首页|国产与进口化学发光分析仪测定甲状腺功能的一致性评价

国产与进口化学发光分析仪测定甲状腺功能的一致性评价

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目的:旨在探讨国产迈瑞CL-6000i化学发光分析仪对甲状腺功能检测的临床应用可行性.方法:参考美国临床和实验室标准协会EP15-A2和EP9-A2方案进行性能验证和方法学比对,用迈瑞CL-6000i与索灵LIAISON XL两种化学发光免疫分析仪分别检测103份新鲜血清标本的促甲状腺激素(TSH)、游离甲状腺素(FT4)和游离三碘甲状腺原氨酸(FT3)水平,比较两种仪器的相关性与一致性.结果:国产迈瑞CL-6000i化学发光免疫分析仪与进口索灵LIAISON XL化学发光免疫分析仪在FT3、FT4和TSH项目的相关性分析上,决定系数R2分别为0.9525、0.9500和0.9741;两种检测系统FT3、FT4和TSH在医学决定水平处,预期偏倚分别为-0.30%~6.10%;7.20%~26.00%;-18.40%~-3.60%.结论:迈瑞与索灵化学发光免疫分析仪具有较好的相关性,在FT3项目检测表现一致性较好,FT4和TSH项目检测系统预期偏倚存在一定差异.
Evaluation of the Consistency for Thyroid Function Detection with the Domestic and Imported Chemiluminescent Immunoassay Analyzers
Objective:Aim to explore the feasibility of clinical application for thyroid function detection by Mindray CL-6000i automated chemiluminescence immunoassay analyzer.Methods:According to CLSI EP15-A2 and CLSI EP9-A2 protocols for performance verification and methodological comparison,the levels of free triiodothyronine(FT3),free thyroxine(FT4),and thyroid-stimulating hormone(TSH)in 103 fresh serum samples were respectively detected by Mindray CL-6000i and LIAISON XL automated chemiluminescence immunoassay analyzers.Then the results were used to compared the correlation and consistency.Results:The coefficients of determination(R2)of FT3,FT4 and TSH between in Mindray CL-6000i and LIAISON XL analyzers respectively are 0.9525,0.9500 and 0.9741.The expected bias of two detection systems FT3,FT4,and TSH at the medical decision level were-0.30%~6.10%;7.20%~26.00%;-18.40%~-3.60%,respectively.Conclusion:Mindray CL-6000i and LIAISON XL analyzers are highly correlated.There is a good consistency in FT3 detection result,and there is a certain difference in the expected bias of the detection systems for FT4 and TSH results.

thyroid function testschemiluminescencemethod comparison

朱德雯、熊静霆

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湖北医药学院附属太和医院检验科(湖北 十堰 442000)

华中科技大学同济医学院附属梨园医院检验科(湖北 武汉 430000)

甲状腺功能检测 化学发光 方法学比对

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(1)
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