页Journal of Changzhi Medical College

摘　　要：目的:对Cobas6000E601全自动电化学发光免疫分析仪检测游离三碘甲状腺原氨酸(FT3)、游离甲状腺素(FT4)和促甲状腺激素(TSH)的性能进行验证和评估。方法:参考美国临床实验室标准化协会(CLSI)的指南文件和相关文献,对Cobas6000E601全自动电化学发光免疫分析仪检测FT3、FT4和TSH的精密度、正确度、线性范围和生物参考区间进行评价。结果:FT3、FT4和TSH 3个项目低值的批内精密度分别为1.72%、1.56%、0.28%,高值的批内精密度分别为1.44%、0.72%、0.85%,均小于1/4TEa(卫计委室间质量评价允许总误差),低值的批间精密度分别为5.72%、6.64%、4.69%,高值的批间精密度分别为5.78%、4.27%、3.69%,均小于1/3TEa;各项目正确度偏倚均小于1/2TEa,且合格率均≥80%,验证合格;各项目线性范围分别为0.95~45.8pmol/L、0.3~93.4pmol/L、0.023~95.4mIU/L,与试剂盒线性范围相符,线性回归分析方程中,相关回归系数r2>0.95,线性良好;生物参考区间与说明书提供的数据相符。结论:Cobas6000E601全自动电化学发光免疫分析仪检测FT3、FT4和TSH 3个项目的精密度、正确度、线性范围、生物参考区间均达到相关标准要求,可以满足临床需求。Objective:To validate and evaluate the performance of free triiodothyronine(FT3),free thyroxin(FT4)and thyroid stimulating hormone(TSH)by Cobas6000 E601 automatic electroluminescent immunoassay analyzer.Methods:The Cobas6000 E601 automatic electroluminescent immunoassay analyzer was used to evaluate the precision,accuracy,linear range and biological reference intervals of FT3,FT4 and TSH with reference to the United states Clinical and Laboratory Standards Insitiute(CLSI)guidelines and related literature.Results:The Low-within precision were 1.72%,1.56%and 0.28%and the high-within precision were 1.44%,0.72%and 0.85%,which were all less than 1/4TEa(The allowable total error of quality evaluation of National Health and Family Planning Commission of the People’s Republic of China).The Low-between precision were 5.72%,6.64%and 4.69%and the high-between precision were 5.78%,4.27%and 3.69%,which were all less than 1/3TEa.The correctness bias of each item was all less than 1/2TEa,and the qualified rates were greater than 80%,The accuracy were qualified.The linear range of each project was 0.95~45.8 pmol/L,0.3~93.4 pmol/L,0.023~95.4 mIU/L and the results were in accordance with the kits.Each testing item showed good correlation(r 2>0.95)and linearity.Biological reference intervals were in line with manufacturer’s standards.Conclusion:The Cobas6000 E601 full-automatic electroluminescent immunoassay analyzer for the detection of FT3,FT4 and TSH meets the requirements of the relevant standards in terms of precision,accuracy,linear range and biological reference intervals,which can satisfy the clinical demands.

关 键 词：电化学发光免疫分析仪 游离三碘甲状腺原氨酸 游离甲状腺素 促甲状腺激素 性能评价 

分 类 号：R440[医药卫生—诊断学]